CLINICAL TOXICOLOGY PART 1-1 *Determine the toxic dose or lethal dose of the investigational agent

INTRODUCTION TO TOXICOLOGY *LD50 – Median lethal dose (Dose that can kill 50% of the
TOXICOLOGY population)
 The science of poisons. *LC50 – Median lethal concentration (Concentration that can
 *Poisons are substances that may cause serious injury into kill 50% of the population)
the body, may also cause disease or even death. *TD50 – Median toxic dose (Dose that can cause toxic effects
 The branch of pharmacology which deals with the to 50% of the population)
undesirable effects of chemicals on living systems, from *TLV – Threshold limit value (The amount of exposure to a
individual cells to complex ecosystems. given agent that is deemed to be safe for a period of time)
 It is the study of the adverse effects of chemical, physical or *NOAEL – No Observe Adverse Effect Level (Can be seen in
biological agents on people, animals, and the environment. experimental toxicology, in researches, scientific studies)
 It is the study of symptoms, mechanisms, treatments and REGULATORY TOXICOLOGY
detection of poisoning, especially the poisoning of people. Gathers and evaluates existing toxicological information to establish
 *Importance: concentration-based standards of “safe” exposure
1. In biomedical area, contributes to physiology and *Gathers infos conducted from experimental so that they can establish
pharmacology of toxic agents, and to understand standards that can be the basis
physiologic phenomena. Example: Muscarine is an CLINICAL TOXICOLOGY
alkaloid from mushroom, a cholinergic agonist that binds Focuses on the effects of substances in patients caused by accidental
in a parasympathetic receptor or cholinoceptors (rest & poisonings or intentional overdoses of medications, drugs of abuse,
digest) household products, or various other chemicals
2. Also use in identification & recognition of hazards DEFINITION OF TERMS
resulting from exposure in chemicals and its effect in HAZARD - likelihood that injury will occur in a given situation or setting
environment, in air, water. Ex. LED containing - Anything that can cause harm or injury
substances& gasoline if inhaled what is its possible RISK - expected frequency of the occurrence of an undesirable effect
effects in our body arising from exposure to a chemical or physical agent
3. Important during drug discovery (to know what is safe to - How great the chance that someone will be harmed by
use to humans & the toxicity tests are performed in the hazard
animals) INTOXICATION - toxicity associated with any chemical substance
4. Important for standard regulation to develop and protect *Ex. possibly to be intoxicated due to continuous use or
human health and environment from the adverse effects prolonged in use in short period of time, alcohol intoxication, caffeine
of the chemicals intoxication, cocaine intoxication, heroine/cannabis intoxication, &
“SOLA DOSIS FACIT VENENUM.” – PARACELSUS water intoxication
✓ *Means the dose makes the poison *Commonly if intoxicated, diminished mental control in px
✓ What is there that is not a poison. All things are poison and POISONING - a clinical toxicity secondary to accidental exposure
nothing is without a poison. Solely the dose determines that OVERDOSE - an intentional exposure with the intent of causing self-
a thing is not a poison. The dose makes the poison. injury or death
✓ PARACELSUS — father of toxicology
MATHIEU ORFILA
 He is considered to be the modem father of toxicology
having given the subject its first formal treatment in 1813 in
his Traité des Poisons, also called Toxicologie Générale.
BRANCHES OF TOXICOLOGY
ENVIRONMENTAL TOXICOLOGY
Deals with the potentially deleterious impact of chemicals, present as
pollutants of the environment, to living organisms
ECOTOXICOLOGY
Deals with the toxic effects of chemical and physical agents on
populations and communities of living organ- isms within defined
ecosystems
OCCUPATIONAL TOXICOLOGY
Deals with the chemicals found in the workplace; identifies the agents
of concern, identifies the acute and chronic diseases that they cause,
defines the conditions under which they may be used safely, and
prevents absorption of harmful amounts of these chemicals HAZMAT DIAMOND
MECHANISTIC TOXICOLOGY
Researches for the mechanism of toxic action (toxicodynamics) of
OPIOID INTOXICATION VS. OPIOID OVERDOSE
poisons REALLY HIGH OVERDOSE
DESCRIPTIVE TOXICOLOGY Muscles become relaxed Deep snoring or gurgling (death
Concerned with toxicity testing, which provides necessary information rattle)
for safety evaluation & regulatory requirements Speech is slowed/slurred Very infrequent or no breathing
FORENSIC TOXICOLOGY Sleepy looking Pale, clammy skin
Concerned with the medico-legal aspects of the harmful effects of Nodding Heavy nod, not responsive to
chemicals on humans & animals. stimulation
*Criminal investigations Will respond to stimulation like Slow heart beat/pulse
EXPERIMENTAL TOXICOLOGY yelling, sternal rub, pinching,
Involves in the investigation of the toxic effects of chemicals in the etc.
biological system; measures different laboratory parameters (LD50,
LC50, TD50, TLV, NOAEL)
 EVIDENCE OF POISONING TYPES OF ANTAGONISM
CORPUS DELICTI — a body of evidence should be present before FUNCTIONAL
someone is convicted of a crime ▪ Chemicals counterbalance each other by exerting opposite
1. Circumstantial Evidence effects on a physiological function.
2. Symptomatic Evidence ▪ Also called Physiological cause has opposite effect in
3. Chemical Evidence physiologic function
4. Post-mortem Evidence Example:
5. Experimental Evidence - Convulsions treated with benzodiazepines (sedative hypnotic
CIRCUMSTANTIAL EVIDENCE drugs)
 Also known as moral evidence - Anaphylactic shock (↑ histamine) treated with epinephrine
 Evidences contributed by circumstances or deduced from - *Epinephrine combined with alpha 1 vasoconstriction
various occurrences and facts. This is not strong evidence. (histamine1)
Examples: CHEMICAL (OR INACTIVATION)
- Motives for poisoning ▪ Chemical reaction between two compounds leads to less of
- Purchasing the poison the toxic compound.
- Keeping the materials used Example:
SYMPTOMATIC EVIDENCE - Antidotes
➢ Includes symptoms observed during poisoning. This is not - Chelators and metals (Deferoxamine for iron poisoning, use of
conclusive though some diseases may be present and similar British anti-lewisite, EDTA & Penicillamine)
symptoms may be observed as those of poisoning. - Antivenins and venoms (Use in snake poisoning)
Examples: DISPOSITIONAL
- Arsenic poisoning is like cholera (common is rice watery stool) ▪ Disposition of toxic chemical is changed so that concentration
- Alcoholic coma may simulate diabetic coma ( a life threatening and/or duration is diminished.
complication that can cause unconsciousness) (diabetic come ▪ e.g. Ipecac, charcoal, pH alteration, metabolism induction or
can be hyper or hypo) inhibition
CHEMICAL EVIDENCE ▪ Anything that alters the Pharmacokinetic property of the
 Evidence obtained by chemical analysis of the suspected poison.
substance, or the vomitus or secretion of the body. RECEPTOR
 This alone is not reliable because the poison may be ▪ Chemicals compete for the same receptor, decreasing
decomposed or changed or it may have been placed elective binding of toxic compound.
anywhere after death. ▪ *Pharmacologic & pharmacodynamic antagonism
POST-MORTEM EVIDENCE ▪ Naloxone and morphine (both for neuroreceptor called
 Can be observed through autopsy. receptor antagonism)
 Evidence from examination of tissues and organs after death. ▪ Tamoxifen and estradiol —antagonist of the estrogen
 *In forensic and crime investigation receptor in breast tissue
EXPERIMENTAL EVIDENCE POISONING EFFECTS
 Determined using physiologic tests. LOCAL EFFECTS - the impression made by the poison to the body
 Obtained by administering the suspected substance to some part it made contact e.g. corrosives *Only on affected area
living animal and noting the effects or symptoms. REMOTE EFFECTS - the effect is produced or developed in an area
 This is not a very conclusive procedure since tolerance may other than that of the site of application e.g. atropine taken orally to
not be the same as in man. produce blurred vision
INTERACTIONS OF POISON COMBINED EFFECTS - the poison possesses both local & remote
ADDITIVE effects
 The combined effect is the same as the sum of effects when - e.g. Phosphorus (in GIT it causes diarrhea, in vomitous it causes
given alone. smoking, luminescent & garlic-like odor, In other site, dysrhythmia
 *same effect, same classification in heart & hypotension)
 1+1=2 Cantharidin (Catharanthus or peri winkle or chicharica that is
SYNERGISTIC anticancer but can also cause poisoning if ingested, causes
 The combined effects are much greater than the sum of abdominal pain in the GIT & remote effect is depression)
effects when given alone. Arsenic (If ingested, in GIT causes diarrhea, Remote effects are
 1 + 1 =3 arrythmia, tingling of fingers and toes )
 Carbon tetrachloride + Ethyl alcohol FACTORS AFFECTING POISONING EFFECTS:
 Pyrethroids + Piperonyl butoxide (PBO) POISON-RELATED
POTENTIATION  Route of Administration - injected, ingested, inhaled
 Exposure to a chemical with no toxicity increases the toxicity *Injected poisons are more toxic as compared to poisons that are
of another compound swallowed
 1+0=2 *Inhalation, fast onset due to its direct in lungs, most common
 Carbon tetrachloride + Isopropyl alcohol = poisoning route of exposure in industrial setting
 MAO inhibitor + cheese (thiamine containing food) =  Concentration/Dose —as the dose in increased, the
hypertensive crisis probability of toxicity increases.
ANTAGONISM  Solubility — poisons which are highly lipid-soluble are
 Co-administration of two chemicals interferes with the toxicity absorbed dermally. Poisons with high water solubility may be
of both or one of them. absorbed faster orally as compared to poisons with poor
 1+1=0 water solubility.
 *Cancellation of effect when combination of two chemicals FACTORS AFFECTING POISONING EFFECTS:
 Why antagonism is important? PATIENT-RELATED
 Age — the liver of pediatric patients is not yet fully developed
which may cause the accumulation of drugs even when given
 at normal doses. Geriatric patients have slower metabolizing *Accumulates can cause
rates as compared to adults aged 20-40. seizures
 Habit— for chronic alcoholics and chain smoker *Short acting opioid analgesics
 Tolerance — in case of nicotine and other drugs used in obstetric analgesia
*Decrease response of drug due to the continuous use Diazepam Desmethyldiazepam (DMDZ),
*2 Types of Tolerance: Oxazepam
1. Dispositional Tolerance – decrease amount of Digitoxin Digoxin
*Example of cardiac stimulant
chemical that reaches the site
2. Receptor Tolerance – most common, same TYPES OF POISONING: BASED ON FREQUENCY
amount of chemical that reaches the site but the target ♣ ACUTE — prompt and there is marked disturbances of
function or death within a short period of time:
receptor is decrease in response (may be desensitized)
 Idiosyncrasy — genetic defects may lead to toxicity • excessive single dose
*Unusual or abnormal response into a drug • taking a strong or true poison
DRUGS AND THEIR TOXIC METABOLITE • Several small doses but frequent administration of a
Parent Compound Metabolite/s drug
Parathion Paraoxon ♣ CHRONIC — gradual and there is a progressive
*Parathion & Malathion is an deterioration of the function of tissues. Usually produced by
example of pesticides taking small doses for an extended period of time.
(organophosphates) ♣ CUMULATIVE — suddenly increased in its intensity of
*Its toxicity is related to action when a certain limit is reached e.g. metal poisons
cholinergic poisoning TYPES OF POISONING: BASED ON DURATION AND
Imipramine Desipramine FREQUENCY
*Imipramine & Amitriptyline, TERM DURATION & FREQUENCY
examples of antidepressant ACUTE less than 24 hours, generally a single dose
Malathion Malaoxon SUBACUTE repeated exposure for a month or less
Methamphetamine P-hydroxyl amphetamine SUBCHRONIC repeated exposure for 1 to 3 months
*Example of sympathetic CHRONIC repeated exposure for greater than 3 months
agonist drug CNS stimulant that
activates sympathetic NS
Acute and chronic exposures can lead to different outcomes. For
Paracetamol N-acetyl-para-quinone imine
example, benzene (C6H6) produces different effect based on duration
Diquat / Paraquat Free radicals / reactive O2
species and frequency.
Ethylene Glycol Oxalic acid  Acute — CNS narcosis
Aspirin Salicylic acid  Chronic — bone marrow damage to leukemia
Allopurinol Alloxanthine
*Enzymes that convert it is Another example, cigarette smoking.
xanthine oxidase  Acute — nervous system stimulation
Amitriptyline Nortriptyline  Chronic — cancer of the mouth, pharynx, larynx, lungs,
Chloramphenicol Glycolic acid metabolite esophagus, pancreas, and bladder, emphysema
Codeine Morphine
Cortisone Cortisol TYPES OF POISONING: BASED ON EFFECTS
Acetohexamide Hyrdoxyhexamide IRRITANTS Cause tissue necrosis on
*Undergoes reduction contact; caustic effects
Phenylbutazone Oxyphenylbutazone e.g. acid (Hydrochloric acids,
*When converted it can cause muriatic acids) & alkali (Sodium
agranulocytosis hydroxide, Potassium
Primidone Phenobarbital hydroxide)
Quinidine 3-hydroxyquinidine NEUROTICS Affect the CNS e.g.
*Anti-malarial hallucinogens (indole, LSD)
Theophylline Caffeine CARCINOGENS Stimulate growth of cancer cells
*Is an example of a drug with e.g. industrial poisons (benzene,
narrow therapeutic index chloroform)
Acetonitrile Cyanide ASPHYXIANTS Cause dyspnea e.g. methane
*Common effects in vessels is gas, carbon monoxide
vasodilatation LACRIMATORS Stimulate flow of tears e.g.
Aromatic hydrocarbons Epoxides organophosphates cholinergic
Ethanol Acetaldehyde drugs
Isopropyl alcohol Acetone STERNUTATORS Cause excessive sneezing e.g.
Methylene chloride Carbon monoxide veratrine (veratrum use as
Methanol Formaldehydes & Formic acid pesticide)
Naphthalene Epoxides ASTHENICS Produce muscular weakness
Chloral Hydrate Trichloroethanol e.g. neuromuscular blockers
*If classified in pharmacology, it (Depolarize & Non-depolarizing-
is alcohol sedative hypnotic but tubocurarine, atracurium,
if it is classified in chemistry as mivacurium that causes
compound it is aldehyde asthenia)
derivative hypnotic NARCOTICS Produce mental weakness/
Prednisone Prednisolone depressions e.g. sedative-
Benzyl alcohol Benzoic acid / Hippuric acid hypnotics, general anesthetics
Meperidine Normeperidine
 - Soluble in NaOCl
REINSCH Heavy metals - Purple black (Sb-
Antimony),
- Dull black (As-
Arsenic),
- Shiny black (Bi-
Bismuth),
- Silvery (Hg-Mercury)
- Needs confirmation via
AAS
RODILLON/ Phenol - Light to dark red color
MILLON (mercurous phenate or
nitrose phenate)
MODIFIED Marijuana - Red color (THC-
DUQUENOIS Tetrahydro-
cannabinol) on TLC
NESSLER Chloroform - Yellow ppt 
(MERCURIC KI) (vs Chloral (iodoform)
hydrate)
NYLANDER Bismuth - White ppt  (Bismuth
subnitrate)
GHS Symbols PHENYL- Nitrobenzene - +Chloroform → aniline
GENERAL MANAGEMENT OF POISON PATIENTS ISOCYANIDE & phenylisocyanide
How Does the Poisoned Patient Die? (irritable odor
1. CNS depression → coma → airway obstruction detected)
2. Severe hypotension (shock) or lethal arrhythmia PICRATE TEST Prussic acid - Yellow to brick red 
3. Cellular hypoxia – decrease of oxygen supply in the body SCHONBIEN- Prussic acid - Deep blue (Guaiac
4. Seizure, muscle hyperactivity and rigidity PAGENSTECHER paper)
5. Severe organ damage KI Hg - Orange ppt , excess
6. Behavioral effects dissolves  → orange
solution (Valser’s
 Initial assessment reagent)
 Evaluate and support vital functions SCHERER P - Black 
A. – Airway (should be cleared of vomitous or any obstruction) MITSCHERLICH P - Phosphorescence
SCHWART’Z Chloroform - Yellowish red color
B. – Breathing (breathing difficulties major cause of death in
RESORCINOL with yellowish green
poisoned or overdosed px) (can use oximeter/oximetry to
fluorescence
measure arterial blood gas)
TOLLEN’S Reducing - Silvery mirror-like ppt
C. – Circulation (monitor HR, BP & urine output) substances  (elemental Ag)
D. – Decontamination (removal of toxin) XANTHOGENATE CS2 - Release of H2S
(Hydrogen sulfide)
DIAGNOSIS
 The substance used in poisoning may be detected or -Ira (3/20/22)
diagnosed.
 The following tables are the different test used to detect
specific poisons and the different signs and symptoms of
poisoning to identify which poison affects the victim.
TEST TO DETECT SPECIFIC POISON
TESTS POISON NOTES
DETECTED
BEILSTEIN Chlorine - Positive test: Green
*toxic in liver flame
BENZOLT Acetone - Indigotine
GUNNING
BROMINE Aniline - Flesh-colored ppt
WATER (tribromoaniline)
BROWN RING Nitrite & - +FeSO4 + H2SO4 →
Nitrate brown ring at the
interface
LIEBEN’S Methanol (vs - Yellow ppt 
IODOFORM Ethanol) (iodoform (CHI3))
MARQUIS’ Common - Dark purple/black
drugs of (Ecstasy),
abuse - Orange to brown
(Amphetamine &
Methamphetamine),
- Purple/black
(Propoxyphene),
- Pink to purple (Heroin
& Opiates),
- Red (Aspirin)
MARSH Arsenic - Mirror-like 
 PSMB411 CLINICAL TOXICOLOGY PART 2 Green Indomethacin, iron, cupric
sulfate
Odor of Breath Substance/s
Red (also vomit) Hemolytic substances
Shoe polish Nitrobenzene
*Serious effect on Bismuth- if there is encephalopathy
Fruity odor Ethanol
*Iron salts- common adverse effect is irritation in the
Garlic Arsenic, phosphorous,
upper GIT (bleeding). Common is black
malathion, thallium
*Red-orange of the stool & body fluids – Anti TB
Mouse urine Coniine
(Rifampicin)
Stale tobacco Nicotine Blood Changes Substance/s
Bitter almonds Cyanide ↓ Blood coagulability Heparin, coumarins,
Sweet, penetrating odor Acetone, chloroform benzene
Pear-like Chloral hydrate Cherry red blood Carbon monoxide,
Rotten egg Hydrogen sulfide cyanide
Mothballs Naphthalene Dark red blood Nicotine
Wintergreen Methyl salicylate Chocolate blood Aniline, nitrites, nitro
*Fruit odor- ester derivatives
*Coniine from Hemlock – example of an alkaloid
*Cyanide- under of hydrocyanic acid (14 CN) has
hydrocyanic that is converted to cyanide of toxic Urinary Changes Substance/s
compounds Dark yellow Picric acid
*Chloral hydrate- sedative hypnotic Yellow brown Aloe, senna
*Methyl salicylate – synonym (Oil of Wintergreen) Odor of violets Turpentine
Skin Discoloration Substance/s Green blue Phenols & derivatives,
Yellow Picric acid, nitric acid methylene blue
Bleaching white Phenol Wine or red brown Caffeine, benzene,
Ash gray Mercuric chloride, rifampicin, lead, mercury,
physostigmine carbon tetrachloride
Deep brown Bromine
Brown black Sulfuric acid, iodine, silver
Discoloration of Gums Substance/s
nitrate
Blue line gum Bismuth, lead
Bluish gray Silver salts
Black line gum Mercury, arsenic
Blue Cyanotics (opium, aniline,
sulfides)
Pale bonds on fingernails Arsenic Visual Disturbances Substance/s
Boiled lobster appearance Boric acid Purple vision Digitalis, marijuana
*Pure phenol- colorless Blurred vision Anticholinergics
*Phenol exposed to air – pink Partial/total blindness Methanol, formic acid,
Vomitus Substance/s solanine
Blue-green Copper Optic neuritis Ethambutol
Ground coffee Sulfuric acid Blood shot eyes Marijuana
Luminous vomit Phosphorous, arsenic *Blurring of vision for Anticholinergics because of dryness
Yellow green Chromium that is because of decrease secretion (sand in the eyes)
*Ethambutol: red-green color blindness
*Antipsychotics that are deposited in the eyes (retinal
Bowel Changes Substance/s
deposit) – Thioridazine
Black Charcoal, bismuth, iron,
*Chlorpromazine – deposited in the cornea of the eyes
lead, magnesium dioxide,
Respiratory Changes Substance/s
silver nitrate
Violent sneezing Veratrine
Clay-like Alcohol, barium
Irritation Sulfur dioxide
White Aluminum hydroxide
Dyspnea Carbon monoxide
Blue Boric acid, methylene
General respiratory Opium, barbiturates,
blue, iodine
depression benzodiazepine, cyanide
 ❖ Administration of precipitants or adsorbents
*These contamination procedures should be performed
Other changes within 1 hour after ingestion or early cases of poisoning
Alopecia Arsenic and when the poison is not yet absorbed.
Tinnitus Salicylates, quinine
Ototoxicity Aminoglycosides, loop Other methods of decontamination includes
diuretics administration of chelating agent, whole bowel
Xerostomia Anticholinergics irrigation, forced diuresis and urinary pH
Bloody sputum Cadmium manipulations, and extracorporeal methods.
Muscular twitching, loss Barium Gastric Lavage
of voice • Also, commonly called gastric irrigation
• Also called stomach pumping
Loose teeth Mercury, lead, • It is the process of cleaning out the contents of
phosphorous the stomach. Such methods are normally used on
Bleeding gums Arsenic, mercury a person who has ingested a poison or overdosed
Lock jaw Strychnine on a drug such as alcohol.
Blister formation Cantharidin Uses:
*Tinnitus- ringing and buzzing of the ears • in patients who are not alert and with diminished
*Loop diuretics- can damage the 8th cranial nerve gag reflex in patients who are seen early (<60
(vestibulocochlear nerve) – resulting to ototoxicity mins) following massive ingestions
Contraindications:
*Vancomycin- ototoxic and also nephrotoxic when
• ingestions of acids, alkalis, or hydrocarbon
combined with aminoglycosides results to increase
ingestions
ototoxicity.
• at risk for Gl perforation
*Xerostomia- associated with the decrease secretions
• combative or convulsive patients
*Cantharidin (Cantharis vesicatoria)– vesicant and it is
Induce Emesis
irritating in the stomach. A blistering agent and that’s
• Emesis can be induced using Syrup of Ipecac.
why there is a blister formation.
NEVER ipecac extract or ipecac fluidextract!
Decontamination
*Fluid extract is 14 x stronger than the syrup
Inhalation Exposures *Syrup of Ipecac: Emetine & Cephalin (Cephaelis
• one of the most dangerous exposures. Poisoned ipecacuanha
patient should be removed from area of exposure *Emetics- releasing the contents in the stomach (GIT) and
and if necessary, give 100% oxygen, assisted there will be loss of electrolytes, decreased potassium that
ventilation, and bronchodilators. also cause cardiotoxicity if too much emesis.
*Once inhaled, there is rapid onset because it is directly to Syrup of Ipecac
the lungs Age Dose (mL)
Dermal Exposures 6-9 months 5
• remove contaminated materials from patients 9-12 months 10
and wash with soap and slightly cool water for 15 1-12 years 15
minutes. >12 years 30
Ocular Exposures
• irrigate eyes with NSS for 15 minutes *After 10 to 15 minutes, give large volume of water (2-3
*Remember: Do not instill any neutralizing solution. glasses of water). Give second if the patient still not
*Check the pH, if base or acid then irrigate or wash the vomiting. Repeat fluid administration (water)
eyes. Continue irrigation until normal pH is obtained in *If emesis is not effective, it means the patient has no gag
the eyes of the patient. reflex and will proceed to gastric lavage.
Oral Exposures *Alternative if No syrup of Ipecac is available: 2
• decontamination of ingested poisons is time tablespoons of dishwashing soap in a glass of water and
dependent. Performing one of these it will induce vomiting.
decontamination procedure should be done as Contraindications:
early as possible: • Children <6 months of age
❖ Gastric lavage • Patients with CNS depression or seizures
❖ Induce emesis • Ingestion of strong acid, alkali, or a sharp object
 • Patients with compromised airway protective Chelator Dimercaprol
reflexes Other Name BAL (British Anti-Lewisite)
• Ingestion of hydrocarbons or petroleum 2,3- dimercaptopropranol
distillates Mechanism serves as the metal acceptor and
• Ingestion of substance with an extremely rapid prevents binding of the —SH
onset of action groups of enzymes to metals
• Ingestion of substance that causes nausea and Indication As, Hg, Pb, Sb, Au
vomiting Contraindication: Fe, Cd, Se
Precipitants Notes Given intramuscularly (IM) in
• Alter the poison by forming an insoluble peanut oil
substance. *Arsenic- lewis metal
Examples: *Peanut oil -as solvent for injection
• Calcium chloride or gluconate Chelator EDTA
• Normal saline solution Other Name Calcium disodium edetate
• Sodium sulfate Ca Na2 ethylenediamine
*Silver Nitrate- Group I tetraacetic acid
*Barium Chloride Mechanism Increases water solubility of metal
*Oxalic acid by forming complexes
Adsorbents Indication Pb, Mn, Zn
• Form physical complexes with poison preventing Notes Given intramuscularly (IM) with
its absorption. procaine HCl
*It adsorbs the toxin from the surface that is to prevent Given intravenously (IV) in D5W or
the absorption NSS
Example:
• Activated charcoal— component of universal Chelator Deferoxamine
antidote and is considered one of the most Other Name Deferoxime
effective antidote (ATM 2:1:1).
DFO or DFOA
• Usual adult dose is 25-100 g. Child dose is usually
Desferal®
half the adult dose. Infant dose is l g/kg.
Mechanism Binds to free iron forming
Chemical that are not adsorbed by activated charcoal:
ferrioxamine complex and enhance
• Ethanol
renal elimination
• Iron
Indication Fe, Al (lesser extent)
• Lithium
Notes Given via IV, IM, SC
• Cyanide
• Ethylene glycol
Chelator Penicillamine
• Lead
Other Name Cuprimine®
• Mercury
• Methanol
Mechanism Works by binding to heavy metals;
• Organic solvents the resulting penicillamine-metal
• Potassium complexes are then removed from
• Strong acids the body in the urine
• Strong alkalis Indication Cu, Pb, Hg
Chelating Agents Notes Given orally (PO)
• These contains electron-donating group that Penicillamine is a hydrolytic
reacts with metal to form complexes. product of penicillin
*These are for metal poisoning
Examples: Chelator Succimer
• Dimercaprol Other Name Dimercaptosuccinic acid
• EDTA DMSA
• Deferoxamime Mechanism Prevent and reverse metal-induced
• Penicillamine inhibition of sulfhydryl-containing
• Succimer
• Unithiol
 enzymes and to protect against the the drug into water soluble or ionized form. For it to be
acute lethal effects of arsenic easily removed in the kidneys.
Indication Pb, Hg, As *Risk: The problem is if there is urinary acidification, it can
Notes It is a water-soluble analog of worsen the renal complications because of the
dimercaprol rhabdomyolysis

Chelator Unithiol Extracorporeal Methods

HEMODIALYSIS
Other Name Dimercaptopropanesulfonic acid
• Water soluble
DMPS
• Small volume of distribution (<0.5L/kg)
Mechanism Exhibits protective effects against
• Low MW (<500 daltons)
the toxic action of mercury and
• Not significantly bound to plasma proteins
arsenic in animal models, and it
increases the excretion of mercury,
*Extracorporeal- performed outside the body
arsenic, and lead in humans
*Small VD-confined within the vessel
Indication As, Pb
Notes A dimercapto-chelating agent that Indications:
is a water-soluble analog of • Effective on ethylene glycol, methanol, paraquat
dimercaprol • Ineffective on ethanol, theophylline, lithium,
salicylates, long-acting barbiturates.

Whole Bowel Irrigation

• The use of cathartics to induce evacuation of
bowel.
• PEG (Golytely®, Colyte®)
• Dosage: 1-2 L/hr (PO or by NGT)
Indications:
• Poorly absorbed substances
• SR preparations
• Body packers of illicit drugs
*Cathartics with electrolytes
Forced Diuresis and Urinary pH Manipulation
• Applicable for substances whose elimination is
primarily renal and has relatively small volume of *From the blood of the poisoned patient, there is a device
distribution with little protein binding. that has arterial pressure and will use heparin for the
Examples: blood not to coagulate, entering the dialyzer that is to
• Osmotic diuretics filter in semipermeable membrane. When the poisoned is
• Sodium bicarbonate filtered there will be a cleared blood and it will be returned
• NH4Cl, HO, Vitamin C to the body.
*Osmotic diuretics- through osmosis, colligative HEMOPERFUSION
mechanism, creating pressure in the nephron and will pull • Passage of anticoagulated blood through a
water and force to release the fluid in the body. It is the column containing activated charcoal or resin
action of osmotic diuretics like Mannitol. particles. Faster than hemodialysis but does not
*Sodium bicarbonate for the manipulation of pH when the correct fluid and electrolyte abnormalities.
cause of poisoning are acidic substances. Sodium Indications:
bicarbonate (Base) and poison (acid) will be neutralized • Effective: Phenobarbital, phenytoin,
then it becomes ionized and water soluble so it can be carbamazepine, methotrexate, theophylline
excreted from the body. Increase elimination. It is used in • Ineffective: Ethanol, methanol
the poisoning of acidic drugs like barbiturates and Volume of distribution (Vd)
salicylate. • Is the apparent volume into which a substance is
*NH4Cl- acidifying agent. It is used in basic drugs like distributed.
methamphetamine, phencyclidine, strychnine, quinine, • A large Vd implies that the drug is not readily
quinidine poisoning and to alter the pH and to convert accessible to measures aimed at purifying the
blood, such as hemodialysis.
 Drugs with large Vd (>5 Drugs with small Vd (<1 Hydrocarbon insecticide Physostigmine
L/kg) L/kg) Parathion Pralidoxime
Antidepressants Salicylate Paraquat Bentonite, fuller's earth,
Antimalarials Phenobarbital NaSO4
Narcotics Lithium *it is an example of
Propranolol Valproic acid herbicide
Antipsychotics Warfarin Barium MgSO4, benzodiazepines
Verapamil Phenytoin DDT Barbiturate
*Large VD of drug that is distributed into different parts
of the body and tissues with different compartments. *dichloro-diphenyl-
*Hemodialysis, hemoperfusion, peritoneal dialysis, trichloroethane
hemodiafiltration *Organophosphate and Carbamate: Examples of indirect
acting cholinergic agonist so give an antagonist like
Antidotes Atropine and Pralidoxime.
• These are agents that neutralize a poison or *Organophosphate action is inhibiting the enzyme
otherwise counteract or oppose it or its actions Acetylcholine esterase for it not to break the acetylcholine
Physiological Antidotes so the acetylcholine will bind to its receptor. The action
• Produces an opposite effects as that of the for organophosphate and carbamate is on the enzyme.
poison *If there will be a cholinergic poisoning and a lot of
*Ex. Anaphylactic shock (Histamine) – bronchoconstriction acetylcholine
the physiologic antidote is Epinephrine. Epinephrine act *Atropine is a physiologic antidote / noncompetitive
on Beta 2 causing bronchodilation (Opposite antidote because organophosphate act on the enzyme
response/effect but different receptor) and atropine act on the receptor. Between Atropine and
*Ex: Steroids and Insulin. Steroid (Glucocorticoid- increase organophosphate, they have different target site but it
blood sugar that binds to type 4 receptor) and Insulin to can counteract the effect of poison (physiologic antidote).
decrease the blood sugar that binds to Type 3 receptor. It is used when the poison is already absorbed.

Chemical Antidotes *In early cases of carbamate and organophosphate

• Change the chemical nature of the poison poisoning will use Pralidoxime.
*Chelation, complexation, chemical reaction, *Pralidoxime- acetylcholine esterase regenerator. It
neutralization will regenerate the enzymes for organophosphate
*Considered as true antidote, specific antidote that can poisoning to break acetylcholine. To less its cholinergic
make the poison harmless by the alteration of the poison. action. It is competitive because the organophosphate
*Ex. Treat Cyanide poisoning by sodium thiosulfate to binds to enzyme and pralidoxime will remove the
convert it to thiocyanate which is nontoxic form by organophosphate in the enzyme. It will regenerate the
altering the form of poison through chemical reaction. enzyme for it to break the acetylcholine.
*Sodium sulfate for Barium poisoning. There will barium Nitrogen Compounds
sulfate that is insoluble and nonabsorbable.
Poison Antidote
Mechanical Antidotes Aniline, Nitrobenzene Methylene blue
• Prevent absorption of the poison *Nitrogen compounds once undergo metabolism, they
*Removing poison without changing it. Ex. Use of are converted into reactive metabolite.
activated charcoal; when given in the early case of
poisoning, it will absorb the toxin and then toxin will be Alcohols & Glycol
released
Poison Antidote
*Use of emetic and cathartic is also mechanical antidote.
Methanol Ethanol, Fomepizole,
*Demulcent- coating the lining of GIT for oral poisoning
Morphine, Vit B9
so the toxin won’t be absorbed.
Ethanol Vit B12
Ethylene glycol Ethanol, Fomepizole, Vit
Agricultural Poisons
B9
Poison Antidote
*Ethanol is used as an antidote for methanol poisoning
Organophosphate Atropine, Pralidoxime
because for it to compete with the enzyme because they
Carbamate insecticide Atropine
have the same enzyme (Alcohol dehydrogenase & Strychnine Diazepam,
Aldehyde dehydrogenase) so while having methanol will Neuromuscular blockers,
give ethanol so the alcohol dehydrogenase will be used *It can cause convulsion Barbiturates, Atropine
to metabolize the ethanol. Methanol will not yet be
metabolized because the toxic form of methanol
Antiseptics
(Formaldehyde and Formic acid) so the oxidation should
be delayed by giving alcohol like ethanol. Poison Antidote
Iodine Starch solution, Na
Aldehyde thiosulfate
Poison Antidote Bleaching agents Na thiosulfate
Formaldehyde Ammonia, NaHC03 Cationic detergents Ordinary soap
Chlorates Methylene blue
Chloramine-T Na nitrite, Na thiosulfate
Hydrocarbons Phenol Castor oil
Silver salts NaCl, Na thiosulfate, K
Poison Antidote
ferricyanide
Kerosene Mineral oil
*Castor oil – used as cathartic
*Chlorinated insecticide contraindicated with castor oil
Corrosives Animal and Plant Hazard

Poison Antidote Poison Antidote

Oxalic acid, phosphate, Ca gluconate Mushrooms Penicilline
fluoride Mushrooms: Pyridoxine, methylene
Ammonia Formaldehyde Monomethylhydrazine blue
Bromine NaCl, NH4Cl Mushrooms: Muscarine Atropine
Mushrooms: Ibotenic Physostigmine
acid, muscimol
Metallic Poisons Rattle snake bite Antivenom, suction,
tourniquet
Poison Antidote
Black widow spider Antivenom
Sb, Au, Bi, W Dimercaprol or BAL
Scorpions Antiserum
Be, Cd, Mn, Se EDTA
Zn, Cr, Ni BAL, EDTA
Cu BAL, penicillamine Poisonous Gases
As BAL, DMSA, penicillamine
Tl Prussian blue or ferric Poison Antidote
ferrocyanide CN Amyl nitrite, Na nitrite, Na
P CuSO4 thiosulfate,
Hg Na formaldehyde sulfoxylate CN hydroxocobalamine,
BAL, DMSA, Penicillamine 100% O2, hyperbaric O2
Pb BAL, EDTA, DMSA, Sulfide Amyl nitrite, Na nitrite
penicillamine, succimer Co 100% O2, hyperbaric O2

Alkaloids Cosmetics

Poison Antidote Poison Antidote

Atropine Physostigmine Bromates Na thiosulfate
Nicotine Diazepam
Quinidine NAHCO3 Food poisoning
Ergot and derivatives Tolazoline, Na
nitroprusside Poison Antidote
Caffeine, theophylline Esmolol Botulism ABE botulinus antitoxin
 Nitrates Methylene blue
Sulfite Epinephrine -purpose of atropine is to *Used to prevent
*Nitrates poisoning: common side effect is reduce CNS stimulation respiratory depression
methemoglobinemia (decrease capacity of red blood and CNS effects in
cells to carry oxygen) in low doses because high doses of Diphenoxylate and also
additional relaxation in
methylene blue can cause methemoglobinemia.
the smooth muscles of
Medicinal Poisons the GIT.
Bromides NaCl
Poison Antidote
Amphetamine Chlorpromazine
Acetaminophen N-acetylcysteine (NAC)
Heparin Protamine SO4 *if want to increase
urinary excretion, you can
*Heparin (Use protamine
use neutralizer like
sulfate) it is also a chemical
ammonium chloride for
antagonism. Heparin
the manipulation of pH.
carrying negative charge
MgSO4 Ca gluconate
and protamine sulfate
Salicylates, NaHCO3
comes from sperm of fish, Phenobarbital
carrying positive charge.
Warfarin Vitamin K *Barbituric acid also used
Tricyclic antidepressants Physostigmine the manipulation of pH
Benzodiazepines Flumazenil Neuromuscular blockers Edrophonium Cl,
ß-blockers Glucagon Neostigmine,
*Beta blocker is cardiac *curare derivatives: Pyridostigmine
depressant tubocurarine, atracurium
Ca channel blockers Glucagon, CaCl2 Iron Deferoxime /
deferoxamine
*Glucagon in heart Isoniazid Pyridoxine
increases CAMP and
contraction. *Vitamin B6 that is to
Digoxin Digoxin-specific Fab prevent peripheral
antibodies neuritis because Isoniazid
Digitalis KCl compete with Vitamin B6
(same binding site) but
*If hypokalemic because it the administration should
needs to consider levels have interval.
of potassium when taking Industrial and Household Toxicology
digitalis. Increase binding
of digitalis in the heart • Ethylene Glycol
when the potassium levels • Methanol
are decreased. The • Formaldehyde
purpose is to contract the • Acetone
heart because low levels • Hydrocarbons
of potassium there will be • Cyanide
less contraction, less • Acids and Bases
positive charges inside the
• Phenol
cell.
• Organophosphate
Opiates Naloxone, Naltrexone,
• Strychnine
Nalorphine
*Opioid antagonist • Carbon Tetrachloride
Atropine+Diphenoxylate Naloxone, Naltrexone, • Carbon Monoxide
(Lomotil®) Nalorphine
 Ethylene glycol Treatment:

• Used in anti-freeze and windshield deicing • Ammonia and NaHCO3

solutions
Acetone
• Excreted by the kidney
• Also known as 2-propanone
Signs and symptoms
• Primary ingredient in nail polish remover, airplane
• Severe metabolic acidosis glues, varnish, and rubber cement
• CNS and cardiopulmonary depression
Signs and symptoms
• Acute renal failure
• Seizure • CNS depression → coma
• Respiratory depression
Metabolites
Treatment:
• Glycolaldehyde, glycolic acid, glyoxylic acid,
oxalic acid • neutralization with milk or water

*Oxalic acid causes Crystalluria because oxalic acid and *Milk is amphoteric that will coat the stomach
urine are acid (Acid-acid) non-ionized so it will increase
Hydrocarbons
the formation of crystals and there will be kidney stones
formation. • Mostly derived from petroleum distillation
• This includes gasoline and kerosene
Treatment:
Signs and symptoms
• Ethanol and Fomepizole (Antizol®)
• Aspiration pneumonia
Methanol
• Chemical-induced pneumonitis
• Also known as wood alcohol, carbinol, methyl
Treatment:
alcohol
• Denaturant, paint remover, solvent • mineral oil
*coat the lining to prevent further irritation
Signs and symptoms
*mineral oil also used as lubricant/laxative also
• Visual disturbance → permanent blindness prevent the absorption of kerosene.
• Metabolic acidosis
*In kerosene poisoning, the use of emetic or gastric lavage
Metabolite will be ineffective. It is contraindicated for the use of
emetic and gastric lavage.
• Formaldehyde, formic acid
Cyanide
Treatment
• Found in most fruits in the Prunus sp. (wild black
• Ethanol and Fomepizole (Antizol®)
berry, apricot, peach, plum, bitter almond, cherry
Formaldehyde laurel, mountain mahogany)

• Also known as formalin, formol *It is found in the seeds that is rich in hydrocyanic acid
• Embalming fluid
• Found in some foods from the Rosaceae fam.
Signs and symptoms (pear, apple, jetberry bush, Prunus sp.)
• Also found in bamboo, cassava, lima beans,
• Similar in presentation to methanol toxicity
linseed
• Local: mucosal irritation
• Nitroprusside, laetrile, nitriles
• Systemic: CNS depression, coma, metabolic
acidosis *Nitroprusside (cyanide) – prussic acid test
Signs and symptoms

• CNS and CV disturbances Mechanism of toxicity

*there will be hypotension, the BP of patient will be • CO + Hgb → carboxy Hgb

decreased because the cyanide is a vasodilator. • CO + cytochrome oxidase → inactivation (cellular
hypoxia)
• Odor of bitter almonds
• Cherry red blood Treatment:

Treatment: • 100% oxygen, artificial air, hyperbaric oxygen

therapy
• Amyl nitrite (inhalation)
• Na nitrite (IV)
• Na thiosulfate IV
• Dicobalt edetate (Kelocyanor®)
• Concentrated Hydroxocobalamin

Carbon tetrachloride

• Used in nonflammable cleaning fluids and fire

extinguishers

Metabolites

• Epoxides
• Phosgene – is also a metabolite of chloroform. A
toxic compound that binds in the liver cells
Strong acids and bases
causing hepatotoxicity. One of the chemicals
used in warfare. The odor resembles like fresh cut • The strong acids are hydrochloric acid, nitric acid,
hay or grass. sulfuric acid, hydrobromic acid, hydroiodic acid,
perchloric acid, and chloric acid.
*Standard in Hepatoxicity studies: Carbon tetrachloride is
• The strong bases are lithium hydroxide, sodium
used to induce hepatotoxicity.
hydroxide, potassium hydroxide, rubidium
Treatment: hydroxide, and cesium hydroxide

• No available antidote, what to do to the patient is Signs and symptoms

when ingested, perform a gastric lavage.
• Base: liquefaction necrosis
• Acid: coagulation necrosis

Treatment:

• Dilutional therapy only.

Carbon monoxide *Emesis and gastric lavage can’t be performed because it

already caused scratches in the lining of GIT. It cannot also
• Product of incomplete combustion or second-
add neutralizing solution. Need first to identify pH and
hand cigarette smoke
then continue washing until the pH is normal and the
• It has 210x more affinity to Hgb as compared to
poison is removed.
oxygen
Phenol
*The oxygen is displaced so the blood will decrease its
capacity to oxygen (carboxyhemoglobin) and it will cause • Also known as carbolic acid
cellular hypoxia (there will be failure at any stage to deliver • Toxic due to its protein denaturant effect
oxygen to cells) • Derivative: Lysol (50% cresol)
Treatment: Signs and symptoms

• Dermal exposure: PEG • Rigor mortis

• Inhalation: 100% humified O2 • Spinal convulsions
• Oral: Castor oil, Mineral oil • Sardonic smile
• Similar to tetanus but faster in development
*Pure phenol -colorless when it is exposed to air, it will
turn into pink color. Treatment:

Organophosphates • Diazepam, phenobarbital, neuromuscular

blockers (antidote)
• This includes parathion and malathion

Mechanism of toxicity

• Binds to acetylcholinesterase forming a stable

phosphate-ester bond inactivation of the
enzyme → increase concentration

*It prevents binding of acetylcholine so the levels of the

acetylcholine will be increased.

Signs and symptoms

• Severe cholinergic symptoms (DUMBBELSS)

• Farmer and Gardener (DUMBBELSS (Diarrhea,
Urination, Miosis, Bradycardia,
Bronchoconstriction, Increase secretion, Emesis,
Lacrimation, Salivation, Sweating)

Treatment:

• Pralidoxime- early cases of poisoning to remove

the binding of drug to the enzyme
• Atropine- (physiologic antidote) if more than 72
hours because there is already an aging of
phosphate in the binding)

Strychnine

• From seeds of Strychnos nux-vomica

*Allosteric inhibition – glycine receptor. The glycine

receptor will bind the glycine to relax the neuron. Because
glycine is an inhibitory transmitter.

*Strychnine will bind to allosteric site to decrease the

binding of glycine so there will be no inhibitory
transmitter and the neurons will be active and resulting to
convulsions.

Mechanism of toxicity

• Blocks glycine receptor (negative

neurotransmitter) convulsant
 C0LINICAL TOXICOLOGY  Arsphenamine (Salvarsan®) – also known as compound 606,
PART 3 magic bullet
HEAVY METALS - Used as treatment in syphilis and trypanosomiasis
LEAD (Pb)  Arsine gas – AsH3, produced by the addition of heat and acid
 Found in canned goods, automobile exhaust, wine glasses, old - Irritating gas with garlic gas like odor and can cause
pipes, cables, paints hemolysis of red blood cells
 *also in some toys SIGNS AND SYMPTOMS:
 *Lead is a metal that can cause poisoning  Mee’s line (white lines in the nails)
MECHANISM OF TOXICITY:  Garlic odor of breath
 Combines with the thiol (-SH) group of enzymes resulting to  Luminous vomitus
inactivation.  Black line on gums
SIGNS AND SYMPTOMS:  Bleeding gums
 Plumbism is the toxicity to lead (Symptoms: peripheral  Alopecia
neuropathy, milky vomitus, black stool, wrist drop/foot drop,  Severe diarrhea
black line on gums) TREATMENT:
 Lead oxide aka Litharge is the yellow oxide of the lead that  BAL (British Anti-Lewisite) or Dimercaprol (+penicillamine
can be created when lead is heated in air if severe)
TREATMENT: IRON (Fe)
 BAL (British Anti-Lewisite popularly known as Dimercaprol,  Used for hemoglobin and myoglobin production
CaNA2EDTA (Calcium disodium versenate or Calcium  Toxicity may arise from malabsorption (Hemochromatosis) or
disodium EDTA), Succimer (if encephalopathy is not present) over-ingestion of OTC preparations (TD: 60 mg/kg, LD: 200-
 *If heavy metal, the common antidote mechanism is through 300 mg/kg)
chelation (chelating agents) SIGNS AND SYMPTOMS:
CADMIUM (Cd)  PHASE 1 – nausea, vomiting, diarrhea, GI bleeding,
 Found in anti-dandruff shampoos, smoke and stink bombs, hypotension
solder  PHASE II – clinical improvement seen 6-24hour post-ingestion
 This metal targets the kidney, lungs and bones  PHASE III – metabolic acidosis, renal and hepatic failure,
SIGNS AND SYMPTOMS: sepsis, pulmonary edema and death
 Itai-itai disease aka It hurts it hurts disease – first discovered TREATMENT:
in Japan (osteomalacia → fracture → severe pain)  Deferoxamine
 Gait disturbance – can affect the manner of walking (There’s a PHOSPHORUS (P)
problem in balance & coordination) TWO FORMS:
 Renal abnormalities  Red – nonpoisonous, found in matches
TREATMENT:  Yellow – highly poisonous, used in fireworks
 EDTA for acute ingestion  + heat / acid → Phosphine gas
MERCURY (Hg) SIGNS AND SYMPTOMS:
 Also known as quicksilver, hydrargyrum  Luminous vomitus
 Elemental mercury (Hg22+ [mercurous] and Hg2+ [mercuric]) is  Garlic odor of breath
used in thermometers, amalgams (pastas in teeth), paints,  Loose teeth
batteries, fingerprint photography TREATMENT:
 Organic mercury: aryl mercurial, thimerosal, ethyl mercury  CuSO4
 *Mercurous chloride example is calomel while Mercuric  Diazepam or barbiturate for seizures
chloride is corrosive sublimate that is the common cause of  Calcium for hypocalcemia
poisoning ALUMINUM (Al)
MECHANISM OF TOXICITY:  Causative agent of Shaver’s disease (also known as Bauxite
 Combination with thiol (-SH) groups → enzyme deactivation pneumoconiosis; occupational exposure to fumes containing
and depression Al and Si)
SIGNS AND SYMPTOMS:  3rd most abundant element and most abundant metal on earth
 Acrodynia (photophobia, anorexia, restlessness, stomatitis,  Used for healing of burns and as abrasive in industries
oliguria, severe diarrhea, pain in appendages, pink palm and  Has constipating and astringent effects
toes)  “Ala tae”
 Hydrargism, Minimata disease (when affected is neurological MECHANISM OF TOXICITY:
syndrome)  Attacks bones and lungs
TREATMENT: TREATMENT:
 BAL for high exposure, Penicillamine for low level exposure  Deferoxamine used as chelating agent
 Na formaldehyde sulfoxinate purpose is to convert the ZINC (Zn)
mercuric (the toxic form) into mercurous ion (which is less toxic)  Used in galvanizing of iron and container for battery cells
ARSENIC (As) DEFICIENCY:
 Also known as the Lewisite metal  Parakeratosis (thick, inflamed, scaly skin)
 Is a metalloid, an example of protoplasmic poison (means it TOXICITY:
could affect all cells)  Metal fume fever (muscle aches and fever)
 Choice of professional poisoners TREATMENT:
 Seen in rodenticide, insecticide  Aspirin + bed rest
USED IN THE PREPARATION OF:  Recovery occur after 1-2 days
 Fowler’s solution – contains 1% KasO2 (Potassium arsenite) OTHER METALS
- Used in the treatment of leukemia Ce - CESIUM
 Donovan’s solution – contains AsI3 (arsenic triiodide) and - Catalyst in the polymerization of resin
HgI2 (mercuric iodide) Au - GOLD
- Used in leprosy and psoriasis - Anti-inflammatory agents for rheumatoid arthritis
 Paris green – combination of cupric acetate and arsenic (RA) which are Aurothiomalate & Aurothioglucose
trioxide (preparations of gold used in RA)
- Used as rodenticide and insecticide, can also be pigment - For non-disseminated lupus erythematosus
(NDLE)
 - Gold dermatitides (contact dermatitis) Mo - MOLYBDENUM
- TX: BAL - Bacterial fixation of atmospheric nitrogen
Ag - SILVER Cr - CHROMIUM
- Found in indelible inks (Silver nitrate) - Glucose tolerance factor
- Protein denaturant - Found in brown sugar & butter
- Argyria -poisoning - TX: BAL, EDTA
- TX: Sodium chloride, Sodium thiosulfate, Mn - MANGANESE
Potassium ferricyanide - Co-factor in enzymatic reactions
Cu - COPPER SUBSTANCE OF ABUSE
- Insecticide, fungicide, H2O purification (Bordeaux NICOTINE
mixture) ➢ CNS stimulant
- Alloys in medicine, emetic, astringent, caustic, ➢ Active ingredient of tobacco (Nicotiana tabacum) for the
escharotic addictive effect
- Wilson’s disease (mental & neurological LETHAL DOSE:
abnormalities) ➢ 40-60 mg (adult); 1.5-2 mg/kg (children)
- TX: BAL, penicillamine TREATMENT:
Co - COBALT ➢ Oral ingestion – activated charcoal, gastric lavage (these
- Manufacture of permanent magnet, batteries & beer procedures are only for early cases of poisoning)
- Found in vitamin B12 AMPHETAMINE / METHAMPHETAMINE
Ga - GALLIUM  CNS stimulant
- Manufacture of arc lamps  Causes CNS stimulation and sympathomimetic effects
Tl - THALLIUM  Indirect acting agonist
- Rat, roach & ant poison  Treatment:
Sn - TIN 1. for ADHD (Attention-Deficit Hyperactivity Disorder) to
- Found in canned milk & other canned products improve focus;
Zr - ZIRCONIUM 2. for narcolepsy or in patients with uncontrollable sleep;
- Ingredient of deodorant & anti-perspirants 3. for exogenous obesity (to decrease appetite)
- Causes granulomas & dermatitis SIGNS & SYMPTOMS:
Os - OSMIUM  Seizure
- Densest metal  Psychosis and agitation
- Staining of microscopic specimen used in electron  Hypertension
microscopy  Arrhythmia
Ni - NICKEL TREATMENT:
- Found in fancy jewelries  Seizure – diazepam, phenytoin
- Produced in fossil fuel combustion  Psychosis and agitation – chlorpromazine, haloperidol,
- Causes contact dermatitis (Nickel’s itch) diazepam
- Most powerful inorganic carcinogen  Hypertension – beta-blocker, alpha-blocker
- TX: BAL, EDTA  Arrhythmia – propranolol, lidocaine
Ba - BARIUM COCAINE
- Depilatory  CNS stimulant
- Green pyrotechnics (gives green color in fireworks)  From Erythroxylon coca
- Baritosis (hoarseness & muscle twitching)  Also known as coke, crack, freebase
- TX: MgSO4, Benzodiazepines  Action: is to inhibit reuptake
Mg - MAGNESIUM SIGNS & SYMPTOMS:
- Natural calcium channel blocker (CCB)  Sympathetic stimulation → hypertension
- 2nd most abundant intracellular cation  Seizure
- Cathartic & anti-convulsant  Psychosis
- Mild: depressed deep tendon reflexes, lethargy &  *Payat, dilat, puyat
weakness TREATMENT:
- Severe: respiratory paralysis & heart block  Seizure – benzodiazepines
- TX: Calcium chloride  Hypertension – labetalol
- “Magtatae”  Psychosis – neuroleptics
Be - BERYLLIUM MARIJUANA
- Most toxic metal  CNS stimulant
- Fluorescent lighting industry  From Cannabis sativa
- Found in neon lamps  Most commonly used illegal drug
- Lung carcinoma & chronic granuloma  Available as hashish or hashish oil it
- TX: EDTA is the resin found in marijuana
B - BORON  *Manifestation: blood shots eyes,
- Vulcanizing rubber hallucination
- Increases thermal coefficient of expansion of glass ACTIVE INGREDIENT:
Bi - BISMUTH  THC (Tetra hydro cannabinol) which is responsible for the
- Beautiful meadow psychoactive property
- Silvering of mirrors NITROUS OXIDE
Sb - ANTIMONY  CNS stimulant
- Found in tartar emetic & brown mixture  Also known as the laughing gas (causes hysterical laughing)
- Protoplasmic poison  May cause diffusional hypoxia
- Similar to Arsenic poisoning TREATMENT:
- May cause MI  Oxygen
- Produces Stibine gas with acid or heat (route: ETHANOL
inhalation)  CNS depressant
- TX: BAL  Also known as grain alcohol, neutral spirit
  Responsible for major medical and socio-economic problems BARBITURATES
 Most commonly & socially accepted substance for abuse  CNS depressant
SIGNS & SYMPTOMS:  Sedative
 CNS depression, acid-base imbalance, impaired thermal  Barbituric acid- Weak acid
regulation, hypoglycemia, psychosis (Wernicke-Korsakoff  Used for induction of anesthesia (ultra-short
syndrome)- deficiency in B1 acting agent) and for the treatment of seizure
 Hypothermia  *Short to intermediate acting – for sedative-
METABOLITES: hypnotics
 Acetaldehyde, acetic acid  *Long-acting- for seizures
TREATMENT: SIGNS & SYMPTOMS:
 Wernicke-Korsakoff syndrome – Vitamin B1 or Thiamine  Mild: Slurred speech, Ataxia, Altered mental status
 Chronic alcoholism or addiction – Disulfiram (Antabuse®)  Severe: Comatose with absence of deep tendon reflexes,
OPIOIDS Cheynes-Stokes (irregular) respiration
 CNS depressant TREATMENT:
 Natural: Opium, Morphine  Forced alkaline diuretics, hemodialysis (for the removal of
 Semi-synthetic: Heroin, Codeine drug into the body)
 Synthetic: Methadone, Meperidine CHLORAL HYDRATE
SIGNS & SYMPTOMS: ♣ CNS depressant
 Triad of opioid toxicity (PRC) – Pin ♣ Sedative
point pupil, Respiratory depression ♣ Also known as Mickey Finn®
& Coma ♣ In vivo metabolism via alcohol
 Seizure (Meperidine) *kapag nagaccumulate ung metabolite ng dehydrogenase to trichloroethanol
Meperidine which is Normeperidine ♣ Knockout drops; similar to barbiturate
 *Meperidine is short acting that is used for obstetric anesthesia poisoning
& analgesia TREATMENT:
 Miosis (constricted pupils) ♣ Supportive
TREATMENT: LYSERGIC ACID DIETHYLAMIDE
 Antagonists: Naloxone, Naltrexone, Nalorphine, Nalmefene  Hallucinogen
 Also known as acid, LSD
 An ergot derivative
MECHANISM OF TOXICITY:
 Inhibits serotonergic firing →
sympathetic stimulation and hallucinations
TREATMENTS:
 Benzodiazepine for seizures
LYSERGIC ACID AMIDE
֎ Hallucinogen
֎ Also known as LSA, ergine
֎ An ergot alkaloid related to LSD but has more GI
effects
MORNING GLORY FAMILY
 Argyreia nervosa
 Ipomea violacea
 Turbina corymbose
- Ololiuqui
RECEPTOR CLINICAL LOCATION
EFFECTS *Psychedelic means it causes hallucinations
μ Analgesia Mesenteric plexus TREATMENT:
Mu Changes smooth Brain ֎ Supportive
muscle tone Spinal cord MESCALINE
Sedation Sub-mucosal plexus  Hallucinogen
Mood alteration  From Lophophora williamsii (peyote
Nausea/vomiting cactus)
 Decreases colonic Mesenteric plexus  Also known as Mescal buttons
Delta transit time Brain TREATMENTS:
 Central analgesia Mesenteric plexus  Supportive
Kappa Decreases colonic Brain METHYLENEDIOXYMETHAMPHETAMINE
transit time Spinal cord  Hallucinogen
Visceral nociception  Also known as MDMA, Ecstasy,
antagonist XTC, E, X, Molly, Mandy
BENZODIAZEPINES MECHANISM OF TOXICITY:
 CNS depressant  Serves as a false neurotransmitter → release of
 Sedative catecholamines
 Causes fatal CNS and respiratory depression when  Inhibition of monoamine oxidase (MAO)
combined with alcohol  Stimulates  and  receptors (similar to amphetamine)
SIGNS & SYMPTOMS: TOXIC DOSE:
 Drowsiness  50-150 mg
 Ataxia – loss of muscle coordination TREATMENT:
 Confusion  Hypertension – Labetalol, Nitroprusside, or Nifedipine
TREATMENT:
 Flumazenil (Mazicon ®)
PHENCYCLINE QUININE Bitter bark
 Hallucinogen *Cinchona bark
 Also known as PCP, angel dust NICOTINE Tobacco
 Associated with dissociative anesthesia AMYGDALIN Prunus sp. (cherry apple)
 *Associated with Ketamine (is an intravenous *Prunus has hydrocyanic acid
anesthetic that is associated with dissociative RICIN Castor bean
anesthesia means the patient appears to be awake *Ricin is the toxic component of
but unconscious in its environment castor bean cause the genus is
SIGNS & SYMPTOMS: Ricinus
 Acute brain syndrome (disorientation, psychosis, coma, SANGUINARINE Bloodroot
seizure) TAXINES Japanese yew
 Hypertension *Source of Taxol
TREATMENT: ARECOLINE Betel nut
 Seizure – Diazepam BRUCINE, STRYCHNINE Nux vomica
 Hypertension – Nitroprusside PICROTOXIN Fish berries
NATURAL POISONS
MYRISTICIN Nutmeg
POISON SOURCE/S NOTES
*First used by prison inmates as
LATROTOXIN Black widow spider → produces hallucinogen
/ Hourglass spider cholinergic signs &
CICUTOXIN Water hemlock
(Latrodectus symptoms, flu shed
COLCHICINE Autumn crocus
mactans) sweating face
CONVALLARIN Lily of the valley
contorted in a
painful grimace with CONIINE Poison hemlock
conjunctivitis, PHENANTHRIDINE Daffodil, jonquil
restlessness & HPN ALKALOIDS
→ TX: Calcium PODOPHYLLOTOXIN American mandrake, Mayapple –
gluconate, source of resin
Antivenom OXALIC ACID & Rhubarb, boston ivy
5-HYDROXYTRYPTAMINE Scorpion → Neurotoxin ANTHRAQUINONES
(Centuroides → TX: Barbiturate SANTONINE Santonica
sculpturatus) & IV antivenom SOLANINE Black nightshade, rotten potato
BEE VENOM Hymenoptera (bee, → Red ants (Formic VERATRINE False hellebore, corn lily
wasps, ants) acid) - itchiness PHYSOSTIGMINE Calabar bean
→ Anaphylactic PHALLOIDINE Death angel
reaction MANIHOTXIN Cassava
→ TX: UROSHIOL Poison ivy
Diphenhydramine *That causes contact dermatitis
& steroids
HYALURONIDASE Snakes → First aid: Suction GROUP MUSHROOM TOXIN NOTES
& tourniquet, I Amanitotoxins, →Hepatotoxins
incision (w/in 20 cyclopeptides →TX: Thioctic acid, Dextrose,
mins to remove Penicilline (interference with
20%) albumin binding), Vitamin K,
→ TX: Antivenom Dexamethasone
TETRODOTOXIN Amphibians (toads, → TX: IA Orellanine, orelline →Nephrotoxins
newts, frogs Barbiturates, →TX: Charcoal
(bufotoxin)), puffer Diazepam hemoperfusion
fishes (convulsions), Ca II Muscimol, Ibotenic →Hallucinogens,
gluconate, acid anticholinergic signs &
Propranolol symptoms
CANTHARIDIN Blister fly / Spanish → Local irritants, →TX: Physostigmine
fly aphrodisiac III Gyrometrin →Hepatotoxin
CLUPEOTOXIN Oysters, sardines → sharp metallic →Hydrolyzes to form
(venerupin), taste, abdominal monomethylhydrazine used as
anchovies pain, vomiting & rocket fuel
diarrhea →Produced by a poisonous
SCROMBOID TOXIN Tuna (saurine) → Confused with mushroom, Gyrometra
Mackerel (gemblid) MSG reactions esculenta
→ May be caused →TX: Pyridoxine HCl,
by dolphin (non- Methylene blue
scromboid) (methemoglobinemia)
CIGUATOXIN Fish organs (liver) → Most common IV Muscarine →Parasympathetic
poison from overstimulation
ingested fish →TX: Atropine
V Coprine →Disulfiram reaction
POISON SOURCE/S →TX: IV NSS, Dopamine or
ABRIN Jequirity bean, scientific name is NE for hypotension
Abrus precatorius VI Psilocin, psilocybin →Hallucinogens
ACONITINE Aconite, Monkshood →TX: Diazepam
ATROPINE Deadly nightshade (Atropa
belladonna)
DIGITALIS GLYCOSIDES Foxglove
 POISON SOURCE/S NOTES NITROBENZENE →Found in shoe polish
SAXITOXIN Dinoflagellates →red tide poisoning, (ESSENCE OF
paralytic shellfish MIRBANE)
poisoning (PSP) CHLORAMINE-T →H2O purifier, mouthwash
AFLATOXIN Aspergillus flavus →Found in →Converted to cyanide derivatives
improperly dried →Cyanosis, respiratory failure, collapse
peanuts →TX: Sodium nitrite, Sodium
→carcinogenic thiosulfate
PTOMAINE Bacterial decay →spoiled food CARBON DISULFIDE →Used in textile industry
TYROTOXICON →expired milk & →Causes RBC hemolysis
dairy products →TX: Amyl nitrite, Sodium nitrite
ERGOT Claviceps purpurea →ergotism: HYDROGEN SULFIDE →Sewer gas, stink damp
convulsion & →Found in petroleum refineries,
gangrene (St. tanneries, mines, & rayon factories
Anthony’s fire) →Causes “gas eye” for workers in
EXOTOXINS Mostly from Gram (+) →Proteinaceous, tunnels
high virulence, small ASBESTOS →Fire retardant (fire proof clothing of
lethal dose firemen)
BOTULINUM C. botulinum →spoiled canned →Causes silicosis & lung CA
TOXIN foods NAPHTHALENE →Moth balls
→neuromuscular →Toilet bowl deodorant
poison →Obtained from coal tar
TETANOSPASMIN C. tetani →causes tetany EOSIN →Found in lipstick
CYTOTOXIN C. perfringens →gas gangrene ALUMINUM →Found in deodorants
ENTEROTOXIN Staphylococcus →most common CHLOROHYDRATE
aureus cause of food BORIC ACID →Antiseptic & fungistatic agent
poisoning →Causes the boiled lobster appearance
→causes TSS TANNIC ACID →Carcinogen found in iced tea
(Toxic Shock ASPARTAME →Artificial sweetener
Syndrome, mostly SACCHARIN →Artificial sweetener
women) TARTRAZINE →Food colorant
DIPHTHERIA Corynebacterium →Protein synthesis NITRITE →Food colorant / preservative
CYTOXIN diphtheriae inhibitor in nerves, → Vasodilator
heart, & kidney cells MSG →Monosodium glutamate
C. ENTEROTOXIN Vibrio cholerae →causes rice water →Causes Chinese restaurant syndrome
stool POTASSIUM →Dough improver
E. ENTEROTOXIN E. coli →traveller’s BROMATE →Neutralizers in cold waves
diarrhea (ETEC) →HBr (irritating acid)
→causes rice water →Vomiting, collapse
stool →TX: Sodium thiosulfate
ENDOTOXINS Mostly from Gram (-) →lipoidal, low BHA / BHT →Butylated hydroxyanisole (BHA)
toxicity, high dose to →Butylated hydroxytoluene (BHT)
become lethal →Carcinogenic anti-oxidant
TYPHOID Salmonella typhosa →causes typhoid
fever VOLATILE CO (acetylene gas), Non- Alkaloids
PROTEUS Proteus species →causes UTI hydrocyanic acid (prussic volatile
acid), alcohols, acetone,
POISON OTHER NAME NOTES phenols, formaldehyde
HCl Muriatic acid →Found in bathroom disinfectants
→White burns
H2SO4 Oil of vitriol →Ground coffee vomitus
→Brown-black burns
HNO3 Aqua fortis →Yellow burns
PHENOL Carbolic acid →Bleaching white burns
NaOH Lye →Found in detergents
Sosa →Forms hard soaps
KOH Caustic potash →Found in detergents
→Forms soft soaps
NaOCl Dakin’s Soln →Bleaching agent

SYNTHETIC POISONS
ISOPROPYL →Ingredient of rubbing alcohol
ALCOHOL →Very toxic (120 mL)
(CRUDE OIL
ALCOHOL)
ETHYLENE OXIDE →Anti-freeze liquid
→ Used in aeronautics
PICRIC ACID →Trinitrophenol
→Colorant in textile industries
ANILINE →Blue oil
→Found in crayons
→TX: methylene blue
 PHARMACEUTICAL DOSAGE FORMS AND DRUG DELIVERY PHARMACOPEIAS
SYSTEMS  The term pharmacopoeia comes from the Greek word
PSMB411 “pharmakon” (drug) and “poiein” (to make).
DRUG  Present Official standard of Purity, Strength, Quality, and
 An agent used in the diagnosis, mitigation, treatment, cure, or Analysis of drugs
prevention of diseases in humans and animals.  *USP/NF (United States Pharmacopeia / National Formulary) –
 DIAGNOSIS: Ex. BaSO4 (Barium sulfate) – used as a contrast commonly used world wide
medium specially if you want to have a x-ray examination of  *British Pharmacopeia, USP (drugs) & NF (excipients)
your GI tract OFFICIAL COMPENDIA
 MITIGATION: Ex. Analgesic ♠ The official compendium contains drug monographs which
 TREATMENT/CURE: Ex. Antibiotics assured availability of quality drugs and pharmaceutical
 PREVENTION: Vaccines, Oral contraceptive Pills (OCP) products.
DEVELOPMENT OF THE PHARMACY PRACTICE LITITZ PHARMACOPEIA
HIPPOCRATES • The first American pharmacopeia published in 1778 at Lititz,
 Greek physician who is credited with the introduction of Pennsylvania.
scientific pharmacy and medicine. • It was a 32-page booklet consisting of 84 internal and 16
 Known as the Father of Medicine external drugs and preparations.
 Theory of humoral pathology DR. LYMAN SPALDING
PEDANIUS DIOSCORIDES • He was called “The father of USP”
 Greek physician and Botanist who was the first to deal with OFFICIAL COMPENDIA (CONT.)
botany as an applied science of pharmacy.  On December 15, 1820, the first USP was published in English
 His work, De Materia Medica, is a milestone in the and Latin. It was a 272-page and 217 drugs were listed in it.
development of pharmaceutical botany and in the study of  At first, the revision of USP was every 10 years but was decided
naturally occurring medicinal materials (Pharmacognosy). to revise it every 5 years (1940).
 Father of Pharmacology  1888, the first National Formulary was published under the title
 Botanist/Pharmacologist “National Formulary of Unofficial Drugs”.
CLAUDIUS GALEN  1975, US Pharmacopoeial convention purchased NF.
 First Pharmacist/Botanist associated with galenicals  1980, the first combined compendium (USP-NF) was
(tinctures, fluidextracts, syrups, ointments) published.
 *Galenicals are the compounds or pharmaceutical  In 1864, the first British Pharmacopoeia.
products/compounds that was made using mechanical means MONOGRAPH
 Originator of the formula for a cold cream, essentially similar to 1. Official Title (Generic Name)
that known today 2. Graphic or Structural Formula
AUREOLUS PHILIPUS THEOPHRASTUS BOMBASTUS VON 3. Empirical Formula
HOHENHEIM 4. Molecular Weight
 Also called PARACELSUS 5. Established Chemical Names
 A Swiss physician and chemist who introduced chemical 6. Chemical Abstracts Service (CAS) Registry Number
science from the traditional botanical science. 7. Chemical Purity – In terms of percentage
 He quoted that “All drugs are poison, it’s just a matter of dose” 8. Cautionary Statement
 He replaced 4 body fluids to 3 chemical constituents namely: 9. Packaging
• Sulfur – combustibility 10. Storage
• Mercury – liquidity 11. Chemical and Physical Tests
• Salt – stability 12. Method of Assay
 *According to Paracelsus, the diseases are chemical OTHER REFERENCES TO DRUG STANDARDS:
abnormalities that can be treated with chemicals  Homeopathic Pharmacopoeia of the United States (HPUS)
KARL WILHELM SCHEELE o Homeopathy – homoios (similar), pathos (disease)
 Swedish pharmacist who discovered the following organic  International Pharmacopoeia/ Pharmacopeia
acids: lactic, tartaric, citric, oxalic and arsenic. Internationalis (Published by WHO)
 He discovered OXYGEN a year before Priestley.  BP
FRIEDRICH SERTURNER  EP
 German pharmacist who isolated morphine from opium. POP QUIZ
PIERRE ROBIQUET 1. He is called the “Father of USP”. DR. LYMAN SPALDING
 He independently isolated codeine from opium. 2. Monographs on excipients and other articles used in
JOSEPH CAVENTOU AND JOSEPH PELLETIER pharmaceutical. OFFICIAL COMPENDIA
 They isolated quinine and cinchonine from cinchona. 3. HPUS stands for? HOMEOPATHIC PHARMACOPOEIA OF
 Also, they discovered strychnine and brucine from Nux THE UNITED STATES
vomica. NEW DRUG DEVELOPMENT AND APPROVAL PROCESS
PIERRE ROBIQUET AND JOSEPH PELLETIER SOURCES OF NEW DRUGS
 Both isolated caffeine  Plant Kingdom
POP QUIZ  Animal sources
1. He is known as the Father of Medicine that proposed the  Microbiological world
Theory of Humoral Pathology. HIPPOCRATES  Biological Source
2. German pharmacist who isolated morphine from opium. PLANT SOURCE
FRIEDRICH SERTURNER  Rauwolfia serpentina (Reserpine)
3. Greek Physician and Botanist who was he first to deal with - Tranquilizer and a Hypotensive agent
botany as an applied science of Pharmacy. PEDANIUS
DIOSCORIDES  Digitalis lanata (Digoxin)
STANDARDIZATION OF DRUGS - A cardiac glycoside
DRUG STANDARDS  Vinblastin and Vinctristine
 The scientific basis for drug products to ensure uniformity and - *From Vinca rosea aka Catharanthus roseus (a Periwinkle
quality leading to the development and publication of plant)
monographs. - For certain types of cancer (Acute Leukemia)
 Pacific Yew Tree (Paclitaxel)
 - *Taxus brevifolia
- For ovarian cancer
ANIMAL SOURCE
 Draculin was developed from vampire bat saliva to treat heart
attacks and strokes in humans
 Endocrine glands of cattle, sheep and swine
- Thyroid extract, insulin and pituitary hormone (used as
Hormonal Replacement Therapy).
 Urine of Pregnant mares
- Source of Estrogens
MICROBIOLOGICAL SOURCE
 Bacitracin – from strain of B. subtilis
 Polymycin B – from B. polymyxa
 Tetracycline – from S. aureofaciens
 Chloramphenicol – from S. venezuelae
 Erythromycin – from S. erythreus
 Neomycin – from S. fradiae
BIOLOGICAL SOURCE Pre-clinical PHASE I PHASE II PHASE III
▪ Serums, Anti-toxins, and Vaccines (living or killed Testing
microorganisms) Years 3.5 1 2 3
▪ These became lifesavers since the discovery of Edward Test Laboratory 20 to 80 100 to 300 1000 to
Jenner on the smallpox vaccine in England in 1796. Population and animal File healthy patient 3000
GOAL DRUG studies IND volunteers volunteers patient
✓ Produces the specifically the desired effect at volunteers
Purpose Assess FDA Determine Evaluate Verify
✓ Administered by the most desired route (Generally orally)
*Mostly safe and easiest route of administration safety and safety and effective- effective-
biological dosage; ness, look ness,
✓ Minimal dosage and dosage frequency activity Bioav for side monitor
✓ Has optimal onset and duration of activity effects adverse
✓ Easily produced at low cost reactions
✓ Pharmaceutically elegant from long-
✓ Physically and chemically stable in various conditions of use term use
and storage Success 5,000
✓ Exhibit no side effect Rate compounds 5 enter trials
✓ Would be eliminated completely and without residual effect evaluated
DRUG DISCOVERY *The goal of clinical trials (Phase I, II & III) is to make sure that the drug
➢ Choosing a Disease – Focus is on the financial return is safe, pure and effective
➢ Choosing a drug Target – Receptor, enzymes and metabolic PRE-CLINICAL STUDIES
processes.  Chemical and Physical Characterization
➢ Medical Folklore  Pharmacology
➢ Existing Drugs  Pharmacokinetics
➢ Combinatorial synthesis  Pharmacodynamics
➢ Molecular Modification  Pharmaceutics
➢ Mechanism-based Design  Analytical studies
➢ Computer-aided Design  Toxicology
➢ Serendipity and Prepared Mind
➢ Use of NMR
➢ Screening of natural products
IDENTIFYING A BIOASSAY
*Bioassay means wants to determine if the compound possess a
pharmacological action
1.) IN VITRO TEST
- Initial bioassay that takes place outside the organism, in an
artificial environment such as a laboratory where drug activity is
tested on isolated tissues, cells, or enzymes.
2.) IN VIVO TEST
- Subsequent bioassay by biological experiment or technique
carried out within a living organism

HUMAN STUDIES
BLINDED STUDIES
✓ Single Blind Studies – The patient does not know or
unaware of the agent administered.
✓ Double Blind Studies – Neither the patient nor the
clinician is award of the agent administered.
 OPEN LABEL STUDIES 3. Microbiological source of Erythromycin. STREPTOMYCES
- Parties are aware of the agents’ identities that will be ERYTHRAEUS
administered to them. DOSAGE FORM DEVELOPMENT
SUBMISSION OF A NEW DRUG APPLICATION DOSAGE FORM
 Submitted to the FDA for review and approval after the  It is a finished formulation of a drug preparation designed to
completion of the clinical trials and requirements have been contain a specific amount of a medication.
met. THE NEED FOR DOSAGE FORMS:
 When the preclinical and clinical studies have proven the IND’s  For protection of drug substance from the destructive
effectiveness and safety by all parameters. influences at atmospheric oxygen or moisture.
PHASE IV *Cause usually oxygen it greatly affects the stability of your
 Phase 4 also known as Post Marketing Studies and drug
manufacturing scale-up activities take place.  For the protection of the drug from the destructive influence of
 Scale-up – increase in the batch size from the clinical batch, gastric acid after oral administration.
submission batch, or to the full-scale production batch size,  To conceal the salty, bitter, offensive taste or odor of a drug
using the finished, marketed product. substance.
 *If it is in phase 4 it means it is already in the market.  To provide liquid dosage forms of substances soluble in the
 Product development may continue. desired vehicle.
 *Also, during Phase 4, if it is given in many people, it is much  To provide liquid preparations of substances that are either
more possible to see the side effects and adverse effects of the insoluble or unstable in the vehicle.
drugs  To make minute or small dose of a drug larger enough to be
 *Also, during Phase 4, the drug can still be recalled and picked up with the fingers.
withdrawn from the market if it is discovered they are toxic  To provide for optimal drug action through inhalation therapy.
ADDITIONAL APPLICATIONS  To provide extended drug action through controlled-release
 ANDA or ABBREVIATED NEW DRUG APPLICATION design.
- Filed for generic copies by competing companies following  To provide optimal drug action from topical administration sites.
expiration of patent term protection.  To provide for the insertion of a drug into one of the body orifice.
- *They will not undergo preclinical and clinical trials since the  To provide for the placement of drugs directly into the blood
drug is already studied for clinical and preclinical, so they will submit stream.
ANDA together with Bioequivalence study PHYSICOCHEMICAL PARAMETERS
 Melting point
 SNDA or SUPPLEMENTAL NEW DRUG APPLICATION
 Phase Rule
- There are changes in synthesis, formulation, analytical
 Polymorphism
standards, containers and labeling of drug products.
 Particle size
- *And also if they have discovered that they can extend the
 Solubility
expiration date or any new stability data
 Membrane permeability
LEAD COMPOUND
 Partition coefficient
 A prototype chemical compound that has a fundamental
 Dissociation constant
desired biologic or pharmacologic activity.
DRUG STABILITY
▪ Example 1: Development of new generations of
STABILITY
cephalosporin antibiotics.
 Capability of a particular formulation in a specific container or
▪ Example 2: Additional H2-Antagonists from the
closure system to remain within its physical, chemical,
pioneer drug Cimetidine.
microbiological, therapeutic and toxicological specifications.
▪ Remember: some of the compounds present or
EXPIRATION DATE
available in the market are still under tests or in
 Limits the time during which the product may be dispensed by
continuous drug development
the pharmacist or used by the patient
 Since most drugs have primary and secondary effects, taking
SHELF-LIFE
advantage of secondary effects leads to a drugs secondary
 Refers to the duration of time during which a drug preparation
indication.
will remain physically, chemically, therapeutically, toxicology
▪ Example: Finasteride (Proscar/Atepros) – primarily
and microbiology stable (possessing NLT 90% of the labeled
used for BPH/ Benign Prostatic Hyperplasia, also
potency).
used now for baldness for men
TYPES OF STABILITY:
PRODRUGS
 Chemical
 A compound that requires metabolic biotransformation after
o Hydrolysis
administration to produce the desired pharmacologically active
o Oxidation
compound.
 Physical
NEW DRUG
 Microbiologic
 A combination of two or more old drugs or change in usual
 Therapeutic
proportions of drugs in an established combination product is
 Toxicologic
considered new if the change alter safety and efficacy.
TYPES OF STABILITY STUDIES:
 A change in previously approved formulation or method of
1. LONG-TERM OR ACTUAL
manufacture constitutes newness since such change can alter
 Conducted under the usual / normal conditions of the
effects and safety of a product.
environment, transport and storage expected during
 A proposed new use for an established drug, a new dosage
product distribution.
regimen or schedule, a new dosage form leads to a drug’s
 25 +/- 2°C, 60 +/- 5% RH (Relative Humidity), 12 mos.
status new and triggers reconsideration for safety and efficacy.
 It makes use of different “climatic zones” also called
POP QUIZ
Global Assessment of Stability of exposure:
1. Filed for the generic copies by competing companies following
expiration of patent term protection. ANDA or ABBREVIATED Zone 1 Temperate
NEW DRUG APPLICATION Zone 2 Subtropical
2. The science of the properties of the drugs and its effects in the Zone 3 Hot and dry
body. PHARMACOLOGY, PHARMACOKINETICS, Zone 4 Hot and humid
TOXICOLOGY, PHARMACODYNAMICS, 2. ACCELERATED
PHARMACEUTICS
  Studies designated to increase the rate of chemical or BUFFERING AGENT
physical degradation of a drug substance or product  Resist changes in pH
by using exaggerated storage conditions.  Citrates, Acetates, Phosphates (CAP)
 40.0 °C, 75 % RH, 6 mos. CHELATING AGENT
EXTEMPORANEOUS PREPARATIONS  Used as stabilizers for heavy metals capable of promoting
֎ NON-AQUEOUS LIQUIDS AND SOLIDS instability
- from a manufactured product → 6 months, or not later than 25%  Edetate disodium, EDTA
of the time remaining COLORANT
- From a USP/NF active → 6 months  Impart color for improved aesthetic appeal
֎ AQUEOUS OR WATER CONTAINING  Dyes and Lakes
- From a manufactured solid form → 14 days stored at cold  Red ferric oxide, caramel, FD&C (Food Drug & Cosmetics) and
temperature D&C (Drug & Cosmetics)
֎ OTHERS → 30 DAYS CLARIFYING AGENT
PREPARATION CATEGORY MONOGRAPH OR  Used as filtering aid for the adsorbent properties
LABEL WARNING  Bentonite
EPINEPHRINE Adrenergic drug Do not use if it is EMULSIFYING AGENT
brown or contains  Promote and maintains dispersion of finely divided particles of
precipitate. a liquid
ISOPROTERENOL Adrenergic Do not use if it is pink  Acacia, spans and tweens, SLS, Cetyl pyridinium chloride
(Bronchodilator) to brown or contains FLAVORANT
a precipitate  Imparts pleasant flavor
PARALDEHYDE Hypnotic Subjected to HUMECTANT
oxidation to form  Prevents drying out of the preparation
acetic acid.  Glycerin, sorbitol, propylene glycol
NITROGLYCERIN Anti-anginal Keep on original LEVIGATING AGENT
container or  An intervening agent used to reduce the particle size
supplemental  Mineral oil, glycerin
container specifically OINTMENT BASES
labeled suitable for  Semisolid vehicle for drug substances
Nitroglycerin tablets SOLVENT
to prevent loss of  An agent used to dissolve another substance
potency.  Water, alcohol, glycerin, mineral oil, Peanut oil, Sesame oil,
Cottonseed oil, Castor oil
PHARMACEUTICAL INGREDIENTS
STIFFENING AGENT
1. ACTIVE INGREDIENT OR ACTIVE PHARMACEUTICAL
 Agents that increase the thickness or hardness of the
INGREDIENT
preparation
 Any component that is intended to furnish pharmacologic
 Cetyl alcohol, paraffin, white wax, yellow wax
activity or other effect in the diagnosis, cure, mitigation,
SUPPOSITORY BASE
treatment, or prevention of diseases or to affect the structure of
 A vehicle for drug substances formulated into suppositories
the body of a man or other animals.
 Cocoa butter, witepsol, wecobee, PEG mixtures
2. INACTIVE OR EXCIPIENT
SURFACTANT
 Any component other than the active ingredient in a drug
 Agents which reduces interfacial tension
product that is used as a carrier for the active ingredients of a
 Benzalkonium chloride, polysorbate 80, SLS
medication. In addition, excipients can be used to aid the
SUSPENDING AGENT
process by which a product is manufactured.
 Increases viscosity and reduces rate of sedimentation
INERT SUBSTANCES ADDED TO ACHIEVE THE FINAL DOSAGE
 CMC, MC, bentonite, acacia
FORM
SWEETENING AGENT
ACIDIFYING AGENT
 Imparts sweetness
 Provide acidic medium for product stability
 Mannitol, saccharin, sorbitol, sucrose
 HNO3 (Nitric acid), HCl (Hydrochloric acid), CH3COOH (Acetic
TABLET EXCIPIENT
acid)
 ESSENTIAL COMPONENTS
ALKALINIZING AGENT
- those that impart satisfactory characteristics to the formulation
 Provide alkaline medium for product stability
(diluent, binders, disintegrants)
 Ammonia solution, sodium borate, sodium carbonate, trolamine
 COMPRESSION AIDS
ADSORBENT
- those that impart satisfactory compression characteristics
 Hold the molecules into its surface for moisture sensitive
(glidants, lubricants, and antiadherents)
products
 SUPPLEMENTARY COMPONENTS
 Cellulose, activated charcoal
- those that give additional desirable physical characteristics to
AEROSOL PROPELLANT
the finished tablets (colors, flavors, sweetening agents, adsorbents)
☻ Develops the pressure in the container and expels the product
FLAVORANTS
☻ DCDFM (Dichlorodifluoromethane), DCTFE
Flavorants degrade due to exposure to light, temperature, oxygen,
(Dichlorotetrafluoroethane), TCMFM
water, enzymes, contaminants, and other components thereby they
(Trichloromonofluoromethane)
must be carefully selected and checked for stability.
ANTIOXIDANT
CORRELATED STRUCTURES:
 Inhibits the process of oxidation for possible cause of product
Salty → salts
deterioration
Sweet taste → organic compounds with –OH groups
 Butylated hydroxytoluene (BHT), sodium bisulfite, ascorbic acid
Bitter taste → N-containing compounds
ANTIFUNGAL AGENT
CARRIERS:
 Prevents growth of fungi
1. OIL-SOLUBLE CARRIERS
 Paraben, benzoic acid, sodium benzoate
- Soybean and other edible oils.
ANTIMICROBIAL PRESERVATIVE
2. WATER-SOLUBLE CARRIERS
 Prevents growth of microorganism
- Water, ethanol, propylene glycol, glycerin, and emulsifiers.
 Benzalkonium chloride, benzyl alcohol, chlorobutanol,
3. DRY CARRIERS
thimerosal, phenol
 - Maltodextrin, corn syrup solids, modified starches, gum arabic, 4. PHENYLMERCURIC NITRATE AND ACETATE- 0.002 to
salt, sugars, and whey protein. 0.01%
TYPES: 5. PHENOL- 0.1 to 0.5%
1. NATURAL FLAVOR 6. CRESOL- 0.1 TO 0.5%
 Derived from fruit or fruit juice, vegetable or vegetable juice, 7. CHLOROBUTANOL- 0.5%
herb, bark, root, and leaves of plants. 8. BENZALKONIUM CHLORIDE- 0.002 TO 0.01%
2. ARTIFICIAL FLAVOR 9. COMBINATION OF METHYLPARABEN AND
 Not derived from natural sources. PROPYLPARABEN- 0.1 to 0.2%
METHODS: POP QUIZ!
1.) Blending 1.) Storage condition temperature for cool. FREEZER (-20◦C),
2.) Overshadowing COLD (2-8◦C), COOL (8-15◦C), CONTROLLED ROOM
SWEETENING AGENTS TEMPERATURE (25◦C), EXTREME (Above 40◦C)
SACCHARIN 2.) Concentration of Phenylmercuric nitrate and acetate as a
 300× sweetness (by weight), E954, FDA Approved 1958 preservative. 0.002 to 0.01%
 Found to cause bladder tumors but by a non-DNA reactive 3.) The general area of study is concerned with the formulation,
mechanism manufacturing, stability, and effectiveness of a Pharmaceutical
 Remains unmetabolized dosage form. PHARMACEUTICS
CYCLAMATE BIOPHARMACEUTICS AND PHARMACOKINETICS
 30× sweetness (by weight), Abbott, E952, FDA Banned 1969 CONSIDERATION
(can cause bladder cancer in rats), pending re-approval ROUTES OF ADMINISTRATION
 Safety has not been demonstrated ORAL ROUTE
ASPARTAME Advantages: Disadvantages:
 160–200× sweetness (by weight), BN: NutraSweet, E951, FDA  Uncomplicated  Slow drug response
Approved 1981  Convenient  Irregular absorption
 metabolized into phenylalanine, aspartic acid, and methanol  Safe  Destruction of certain
 Because of metabolism to phenylalanine, it is discourage to use drugs at the GIT.
for person with phenylketonuria. Proper labeling shall apply. RECTAL ROUTE
 Because they cannot metabolize phenylalanine adequately, Advantages: Disadvantages:
this can result to hyperphenylalaninemia (mental retardation  Drugs are destroyed by  Inconvenient, frequently
and affect the fetus) GI fluids when oral route irregular
SUCRALOSE is precluded  Difficult to predict.
 600× sweetness (by weight), Tate & Lyle, E955, FDA Approved  When patient is
1998 unconscious, or
ACESULFAME K incapable of
 structurally similar to saccharin swallowing.
 130 times as sweet as sucrose PARENTERAL ROUTE
 More stable than aspartame
Advantages: Disadvantages:
STEVIA
 Rapid absorption  Strict sterility required
 from Stevia rebaudiana bertoni  Doses are smaller  More expensive
 Natural, safe, non-toxic  Used for uncooperative,  Difficult to recover
 30 times as sweet as sucrose unconscious patients,  Requires competent
COLORANTS or those unable to trained personnel for
NATURAL accept oral medication. proper administration.
֎ Minerals, Plants, animals A. INTRAVENOUS INJECTION
֎ Ex. Red ferric oxide, anattenes, cochineal  Used when a rapid clinical response is necessary
SYNTHETIC B. INTRA-ARTERIAL INJECTION
 William Henry Perkin accidentally discovered  Used in certain special situations, to deliver a high
mauverine/mauve on 1856, the first synthetic dye. concentration of drug to a particular tissue.
 Contains chromophore C. INTRATHECAL INJECTION
 *Chromophore – this are atoms that produces colors  Given via lumbar puncture and injection into the
CLASSIFIED INTO: subarachnoid space.
1. FD and C – Food, Drugs and Cosmetics D. INTRAMUSCULAR INJECTION
2. D and C – Drugs and Cosmetics  Drugs may be injected into the arm (deltoid), thigh
3. External D and C – means applied externally (vastus lateralis) or buttocks (gluteus maximus).
DYES E. SUBCUTANEOUS INJECTION
 In the form of diluted solutions. Greater accuracy in  Used for drugs like insulin, absorption is slower
measurement than IM
LAKES TOPICAL APPLICATION
 Pigments added to liquid dyes. Commonly, they are in the form Advantages: Provides direct local effects
of fine dispersions or suspensions. A. EYE
FD&C YELLOW NO.5 (TARTRAZINE)  For desired local effects.
♣ Cause allergy in humans B. INTRAVAGINAL
FD&C RED NO.4 (MARACHINO CHERRIES)  For infections or contraceptives.
♠ External application and cosmetics C. INTRANASAL
FD&C RED NO. 2 (AMARANTH)  For alleviation of local symptoms.
֎ researchers in Russia reported that it can cause cancer in rats. D. SKIN
PRESERVATIVES  minimimal systemic exposure
EXAMPLES AND THEIR CONCENTRATIONS: E. DRUG PATCHES
1. BENZOIC ACID- 0.1 to 0.2%  (drug enters systemic circulation by zero order
2. SODIUM BENZOATE- 0.1 to 0.2% kinetics – a constant amount of drug enters the
3. ALCOHOL- 15 to 20% circulation per unit time)
*Alcohol preparations that has 15% & above concentration are
already self-preserving
 INHALATION  Extrahepatic sites: lung, kidney, intestine, skin and placenta
 Volatile anesthetics, as well as many drugs which affect and GI tract
pulmonary function, are administered as aerosols.  The general goal of drug metabolism is to transform such
compounds into more polar (i.e., more readily excretable) water
DRUG ABSORPTION soluble products.
BIOLOGIC FACTORS PHYSICOCHEMICAL PHASE 1 PHASE 2
FACTORS Phase I reactions refer to those
- Membrane permeability - pH partition which convert a drug to a more
- Blood flow - Ion Trapping polar compound by introducing or
- Gastric emptying time unmasking polar functional
- Drug binding groups such as -OH, -NH 2 , or -
SH.
TRANSPORT MECHANISM DRUG ELIMINATION
1. PASSIVE DIFFUSION  The kidney is the most important organ for the excretion of
 Describe the passage of drug molecules through a membrane drugs and/or their metabolites.
that does not actively participate in the process.  Some compounds are also excreted via bile, sweat, saliva,
 The absorption process is driven by the concentration gradient exhaled air, or milk, the latter a possible source of unwanted
existing across the membrane. exposure in nursing infants.
 It is described by the Fick’s first law. BIOAVAILABILITY
Examples:  Bioavailability is the proportion of a drug that is delivered to its
 Weak organic acids site of action in the body.
 Weak organic bases IMPORTANCE:
 Organic nonelectrolytes (alcohol, urea)  The amount or proportion of the drug absorbed from a
 Cardiac glycosides formulation or dosage form.
1.1. CONVECTIVE (PORE) TRANSPORT  The rate or speed at which the drug was absorbed.
 Drug transport across tight (narrow) junctions between cells or  The duration of the drug’s presence in the biological fluid or
transendothelial channels of cells tissue as correlated to patient response.
 Drug molecules dissolved in aqueous medium at the absorption  The relationship between drug blood levels and therapeutic
site move along the solvent through the pore effectiveness or toxic effects.
 Also known as paracellular transport PARAMETERS FOR ASSESSMENT
Examples: PEAK HEIGHT CONCENTRATION
 Inorganic and organic electrolytes up to 150 to  is the maximum drug concentration observed in the blood
400MW plasma or serum following a dose of the drug (cmax)
 Ions of opposite charge of pore lining TIME OF THE PEAK CONCENTRATION
 Ionized sulfonamides  the time required to achieve the maximum level of drug in the
2. SPECIALIZED TRANSPORT SYSTEM blood (Tmax)
2.1. ACTIVE TRANSPORT AREA UNDER THE CURVED
- type of specialized transport system where movement of the  a representative of the total amount of drug absorbed into the
drug molecule is against the concentration gradient circulation following the administration of a single dose of that
2.2. FACILITATED DIFFUSION drug (AUC)
- also a type of specialized transport system where movement of BIOEQUIVALENCE
drug is not against concentration gradient - means the drugs have the same bioavailability
2.3. ION PAIR TRANSPORT PHARMACEUTICAL EQUIVALENTS
- Strong electrolytes drugs are highly ionized or charged  drug products that contain identical amounts of identical active
molecules, penetrate membranes poorly ingredient
Examples: BIOLOGICAL EQUIVALENTS
 Quaternary ammonium compounds  pharmaceutical equivalents which when administered to the
 Sulfonic acids same individual, in the same dosage regimen, will result in
2.4. PINOCYTOSIS / ENDOCYTOSIS comparable bioavailability
- engulfing vesicles PHARMACEUTICAL ALTERNATIVES
Examples:  drug products that contain identical therapeutic moiety but not
 Fats, glycerin, starch necessarily same amount or dose or form
 Parasite eggs  *Same pharmaceutical or active ingredient but different in dose,
 Vitamins A, D, E and K dosage form
 Plastic particles, hairs and yeast cells THERAPEUTIC EQUIVALENTS
 Ferritin and insulin ♣ drug products that are pharmaceutical equivalents and can be
DRUG DISTRIBUTION expected to give the same therapeutic effect when
CENTRAL COMPARTMENT administered to the patient under the conditions specified in the
 The central compartment includes the well-perfused organs labeling
and tissues (heart, blood, liver, brain and kidney) with which DOSAGE REGIMEN
drug equilibrates rapidly. USUAL DOSE
PERIPHERAL COMPARTMENT(S) ♠ the amount that may be expected to produce, in adults, the
 The peripheral compartments include those organs which are medicinal effect for which it is intended
less well-perfused, and with which drug therefore equilibrates INITIAL DOSE
more slowly. ♦ also the priming or loading dose, is the amount required to
 Ex. Bones, Tendons, Cartilages attain the desired concentration of the drug in the blood or
SPECIAL COMPARTMENTS tissues
 These include cerebrospinal fluid (CSF) and central nervous PEDIATRIC DOSE
system (CNS), the blood brain barrier, pericardial fluid,  dose administered to children
bronchial secretions and fluid in the middle ear PROPHYLACTIC DOSE
METABOLISM  the amount administered to a patient before exposure or
 a.k.a Drug Biotransformation contraction of the illness
 Liver is the primary organ for metabolism
THERAPEUTIC DOSE attached to or accompanying any
 the amount which is administered to a patient after the pharmaceutical specialties
exposure or contraction of an illness LABELING means all labels and other written, printed, or
USUAL DOSAGE RANGE graphic matter upon any article or on any of its
 amounts of drug that may be prescribed within the work of usual container or wrappers accompanying such
medical practice articles.
POP QUIZ! INNER LABEL label on or affixed to an immediate container of
Mario is a missionary priest based in South Africa. Recently a pandemic a drug
occur causing hundreds and thousands of death due to malaria. Before OUTER LABEL labels on or affixed to the outside package of a
his flight, he was administered with Chloroquine to avoid the drug.
development of the disease. What type of dosage regimen does Mario PRODUCT’S a written, full disclosure and balanced
administered? PROPHYLACTIC DOSE PACKAGE presentation of the positive as well as the
LABELING, PACKAGING AND STORAGE INSERT negative aspects of the drug product to enable
CONTAINER the prescriber to utilize the drug most safely and
a device that holds a drug and is, or may be, in direct contact with the effectively
drug. The immediate container is that which is in direct contact with the *Outsert (outside)
product. The closure is part of the container.
TYPES OF CONTAINERS: STORAGE CONDITIONS
WELL-CLOSED COLD between 2 to 8°C
- it protects the contents from extraneous solids and from loss of FREEZER (-20) to (-10°C)
the drug under ordinary conditions of handling, shipment, storage and
ULTRA FREEZE (-80°C)
distribution
COOL between 8 and 15° C
TIGHT CONTAINER
- protects the contents from contamination by extraneous liquids, ROOM 15 and 30°C
solids or vapors from loss of the drug and from efflorescence, TEMPERATURE
deliquescence or shipment, storage and distribution WARM between 30 and 40°C
HERMETIC CONTAINER EXCESSIVE HEAT any temperature above 40°C
- container that is impervious to air or any other gas under the
ordinary or customary conditions of handling, shipment, storage and SOLID DOSAGE FORMS
distribution POWDERS
LIGHT-RESISTANT CONTAINERS “Powder" refers to a dosage formulation that is solid in physical state but
- containers that prevent photochemical decomposition of the formulation may be composed of only the active drug or may be a
substances that are photosensitive. mixture of the active drug and other ingredients.
SINGLE DOSE CONTAINER *Base dosage form
- in which the quantity of the sterile drug contained is intended ADVANTAGES:
as single dose and which cannot be resealed once opened. ● Each dose can contain a different amount of active drug
MULTIPLE-DOSE CONTAINER ● Can be administered easily to infants and young children who
- hermetic container which permits withdrawal of successive cannot swallow tablets or capsules
portions of the contents without changing the strength or endangering ● Drug will have a rapid onset of action since disintegration is not
the quality or purity of the remaining portions required
SINGLE –UNIT CONTAINER ● Drugs tend to most stable as a solid
- one that is designed to hold a quantity of drug intended for ● Can be made into many different dosage formulations
administration of a single dose POWDER FINENESS
MULTIPLE-UNIT POWDER DEFINITION
- contain one or more dose of the medication VERY COARSE (NO. 8) All particles pass through a No. 8 sieve
SINGLE USE PACKAGE and not more than 20% pass through a
- a unit dose package at the time a prescribing physician orders No. 60 sieve.
that particular amount of the drug for a specific patient COARSE (NO. 20) All particles pass through a No. 20 sieve
SPECIAL TYPES OF CONTAINERS: and not more than 40% pass through a
CHILD-SAFETY CONTAINER No. 60 sieve.
♦ CR container, one that is difficult for children under 5 years of MODERATELY All particles pass through a No. 40 sieve
age to open or to obtain harmful amount of the contents COARSE (NO. 40) and not more than 40% pass through a
TAMPER-RESISTANT CONTAINER No. 80 sieve.
♦ one having indicators or barriers to entry which, if breached or FINE (NO. 60) All particles pass through a No. 60 sieve
missing, can reasonably be expected to provide visible and not more than 40% pass through a
evidence to consumers that tampering has occurred No. 100 sieve.
OFFICIAL GLASS TYPES VERY FINE (NO. 80) All particles pass through a No. 80 sieve.
TYPE I highly resistant-borosilicate glass There is no limit to greater fineness
TYPE II treated-soda lime glass
TYPE III soda-lime glass COMMINUTION METHODS
TYPE IV general purpose soda-lime glass TRITURATION OR Grinding a drug in a mortar to reduce
*The best is the Type I glass COMMINUTION its particle size
PLASTIC CONTAINERS FITZMILL COMMINUTING example of mill used in large scale
ADVANTAGE DISADVANTAGE MACHINE grinding and pulverization
● Lightness of weight ● Permeability LEVIGATION reduces the particle size by triturating
● Versatility ● Leaching it in a mortar or spatulating it on an
● Convenience ● Sorption ointment slab or pad with a small
● For unit-dose delivery ● Alteration of container amount of a liquid in which the solid is
● Transmission of light not soluble.
Example of levigating agents:
LABELING 1. Mineral oil
LABEL means a display of written, printed or graphic 2. Glycerin
matter upon the immediate container, or
 BLENDING METHODS ● SECOND METHOD-
SPATULATION Mixing is with the aid of a spatula; not suitable “Fluid-bed
for large quantities of powders; suitable for Granulation” or fluid
powders capable of forming eutectic mixtures bed processing is done
*Eutectic means two solid if they come in by placing the particles
contact with each other they decrease their in a conical piece of
melting point so they can be liquidify equipment and
TRITURATION For comminution and mixing as well; light vigorously dispersed
trituration ensures light diffusible powders while and suspended while a
heavy trituration results to fine and dense liquid excipient is
powders sprayed on them and
GEOMETRIC For potent substance mixed with large amounts the product is dried,
TRITURATION of diluents. forming granules or
OR DILUTION *The addition of potent substances should be in pellets of defines
small proportion to make sure they are uniformly particle size.
distributed
SIFTING Using sifters to produce light, fluffy powders CAPSULES
TUMBLING Large containers which rotates generally by a  are solid dosage forms in which one or more medicinal or inert
motorized process substances are enclosed within a small gelatin shells.
 Empty capsule shells are made of gelatin, sugar, and water.
BULK POWDERS  Can be clear, colorless, tasteless, and colored with various
DUSTING POWDERS ● fine medicinal (bulk) powders FD&C and D&C dyes.
intended to be dusted on the skin ADVANTAGES OF CAPSULES:
by means of sifter-top containers.  Conveniently carried
● Bentonite, kaolin, kieselguhr,  Readily identified
magnesium carbonate, starch,  No need to use spoons or measuring devices
and talc  Accurate amount
DOUCHE POWDERS They are most commonly intended for  Most capsules, like tablets, are tasteless when swallowed.
vaginal use although they may be  Available to many dosage strengths
formulated for nasal, otic or ophthalmic  Manufacturers’ name and product code number could emboss
use or imprint on the surface to be easily identified.
GELATIN
INSUFFLATIONS Are extremely fine powders to be
1. PORK SKIN GELATIN
introduced into body cavities.
- contributes to the plasticity and clarity to the blend, thereby
POWDER SPRAYS In contrast to dusting powders, powders
reducing haze or cloudiness of the capsules.
dispensed under pressure will deliver
2. CALF BONE GELATIN
targeted and uniform application at the
- gives tough and firm film but tends to be hazy and brittle by
desired site
itself.
HARD GELATIN CAPSULES
DIVIDED POWDERS
 Aka Dry Filled Capsules (DFC) or Telescoping Capsules
CHARTULAE/POWDER PAPERS (CHART)
 When humidity is low, the capsules become brittle; if humidity
Single doses of powdered medicinals individually wrapped in
is high, the capsules become flaccid and shapeless.
cellophane, metallic foil, or paper.
 Empty capsules are numbered from 000 (the largest size that
TYPES OF POWDER PAPERS:
can be swallowed) to 5 (the smallest size)
● Vegetable parchment – moisture resistant
 Consist of body and Cap.
● White bond paper – usually doesn’t have moisture resistant
LIMITATIONS OF CAPSULES AS DOSAGE FORMS:
effect
♣ Not used for extremely soluble salts such as KI, KBr, or
● Glassine - moisture resistant
Ammonium chloride due to sudden release of the drug in the
● Waxed – water proof paper
GIT, which may be irritating.
GRANULES
♣ Not used for highly efflorescent or deliquescent material.
 Are particles ranging in size from about 4 to 12-sieve size
METHOD OF PRODUCTION OF HARD GELATIN CAPSULE:
range.
 The “pin method” is adapted with use of completely automatic
 The most popular compounded granulation is the effervescent
machines consisting of dipping, spinning, drying, stripping, and
powder (sometimes called effervescent salts).
joining the capsules. The entire process takes about 45
METHODS OF PREPARING GRANULES:
minutes.
1. DRY METHOD
PREPARATION OF FILLING HARD GELATIN CAPSULES:
2. WET METHOD
“PUNCH METHOD”
DRY METHOD WET METHOD Using a spatula, the powder mixture is formed into a cake having a depth
● FIRST METHOD- The ● FIRST METHOD- of approximately 0ne-fourt to one-third the length of the capsule body.
dry powder is passed moistening of the The capsule body is held between the thumb and forefinger and punch
through a roll compactor powder mixture and vertically into the powder cake repeatedly until filled. This is not done
(also called roll press or passing of the resulting with bare hands.
roller compactor) and paste through a screen “CAPSULE FILLING MACHINES”
then through a of the mesh size to Some capsule filling machines are hand-operated that are used by
granulating machine. produce the desired pharmacists on regular preparations. It can produce 200 to 2000
● SECOND METHOD- size of granules. The capsules per hour. Some capsule filling machines are more complicated
“Slugging” or the granules are placed on and are used by manufacturing firms.
compression of powder drying trays and dried
mixture into larger by air or under heat.
tablets or slugs on The granules are
compressing machine periodically moved on
under 8,000 to 12,000 the drying tray to
pounds of pressure. prevent adhesion into a
larger mass.
 SPECIALLY-DESIGNED CAPSULES analysis of the proportion of drug
SPANSULE dissolved.
- Ends of both bodies and cap WEIGHT VARIATION AND The USP requires adherence to
are highly tapered/narro wed. Used CONTENT UNIFORMITY standards for weight variation and
by Smith Kline Beecham. content uniformity for capsules to
assure the accuracy of dosage units.
STABILITY TESTING This is to determine the intrinsic
stability of the active drug molecule
and the influence of environmental
PULVULES factors such as temperature,
- End of the body producing peg humidity, light, formulative
is tapered but the cap making peg is components, and the container.
rounded. Used by Eli Lilly.
TABLETS
KAPSEAL
- This is a distinctive looking ֎ Solid dosage forms contain drug with or without suitable
capsule because of the sealing with diluents prepared by Compression or Molding
a colored band of gelatin. This is ֎ Are solid dosage forms of medicinal substances usually
used by Parke-Davis. prepared with the aid of suitable pharmaceutical adjuncts.
CHARACTERISTICS OF IDEAL TABLETS:
 Free of defects
 Strong enough to withstand the mechanical stresses of
production
CONI-SNAP  Chemically and physically stable over time
- The rim of the capsule body is  Capable of releasing medicinal agents in a predictable and
not straight but tapered slightly. This reproducible manner
eliminates splitting of the joined TABLET EXCIPIENTS:
capsule  Essential Components
 Compression Aids
 Supplementary components
ESSENTIAL COMPONENTS
DILUENTS ● Are fillers designed to make up the
required bulk of the tablet when the
drug dosage amount is inadequate.
● Common diluents include kaolin,
SOFT GELATIN CAPSULES lactose, mannitol, starch,
 Also referred to as “Pearls” or SGC microcrystalline cellulose, powdered
 Oblong, elliptical, or spherical in shape, may be used to contain sugar, and calcium phosphate.
liquids, suspensions, pasty materials, dry powders, or BINDERS AND  Are added in either dry or liquid form to
pelletized materials. ADHESIVES promote granulation or to promote
SUBSTANCES TO BE FILLED IN SGC cohesive compacts during direct
 Water immiscible, volatile and nonvolatile liquids such as compression.
vegetable and aromatic oils, aromatic and aliphatic Examples:
hydrocarbons, chlorinated hydrocarbons, ethers, esters,  10%-20% aqueous preparation of
alcohol and organic acids. cornstarch
 Water miscible, nonvolatile liquids such as polyethylene  25%-50% solution of glucose
glycols, and nonionic surface-active agents as polysorbate.  Molasses
 Water miscible and relatively nonvolatile compounds, as  various natural gums
propylene glycol and isopropyl alcohol, depending upon factor  cellulose derivatives (CMC,
as concentration used and packaging conditions. microcrystalline cellulose)
METHODS OF PREPARING SGC:  Gelatins
1. Plate Process (the oldest method)  povidone
2. Rotary Die Process DISINTEGRANTS  These are added to tablet formulations
3. Reciprocating Die Process to facilitate disintegration when the
MICROENCAPSULATION tablet contacts water in the
A process by which solids, liquids, or even gases may be enclosed in gastrointestinal tract.
microscopic particles by formation of thin coatings of wall material Examples:
around the substance. Gelatin is a common wall-forming material. This  cornstarch and potato starch
process has originated in the late 1930s.  starch derivatives
TESTS FOR CAPSULES:  cellulose derivatives
DISINTEGRATION TEST The capsules are place in a basket  clays and cation exchange resins.
rack assembly which is immersed 30
times per minute into a 37 degree COMPRESSION AIDS
Celsius controlled fluid. To satisfy the LUBRICANTS Reduce the friction that occurs between the
test, the capsules disintegrate walls of the tablet and the walls of the die cavity
completely into a soft mass having when the tablet is ejected. Talc, magnesium
no palpably firm core and only some stearate and calcium stearate are commonly
fragments of the gelatin shell remain. used
DISSOLUTION TEST The capsules are place in a vessel ANTIADHERENTS Reduce sticking, or adhesion, of the tablet
with a dissolution medium (37 +/- 0.5 granulation or powder to the faces of the
degree Celsius temperature). Then a punches or the die walls.
stirrer is rotated at a specified speed. GLIDANTS Promote the flow of the tablet granulation or
Then, it is withdrawn for chemical powder by reducing friction among particles
 ● Using sucrose or lactose
SUPPLEMENTARY COMPONENTS IMMEDIATE-RELEASE ● Designed to disintegrate and release
● Colorants TABLETS their medication with no special rate
● Flavoring agents controlling features
● Sweetener INSTANTLY ● RDTs dissolve in the mouth within 1
● Adsorbents (Ex. Bentonite, Magnesium oxide, Magnesium DISINTEGRATING OR minute
carbonate) DISSOLVING TABLETS ● Prepared into lyophilized foam mixture
TABLETING MACHINE and compression
HOPPER For storing the granulation material EXTENDED-RELEASE ● These are designed to release the
for compression TABLETS drug in the predetermined time.
FEED FRAME/FEED SHOE For distributing the granulation
material into the die cavities
METHODS OF PREPARING COMPRESSED TABLETS
DIE CAVITIES For controlling the size and shape of
DIRECT COMPRESSION Powders must possess free flowing as
the tablets
well as cohesive properties that enable
PUNCHES (UPPER AND For compacting the granulation
them to be compressed directly in a
LOWER) material within the die cavities
tablet machine without need of either
CAMS For guiding the punches
wet or dry granulation.
Example is KCl
PERORAL SOLID DOSAGE FORM READY FOR WET GRANULATION This method has more operational
ADMINISTRATION manipulations, and is more time-
COMPRESSED ● Are formed by single compression and consuming than the other methods.
TABLETS have no special coating, they are made The wet granulation method is not
from powdered, crystalline, or granular suitable for drugs which are
materials, alone or in combination with thermolabile or hydrolyzable by the
excipient such as binders, disintegrants, presence of water in the liquid binder.
diluents, and colorants DRY GRANULATION The ingredients in the formulation are
MULTIPLE ● Layered tablets are prepared by intimately mixed and pre-compressed
COMPRESSED compressing a tablet granulation around on heavy duty tablet machines. The
TABLETS a previously compressed granulation. slug which is formed is ground to a
● The operation is repeated to produce uniform size and compressed into the
multiple layers. finished tablet.
COMPRESSION- ● Compresses an outer shell around the
COATED, OR DRY- tablets. PROCESSING PROBLEMS
COATED, TABLETS ● Thinner, more uniform coating than CAPPING Is the partial or complete separation of the top
sugarcoating, and it can be used safely or bottom crown from the main body of the
with drugs that are sensitive to moisture tablet.
SUGAR- AND ● Are compressed tablets that are LAMINATION Is separation of a tablet into two or more
CHOCOLATE-COATED coated for various reasons. The coating distinct layers.
TABLETS may be added to protect the drug from PICKING Is removal of the surface material of a tablet
air and humidity, to provide a barrier to a by a punch.
drug's objectionable taste or smell, or to STICKING Is adhesion of tablet material to a die wall.
improve the appearance of the tablet. MOTTLING Is unequal color distribution.
FILM-COATED ● Are compressed tablets that are PEELING Is the large amounts of film flaking from the
TABLETS coated with a thin layer of a water- tablet surface.
insoluble or water-soluble polymer. ORANGE PEEL Is the roughness of the tablet surface due to
GELATIN-COATED ● Capsule-shaped compressed tablet EFFECT failure of the spray droplets to coalesce.
TABLETS ● Coating facilitates swallowing, BRIDGING Is the filling-in of the score line or indented
tamper-evident design logo.
ENTERIC COATED ● Modified-release tablets TABLET EROSION Is the disfiguration of the core tablet.
● Intended to pass through the stomach
intact to disintegrate and release their TABLET EVALUATION
content for absorption along the 1. Weight variation test
intestines 2. Content Uniformity
BUCCAL AND ● Flat and oval tablets intended to be 3. Tablet thickness
SUBLINGUAL dissolved in the buccal pouch or beneath 4. Tablet hardness and friability
TABLETS the tongue 5. Tablet disintegration
CHEWABLE TABLETS ● Disintegrate smoothly and rapidly 6. Tablet dissolution
when chewed or allowed to dissolve in
the mouth. POP QUIZ!
● These tablets contain specially colored 1. This problem is characterized by the appearance of small
amounts of film fragments flaking from the table surface.
and flavored mannitol and yield a
PICKING
creamy base.
2. Specially designed capsules that consist of highly tapered
EFFERVESCENT ● Compressing granular effervescent
bodies and cap used by Smith Kline Beecham. SPANSULE
TABLETS salts or other materials that release 3. Container that is impervious to air or any other gas under the
carbon dioxide gas when they come into ordinary or customary conditions of handling, shipment,
contact with water. storage and distribution. HERMETIC CONTAINER
MOLDED TABLETS ● Tablets that are soft and soluble and
rapidly dissolves
TABLET TRITURATES ● Compressed or molded, small, IraG >.< (04/16/22)
cylindrical containing small amount of
potent drugs
 PHARMACEUTICAL DOSAGE FORMS AND DRUG DELIVERY with or without flavoring,
SYSTEMS sweetening, or coloring agents
PSMB 411 dissolved in water or co-solvent
LIQUID DOSAGE FORMS water mixtures.
 Solutions *Add Flavoring, sweetening,
 Syrups coloring – if it is intended for
 Elixirs children
 Spirits OPHTHALMIC SOLUTION Sterile preparation to be used on
 Special Application Solutions the eyes.
SOLUTIONS
• Liquid preparations that contain one or more chemical Ophthalmic drops should be
substances dissolved in a suitable solvent or mixture of clear and practically free from
mutually miscible solvents. particles when examined under
• *It is a homogenous mixture (will only see one phase that is the suitable conditions of visibility.
liquid phase) It is homogenous because the solid particle that TOPICAL SOLUTIONS Are solutions, usually aqueous
is dissolved in a suitable solvent. The solid phase will not be but often containing other
seen, only the liquid phase. solvents such as alcohol and
ADVANTAGES: polyols, intended for topical
1. Completely homogenous doses application to the skin, or as in
2. Immediate availability for absorption and distribution the case of Lidocaine Oral
3. Provides a flexible dosage form Topical Solution, to the oral
- it means you can easily adjust the dose of the drug that is mucosal surface.
depend on the age of the patient or any other factors affecting
the dosage of the drug. The term “lotion” is applied to
*Solutions- are easier to swallow. solutions or suspensions applied
*Prerequisite of absorption (need to be in solution so there will be topically
fast and high bioavailability compare to other dosage form. ACCORDING TO SOLVENT USED
*Solutions can be used in any route of administration) AQUEOUS SOLUTIONS Solutions that contain water as
- it can be an oral the solvent.
- it can be an IV NON-AQUEOUS SOLUTIONS Solutions that contain a solvent
other than water. Ether,
CLASSIFICATION benzene, petrol, carbon
ACCORDING TO ROUTE OR ACCORDING TO SOLVENT tetrachloride are some common
SITE OF APPLICATION USED solvents.
- Otic - Aqueous and non-
- Oral aqueous COMPOSITION OF SOLUTIONS:
- Ophthalmic *Aqueous – water  SOLUTE (smallest amount)
- Topical *Non-aqueous- other *Usually it is the solid phase
solvent  SOLVENT (Larger amounts, can dissolve the solute, nontoxic,
safe for ingestion or topical application, aesthetically
ACCORDING TO ROUTE OR SITE OF APPLICATION acceptable)
OTIC SOLUTIONS Intended for instillation in the  ADDITIVES (Colorants, flavorants, preservatives or buffering
outer ear, are aqueous, or they agents)
are solutions prepared with CONCENTRATED AND DILUTED SOLUTIONS:
glycerin or other solvents and  The solution that has a greater proportion of solute is said to
dispersing agents. be more concentrated than the other that has a lesser
proportion.
EXAMPLES:
● Antipyrine and *Concentrated- meaning it has larger amount of the solute
Benzocaine Otic  If the proportion of solute is less, the solution is said to be dilute.
Solution
*Benzocaine- used to relieve ear * Generally, the diluted acid is around 10% for it to be a diluted
pain or any swelling in the ear except acetic acid. Because acetic acid for it to be diluted, it
● Neomycin, Polymyxin B has a 6% concentration.
Sulfates and SOLUBILITY
Hydrocortisone Otic  the expression of the quantity of a drug that can be maintained
Solutions in solution in a given solvent at a given temperature and
*Used for the infection in the ear pressure.
that is common in swimmer’s  It is usually expressed as the number of milliliters of solvent
ear and children required to dissolve 1 gram of the drug.
ORAL SOLUTIONS Are liquid preparations, intended
for oral administration, that
contain one or more substances
 *The amount of water dissolved in every 1g of the drug. The
unit is in grams and ml. Usually they use the word part, but it
can also use the word grams and ml.
DESCRIPTIVE TERM PARTS OF SOLVENT SOLUBLE INSOLUBLE
REQUIRED FOR 1 PART OF nitrates, chlorates, acetates, Hydroxides and oxides
SOLUTE chlorates and lactates
Very soluble <1 Sulfates, sulfites and Phosphates, carbonates,
Freely soluble 1-10 thiosulfates silicates, borates and
Soluble 10-30 hypochlorites
Sparingly soluble 30-100 Chlorides, bromides, iodides
Slightly soluble 100-1,000 Ammonium and quaternary
Very slightly soluble 1,000-10,000 ammonium salts
Practically insoluble >10,000 Salts of monovalent cations
SATURATED AND SUPERSATURATED SOLUTIONS: SOLVENTS:
SATURATED SOLUTION 1. WATER
• Is one that contains the maximum amount of solute that the TYPES OF WATER:
solvent will accommodate at room temperature and pressure. A. POTABLE WATER
SUPERSATURATED SOLUTION - Water that is fit to drink.
• Is one that contains a larger amount of solute than the solvent - Unsuitable for certain pharmaceutical purposes
can normally accommodate at that temperature and pressure.  Hard water – with soluble salts of Ca and Mg
*They are unstable because there are parts that are undiluted *Usually it has precipitation of soap and it blocks the
and undissolved particles. In the long run, it can precipitate. drainage
FACTORS AFFECTING SOLUBILITY *Not foamy
TEMPERATURE  solubility with an  in  Soft water – treated with lime or ammonia
temperature HARD WATER VS SOFT WATER
PRESSURE  in pressure =  solubility of a HARD WATER SOFT WATER
gas in a liquid APPLIANCES • Leaves • Can contain
deposits of high levels
*Carbonated drinks because limescale of corrosive
they are dissolved in high • Stains salt
pressure however once opened it water • Cleans
will have bubbles. fixtures dishes with
PH OF THE SOLUTION WEAK BASES – not very • Can leave less water
soluble in water but soluble in clothes
dilute acid solution discolored
DRINKING • Has • Can
WEAK ACIDS – form water potential deprive
soluble salts in basic solution health drinkers of
PARTICLE SIZE The larger particles are generally benefits vital
less soluble. from minerals
calcium and • Has higher
*The smallest the particle size, magnesium levels of
the more it is soluble. • Generally, sodium
PHYSICAL AGITATION More rapid dissolution tastes
NATURE OF THE SOLUTE "Like dissolves like." better
*Water soluble dissolves it in SKIN • May harm • Lathers
water. Lipid soluble dissolves it in your hair soap well
a lipid solvent. • Can trigger • Rinses
eczema shampoo
NATURE OF SOLUTE AND SOLVENT • Strips skin from hair
SOLUTE POLAR SOLVENT NON-POLAR of surface easier and
SOLVENT oils quicker
POLAR Soluble Insoluble • Energy Tip: using water softener can extend the life of
NON-POLAR Insoluble Soluble appliances and lower energy costs
IONIC Soluble Insoluble B. PURIFIED WATER
GENERAL CONSIDERATIONS: - Clear, colorless, odorless and neutral (pH 5 – 7)
✓ Organic compounds increasing in molecular weights reduces PREPARATION OF PURIFIED WATER:
its solubility in polar solvents  Distillation
*Octanol – it is not really soluble or not water soluble since the  Ion-Exchange
number of carbon increases, the water solubility decreases.  Reverse Osmosis
✓ Branched chains are more soluble than straight chain PREPARATION OF PURIFIED WATER
compounds DISTILLATION Water is first heated to boiling.
Then the water vapor rises to a
 *Distilled water is called the condenser where cooling water D. STERILE WATER FOR INJECTION
Hungry water lowers the temperature so the - sterilized by autoclaving in sealed containers immediately
*Used in Industrial processes vapor is condensed, collected (within 4-6 hours of collection) to prevent the development of
and stored. bacteria from which pyrogens are derived.
ADVANTAGES DISADVANTAGES E. WATER FOR INJECTION FREE FROM DISSOLVED GASES
➢ Removes a broad range of  Some contaminants can be - water must be free from dissolved carbon dioxide and other
contaminants carried into the condensate dissolved air.
➢ Reusable  Requires careful maintenance F. BACTERIOSTATIC WATER FOR INJECTION
to ensure purity - Sterile water for injection containing one or more suitable
 Consumes large amounts of antimicrobial agents.
energy *Add anti-microbial agent – Benzyl Alcohol
 System usually takes a large *Ideally, parenteral solutions should not have preservatives but
space on counter bacteriostatic water for injection has a preservative.
ION EXCHANGE The ion exchange process *Bacteriostatic water for injection usually in 30 mL only.
percolates water through bead- Because larger volume also equals to larger preservative.
like spherical resin materials. G. STERILE WATER FOR IRRIGATION
Ions in the water are exchanged - sterile, distilled, nonpyrogenic water for injection intended only
for other ions fixed to the beads for sterile irrigation, washing, rinsing and dilution purposes.
ADVANTAGES DISADVANTAGES 2. ALCOHOL
➢ Removes dissolved inorganics  Does not effectively remove  considered the primary solvent for many organic compounds
effectively. particles, pyrogens or bacteria.  94.9 – 96% ethanol by volume
➢ Regenerable  DI beds can generate resin  Miscible with water, preserving action
➢ Relatively inexpensive initial particles and culture bacteria.  Alcohol content limits:
capital investment  High operating costs over  Under 6 y/o – 0.5%
long-term.  6 to 12 y/o – 5%
REVERSE OSMOSIS In water purification systems,  Over 12 and adults – 10%
hydraulic pressure is applied to 3. DILUTED ALCOHOL
the concentrated solution to  Mixture of equal volumes alcohol and water
counteract the osmotic pressure.  Frequently, combination of ethanol and water (Hydroalcoholic
Pure water is driven from the mixture) allows easier dissolution of both lipophilic and
concentrated solution and hydrophilic molecules.
collected downstream of the 4. ETHYL RUBBING ALCOHOL
membrane.  70% of ethanol, additives
ADVANTAGES DISADVANTAGES  volatile, flammable
 Rubefacient, germicide,
➢ Effectively removes all types  Flow rates are usually limited
of contaminants to some extent to a certain gallons/day rating. antiseptic, vehicle for topical
(particles, pyrogens, *it has to pass to semi permeable preparation
microorganisms, colloids and membrane that’s why it is limited
5. ISOPROPYL RUBBING ALCOHOL
dissolved inorganics)
➢ Requires minimal  70% isopropyl
maintenance.  External application as rubefacient and
*Osmosis – the movement of water from high water content to a lower soothing rub and as a vehicle for topical
water content products
*High water content- diluted  91% is for diabetic patients in preparing
*Low water content- the solution is concentrated needles and syringes for hypodermic
From low concentration of solution to a larger concentration (High injections of insulin and for disinfecting the
water content to less water content) skin.
Osmosis – is a natural phenomenon where it will pass through a semi *Isopropyl is better than ethyl alcohol. It is only the exception
permeable membrane. to the rule, if there is branching, decrease of activity but for
Reverse Osmosis- meaning you apply pressure on the one that is Isopropyl. The branching increases the activity of the isopropyl
concentrated. The movement is from high to low water content (From solution.
low water content to high water content) Put pressure on the one with 6. GLYCERIN, GLYCERINE, GLYCEROL
low water content so that the water is going to higher water content.  Clear, syrupy liquid, sweet taste
 a simple polyol (sugar alcohol)
compound.
 Miscible with water and alcohol
 Viscous, preservative action
*Polyol- contains two or more OH group
C. WATER FOR INJECTION *Viscous in nature
- is water purified by distillation or by reverse osmosis, free from 7. PROPYLENE GLYCOL
pyrogen.  1,2-propanediol or propane-1,2-diol,
 Viscous liquid, miscible with water,
acetone, chloroform and alcohol
  One of the major ingredients of the liquid used in electronic ingredients in the preparation of
cigarettes. tinctures and fluid extracts.
DIGESTION  This is a form of maceration in
OTHER NON-POLAR SOLVENTS: which gentle heat is used during
● HYDROCARBONS the process of extraction.
● PEANUT OIL - refined fixed oil from peanuts (Arachis  It is used when moderately
hypogaea) elevated temperature is not
● SESAME OIL – a.k.a til oil, edible vegetable oil derived from objectionable. The solvent
sesame seeds (Sesamum indicum) efficiency of the menstruum is
● CORN OIL - refined fixed oil obtained from the embryo of Zea thereby increased.
mays INFUSION  The process of extracting
● COTTONSEED OIL - fixed oil from seeds of cultivated varieties chemical compounds or flavors
of the cotton plant (Gossypium) from plant material in a solvent
● MINERAL OIL - mixture of liquid hydrocarbons from petroleum such as water, oil or alcohol, by
PREPARATION OF SOLUTIONS: allowing the material to remain
1.) SIMPLE SOLUTIONS suspended in the solvent over
• Done by dissolving the solute in a suitable solvent, which may time
contain other ingredients, which stabilize the active ingredients. DECOCTION  The crude drug is boiled in a
EXAMPLES: specified volume of water for 15
● Calcium hydroxide topical solution USP (lime water) minutes it is then cooled and
● Sodium phosphates oral solution USP strained or filtered.
● Strong iodine solution USP  Suitable for extracting water-
2.) SOLUTION BY CHEMICAL REACTION soluble and heat stable
• Is prepared by reacting two or more solutes with each other in constituents
a suitable solvent.  Typically used in preparation
EXAMPLE: of Ayurvedic extracts.
● Aluminum Subacetate POP QUIZ!
● Topical Solution 1. Method of purifying water that percolates water through bead-
like spherical resin materials that exchange the ions fixed to
beads. – ION EXCHANGE
2. Is one that contains a larger amount of solute than the solvent
can normally accommodate at that temperature and pressure.
3.) SOLUTION BY EXTRACTION – SUPERSATURATED SOLUTION
• Drugs or pharmaceutical necessities vegetable or animal origin 3. The process of extracting chemical compounds or flavors from
are often extracted with water or with water containing other plant material in a solvent such and allowing the material to
substances. remain suspended in the solvent over time. - INFUSION
METHODS: SYRUPS
● Maceration • These are concentrated aqueous preparations of sugar-
● Decoction substitute with or without added flavoring agents and medicinal
● Percolation substances.
● Digestion ADDITIVES:
● Infusion  Polyols, such as glycerin or sorbitol, may be added to retard
EXTRACTION METHODS crystallization of sucrose or to increase the solubility of added
MACERATION  Is the process in which the ingredients.
solid ingredients are placed in a  Alcohol often is included as a preservative and also as a
stoppered container with the solvent for flavors.
whole of the solvent and allowed  Further resistance to microbial attack can be enhanced by
to stand for a period of at least incorporating antimicrobial agents.
three days, with frequent MEDICINAL ☺ Are those to which therapeutic
agitation. The mixture is strained SYRUPS compounds have been added (e.g.
and the marc pressed, and the Guaifenesin Syrup)
combined liquids are clarified by NON-MEDICATED ☺ Are syrups containing flavoring agents
filtration or by decantation after OR FLAVORED but not medicinal substances.
standing. VEHICLES
PERCOLATION  Is where the active ingredients FLAVORING ☺ Are syrups containing pleasantly flavored
are extracted from a macerated SYRUPS substances (e.g. Cherry Syrup, Acacia
drug mass in a narrow cone- Syrup, etc.).
shaped vessel open at both ends SIMPLE SYRUP ☺ Contains only sucrose and purified water
(percolator) through the passage (e.g. Syrup USP).
of an extracting liquid called ADVANTAGES:
menstruum.  Provides a pleasant means of administering a liquid form of
 This is the procedure used disagreeable tasting drug.
most frequently to extract active
  They may particularly effective in the administration of drugs to  With a few exceptions, non-potent tinctures represent 20 g of
youngster, since their pleasant taste usually dissipates any the drug per 100 ml of tincture.
reluctance on the part of the child to take the medicine.  Percolation is the procedure of choice when the crude drugs
 The fact that syrups contain little or no alcohol adds to their are cellular in structure; plant exudates tend to become
favor among parents. impacted in the percolator and stop the flow so that maceration
PREPARATION OF SYRUPS is preferred in such preparations.
SOLUTION WITH HEAT The sucrose usually is added to MISCELLANEOUS SOLUTIONS:
the purified water or aqueous  Aromatic Waters
solution and heated until solution is  Diluted Acids
affected, then it is strained and  Spirits
sufficient purified water is added to AROMATIC ✓ Aromatic waters, known also as medicated
make the desired weight or WATERS waters, are clear, saturated aqueous solutions
volume. of volatile oil or other aromatic or volatile
AGITATION WITHOUT HEAT This process is used in those substances.
cases where heat would cause the EXAMPLES:
loss of valuable, volatile ● Aromatic waters prepared from
constituents. essential oils, e.g. peppermint water,
ADDITION OF A This method is used in those cases have been used as carminatives.
MEDICATING LIQUID TO in which fluidextracts, tinctures, or ● Chloroform water, is used in
SYRUP other liquids are added to syrup to expectorants preparations.
medicate it. ● Rose water is a perfume.
PERCOLATION In this procedure, purified water, or PREPARATION OF AROMATIC WATERS
an aqueous solution, is permitted Distillation  The distillation method consists of placing the
to pass slowly through a bed of method odoriferous portion of the plant or drug from
crystalline sucrose in a cylindrical which the aromatic water is to be prepared in a
percolator, thus dissolving it and suitable still with sufficient purified water and
forming a syrup. then distilling most of the water. The aqueous
phase, which may require further clarification, is
the product.
ELIXIRS  Example: Orange flower water
♦ Defined by the USP as "clear, sweetened, hydroalcoholic Solution method ☻ In solution method the volatile substance is
liquids intended for oral use. agitated with purified water for a period of 15
♦ Alcohol content ranges from 5-40% (10-80 proof) minutes.
EXAMPLES OF MEDICATED ELIXIRS: ☻ The mixture is then set aside for at least 12
 Dexamethasone elixir USP hours, to ensure saturation, before it is filtered
 Phenobarbital elixir USP through wetted filter paper
ELIXIRS CONT. ☻ Example: Chloroform water
 The main ingredients in elixirs are ethanol and water but Alternate The volatile material is mixed thoroughly with
glycerin, sorbitol propylene glycol, flavoring agent, solution method 15 gm. of purified talc. This mixture is agitated
preservatives, and syrups often are used in the preparation of with a liter of purified water for 10 minutes, prior
the final product. The solvents are often used to increase the to filtration.
solubility of the drug substance in the dosage form.  The talc or other inert material functions as
 Elixirs containing over ten to twelve percent of alcohol are both a filter aid and a distribution agent.
usually self-preserving and do not required the addition of an Dilution method  An alcoholic solution of the essential oil is
anti-microbial agent for their preservative. mixed with water and talc. The mixture is
 PREPARATION: Simple Solution with Agitation - and / or by agitated; after several hours it is filtered. The
the admixture of two or more liquid ingredients. concentrate contains between 50 and 55 per
*without any application of heat. Usually concentration that cent alcohol by volume. One volume of
contain 10-12% of alcohol that is self-preserving. concentrate is diluted with 39 volumes of water,
ELIXIRS CONT. producing aromatic water which contains less
• An elixir may contain both water- and alcohol-soluble than 1.5 per cent of alcohol.
ingredients. If such is the case, the following procedure is  Concentrated waters, such as peppermint,
indicated: dill, cinnamon, and caraway, may be prepared
 Dissolve the water-soluble ingredients in part of the water. as follows:
 Add and solubilize the sucrose in the aqueous solution. Essential oil 2 ml.
 Prepare alcoholic solution containing the other Alcohol 90% 60 ml
ingredients. Talc 5 g.
 Add the aqueous phase to the alcoholic solution, filter, and Water to 100 ml.
make to volume with water. DILUTED ACIDS  The diluted acids in the USP are aqueous
TINCTURE solutions of acids, of a suitable strength for
 Are alcoholic or hydroalcoholic solutions prepared from internal administration or for the manufacture of
vegetable or chemical substances. other preparations.
 Tinctures of potent drugs represent the activity of 10 g of the
drug in each 100 ml of the tincture; they are 10% tinctures.
 Strengths of the official undiluted acids are • Each mL contains 1g of crude material it represents
expressed as percentages in weight (w/w) EXAMPLES
Strengths of the official diluted acids are  Cascara Sagrada Fluid extract, Garlic Fluidextract, Licorice
expressed as percent in volume (w/v) Fluid extract, and Senna Fluidextract
EX: Diluted hydrochloric acid USP has been *Fluidextracts- prepare through the process of percolation
used in the treatment of achlorhydria.
*Achlorhydria- a disease where the stomach is EXTRACTS
not able to secrete HCL. HCL is important in the  Are concentrated preparations of vegetable (or animal) drugs. Most
digestion of foods. extracts are prepared by percolation followed by the evaporation of
SPIRITS  Spirits, sometimes known as essences, are all or nearly all the menstruum, yielding a powdered or ointment-like
alcoholic or hydroalcoholic solutions of volatile product of extracted drug in concentrated form.
substances with alcohol contents ranging from  On a weigh-for-weight basis, extracts commonly are two to six times
as potent as the crude drug.
62-85% (124-170 proof).
- 1 g of extract is more likely equivalent to 2-6 grams of crude
 A spirit or spirit-like preparation may be used drugs.
in the formulation of aromatic waters or other Extracts are in 3 forms:
pharmaceuticals that require a distinctive flavor. a. Semiliquid extracts or those with syrupy consistency
 Whisky and Brandy are prepared by prepared without the intent of removing all or even most of the
distillation. menstruum
b. Pilular or solid extracts of a plastic consistency prepared with
 Compound Orange Spirit, Camphor Spirit,
nearly all of the menstruum removed
and Compound Cardamon Spirit are prepared c. Powdered extracts prepared to be dry by the removal or all of
by simple solution. the menstruum.
 Peppermint Spirit, USP is prepared by POP QUIZ!
solution with maceration. ♣ This are alcoholic or hydroalcoholic solutions prepared from
vegetable or chemical substances. - TINCTURE
NON-AQUEOUS SOLUTIONS ♣ These are concentrated aqueous preparations of sugar
substitute with or without added flavoring agents and medicinal
LINIMENTS
substances. - SYRUP
 They were once called embrocations. ♣ It is the expression of the quantity of a drug that can be
 Are alcoholic or oleaginous solutions or emulsions of maintained in a given solvent at a given temperature and
various medicinal substances intended to rubbed on the skin pressure. – SOLUBILITY
 Hydroalcoholic liniments DISPERSE SYSTEM
 Oleaginous liniments  The term “Disperse System” refers to a system in which one
 Emulsion liniments or insoluble-containing liniments must have substance (The Dispersed Phase) is distributed, in discrete
units, throughout a second substance (the continuous Phase
a “Shake well.” label. or vehicle).
 Are never taken internally  Each phase can exist in solid, liquid, or gaseous state.
 Are prepared in the same manner as solutions, emulsions, or COMPONENTS:
suspensions A. DISPERSION MEDIUM
COLLOIDIONS  also called “external phase”
 Collodions are liquid preparations containing pyroxylin (a  The liquid vehicle, to which the insoluble drug is
distributed.
nitrocellulose) in a mixture of ethyl ether and ethanol.
B. DISPERSE PHASE
 They are applied to the skin by means of a soft brush or other  also called “internal phase”
suitable applicator and, when the ether and ethanol have  The undissolved or immiscible drug distributed
evaporated, leave a film of pyroxylin on the surface. throughout the liquid vehicle.
 EXAMPLE: salicylic acid collodion USP, contains 10% w/v of Particles of dispersed phase vary in size
salicylic acid in flexible collodion USP  0.1 nm-0.5 𝜇m colloidal dispersion
 Are prepared by dissolving 4% w/v pyroxylin in 3:1 mixture of  10-50 𝜇m coarse dispersion (Suspension & emulsion)
 0.5 – 10 𝜇m fine dispersion (Magmas & gels)
ether and alcohol.
SUSPENSIONS  Suspensions are heterogenous
 FLEXIBLE COLLOIDION - Prepared by adding 2% camphor system consisting of 2 phases
and 3% castor oil to collodion. Castor oils makes the product  The continuous phase is
flexible for ease in skin areas that are normally moved. The generally liquid or semisolid &
camphor gives a water-proof effect. dispersed or internal phase is
GLYCERINS particulate matter.
 Glycerins or glycerites are solution or mixtures of medicinal ADVANTAGES DESIRED FEATURES
substances in not less than 50% by weight of glycerin.  Suspension can  Particles should settle slowly
improve chemical and redispersed readily upon
 Glycerin is used as the sole solvent for the preparation of
stability of certain drug. shaking of its container.
antipyrine and benzocaine otic solution USP. E.g Procaine penicillin  The particle size of the
 Glycerins are hygroscopic and should be stored in tightly G suspension should remain fairly
closed containers.  Drug in suspension constant throughout long
LIQUID PREPARATIONS PREPARED BY EXTRACTION exhibits higher rate of periods of undisturbed standing
PROCESSES: bioavailability than  The suspension should pour
FLUIDEXTRACTS other dosage forms. readily and evenly from its
Bioavailability is in container.
• Are also known as Liquid Extracts following order.
• Are preparation containing plant matter, containing alcohol as  Solution > Suspension
solvent, or preservative, or both > Capsule >
 Compressed Tablet > ORAL SUSPENSION
Coated Tablet  Liquid preparation containing solid particles dispersed in a
 Duration and onset of liquid vehicle, with suitable flavoring agent, intended for oral
action can be administration
controlled. E.g.  Some suspensions labeled as Milks or Magmas fall into this
Protamine Zinc-Insulin category.
suspension Examples:
 Suspension can mask  Milk of Magnesia
the unpleasant bitter  Bentonite Magma
taste of drug. E.g. TOPICAL SUSPENSIONS
Chloramphenicol  Liquid preparation containing solid particles dispersed in a
ADDITIONAL CLASSIFICATION OF liquid vehicle, intended for application to the skin.
COMPONENTS OF SUSPENSIONS  Lotions
SUSPENSION  Gels
♣ Flocculating agents- Based on Particle size  LOTIONS- are generally suspensions of solid materials in an
enhance particle ♣ Coarse suspensions are aqueous vehicle
“dispersability suspensions having particle ADVANTAGES
♣ Viscosity enhancers- sizes of greater than about  It may be preferred over semisolid preparations
reduce sedimentation 1 micron in diameter because of their non-greasy character
rate in the flocculated ♣ Colloidal suspension  Increased spread ability over large areas of skin
suspension contains particles that is  It leaves a thin coating of medicament on the skin
♣ Preservatives- not visible to the naked surface
prevents the growth of eye, the particles being  GELS- sometimes called jellies. Semisolid system consisting
microorganisms 1nm to 1𝜇m in diameter. of either suspension made up of small inorganic particles or
♣ Stabilizers- any They can be subdivided large organic molecules interpenetrated by a liquid
additive used in into: ADVANTAGES
substance and  Lyophilic  As a vehicle for the presentation of water-soluble
compounds to keep Colloidal medicaments, it is ideal because of their high-water
them stable, retard Suspension content
deterioration which form  Products tend to be smooth
♣ Wetting agents- they spontaneously *it consists of two-phase system
are added to disperse when agents with  OTIC SUSPENSIONS- liquid preparations containing
solids in continuous a high affinity for micronized particles intended for installation in the outer ear.
liquid phase. the continuous  OPHTHALMIC SUSPENSIONS- sterile liquid preparation
*To decrease contact phase are containing solid particles dispersed in a liquid vehicle intended
angle dispersed. for application to the eye.
 Lyophobic FLOCCULATED DEFLOCCULATED
Colloidal  Particles form loose  Particles exist as
Suspension- aggregates and form a separate entities
which are network like structure  Rate of sedimentation
thermodynamically  Rate of sedimentation is slow
unstable. is high  Sediment is slowly
Based on Route of Administration  Sediment is rapidly formed
ORAL formed  Sediment is very
 Magmas  Sediment is loosely closely packed and a
 Milk packed and doesn’t hard cake is formed
TOPICAL form a hard cake  Sediment is difficult to
 Lotions  Sediment is easy to redisperse
 Gels redisperse  Suspension is pleasing
OTIC  Suspension is not in appearance
OPHTHALMIC pleasing in appearance  They don’t stick to the
 The floccules stick to sides of the bottle
Based on Electrokinetic Nature of the side of the bottle.
Solid Particles
♣ Flocculated- In flocculated PREPARATION OF SUSPENSION
suspension, formed flocs DECIPITATION METHODS
(loose aggregates) will  This process is done by dispersing the finely divided powders
cause increase in in an appropriate liquid vehicle
sedimentation rate due to  The use of surfactants is desirable to ensure uniform wetting
increase in size of of the hydrophobic factors
sedimenting particles. PRECIPITATION METHODS
♣ Deflocculated- is the  This is performed by effecting precipitation in the liquid
absence of association vehicle:
which occurs when  Organic Solvent Precipitation
repulsive forces between  Precipitation effected by changing the pH
particles predominate.  By Double Decomposition Method
Particles repel each other FACTORS TO CONSIDER IN PREPARING SUSPENSION
and remain as discrete,  Wetting of the particles:
single particles.  Hydrophilic can be disperse easily
 Difficult to disperse and float on the surface due to
hydrophobic surface or entrapped air.
 Packaging and Storage of Suspensions
*High contact angle – not easily wet 1) Should be packaged in wide mouth containers having adequate air
*Almost zero wetting angle- meaning complete wetting. HLB space above the liquid.
value for wetting agent is 7-9 2) Should be stored in tight containers protected from: freezing,
excessive heat & light
 Particle size 3) Label: "Shake Before Use" to ensure uniform distribution of solid
 Too large or too small particles should be avoided. particles and thereby uniform and proper dosage.
Larger particles will settle faster at the bottom of the 4) Stored in room temperature if it is dry powder (250C). It should be
container and too fine particles will easily form hard stored in the refrigerator after opening or reconstitute.
cake at the bottom of the container.
 The particle size can be reduced by using mortar and EMULSION
pastel but in large-scale preparation different milling  a dispersed system containing at least two immiscible liquid
and pulverization equipments are used. phases. The majority of conventional emulsions in
 Sedimentation pharmaceutical use have dispersed particles ranging in
 The velocity of sedimentation of particles in a diameter from 0.1 to 100 um.
suspension can be determined by using the Stoke’s  Phases:
law:  dispersed liquid - internal or discontinuous phase
 Where:  dispersion medium - external or continuous phase
 v= velocity of sedimentation
 d= diameter of the particle What is the difference between Emulsion and Suspension?
 g= acceleration of gravity  Emulsion is a combination of two immiscible liquids whereas,
 p1= density of the particle in a suspension, the two components can be of any phase.
 p2= density of the vehicle  he stability of emulsions can be increased by adding
 h= viscosity of the vehicle emulsifiers.
 The particles in a suspension can be separated by filtering,
but particles/droplets in an emulsion cannot be separated by
filtering.
Types of Emulsion
 Water-in-oil (w/o) emulsions – Water is dispersed as droplets
in an oil or oleaginous medium.
 (cannot be removed by water)
 Nernst and Zeta Potential  Used for external preparations when emollient, lubricating,
 The difference in electric potential between the actual or protective properties are desired.
surface of the particle and the electroneutral region is  Oil-in-water (o/w) emulsions – oils, petroleum hydrocarbons,
referred to as Nernst potential. and / or waxes are the dispersed phase, and water or an
 The potential difference between the ions in the tightly aqueous solution is the continuous phase.
bound layer and the electroneutral region, referred to as  (washed by water)
zeta potential  Oil is dispersed as droplets in an aqueous medium.
 formed if the aqueous phase constitutes >45% of the total
weight and hydrophilic emulsifier is used
 O/W emulsions are used topically, orally, or parenterally.
 Multiple emulsions – o/w/o or w/o/w.
 Water-oil-water
 Oil-water-oil
 Microemulsion – appear as translucent or transparent and
have droplet diameter in the nanometer range.
 The advantage of microemulsions as dosage forms as
compared to conventional emulsions is their smaller
droplet size, which increases drug release, and their
superior physical stability.
 Thermodynamically stable, optically transparent isotropic
mixtures of biphasic o/w system stabilized with surfactants
 With droplets with the size of 100Å - 1000Å
 Use for more rapid and efficient delivery of drugs following
oral or transdermal drug delivery system
Factors that determine the type of emulsion
1. Emulsifier – Some emulsifiers form either w/o or o/w emulsion, others
form only one type
2. Phase ratio – Phase present in greater concentration tends to be
external phase
3. Order of mixing – The phase that is being added by portions tends to
be the internal phase.
Identification of Emulsion Type
 Deflocculation and flocculation  O/W and W/O
 Deflocculation of particles is obtained when the zeta  Miscibility test/Drop Dilution Test
potential is higher than the critical value and the repulsive  Conductivity test/Fluorescence test
forces supersede the attractive forces.  Dye-solubility test
 The addition of a small amount of electrolyte reduces the
zeta potential. When this zeta potential goes below the
critical value, the attractive forces supersede the repulsive
forces and flocculation occurs.
 Emulsifying Agents
 Emulsifier or surface-active agent (SAA) is molecule which has
 Fluorescence test - oils give fluorescence under UV light, two parts, one is hydrophilic and the other is hydrophobic. Upon
while water doesn’t. the addition of SAA, it tends to form monolayer film at the
 Miscibility/Dilution Test - O/W emulsion can be diluted with oil/water interface.
water and a W/O emulsion with oil. When oil is added to an
O/W emulsion or water to a W/O emulsion, the additive is not
incorporated into the emulsion and separation is apparent.

1. Natural emulsifying agents – substances derived either form animal

or plant sources
A. Those from vegetable source
acacia
 Tragacanth
 Pectin
 derivative of cellulose
B. Those from animal source
 Conductivity Test - When pair of electrodes connected to a  Gelatin
lamp and an electrical source is dipped into an O/W emulsion,  Cholesterol
the lamp lights because of the passage of current between the  wool fat
two electrodes. If the lamp does not light, it is assumed that the
system is W/O. 2. Finely divided solids – substances adsorbed in the water interface
to form a coherent film.
 Examples: Bentonite, veegum, magnesium hydroxide,
aluminum hydroxide and magnesium trisilicate
3. Synthetic emulsifying agents - or surface-active agents, they
contain both the lipophilic and hydrophilic groups.
 Anionic emulsifying agents
 Alkali soap:
♣ e.g. sodium, potassium and ammonium salts of fatty
acids
♣ Form o/w emulsions
♣ in acidic condition precipitated Fatty acid
♣ For external use
♣ Incompatible with polyvalent cations
 Cationic surfactants
 Quaternary ammonium compounds:
 Dye-solubility Test - The knowledge that a water-soluble dye ♣ E.g. Cetyl trimethylammonium bromide (Cetrimide)
will dissolve in the aqueous phase of an emulsion while an oil- and benzalkonium chloride
soluble dye will be taken up by the oil phase. Thus, if ♣ Disadvantages:
microscopic examination shows that a water-soluble dye has  Toxicity and irritancy
been taken up by the continuous phase, we are dealing with an  Incompatible with anionic surfactants, polyvalent
O/W emulsion. If the dye has not stained the continuous phase, anions
the test is repeated using a small amount of an oil-soluble dye.  unstable at high pH
Coloring of the continuous phase confirms that the emulsion is  It has marked antibacterial and anti-infective
of the W/O type. properties
  Non-ionic  Creams contain emulsifiers and preservatives which may
 toxicity and irritancy so suitable for oral and Parenteral cause contact allergy
administration  Preparation of Creams
 High degree of compatibility  Preparation of cream involves separating the formula
 Less sensitive to change pH or to addition of electrolytes components into two portions:
 E.g., Tweens (polyethylene fatty acid ester) O/W  Lipid portion
 E.g., Span (sorpitan fatty acid ester) W/O  Aqueous portion
 D- Amphoteric surfactants OINTMENT
 charge depending on the pH of the system  Semi-solid preparations intended for external application to the
 low pH cationic skin or mucous membranes.
 high pH anionic  Strong emollient effect makes it useful in dry skin conditions
 i.e., lecithin: used to stabilize i.v., fat emulsion  Occlusive effect enhances penetration of active drug and
SEMI-SOLID DOSAGE FORMS improves efficacy (especially in thickened, lichenified skin)
Topical Dosage Forms  Provides a protective film on the skin (Irritant dermatitis)
 Topical dosage form is a medication that is applied to body  Greasy, sticky, retains sweat (therefore, not suitable in wet
surfaces such as the skin or mucous membranes. weepy dermatitis, hairy areas, skin prone to folliculitis, or hot
 Many topical medications are epicutaneous. weather conditions)
 Topical medications may also be inhalational, such as asthma  Contains no water and does not require a preservative
medications, or applied to the surface of tissues other than the Oleaginous Base
skin, such as eye drops applied to the conjunctiva, or ear drops ♣ On application on the skin, they have an emollient effect,
placed in the ear, or medications applied to the surface of a protect against the escape of moisture, are effective as
tooth occlusive dressings, and can remain on the skin for long
 As a route of administration, Topicals are medications that periods without drying out, and because of the immiscibility
contrasted with enteral (in the digestive tract) and with water are difficult to wash off.
intravascular/intravenous (injected into the circulatory system ♣ Not water washable, incorporation of water with some degree
 They are intended for local effect but they may also cause of difficulty.
systemic effects. ♣ When powdered substances are to be incorporated into
Advantages of Topical Drug Delivery hydrocarbon bases, liquid petrolatum (mineral oil) may be used
 Avoidance of first pass metabolism. as the levigating agent.
 Convenient and easy to apply. Petrolatum, USP
 Avoidance of the risks and inconveniences of intravenous ♣ It is a purified mixture of semi-solid hydrocarbons obtained
therapy and of the varied conditions of absorption, like pH from petroleum.
changes, presence of enzymes, gastric emptying time etc. ♣ It is an unctuous mass, varying in color from yellowish to light
 Achievement of efficacy with lower total daily dosage of drug amber.
by continuous drug input. ♣ It melts at 38°C to 60°C and may be used alone or in
 Avoids fluctuation in drug levels, inter- and intrapatient combination with other agents as an ointment base.
variations. White Petrolatum, USP
 Ability to easily terminate the medications, when needed. ♣ It is a purified mixture of semi-solid hydrocarbons from
 A relatively large area of application in comparison with buccal petroleum that has been wholly or nearly decolorized.
or nasal cavity ♣ It is used as the same purpose as petrolatum, but because of
 Ability to deliver drug more selectively to a specific site. its lighter color, it is considered more aesthetically pleasing by
 Avoidance of gastro-intestinal incompatibility. some Pharmacist and patients.
 Providing utilization of drugs with short biological half-life, Yellow Ointment, USP
narrow therapeutic window. ♣ This ointment has the following formula:
 Improving physiological and pharmacological response.  Yellow wax... 50g
 Improve patient compliance.  Petrolatum... 950g
 Provide suitability for self-medication. White Ointment, USP
Disadvantages of Topical Drug Delivery ♣ This ointment differs from yellow ointment by substitution of
 Skin irritation of contact dermatitis may occur due to the drug white wax (bleached and purified yellow wax) and white
and/or excipients. petrolatum in the formula.
 Poor permeability of some drug through the skin. Absorption Base
 Possibility of allergenic reactions. ♣ Absorption bases are not easily removed from the skin.
 Can be used only for drugs which require very small plasma Two types:
concentration for action. a) Those that permits the incorporation of aqueous solutions resulting in
 Enzyme in epidermis may denature the drugs the formation of w/o emulsions.
 Drugs of larger particle size not easy to absorb through the skin b) Those that are w/o emulsions that permit the incorporation of
additional quantities of aqueous solutions.
Classification of Topical Drug Delivery Water-Removable Base
Solid Liquid Semi-solid ♣ Are o/w emulsion resembling creams
 Powder  Lotion  Ointment ♣ Easily washed from the skin, hence called Water Washable
 Aerosol  Liniment  Cream ♣ Easily washed from the skin and can absorb serous discharge.
 Plaster  Solution  Paste Water-Soluble Bases
 Emulsion  Gel ♣ Do not contain oleaginous components
 Suspension  Suppository ♣ Are completely water-washable, hence called Greaseless
 Aerosol ♣ They soften greatly with the addition of water and usually
used for incorporation of solid substances
CREAMS Preparation of Ointment
 Emulsion of water and oil INCORPORATION METHOD
 Classified as oil in water (o/w) or water in oil (w/o) emulsions ♣ This method involves the blending of an ingredient into the
 O/W creams spread easily and do not leave the skin greasy vehicle.
and sticky ♣ This is done using a glass slab and a pair of spatulas for small
 W/O creams are more greasy and more emollient volumes or using a mortar and pestle for larger volumes.
FUSION METHOD
♣ This method is used to incorporate ingredients with solid, hard
properties such as waxes.
♣ All or some of the components of an ointment tare combined
by being melted together and cooled with constant stirring until
congealed
PASTE
 It is a semi-solid preparations intended for application to the
skin.
 They generally contains a larger proportion of solid material
(25%) than ointment and therefore stiffer.
 Addition of powder improves porosity (breathability).
Plasters
 Are solid or semi-solid adhesive masses spread on a backing
of paper, fabric, moleskin, or plastic.
*Example: Salicylic plaster
Glycerogelatins
 Are plastic masses containing gelatin, glycerin, water, and an
added medicinal substance such as Zinc Oxide.
*Around 15% gelatin, 40% glycerin, 35% water, 10% medicinal
agents
Gels (Jellies)
 Are semisolid systems consisting of dispersions of small or
large molecules in an aqueous liquid vehicle rendered jelly-like
by the addition of a gelling agent.
Classification of Gels
1. Single Phase Gels – preparation in which the macromolecules are
uniformly distributed throughout a liquid with no apparent boundaries
between the dispersed macromolecules and the liquid.
2. Two Phase Gels - Consisting of floccules of small distinct particles.
Preparation of Gels
♣ Formed by dispersing the molecule in the continuous phase
♣ By cross-linking the dispersed molecules
♣ By changing the Ph
♣ By reducing the continuous phase
Lotion
♣ A loosely used term that nowadays includes any liquid
preparation in which inert or active medications are suspended
or dissolved
♣ Most lotions are aqueous or hydroalcoholic systems; small
amounts of alcohol are added to aid solubilization of the active
ingredient(s) and to hasten evaporation of the solvent from the
skin surface
♣ Most acne lotions are hydroalcoholic which evaporate fast;
they are non-sticky and drying
♣ Emulsion type lotions are usually not drying, depending on the
water content (higher water and/or less oil is more drying)
♣ Lotions are easy to apply to large areas
♣ Lotions are suitable for hairy areas, skin prone to
folliculitis/acne, intertriginous areas
Factors to consider when choosing a topical preparation:
 Always consider the effect of the vehicle. An occlusive vehicle
enhances penetration of the active ingredient and improves
efficacy.
 The vehicle itself may have a cooling, drying, emollient, or
protective action. It can also cause side effects by being
excessively drying or occlusive.
 Match the type of preparation with the type of lesions. For
example, avoid greasy ointments for acute weepy dermatitis.
 Match the type of preparation with the site e.g., gel or lotion for
hairy areas).
 Consider irritation or sensitization potential. Generally,
ointments and w/o creams are less irritating, while gels are
irritating. Ointments do not contain preservatives or emulsifiers
if allergy to these agents is a concern.
 PHARMACEUTICAL COSMETICS  EUMELANIN is the dominant pigment in brown hair, and
PSMB black hair while PHEOMELANIN is dominant in red hair.
OVERVIEW OF COSMETIC SCIENCE TYPES OF HAIR:
COSMETIC SCIENCE  VELLUS (LANUGO) HAIR: short, fine, downy, unpigmented
This is the study of the effects that raw materials and the mixtures can hair on body.
have a part of human body for example the hair, skin, lips and nails.  TERMINAL HAIR: long, thick, pigmented hair found on
What is Cosmetics? scalp, legs, arms, and body.
- Cosmetics means any article intended to be rubbed, SHAPES OF HAIR:
poured, sprinkled or sprayed on, or introduced into, or  The shape of the hair shaft determines whether hair is
otherwise applied to, the human body or any part thereof straight or curly.
for cleansing, beautifying, promoting attractiveness, or  If the shaft is round, the hair is straight.
altering the appearance, includes any article intended for  If the shaft is oval, the hair is wavy.
use as a component of cosmetic.  If the shaft is flat, the hair is curly or kinky
HISTORY
 The word ‘‘cosmetic’’ is derived from the Greek word
Kosm tikos, meaning ‘‘having the power to arrange, skilled
in decorating giving kosmein, ‘‘to adorn,’’ and kosmos,
‘‘order, harmony’’,
 But the true origin of cosmetics probably lies further still in
antiquity, because early cave paintings of 30,000 years ago
depict the use of body adornment (rudimentary cosmetics)
in the rituals of mating and hunting.
 Cosmetics used essentially with 3 goals in mind:
1. Enhance personal appeal thru the decoration of the
body;
2. To camouflage flows and integument;
3. To alter or to improve upon nature.
TYPES OF COSMETICS INGREDIENTS
 FUNCTIONAL INGREDIENTS
- Are the ones that provide the benefit of cosmetics.
- They include cleansers (surfactants), conditioning agents,
colorants, fragrances, reactive ingredients, film formers, and
drug actives. Every cosmetic you’ve ever used or made has
at least one functional ingredient.
 AESTHETIC INGREDIENTS
- Are those that help make delivery of the functional
ingredients more acceptable.
- These are ingredients like solvents, thickeners, ANATOMY OF HAIR:
preservatives, fragrances, pH adjusters, plasticizers, fillers, I – THE SHAFT
appearance modifiers, anti -oxidants, anti - irritants, and  A – The medulla
delivery systems.  B – The cortex
 CLAIMS INGREDIENTS  C – The cuticle
- Are ingredients added to a formula at a low level for the II – THE ROOT
primary purpose of getting to put the ingredient name on the • A – The hair bulb
label. • B – The erector pili muscles
- This includes ingredients like natural extracts, vitamins,
proteins, biotechnology, and fanciful made -up ingredient
names.
HAIR PRODUCTS
HAIR AND HAIR FOLLICLES
Hair is composed primarily of proteins (88%).
These proteins are of a hard fibrous type known as keratin.
Keratin protein is comprised of what we call "polypeptide chains.”
CHEMICAL COMPOSITION OF HAIR:
 Hair made up of 20 amino acids.
o Body produces 11 of the 20, the remainder must
come from diet.
 Proteins are sources of amino acids.
 A healthy diet is necessary for healthy hair.
HAIR COLOR
 All natural hair colors are the result of two types of hair
pigments. A. HAIR SHAFT
 Both of these pigments are Melanin types, produced inside There are 3 main layers of the hair shaft.
the hair follicle and packed into granules found in the fibers. 1. CUTICLE: The outermost layer of the hair.
 2. CORTEX: The middle layer of hair; a fibrous protein core e. Clarifying agents
formed by elongated cells containing melanin pigment. f. Antidandruff agents
3. MEDULLA: Innermost layer; also referred to as the pith g. Conditioning Agents
(Core) of the hair. h. Thickening agents
B. ROOT i. Sequestering Agents
- The hair bulb HAIR TONICS AND CONDITIONERS
- The erector pili muscles The term “hair tonic” has been used for some hair preparations
because the term is used in therapeutics.
Hair tonic is one kind of hair repairing tonic and retexturing the hair.
There are two distinct types of products:
1. Products those deals with specific problems of the hair. E.g.,
greasy hair, dandruff.
2. Those products which are intended for improving, restoring,
& maintaining the condition of the hair.
MEDICATED PRODUCTS
 The purpose of this products is to cure, to reduce, to restrain
& some abnormality in the function of scalp.
HAIR LIFE CYCLE
 In the past, use was often made of irritant, keratolytic,
3 PHASES IN HAIR LIFE CYCLE:
rubefacient compounds.
 ACTIVE-GROWTH PHASE (ANAGEN): Active growth
 The recent trend is that the treatment should rather bring
period is 2-5 years before replacement.
about a return to a normal state & promote balance.
 TRANSITION PHASE (CATAGEN): lasts one or two weeks
 Medicated products are mainly deal with dandruff,
& hair follicle shrinks about 80%.
seborrhea & hair loss.
 RESTING PHASE (TELOGEN): After five or six weeks,
CONDITIONERS
dermal papilla reconnects to base of hair follicle and
Hair conditioners are viscous liquid that is applied to the hair & are
bloodstream. The hair re-enters the active-growth phase and
usually used after washing the hair with shampoo.
a new hair begins to from.
 It is designed to restore hair to its natural state.
 It has the ability to repair damage hair by providing shiny look
to the hair fibers.
 Hair conditioner restores the texture & appearance of the
rough & harsh hair.
 Hair conditioner are used to render the hair shiny, easy to
comb & free from dryness.
TYPES OF CONDITIONERS
PACK ◼ It is heavy and thick.
CONDITIONERS ◼ A high content of surfactant it is able to bind
the hair structure & glue the hair surface scale
together & tend to form thicker layer on the hair
surface.
SHAMPOO ◼ These are usually applied to the hair for a
 The word shampoo is derived from Hindustani chāmpo. longer time.
 Shampoo is a hair care product that is used for the removal
LEAVE IN  They are thinner & have different
of oils, dirt, skin particles, dandruff, environmental
CONDITIONERS surfactants.
pollutants and other contaminant particles that gradually
 It is lighter, less viscous mixture & provides
build up in hair.
a significantly thinner layer on the hair
CLASSIFICATION OF SHAMPOO:
 This is designed to be used in a similar way
I. BASED ON APPEARANCE
to hair oil preventing tangling of hair & keeping
a) Powder Shampoos
it smooth.
b) Liquid Shampoos or Lotion
ORDINARY  It combines some aspects of both packs &
c) Gel Shampoos or Solid Cream
CONDITIONERS leave in ones.
d) Cream Shampoos
 These are generally applied after the use of
e) Oil Shampoos
shampoo.
f) Miscellaneous-anti dandruff, medicated shampoo
 Further, it can be characterized into 3 main
II. BASED ON USE
type:
a) Conditioning Shampoos
a) MOISTURIZER
b) Antidandruff and Therapeutic
✓ These are organic solvent
c) Baby
concentrated with humectant.
d) Balancing
✓ Humectant is to retain the
e) Clarifying
moisture into the hair.
COMPOSITIONS OF SHAMPOO:
✓ These conditioners may not
a. Water
contain protein.
b. Surfactants
b) RE-CONSTRUCTERS
c. Foam boosters and stabilizers
d. Opacifiers
 ➢ It contains proteins for TYPES OF HAIR COLORANT:
hydrolyzation. TEMPORARY  Temporary hair color is available in various
➢ Human hair keratin protein HAIR COLOR product forms including rinses, shampoos,
has a low molecular weight. gels, sprays, foams.
➢ This protein penetrates the  This type of hair color is typically used to
hair shaft & gives a shiny hair. give brighter, more vibrant shades or colors
c) DETANGLES such as orange or red, that may be difficult to
☺ These are acidifiers & have achieve with semipermanent and permanent
low pH. hair color.
☺ The function is to close the SEMI- ☺ Give stronger & more permanent
cuticle of the hair, which cause PERMANENT coloration to hair than temporary hair colorant
tangles. HAIR COLOR ☺ Some colors are removed in 4-8
☺ The protection or shield shampooings.
☺ Dyes used are: NAN
mechanism is done by
● Ntirophenyledenediamine,
surfactant & polymers. ● Aminoanthraquinones,
COMPOSITIONS OF CONDITIONERS: ● Nitroaminopheols
a. Surfactants ☺ Mixture is prepared before preparing color
b. Partially or totally hydrolyzed proteins shades. It should be studied on white wool
c. Oily materials or hair. Semi hair color has no Ammonia.
d. Glossers PERMANENT  All "permanent" haircolor products and
e. Humectant HAIR COLOR lighteners contain both a developer, or
f. Thickeners oxidizing agent, and an alkalizing
g. Bodying agent ingredient as part of their ammonia or an
h. Perfumes ammonia substitute.
HAIR COLORANTS  The purpose of this is to:
The colouring of hair is one of the most important acts of adornment ● raise the cuticle of the hair fiber so
among those made by men and women since the origin of man. The the tint can penetrate,
reasons for getting the hair coloured have been: ● facilitate the formation of tints
 To change the natural colour within the hair fiber,
 To colour the white hair which begin to appear with age ● bring about the lightening action of
 To change the colour of the hair temporarily on a particular peroxide.
occasion.  When the tint (color) containing the
RAW MATERIALS alkalizing ingredient is combined with the
Differ from manufacturer to manufacturer. But in general, hair dyes developer (usually hydrogen peroxide), the
include: peroxide becomes alkaline and diffuses
 modifiers, through the hair fiber, entering the cortex,
 antioxidants, where the melanin is located.
 alkali,  The lightening occurs when the alkaline
 soaps, peroxide breaks up the melanin and replaces
 ammonia, it with new color.
 wetting agents,
 fragrance, SAFETY AND EVALUATION: HAIR CARE PRODUCTS
RAW MATERIALS  Hair care product performance and safety ultimately
 A variety of other chemicals used in small amounts that determine product success and longevity. For best market
impart special qualities to hair (such as softening the texture) results, precisely planned performance and safety
or give a desired action to the dye (such as making it more evaluations are required.
or less permanent).  Moreover, international regulatory agencies require a
 Dye chemicals are usually amino compounds. demonstration of product safety to ensure that new-to-
OTHER CHEMICALS USED IN HAIR DYES: market products will not pose health risks or harm to
MODIFIERS  Which stabilize the dye pigments or consumers.
otherwise act to modify the shade. Phases of comprehensive hair care product performance testing:
 May bring out color tones, such as PHASE I: PRE-CLINICAL TESTING:
green or purple, which complement the  Because hair care products will contact the skin and hair and
dye pigment. e.g. resorcinol will likely contact the eyes, pre-clinical dermal and ocular
ANTIOXIDANTS  Protect the dye from oxidizing with air. toxicity and irritation testing is required early in the
 Most commonly used is sodium sulfite. safety evaluation process.
PHASE II: CLINICAL STUDY DATA COLLECTION AND
ALKALI  Are added to change the pH of the dye
EVALUATION
formula, because the dyes work best in a
 Panelists are recruited and scheduled according to the initial
highly alkaline composition.
study design and timeline.
 Ammonium hydroxide is a common
 Clinical data can vary in type, complexity, and collection
alkali.
intervals.
 TRICHOLOGICAL  The trichological analysis determines
(HAIR COUNT) changes in hair growth patterns. During this
ANALYSIS test, a trained professional uses a
dermascope or videoscope to survey the
scalp and record changes in observed hair
growth patterns.
TRACTION TEST ✓ The Traction Test also known as
Gravimetric “Pull” Analysis,
“Sabouraud’s sign,” or “the pull - out
sign” is used to measure hair shedding
patterns.
✓ Prior to shampooing, 20 -60 strands of
subjects’ hair are grasped at the base of the
strands and tugged firmly away from the FUNCTIONS OF THE SKIN:
scalp. 1. Protection - *First line defense against bacteria and viruses,
✓ Active hair shedding is indicated by pulling and it protects underlying structures from ultraviolet radiation
more than 10% of strands from the scalp. and dehydration
HAIR PLUCK  The “Hair Pluck” Test evaluates changes 2. Vitamin D production - *This is commonly needed for calcium
TEST in hair growth cycles and in hair breakage absorption
over time using hair shafts “plucked” from 3. Sensation - *Sensory preceptors
the scalp. 4. Excretion - *Small amount of waste products are lost thru
REGIMENTED  The Regimented Combing Technique is perspiration
COMBING used to assess changes in hair fallout rates. 5. Body temperature regulation - *If too hot, the dermal blood
TECHNIQUE  For this test, panelists are asked to use a
vessels dilate, if too cold, the dermal blood vessels constrict.
specific combing technique to evaluate hair
fallout rates. EPIDERMIS
TENSILE TEST  Tensile Tests measure any alterations in  The epidermis is an avascular structure, made up of many
hair strength and resilience. Hair tensile layers of cells.
strength is measured using the Dia-Stron  The special structure of the epidermis is classified as
Mini Tensile Tester (MTT). stratified squamous epithelium and is typical of vertebrate
 The MTT device uses 3-point bending and animals.
torsion tests to measure the force overtime
 It is responsible for producing the main barrier known as
required to elongate and break a strand of
hair. the horny layer or stratum corneum, which forms the
outermost part of the epidermis.
SKIN CARE PRODUCTS  The horny layer is made up of water -resistant dead cells,
SKIN called corneocytes, which are segmented together with a
 Skin is the outer covering of the body and is the largest organ complex lipid material.
of the integumentary system. The lower living layers of the epidermis can also be subdivided as
follows:
1.) the germinative or basal layer;
2.) the stratum spinosum or prickle cell layer;
3.) the stratum granulosum or granular layer, which is
characterized by the presence of distinctive keratohyalin
granules.
DERMIS
✓ The dermis functions as a supporting frame to the epidermis,
supplying it with nutrients via the blood capillaries. It also
supports the sensory nervous system, secretory glands and
hair follicles.
✓ Unlike the epidermis, which is a cellular structure, the
underlying dermis consists of connective tissue.
COMPOSITIONS OF DERMIS:
BIOLOGY OF THE SKIN: 1.) COLLAGEN AND ELASTIN
 Glabrous skin, found on the palms and soles of the feet, - Collagen forms the major constituent of the fibrous protein
lacks hair follicles and sebaceous glands but has a very thick which gives the skin its tensile strength.
epidermis and encapsulated sense organs in the dermis. 2.) GROUND SUBSTANCE
 In hairy skin, hair follicles and sebaceous glands are both - The dermal ground substance consists of salt, water and
present, but there are no encapsulated sensory organs. glycosaminoglycans. The latter form complexes with protein
 Facial skin has large sebaceous glands associated with fine molecules known as proteoglycans.
vellus hairs, contrasting sharply with the scalp, which 3.) MAST CELLS
contains large hair follicles. - The mast cells, which are the second major cell type in the
dermis, can be found close to the small blood vessels.
4.) SWEAT GLANDS
5.) SENSORY SKIN RECEPTORS
HYPODERMIS CHEMICAL ➢ Chemical exfoliants include scrubs
 Below the epidermis is a layer of fatty or adipose tissue containing salicylic acid, glycolic acid,
called the hypodermis. fruit enzymes, citric acid, or malic acid
 The cells in this layer synthesize and store fat as an energy which may be applied in high
reserve. This is to help insulate the body from low external concentrations by a medical professional,
temperatures and to act as a buffer against trauma. or in lower concentrations in over -the -
 On a more familiar note, the hypodermis provides the body counter products
with its contours, whether they are attractive curves or ➢ Chemical exfoliation may involve the
unwelcome bulges. use of products that contain alpha
SKIN TYPES: hydroxy acids (AHAs), beta hydroxy acids
NORMAL Soft smooth skin with a healthy appearance (BHAs), or enzymes that act to loosen the
OILY Shiny with enlarged pores. Often glue -like substance that holds the cells
blemished together, allowing them to ease away.
DRY Fine texture, flaky, many expression lines,
poor elasticity 3) TREATMENTS
SENSITIVE Florid with broken capillaries, fine textured,  are used to address specific skin concerns such as
like dry skin acne, dark spots, hyperpigmentation, fine lines and
BLEMISHED Excessively oily with blemishes inflammation. Skin treatment products are all
TYPES OF SKIN CARE PRODUCTS: regulated and have to be approved by the FDA.
1) CLEANSERS  They can be in the forms of creams, gels, lotions,
 is a facial care product that is used to remove solutions, serums and medicated facial pads.
make-up, dead skin cells, oil, dirt, and other types 4) SERUMS
of pollutants from the skin of the face. This helps to  Serums usually contain antioxidants, which help
unclog pores and prevent skin conditions such as fight free radical damage.
acne.  They can also contain anti -aging ingredients such
 A cleanser is the first step in a skin care regimen as retinols and peptides, which stimulate collagen
and can be used in addition of a toner and production.
moisturizer, following cleansing.  Because they penetrate deep into the skin, these
FACE CLEANSERS: products are great for hydrating dry skin.
a.) Cream cleansers  They are best used after your cleanser, and they
b.) Foam cleansers can be used underneath moisturizer to treat the
c.) Oil cleansers skin while sleeping.
d.) Clay cleansers 5) SUNSCREEN
e.) Micellar cleansers  is a lotion, spray, gel, foam, stick or other topical
f.) Powder cleansers product that absorbs or reflects some of the sun's
g.) Bar cleansers ultraviolet (UV) radiation and thus helps protect
h.) Cleansing mitts / clothes / wipes against sunburn.
i.) Charcoal cleanser  Diligent use of sunscreen can also help to slow or
j.) Honey cleanser temporarily prevent the development of wrinkles,
k.) Vitamin C cleanser dark spots and sagging skin.
2) EXFOLIATOR TYPES OF SUNSCREEN:
 Exfoliating is the process of removing dead skin PHYSICAL  stay on the surface of the skin and
cells from the surface of your skin using a SUNSCREEN mainly deflect the UV light.
chemical, granular substance, or exfoliation tool. EXAMPLES:
 Your skin naturally sheds dead skin cells to make I. ZINC OXIDE - an opaque,
room for new cells every 30 days or so. But full - spectrum sunscreen
sometimes, dead cells don’t shed completely. This also used to give opacity to
can result in dry, flaky patches and clogged pores. face powder and
Exfoliating can help prevent this. foundation.
TYPES OF EXFOLIATION: II. TITANIUM DIOXIDE - a full
MECHANICAL ✓ This process involves physically -spectrum, which means
scrubbing the skin with an abrasive. that it protects the skin from
✓ Mechanical exfoliants include both UVA and UVB rays. It
microfiber cloths, adhesive exfoliation is also used to give opacity
sheets, micro-bead facial scrubs, crepe to face powder, eye
paper, crushed apricot kernel or almond shadow, and foundation.
shells, sugar or salt crystals, pumice, and CHEMICAL  Which absorb the UV light.
abrasive materials such as sponges, SUNSCREEN EXAMPLE: UV organic filters
loofahs, and brushes.
✓ People with dry skin should avoid 6) CHEMICAL PEEL
exfoliants which include a significant  remove the outer layer of the skin, which means
portion of pumice, or crushed volcanic they tend to go deeper to remove more excess
rock. dead skin cells than exfoliators.
  They usually contain glycolic, salicylic or lactic or allergens in cosmetic products) permeate it, the resulting
acids. adverse effects may cause considerable discomfort to the
7) TONER consumer.
 it shrinks pores and restores skin to its natural pH  Even minor disturbances of the skin surface can produce
balance. discomfort, especially in the facial area which has an
 this is important because when our pH levels are extensive network of sensory nerves.
thrown out of whack due to soaps and chemicals in TYPES OF COSMETICS ALLERGIC REACTION
cleansers, oil production increases, causing a cycle 1.) CONTACT DERMATITIS
of breakouts.  This is a nonspecific term used to describe any
 can be used after a cleanser twice a day to inflammatory skin disease resulting from contact with an
remove excess traces of makeup or other residue irritant or allergenic substance.
from the skin.  Whatever the causative agent, the clinical features are
8) MOISTURIZER similar: itching, redness, and skin lesions.
♣ A product that adds water, and often some TYPES OF CONTACT DERMATITIS:
emollients, to the skin. A variety of types of A. IRRITANT CONTACT DERMATITIS (IRRITATION)/ ICD
moisturizers are available (for various skin types),  It is a term given to a complex group of localized
and are necessary for all skin types to prevent inflammatory reactions that follow
dehydration. nonimmunological damage to the skin.
♣ Replaces water lost from the skin  The inflammation may be the result of an acute
o Dryness and flexibility cannot be corrected toxic (usually chemical) insult to the skin, or of
with oils - Only Water repeated and cumulative damage from weaker
o Oil is used to limit the evaporation of irritants (chemical or physical).
water.  There is no definite laboratory test for ICD —
INGREDIENTS OF MOISTURIZERS diagnosis is by clinical morphology, of course,
HUMECTANT ➢ An ingredient in skin or Examples: and appropriate negative patch -test results.
hair products that draws  Glycerine CATEGORIES OF ICD:
moisture from the air to  Propylene glycol ACUTE IRRITANT CUMULATIVE DELAYED ACUTE
moisturize the skin and  Sorbitol CONTACT IRRITANT IRRITANT
also promotes the  Urea DERMATITIS CONTACT CONTACT
retention of moisture in  Lactic acid DERMATITIS DERMATITIS
the skin  Hyaluronic Acid Acute ICD is the Cumulative irritant Some chemicals
EMOLLIENT ➢ Supple, waxlike, Examples: result of a single contact dermatitis or produce acute
lubricating, thickening  Sunflower seed overwhelming chronic ICD irritation in a
agents that prevent water oil exposure to a strong develops as a result delayed manner so
loss and have a softening  Olive oil irritant or a series of of a series of that the signs and
and soothing effect on the  Allantoin brief physical or repeated and symptoms of acute
skin.  Cocoa butter chemical contacts, damaging insults to irritant dermatitis
➢ A skin conditioning  Myristyl Myristate leading to acute the skin. The insults appear 12 to 24
agent which helps  Mineral oil inflammation of the may be chemical or hours or more after
maintain the smooth, soft skin. physical. the original insult.
pliable appearance of the B. ALLERGIC CONTACT DERMATITIS
skin.  ACD occurs when a substance comes into contact
➢ Usually, a grease or an with skin that has undergone an acquired specific
oil that softens the skin alteration in its reactivity as a result of prior
and protects it from exposure of the skin to the substance eliciting the
dryness. dermatitis.
OCCLUSIVES ➢ Substances that hold Examples:  The skin response of ACD is delayed,
strongly to the surface of  Petrolatum immunologically mediated (Type IV), and consists
the skin, preventing  Lanolin of varying degrees of erythema, edema, papules,
access to the air and  Candililla wax and papulovesicles.
increasing absorption of  Dimethicone  Patch testing is the gold standard.
cosmetic treatments. C. PHOTOIRRITANT CONTACT DERMATITIS
➢ Usually refers to an  It is a chemically induced nonimmunological skin
occlusive shield or film irritation requiring light. This reaction will occur in all
that is spread onto the individuals exposed to the chemical–light
skin to slow or prevent combination.
moisture evaporation.  Bergapten, a component of bergamot oil, is a
SAFETY AND EVALUATION: SKIN CARE PRODUCTS potent photo-irritant that causes berloque
 One of the skin’s primary physiological functions is to act as dermatitis.
the body’s first line of defense against exogenous agents. D. PHOTOALLERGIC CONTACT DERMATITIS
 However, the skin should not be viewed as a flawless  It is an immunological response to a substance that
physicochemical barrier. requires the presence of light.
 Many low–molecular weight compounds are capable of
penetrating this barrier. When toxic agents (such as irritants
  The substance in the skin absorbs photons and is  Excipients and Emulsifiers
converted to a stable or unstable photoproduct,  Coloring Agents
which binds to skin proteins to form an antigen, PRODUCT SAFETY TESTING
which then elicits a delayed hypersensitivity Such safety information could be based on the individual toxicity of
response. ingredients but testing the final product is important and pertinent
 Examples of photoallergens present in cosmetics particularly in the following cases:
are musk ambrette and 6-methylcoumarin, which ✓ A new ingredient known to cause slight eye or skin irritation
are present in fragrances. is present
2.) CONTACT URTICARIA SYNDROME/ CUS ✓ Significant modifications of the formulation have been made;
♣ It represents a heterogeneous group of ✓ The vehicle used in the formulation results in significantly
inflammatory reactions that appear, usually within a greater skin penetration
few minutes to an hour, after contact with the ✓ Interaction between ingredients is likely to result in the
eliciting substance. formation of a new, potentially toxic or irritant substance
♣ Clinically, erythematous wheal -and -flare reactions ✓ There is a specific safety claim
are seen, and sensations of burning, stinging, or TYPES OF SAFETY ASSESSMENT
itching are experienced. PATCH TEST  A test for determining allergic
♣ Diagnosis may be achieved by a variety of skin sensitivity that is made by applying to the
tests —the open test is the simplest of these and is unbroken skin small pads soaked with the
the ‘‘first -line’’ test. allergen to be tested
 The 48-hour patch test allows the
TYPES OF CONTACT URTICARIA SYNDROME
assessment of the primary irritation
NONIMMUNOLOGICAL IMMUNOLOGICAL CONTACT potential of a topical product.
CONTACT URTICARIA URTICARIA  The test is conducted on a panel of at
➢ It is the most common class ✓ These are immediate (Type I) least 25 subjects. The patches used can
of CUS. The reaction usually allergic reactions in people who be occlusive or semi-occlusive depending
remains localized. have previously been sensitized on the nature of the product.
HUMAN REPEAT  A test for determining the irritation
➢ Examples of cosmetic to the causative agent.
INSULT PATCH and/or sensitization potential of a test
substances known to produce ✓ ICU is IgE mediated and is material(s), in support of sensitive skin
TEST (HRIPT)
NICU are preservatives (e.g., more common in atopic claims, after repeated application under
benzoic acid and sorbic acid) individuals. Food substances occlusive or semi-occlusive patches to
and fragrances (e.g., cinnamic are common causes of ICU. the skin of human subjects.
aldehyde)  The HRIPT consists of 2 phases, and
3.) ACNEGENICITY sometimes 3.
 This refers to the capacity of some agents to cause PHASE 1: INDUCTION PHASE
acne or aggravate existing acne lesions. – Where the product is applied to the skin
 This term may be subdivided to include 9 times during the course of 3 weeks then
comedogenicity and pustulogenicity. this is followed by a 2-week rest period
TYPES OF ACNEGENICITY after the skin is exposed to the product
COMEDOGENICITY PUSTULOGENICITY again
PHASE 2: ELLICIT PHASE – A
→ This is the capability of an → This refers to the capability of
response in phase 2 is usually allergic in
agent to cause hyperkeratinous an agent to cause inflammatory
nature and the Phase 3 is used to verify
impactions in the sebaceous papules and pustules, usually in
the better defined reaction.
follicle, or the formation of a relatively short period of time.
microcomedones, usually in a NON-  A test to evaluate the skin condition
COMEDOGENIC before and after one month of product
relatively short period of time.
TEST usage. The evaluator counts the number
SAFETY AND EVALUATION: SKIN CARE PRODUCTS of comedons and blackheads on the
FACTORS CONTRIBUTING TO CONTACT ALLERGIC forehead, cheeks and chin.
REACTIONS TO A COSMETIC PRODUCT:  Alternatively, a non-comedogenic
 Frequency of Use claim can be assessed via a microscopic
 Composition examination of the skin after application
 Concentration of Ingredients of patches containing the product
 Purity of Ingredients NON-ACNEGENIC  a test to evaluate skin condition before
 Common Use of Cosmetic Ingredients in Pharmaceuticals TEST and after one month of product usage.
 Cross -Sensitivity The evaluator counts the number of acne
 Penetration -Enhancing Substances lesions (papules and pustules) on the
 Application Site forehead, cheeks and chin.
 Condition of the Skin PERIOCULAR  A test that allows to assess the
 Contact Time TOLERANCE TEST irritation potential of a topical product
COMMON COMPONENTS THAT CAUSE COSMETIC ALLERGIC applied on the eye contour area.
REACTION:  The study is conducted under the
 Fragrance Ingredients supervision of an ophthalmologist. The
 Preservatives condition of the eye and around the eye
 Antioxidants area is examined before and after a given
 ‘‘Active’’ or Category-Specific Ingredients period of product usage.
PART 2 (W/O SIDENOTES) solution that can irritate skin and which is most
ORAL CARE PRODUCTS often exhibit by rash around the mouth.
ORAL HYGIENE  FLUORIDE – anticariogenic; replaces the hydroxyl
- is the practice of keeping the mouth and teeth clean to ion in hydroxyapatite with the fluoride ion, forming
prevent dental problems, most commonly, dental cavities, fluoroapatiteon the surface of the enamel and
gingivitis, periodontal (gum) diseases and bad breathe. hardens it, leading to a more acid-resistant enamel.
- The purpose of oral hygiene is to prevent the build-up of  TRICLOSAN – antimicrobial agent which helps
plaque, the sticky substance formed by the attachment of prevent gingivitis, plaque, cavities, and tartar.
bacteria coating that adheres to the pellicle, which is a thin  DESENSITIZING AGENTS – reduce pain in
acellular, glycoprotein. MOUTHWASHES / ORAL RINSES
- Plaque, when not removed within 24 hours, forms a  Rinse two times a day with a capful. Rinse for 1 minute and
substance called CALCULUS OR TARTAR. spit. If used in conjunction with the toothpaste use the rinse
- Plaque calcifies when calcium salt precipitates from the first, then brush.
saliva.  May contain astringents, demulcents, detergents, flavors,
ANTICARIES AGENTS germicides, and fluoride
 The formation of caries (tooth decay) is attributed to the o COSMETIC MOUTHWASHES – to freshen breath;
action of acids obtained from oral bacterial metabolism of nontherapeutic and no antiseptic property.
dietary carbohydrates. The build-up of plaque on the tooth Classified based on ingredients, alcohol content,
surface usually aids the decay process by forming pockets and appearance.
or crevices on the teeth surface. o ANTIPLAQUE MOUTH RINSES – claim to prevent
 Brushing removes material from tooth before it hardens into formation of tartar, having the same ingredients as
calculus. tartar-control toothpaste. Ex. Cetylpyridium
APPROACH TO CARIES PREVENTION: chloride, chlorhexidine (staining is associated with
✓ Flossing the overuse of these two ingredients)
✓ Brushing COSMETIC WHITENING PRODUCT
*Accompanied by fluoride administration either given internally or 1. CARBAMIDE PEROXIDE 10%
topically to the teeth  It is a tooth whitener, carbamide peroxide, a mild anti-septic,
ORAL HYGIENE PRODUCT also called urea hydrogen peroxide, perhydrit, hyperol, or
DENTRIFICES perhydol, is an addition complex of hydrogen peroxide with
♦ Products that enhance the removal of stains and plaque by urea, which has a mild effect.
the toothbrush.  Reacts with water in saliva, carbamide peroxide dissociates
1. Toothpastes to hydrogen peroxide (34%) & urea.
2. Mouthwashes  Haywood and Heymann introduced bleaching of teeth with
3. Cosmetic whitening products 10% carbamide peroxide gels placed in custom-built trays to
4. Mouth/Breath Spray be worn by patients at night for 2-6 weeks.
5. Fluoride gel 2. HYDROGEN PEROXIDE
TOOTHPASTES  Active ingredient in some cosmetic whiteners in gel or liquid
 Used to decrease the incidence of dental caries, reduce form.
mouth odors, and enhance personal appearance. Possible risk in using cosmetic whitening products:
 Brush with soft toothbrush for 2 minutes. No RINSING, o Alteration of normal flora
EATING, or DRINKING for 20 minutes. o Tissue damage
 MOST COMMON INGREDIENTS: o Tooth sensitivity
o ABRASIVES – responsible in removing plaque. Ex. o Gingivitis
Silicates, sodium bicarbonate, dicalcium o Potentiation of carcinogenic effects of other agents
phosphate, sodium metaphosphate, calcium FLUORIDE GEL
pyrophosphate, calcium carbonate, magnesium ֎ Prescribed high-concentrated topical agent (1-2%) intended
carbonate, and aluminum oxides. High-abrasive either for professional applications in plastic/disposal trays
formulations are not advisable for long-term use as 2- 4 times per year or self-applied with aid of a toothbrush
it may lead to eventual exposure to root surfaces. once or twice per week.
o SURFACTANTS – foaming agents that aid in the ֎ The formulations are based on sodium fluoride, acidulated
removal of debris. Most frequently used are sodium phosphate fluoride or amine fluoride.
lauryl sulfate and sodium dodecyl benzene ֎ The gels are flavored but contain no abrasive cleaning
sulfonate. agents or preservatives.
o HUMECTANT –prevents the drying of the FLUORIDE’S ACTION IN INHIBITING CARIES
preparation. Ex. Sorbitol, glycerin, and propylene a) Fluoride decreases the solubility of enamel in acid
glycol. b) Fluoride has enzyme inhibitory properties
o SUSPENDING AGENTS – add thickness to the
formulation. Ex. Methylcellulose, tragacanth,  Oral route places fluoride into systemic circulation allowing
karaya gum. fluoride to laid down in unerupted teeth as they are formed.
o FLAVORING AGENTS – sorbitol or saccharin SODIUM FLOURIDE USP
 SPECIAL INGREDIENTS: PROPERTIES:
 PYROPHOSPHATES – for tartar-control; retard the  Occurs as a white, odorless powder which is soluble in water
formation of tartar. However, they form an alkaline and insoluble in alcohol
USES:
  Officially used as dental prophylactic  These are a suspension of pigments in an emulsion base,
o 2% aqueous sol’n is widely used topically. Usual the same types as those used for facial moisturizers.
procedure is a series of 4 treatments: beginning at  Traditionally they were based on either anionic or cationic
the age of 3; ages 7, 11 and 13 as the permanent emulsification systems.
teeth erupts  The major components of this type of system are: emollient
STANNOUS FLOURIDE USP oils; emulsifiers; humectants; pigment wetting agents;
SYNONYM: Tin Diflouride pigment suspending agents; pigments; pigment extenders,
PROPERTIES: e.g. talc, kaolin; water; preservatives; fragrance; additives if
 Stannous fluoride occurs as a white crystalline powder and required, e.g. vitamins, sunscreens, etc.
has a bitter salty taste. It melts at about 213 degrees Celsius; TYPES OF DECORATIVE COSMETIC PRODUCTS
 Freely soluble in water; insoluble in alcohol, ether and A. FACIAL MAKE-UP
chloroform  Facial Makeup Products are products that are used to color
USES: and highlight facial features. They can either directly add
 extensively used for topical fluoride application or alter color or can be applied over a foundation that serves
o A simple application of a freshly prepared 8% to make the color even and smooth.
solution at 6 to 12 months intervals is used INGREDIENTS OF FACIAL MAKE-UP
 it requires only 1 application per treatment as compared to a TALC  It is the main component of face powders; in
series of 4 application per treatment of NaF some products it could comprise up to 70% or
o solution is applied to a cleaned, dry teeth 75% of the formulation.
PUMICE USP  Talc is used mainly because of outstanding
SYNONYMS: Pumice Stone; Piedra Pomez spreadability (slip) and low covering power
PROPERTIES: (translucency).
 substance of volcanic origin; consisting chiefly of complex  Grades of talc should be judged on slip,
silicates of aluminum, potassium and sodium smoothness, fineness, grit, density, colour and
 occurs as very light, hard, rough, porous grayish masses, or odour. In addition a check should be made for
as a gritty gray powder impurities such as carbonates and water-soluble
 Pumice is odorless and tasteless; stable in air; practically iron and the talc must be free from asbestos.
insoluble in water and is not attacked by acids. KAOLIN  Also known as 'China clay', a naturally
DECORATIVE COSMETIC PRODUCTS occurring compound, is a hydrated aluminium
Decorative cosmetics, for skin, hair and other appendages, e.g. lips silicate.
and nails, can be divided into those which aim to:  There are three different groups of clays
 Improve and/or protect and maintain good health (kaolinite, nacrite and dickite) having
 Enhance and change appearances and at the same time essentially the same formula (Al2O3 • 2SiO2 •
cover up defects. 2H2O) that are classified as kaolin.
The formulation of the finished products starts with a clear  It is almost white in colour. It has less slip than
understanding of the target consumer requirements and any product talc, and the product can end up with a harsh
claims that the marketing department wish to make feel.
These considerations could be: ZINC OXIDE  It is occasionally used at moderately low levels
▪ Performance in face powders because it has quite good
▪ User type covering power, is slightly astringent and a
▪ Usage instructions recognized skin protectorant; it therefore imparts
▪ Method of application soothing properties to the skin.
▪ Type of packaging that will hold the product. CALCIUM  Also known as ‘Precipitated Chalk’, Calcium
TYPES OF DECORATIVE COSMETIC PRODUCTS CARBONATE Carbonate is a mildly alkaline, white, odourless
I. FOUNDATION MAKE-UP microcrystalline powder available in special
 These are used to unify the colour of the skin, to cover grades with differing particle sizes and densities.
blemishes and skin defects and to provide a basis for further  It is mainly used because of its excellent
enhancement by the application of lip and eye colour absorption characteristics.
cosmetics.  It is matte and can give a 'bloom' effect to the
 Many of these modern types are also used for their skin-care coating on the face.
benefits, with additions such as sunscreens, natural extracts  As a material, it has good absorption
and vitamins, so that with pigmented products the consumer characteristics and, like kaolin, it may also be
applies colour whilst looking after her skin. used to remove some of the inherent shine of
FORMS OF FOUNDATION: talc.
CAKE FOUNDATION MAKE-UP  Excessive use is not recommended (greater
☻ It was modified and developed from that used in the theatre than 15%) because of its undesirable dry
and film industries. powdery feel and adverse effect on the slip of the
☻ The professionals used stick make-up which became Max product.
Factor's Pan Sticks, the first products to become OTHER IMPORTANT INGREDIENTS OF FACIAL MAKE-UPS:
commercially available.  Magnesium carbonate
☻ They were a mixture of talc, kaolin, magnesium carbonate,  Metallic soaps
titanium dioxide and iron oxides added to molten waxes and  Starches
oils.  Walnut flour
LIQUID FOUNDATION MAKE-UP  Micronized plastics
  Mica ► The base ingredients used in pressed
 Fumed silica powder eyeshadows are very similar to
 Colorants those used in face powder. Talc is the
 Preservatives main constituent with zinc stearate to
 Fragrances act as a powder binder and also give
TYPES OF FACIAL MAKE-UP skin adhesion.
FACE POWDERS ☺ These are used to cover minor CREAM EYESHADOW ⚫ This has to be of the correct
imperfections and reduce the shine that consistency, such that it can spread
appears on the skin due to sebum or easily on the skin, but not be greasy or
perspiration.
crease during wear, and the pigments
☺ They are required to give a matte,
or pearls in the pot or tube in which they
smooth finish to the skin and remain this
are sold remain suspended.
way for as long as possible
FORMS OF FACE POWDERS: EYESHADOW STICKS  These are manufactured using
a.) LOOSE FACE POWDERS similar ingredients and methods of
b.) COMPACT FACE POWDERS production to lipsticks and other stick
TWO WAY  These are a form of compact powder products.
FOUNDATION foundation that can be applied to the skin II. MASCARA
MAKE-UP by use of either a wet or dry sponge.  The colour, thickness and length of eyelashes are enhanced
 The overall function is to provide a by using suspensions of coloured pigments in a film-forming
natural-looking smooth finish. medium to which lengthening ingredients such as nylon flock
 In many ways they combine the can be added.
properties of a foundation with that of a FORMS OF MASCARA
face powder, with extended wear and the CAKE MASCARA  These were the first type of
potential to minimize the appearance of product to appear on the market
wrinkles, blemishes and skin pores. in the 1920s and are still
BLUSHERS  Blushers, often also called rouges, are available today.
applied to the cheeks, usually over a  Application is by wetting the
foundation make -up, to emphasize and brush and rubbing it onto the
highlight the cheek bones. They also give cake to pick up product, and
structure to the face then using the brush to transfer
 Most are now compressed powders or the product to the lashes.
emulsions, but previously they have been  Most formulations of this type
available as aqueous gels that contained tend to have little water
water -soluble dyes which actually resistance and will smudge if
stained the skin. the wearer cries or rubs her
FORMS OF BLUSHERS eyes. This is because they are
A.) PRESSED POWDER BLUSHERS based on a soap/wax/pigment
B.) LIQUID BLUSHERS blend which is emulsified when
C.) WAX-BASED BLUSHERS the wet brush is applied to the
D.) BRONZING POWDERS surface.
TYPES OF DECORATIVE COSMETIC PRODUCTS CREAM MASCARAS  The most common type of
A. EYE PRODUCTS mascara used today.
 Eyes are the dominant features of the face, especially during  This type is packaged in
conversation. They reflect emotional states as well as being small thin plastic bottles with an
indicative of our state of health. integral applicator (or wand)
 Modern eye make-up products include eye liners and pencils incorporated into the cap.
for the eyebrows and to contour the eyes, eyeshadows of  The formulations are either
different forms and mascara for the eyelashes. oil-in-water emulsions with a
TYPES OF EYE MAKE-UP: film-former incorporated, to give
I. EYESHADOW water and smudge resistance,
 Eyeshadow is used to give colour and gloss to the eyelids. or totally anhydrous, to give
 This is the most fashion - conscious area of decorative totally waterproof products.
cosmetics, the popular shades varying with the season and WATERPROOF MASCARAS  The best way to make
clothes that are in fashion at the time. something waterproof is to
FORMS OF EYESHADOW exclude water from it totally and
PRESSED POWDER ► The commonest form of use ingredients that are
EYESHADOW eyeshadows. insoluble in water.
► These are sold as single colors in a  Waterproof mascaras are
small compact with or without an therefore usually solvent -based
applicator, or as collections of colors systems. The basic solvent has
that tone together in larger compacts or to be volatile to give a quick-
tins with a number of applicators. drying formulation.
III. EYELINERS
  These are applied to the rims of the eyelids following the which the product is dispensed, and with which the
eyeshadow to accentuate the shape of the eyes. outline of the lips can be drawn.
FORMS OF EYELINERS: SAFETY AND EVALUATION: DECORATIVE COSMETIC
A) Liquid eyeliners PRODUCTS
B) Pen-Type eyeliners ANALYSIS OF COSMETICS INCLUDES:
C) Eye pencils 1.) Physical analysis
TYPES OF DECORATIVE COSMETIC PRODUCTS 2.) Microbiological analysis
A. LIP PRODUCTS 3.) Chemical analysis
 Lip products have been used since ancient times to enhance EVALUATION: POWDERS
the appearance of the lips by imparting colour and gloss, and FINENESS OF POWDER  Microscopic Method
by re-defining the outline of the lips.  Air separation technique
 The three most common products used to achieve this are  Sieving method
lipsticks, lip glossesand lipliners, of which lipsticks are the - Residue on 75 μ sieve
most common. should be NMT 2 % & 0n
RAW MATERIALS USED IN LIP PRODUCTS: 150 μ NMT 0.5 %
I. OILS APPARENT DENSITY
 Castor oil is the main oil used in lipsticks. It is very thick SHADE AND  Comparison with standard shade
and maintains this viscosity when hot, making it ideal as UNIFORMITY OF SHADE kept for this purpose
a suspending medium for the colouring agents.  Commonly std and sample both
 Oleyl alcohol is a widely used cosolvent in lipsticks. It are placed between two glass plates
aids pigment dispersion and has a pleasant skin feel and compared Observed in natural
and virtually no taste or odour. light.
II. WAXES ODOR ➢ No physical measure for odor.
 Waxes are considered as unctuous solids with different PRESSURE APPLIED ON ◼ By Penetrometer
levels of lustre and plasticity. COMPACT POWDER
 In lip products they are used to give structure to lipsticks BREAKING POINT ✓ Cake is dropped on wooden (8-10
and lipliners; they also help them to keep their form in in) or thick rubber mat (6 feet)
high temperatures. MATTER INSOLUBLE IN  Boil 1 gm. with 200ml, filter, dry
 All the waxes used must be flexible but not brittle and WATER and check the residue
have the ability to retain oils in their crystal structure. MOISTURE AND  By drying powder at 105 C to
 A combination of hard and soft waxes is used to give VOLATILE MATTER constant weight.
the balance of application and rigidity required by the
pH OF AQUEOUS ☺ By making suspension in water of
consumer.
SOLUTION 10 % or filtrate may be used.
III. COLORS
PAY-OFF  the pay-off character, i.e.
 The colour of the lipstick is the main reason for its
adhesion with the puff of compact or
purchase.
pressed powder should be tested on
 The most popular shades are variations on types of red, the skin
from pinks through to true reds.
 Many lipsticks also contain pearls to give a high degree
EVALUATION: LIPSTICK
of gloss to the lips.
MELTING POINT  The determination of melting point is
 The lips can either be coloured by covering them with a
DETERMINATION done in order to determine the storage
suspension of pigment or by staining them with a dye
TEST characteristics of the product.
dissolved in the lipstick.
 The inciting point of lipstick base should
TYPES OF LIP PRODUCTS
be between 60 to 65°C in order to avoid
I. LIPSTICKS
the sensation of friction or dryness during
 A lipstick, which is by far the commonest form of lip
application.
product, consists of a wedge- or 'bullet'-shaped stick
 The method of determination is known
that is moulded hot and then cooled before being placed
as capillary tube method.
into a small plastic cup or godet, which is held in a
CAPILLARY TUBE METHOD:
plastic or metal case.
(a) In this method, about 50 mg of lipstick is taken and is
 The godet can be moved up and down inside the case
inserted into a glass capillary tube open at both ends.
by a screw or push action.
(b) The capillary tube is ice cooled for about hrs and then
 When the stick is at the bottom of the case the whole is
placed in a beaker containing hot water and a magnetic
sealed by a cap.
stirrer.
II. LIP GLOSSES
(c) The temperature at which material starts moving through
 These products are usually far more liquid than a
the capillary is said to be the melting point temperature.
traditional lipstick and the use of waxes is limited.
(d) Another important parameter is the droop point which
 They are usually dispensed from clear tubes to which is
determines the temperature at which the product starts
fitted either a rollerball in a housing or a cap that
oozing out the oil and becomes flattened out.
incorporates a wand with an applicator attached to the
(e) The melting point should be higher than the droop point
bottom.
which determines the safe handling and storage of
III. LIP LINERDS AND PENCILS
finished product.
 These are most often slim pencils, or fluids encased in
special 'pens' to which is attached a fine brush through
 BREAKING LOAD ✓ This test is done in order to determine microbe grow as separate
POINT TEST the strength and hardness of the lipstick. colonies
✓ In this method, the lipstick is placed in SPREAD-PLATE  An aliquot of the diluted sample
hori7zontal position, 1 inch from the base TECHNIQUE is placed to the agar surface and
and weights with increasing loads are is spread uniformly with a sterile
attached to it. the weight at which the bent rod. Incubate it at suitable
lipstick starts breaking, known as the temperature and condition. After
breaking load point. few days, different kinds of
✓ The test shall be carried out in specific microbes grow as separate
condition and at about 25 °C colonies.
temperatures. STREAK-PLATE  In this technique, the sample is
DETERMINATION ☻ This is a test for determining the TECHNIQUE appropriately diluted and a small
OF THIXOTROPIC uniformity in viscosity of base. The aliquot is transferred to an agar
CHARACTER instrument used for the determination of plate. The bacteria are then
thixotropic character is known as the distributed evenly over the surface
penetrometer. by a special streaking technique.
TEST FOR  This is a test to determine the force MEMBRANE FILTRATION  A known amount of pretreated
APPLICATION to be applied during application. METHOD material or its dilution is passed
FORCE  In this method, two lipsticks are cut to through membrane filter
obtain flat surfaces which are placed one assembly. Wash it 3 successive
above other. A smooth paper is placed times each of 100 ml of buffered
between them which is attached to a Na Cl-peptone solution. Transfer
dynamometer to determine force required the membrane on the surface of
to pull the paper indicates the force solidagar medium in a sterile Petri
application. dish. The dish is incubated at
DETERMINATION  The study of surface property of the suitable temperature and
OF SURFACE product is carried out in order to check conditions.
CHARACTERISTICS the formation crystal on the surface or the CHEMICAL ANALYSIS ON COSMETICS
contamination by microorganism or Chemical analysis of cosmetics is very important to ensure that only
formation of wrinkles and the exudation of permitted ingredient are added to the product, information on the label
liquid. is correct or not, and to help in forensic investigation.
DETERMINATION  The test is done in order to determine GENERAL METHODS:
OF COLOR the uniform dispersion of color particle. I. Determination of methanol in relation to ethanol or 2-
DISPERSION The size of the particle is determined by propanol by gas chromatography.
the microscopic studies and it should not II. Determination of dichloromethane and 1,1,1
be more than 50µ. trichloroethane by gas chromatography.
MICROBIAL ANALYSIS ON COSMETICS III. Determination of chlorobutanol by gas chromatography.
The detection and elimination of microbial contamination of cosmetics IV. Determination of hexachlorophene by gas
is very important to maximize shelf life. It is done to ensure product chromatography.
quality, consistency and performance and to meet federal regulations. V. Determination of water by gas chromatography.
Sample preparation for microbiological analysis: VI. Determination of propylene glycol by gas
 For liquid: take 1 ml of liquid and dilute with 9 ml of modified chromatography
letheen broth(MLB) in screwcap test tube DETERMINATION OF COLORING AGENTS IN COSMETIC
 Solid and powders: weigh 1 gm of sample in to screw-cap PRODUCTS
test tube containing 1 ml sterile tween 80. Disperse product  Thin-layer chromatography
in tween 80 with sterile spatula. Add 8 ml sterile MLB and  Liquid chromatography
mix thoroughly.  Spectrophotometry
 Wax / fatty products (lipsticks): weigh 10 gm of sample in  Other methods:
to sterile tween 20. disperse with a sterile spatula to form a o Dyes in lipstick --- Micellar electrokinetic capillary
paste. Add 78 ml sterile MLB and mix thoroughly. chromatography (MEKC) with diode array UV
METHODS FOR MICROBIAL ANALYSIS detection
POUR-PLATE TECHNIQUE ☺ The sample should be diluted ANALYTICAL METHODS USED FOR PRESERVATIVES IN
successively with sterile water. COSMETICS
The agar medium is maintained in 1. Ion-pair and reversed-phase LC with UV/Vis detection,
molten state at 45˚c. 1 ml of 2. Thin layer chromatography (TLC)
diluted sample is added to sterile 3. Capillary electrophoresis (CE)
petri dish to which is then poured 4. Capillary zone electrophoresis (CZE)
9 ml of sterile, cool agar medium. 5. Gas chromatography (GC) with flame ionization detector
☺ The contents are thoroughly (FID), electron capture detector (ECD) or mass spectrometry
mixed and allowed to solidify. The (MS) detector used for preservative determination
dish is incubated at suitable PERFUMERY
temperature and conditions. After  defined by the FDA as a combination of chemicals that gives
few days, different kinds of a distinct scent
  described in a musical metaphor as having three sets of E.g. Faberge Brut
notes, making the harmonious scent accord. 5. FRUITY: Aromas of fruits other than citrus.
TOP NOTES MIDDLES NOTES BASE NOTES
➢ First notes ✓ Its main body of  Foundation of a
perceived after perfume fragrance.
applying a perfume. ✓ Act to mask the  Long-lasting
➢ Consist of the most unpleasant initial aromas that usually
volatile compounds, impression of form accords with
which evaporate very BASE NOTES the heart notes.
quickly.  Provides a
➢ Short-lived but fragrance’s
strong and sharp. longevity and can
➢ Short-lived but usually last for E.g. Ginestet, Botrytis
strong and sharp. hours. 6. GOURMAND: Scent with edible or desert like qualities.
E.g. E.g. Rose,lemon, E.g. sandalwood, E.g. Thierry Mugler’s Angel
Citrus(lemon,orange), nutmeg vanilla, amber FRAGRANCES USED IN PERFUME CAN BE FOUND FROM
Light fruits(grapes, FOLLOWING SOURCES
berries) PLANT SOURCES ANIMAL SYNTHETIC
SOURCES
Bark Civet Calone Terpenes
Flowers Honeycomb Argumen Aldehyde
Blossom Deer musk Amber Amyris
Fruits Ambergris Calone
Resins Hyraceum
Roots Seed
Wood etc.

CLASSIFICATION OF PERFUMES
 Based on Concentration of Fragrance & duration of lasting.
CLASS % OF AROMATIC DURATION
COMPOUND (HOURS)
PARFUME 20-30 6-8
EAU DE 15-20 4-5
PARFUME
EAU DE TOILETTE 5-15 2-3
EAU DE 2-4 2
COLOGNE
EAU FRAICHE 1-3 2 MANUFACTURING PROCESS
 Men’s fragrances are usually eau de toilette strength. As I. COLLECTION:
alcohol exerts a drying effect upon the skin through its Before manufacturing process begins the sources of suitable
solvent action on skin’s natural moisturizers and so do toilet fragrances are collected in the manufacturing centre.
waters. There are two ingredients to counteract this II. EXTRACTION:
dehydrating effect: emollients, such as light, non-volatile oils Oils are extracted from plants and other substances by several
to retard water loss from the skin, and humectants, such as methods like:
glycerin and propylene glycol A. STEAM DISTILLATION
 Delivery systems for alcoholic fragrances include pump - Steam is passed through plant materials held in a still,
sprays and pressurized packs, or aerosols. All products in whereby the essential oil turns to gas. This gas is then
aerosol form must now be environmentally harmless by passed through tubes, cooled, liquefied and collected.
containing no cfcs propellant. B. SOLVENT EXTRACTION:
CLASSIFICATION OF PERFUMES: - The flower parts are dissolved in benzene or petrolatum that
Perfumes can further be classified into following classes: retains the fragrance of the flower. Alcohol is used to
1. BRIGHT FLORAL: Fragrance from one or several flowers. dissolve the fragrance and heated to obtain it after
e.g. Estee lauder’s Beautiful evaporation of alcohol.
2. GREEN: Fragrance from cut grass or leaf. C. ENFLEURAGE:
e.g Calvin Klein’s Eternity - Flowers are kept in glass sheet with grease that absorb the
3. AQUATIC: A clean smell reminiscent of ocean. fragrance of flowers.
e.g. Davidoff, Cool Water D. EXPRESSION:
4. CITRUS: Has freshening effect. - The citrus fruits or plants are manually or mechanically
pressed until all the oil is squeezed out.
 III. BLENDING:  Deodorants and Antiperspirants: Perfumes for these product
Once the perfume oils are collected, they are ready to be blended categories need to be completely free from any possibility of
together according to a formula determined by a master in the field, irritant or sensitizing activity towards the skin, while imparting
known as a "nose.” fresh and cleanly fragrance at levels sufficiently modest not
After the scent has been created, it is mixed with alcohol. Most full to interfere with any personal perfume being used at the
perfumes are made of about 10-20% perfume oils dissolved in alcohol same time
and a trace of water. THE IDEAL SOLVENT
IV. AGING: for use in liquid products should have the following attributes:
Fine perfume is often aged for several months or even years after ֎ Good solvent for all aromatic materials within a temperature
blending to ensure that the correct scent has been achieved. range of –10 to +40.,
COMPOSITION OF PERFUME ֎ Colorless, preferably mobile, liquid,
Perfumes are mainly composed of – ֎ Odorless, Non-flammable, Suitably high volatility,
1. ESSENTIAL OILS: ֎ In all respects non-toxic and safe to use
Derived from natural aromatic plant extracts and/or synthetic aromatic ֎ Non-reactive with perfume ingredients Lifting agent for top
chemicals. E.g. limonene, linalool, geraniol, citraletc. notes
2. FIXATIVES ֎ Resistant to atmospheric oxidation
Natural or synthetic substances used to reduce the evaporation rate. ֎ Thermally stable in sunlight, Non-staining
E.g. benzyl benzoate, benzyl alcohol etc.
֎ Miscible with water in all proportions, Non-foaming in water,
3. SOLVENTS
on shaking
The liquid in which the perfume oil is dissolved in is usually 98%
֎ Readily available at low cost
ethanol and 2% water.
֎ Good skin feel (not too oily, not too dry)
Alcohol allows fragrance to spread along with it and does not permit
֎ Environmentally acceptable
microbial growth in the perfume.
COMMON SOLVENTS USED IN PERFUMERY
INGREDIENTS CAUSING ALLERGIC REACTION
Alcohol:
INGREDIENTS USE SIDE EFFECTS
 Denatured alcohol of high quality and 96% or 100% nominal
ACETONE Solvent Inhalation cause
ethanol content is, currently, still the solvent of choice for
dryness of mouth &
most personal fragrances, having the disadvantages only of
throat
flammability, toxicity if abused and moderate drying effect
ETHYL ACETATE Solvent Defatting effect on
upon the skin.
skin &may cause
 Ethanol is reactive with fragrance materials such as
drying & cracking
aldehydes and many esters but since such interactions are
BENZYL Fixative Skin irritation,
well known and lead to formation of products of acceptable
ALCOHOL redness, pain
odor they do not give rise to problems.
BENZYL Fixative – sweet Skin irritation like
BENZOATE balsamic odor blisters Itching,
redness -IRA G. (MAY 3, 2022)
SANDALWOOD Fragrance Hypersensitivity
QUALITY ASSURANCE
 This requires good instrumentation such as capillary gas
chromatography and possibly with a coupled mass
spectrometer.
 Also good manufacturing practice (GMP) in storage,
production and finishing area is important.
 Further, to assure that cross-contamination does not take
place in compounding.
 Also stock rotation (to use the old material first).
THERMAL STABILITY:
 Destruction of perfume molecules is proportionally related to
increase in temperature.
 Accelerated storage test, as a measure of the stability of the
product and its fragrance over the much longer period of its
shelf life, in the much cooler environment of its storage and
use.
 Heat is frequently used during manufacture but the
temperature must be closely controlled to maximize the
efficiency of the process without causing decomposition of
the product.
PHOTOSENSITIVITY:
 Sunlight and to a lesser extent the ordinary forms of artificial
light, are in general harmful to aromatic materials, and
perfumed products of all kinds, which must therefore be
protected from light at all times.
 MANUFACTURING PHARMACY the components of the chart or the planning as
MODULE 5 organizational plan well as the position
PSMB 411 description
MANUFACTURING PHARMACY LEVELS OF TOP MANAGEMENT
 The complete set of activities to produce a drug that LEVEL 1
compromise production and quality control from dispensing  “Board of Trustees”
of materials to the release for distribution of the finished  Protects and makes the most effective use of the assets of the
product the manufacture, propagation, preparation and company
processing of a drug product in a large scale LEVEL 2
 *Manufacturing company means it covers all production or  “President of the Company”
quality control steps before it has to be marketed.  General management of the business
 The making by physical, chemical, biological or any other  Active planning, direction, coordination and control of the
procedure of any article that meets the definition of drugs business
 The manipulation, sampling, testing or control procedures LEVEL 3
applied to the final product or any other part of the process  “Vice-Presidents, General Managers and Department
 The packaging, repacking or changing the container, wrapper Managers”
or label of any drug package in preparation for its distribution  Management of the major divisions/departments of the
from the manufacturer to the final user company
DRUG ESTABLISHMENTS DEPARTMENTS IN A DRUG ESTABLISHMENT (QREMMPP)
 Any organization or company involved in the manufacture, 1. Research Department 2. Production
importation, repacking and/or distributions of drugs or *This is involved in the Department
medicines. development of a newly existing *The manufacturing of the drug
1. DRUG MANUFACTURER (EPBVMT) product product
TYPES: 3. Quality Control 4. Marketing Department
a. Ethical b. Proprietary c. Biologicals Department *It promotes the maximum
Manufacturers / Generic Manufacturers *This is the heart and the soul of volume of sale
→ they manufacture Manufacturers → VACCINE, the drug establishment for a *Release of drug product
PRESCRIPTION → they manufacture TOXOID, ANTI- manufacturing pharmacy
DRUGS (RX BRANDED AND SERA, *Here is the standardization,
Products) GENERIC BIOTECHNOLOGY testing, assays of the active
PRODUCTS ingredients, testing of the
d. Veterinary e. Medicinal f. Toll / Contract pharmaceutical aids, testing of
Products Chemical Manufacturers drug product for release if they
Manufacturers Manufacturers → comply with the standards
→ DRUGS USED → ACTIVE MANUFACTURING 5. Engineering 6. Purchasing
FOR ANIMALS INGREDIENT / DRUGS FOR THE Department Department
PURE EXCIPIENT OTHER COMPANY → Locating, installing, repairing → Purchase, receive and
“INTERPHIL” and maintaining the equipment responsible for the inventory of
*Interphil is the and facilities supplies
largest toll for the *It locates, install, repairs and *The inventory control, the
contract maintain the equipment planning as well as the
manufacturers in the scheduling
Philippines 7. Medical Department 8. Warehouse Division
2. DRUG IMPORTER/EXPORTER/DISTRIBUTOR *You’ll need the physical and *This is where the ingredients in
 Imports or exports raw materials, active ingredients or finished medical examination of your the manufacturing drug product
products for its own use or for wholesale distribution on whole employees located like the raw material
sale basis section, in-process, the finished
3. DRUG TRADER product, the return goods and the
 Registered owner of the drug product but subcontracts toll dispensing section
manufacture of such products to a licensed manufacturer PRODUCTION CONTROL SECRETIONS
 May also engage in distribution and or marketing of products  Purchasing
 *Any establishment or an establishment which is a registered  Inventory Control
owner of a drug product that procures the raw materials and  Planning and Scheduling
packaging components and provides the production WAREHOUSE DIVISION SECTIONS
monographs, it provides the quality control standards and the  Raw Materials Section
procedures but it subcontracts the toll manufacturer or the 3 Areas:
manufacturer of a product to a license manufacturer.
• Quarantined Area (For further checking and testing)
ORGANIZATION:
• Approved for Use Area (Means approved by the
 A mechanism for determining and assigning duties to people
standard)
in order to work effectively
BASIC ORGANIZATION: • Rejected Area (Not approved by the standard)
 Combination of (5M) Manpower, Money, Machines, Materials  In-Processed Section
and Methods so coordinated to fulfill an economic objective  Finished Products Section
 Returned Goods Section
Basic ELEMENTS of Basic TOOLS of Organization
 Dispensing Section
Organization
RESEARCH AND PRODUCT DEVELOPMENT
 Division on  Organizational Planning
3 Areas:
responsibility (*Have to (Org. chart)
 Chemical Research
divide the responsibility  Position Description
 Biological Research
or the rules) (Job Description)
 Analytical Research
 Delegation of authority  Organizational Manual
3 STAGES FOR RESEARCH:
 Determination of the (Management Guide) –
1. PRELIMINARY – market search, literature review, patient
interrelationship among this is the combination
search
the functions of each of of the organizational
 2. APPLIED RESEARCH – chemical studies, development of and how to manage them and of course more about
chemical process the best dose that will be given to the patients
3. CLINICAL RESEARCH STAGE – manufacturing ● Phase 2 trials are more larger than Phase 1, they
requirements, costing, product control, patent application maybe up to 100 or so people taking part of this.
CURRENT GOOD MANUFACTURING PRACTICES (cGMP) Sometimes the phase 2 trials, a new treatment is
♠ Chapter 21 of the Code of Federal Regulations Part 211 compared with another treatment so in this phase it is
♠ Were first promulgated by the US Food and Drug commonly used with dummy drug or placebo.
Administration (FDA) in 1963; and finalized in 1979 -WHO 2007 ● Phase 3 trials aims to find out which treatment works
♣ System of quality assurance aimed at ensuring that products better for a particular type of disease, checks also the
are consistently manufactured to a quality appropriate for side effects and how the treatment affects the people’s
intended use and is concerned with manufacturing and quality quality of life. They maybe compare the standard
control process and procedures treatment with a completely new treatment, different
♣ *cGMP means we should follow in our protocols and guidelines doses of the same treatment, having the same
♣ *Its goal is to produce drug products that are safe, effective and treatment more or less often a new way of giving a
efficient standard treatment. Ex. Radiotherapy
PHILIPPINE GMP REGULATION ✓ For the Pre-Clinical studies, it have the Long term animal
֎ AO43 1999 – adoption of the 1st edition of the current GMP toxicity, Product Formulation, Manufacturing Control and
guidelines by FDA Package and Label design
֎ AO2012-0008 – Adoption and implementation of the PIC/s ✓ Next is the NDA or New Drug Application and after the NDA,
GMP as the standard on the manufacturer (PIC/s – the phase 4 or Post marketing will be pushed further.
Pharmaceutical Inspection Convention) ANDA OR ABBREVIATED NEW DRUG APPLICATION
֎ FDA MC 2012 (FDA Memorandum Circular 2012) – Philippine  Filed for generic copies by competing companies following
FDA mandated all drug manufacturers to ensure strict and expiration of patent term protection.
full compliance to the newly adopted PICS (Pharmaceutical SNDA OR SUPPLEMENTAL NEW DRUG APPLICATION
Inspection Co-operation Scheme) ♦ There are changes in synthesis, formulation, analytical
standards, containers, and labeling of drug products.
AO43 s 1999
 Part of quality assurance which ensures that medicinal
products are consistently produced and controlled to the
quality standards appropriate to their intended use.
CHAPTERS OF PIC/s GMP 2009
I. QUALITY MANAGEMENT
II. PERSONNEL
III. PREMISE AND EQUIPMENT
IV. DOCUMENTATION
V. PRODUCTION
VI. QUALITY CONTROL
VII. CONTRACT MANUFACTURE AND ANALYSIS
VIII. COMPLAINTS AND PRODUCT RECALL
IX. SELF-INSPECTION
CONTAINER
 Device that holds a drug and is or may be in direct contact with
the drug
2 TYPES:
 PRIMARY CONTAINER – these are the immediate container
for example the cap liner, bottle and rubber cotton
THE FLOW OF THE STAGES OF DRUG DISCOVERY AND - Means in direct contact with the drug
DEVELOPMENT: - PURPOSE: For protection (protect the preparation from
✓ First is the New Chemical Entity, we have to take note their the environmental hazard)
Organic Synthesis and their Molecular Modification, if done with  SECONDARY CONTAINER – It encloses the primary
the New Chemical Entity proceed with Pre-Clinical Studies; container
✓ Pre-Clinical Studies have the Chemistry of the drug product, - For example, the carton, the boxes
the Physical properties, then the Biological and the Pre- - PURPOSE: design for final market presentation
formulation, then after Pre-Clinical proceed with IND 4 COMMON PRIMARY CONTAINERS:
✓ For the IND or Investigational New Drug, you have the Clinical 1. WELL- Protects against extraneous solids and
trials and the continuation of the Pre-Clinical Studies CLOSED liquids, loss of drug under ordinary
✓ For the Clinical trials, it has common phases which are Phase CONTAINER conditions of handling, shipment, storage
1, 2 & 3: and distribution
● For Phase 1, this are usually small trials that recruiting 2. TIGHT Protects from extraneous solids, liquids or
only a few patients and the trial may be open to people CONTAINER vapors, from loss of drug and from
with any type of diseases or any type of usually who efflorescence, deliquescence or evaporation
have already had all other available treatments. The *Efflorescence is the migration of the salt in
aim of Phase 1 is to find out surface of the container
o how much of the drug is safe to give, 3. HERMETIC Impervious to air or any other gases under
o what are the side effects of the drug, CONTAINER ordinary conditions of handling, shipment,
o what happens to the drug in the body, storage and distribution
o or what is its common effects Generally sterile
● The meaning of the Phase 1 trial is to find out about 4. LIGHT Protects the contents from photochemical
the doses and the side effects RESISTANT deterioration amber, opaque blue
● Phase 2 trial aims to find out if the new treatment CONTAINER
works well enough to be tested in a larger phase 3 trial ACCORDING TO QUANTITY HELD
(means is it okay to test in a larger scale of people), 1. SINGLE-UNIT
also it test here more about the side effects of a drug
 - Designed to hold a quantity of drug intended for ✓ Based on the principle that a young child is
administration as a single dose unlikely to coordinate two or more separate
- Sterility is not assured after opening actions to achieve a successful opening
- Ex. Pre-filled syringes, ampoules, blister packages (or 2.TAMPER-  Uses an indication or barrier to entry that is
strips) RESISTANT distinctive by design, or must employ an
2. MULTIPLE-UNIT CONTAINER identifying characteristic which if breached or
- Contains more than a single dose of the medication missing can reasonably be expected to provide
- EX. Vial visible evidence to consumers that tampering has
MATERIALS USED FOR PACKAGING: occurred
1. GLASS  Film wrappers, blister/strip packs, bubble
Type General Uses Test packs, shrink seals/bands, foil, paper or plastic
Description pouches, bottle seals, tape seals, breakable caps,
I HRBSG For parenteral PG TEST sealed tubes, sealed cartoons, aerosol
II TSLG For parenteral WA TEST containers, cans
III SLG For parenteral PG TEST
NP GPSLG Other products PG TEST OTHER CONTAINER MATERIALS:
except LINER Provides additional hermetic seal
parenteral *EX. Paper seal
*HRBSG - High Resistant Borosilicate Glass INNER SEAL For tamper resistance
*TSLG – Treated Soda Lime Glass *Commonly opened in a container (Inner seal)
*SLG – Soda Lime Glass RUBBER Hermetic seals for vials
*GPSLG – General Purpose Soda Lime Glass STOPPER
*NP – Non-parenteral COIL Prevent damage during shipment
2 TESTS THAT USED FOR GLASS: EX. Cotton, Bubble wraps
POWDERED GLASS TEST DESICANT Absorbs moisture
 Performed on ground/powdered glass to expose internal EX. Silica gel
surface PACKAGE Others: Metal, Rubber, Paper and Board
 Tests the leaching potential of the glass INSERT
 Alkali titrated with 0.02 N sulfuric acid
 *Commonly used in Type I, III & NP COLD PLACE < 8 DEGREE CELSIUS
WATER ATTACK TEST FREEZER -25 to -10 deg C
 Exposure of the glass with sulfur dioxide at 121C REFRIGERANT 2-8 deg C
 *It measures the alkali release from the glass COOL 8-15 deg C
 *Commonly used in Type II glass container
2. PLASTIC
ROOM TEMPERATURE TEMP PREVAILING AT THE AREA
 Does not apply to a single material but rather to a vast number
*CONTROLLED ROOM 15-30 deg C
of materials each developed to have desired features
TEMPERATURE
 ADV: Lightweight, Flexibility, Resistance to impact
WARM 30-40 deg C
 DISADV: Permeability, Leaching, Sorption, Transmission of
light, Alteration of container upon storage EXCESSIVE HEAT ABOVE 40 deg C
 TWO TYPES:
• THERMOPLASTIC – squeezy TYPES OF POWDERS AND GRANULES
• THERMOSET – firm & grid BULK (DODI-TAD) DIVIDED AKA CHARTULA
PLASTIC MATERIALS ◼ NON-POTENT ◼ POTENT
PE ⚫ Cannot be autoclave ◼ BLOCK AND DIVIDE ◼ GEOMETRIC
⚫ Low-density – dropper & sprays ◼ NOT INDIVIDUAL DILUTION
⚫ High-density – solid oral preparations DOSE ◼ INDIVIDUAL DOSE
PET ☺ For beverages
◼ WIDE MOUTH • BOND PAPER
☺ APETG (amorphous PET glycol)
PLASTIC/GLASS CONTAINER • GLASSINE
☺ PETG (PET glycol)
OR SIFTER TOP OR AEROSOL • VEG. PARCHMENT
☺ Have transparency and luster
CONTAINER • WAXED
PP ✓ Autoclavable COMMON CHARACTERISTICS:
PVC  Rigid & good clarity HYGROSCOPIC
 blister packaging - Absorbs moisture, but does not dissolve
*PE – Polyethylene DELIQUESCENT
- this is the most widely used thermoplastic polymer for fabricated parts - Absorbs moisture and eventually dissolves
and for components EFFLORESCENT
- these are available in variety of grids and formulation to soothe the - Releases water of crystallization
different needs EFFERVESCENT
*PET – Polyethylene Terephthalate - Releases carbon dioxide gas in water
*PP – Polypropylene COMMUNITION
- It is also a thermoplastic, addition polymer made from the combination - Particle size reduction
of propylene monomers PRINCIPAL MEANS OF MILLING:
*PVC – Polyvinyl chloride 1. Cutting / shearing mill (CUTTING)
- Most third widely produced synthetic polymer of plastic 2. End runner mill – (COMPRESSION)
SAFETY PACKAGING 3. Hammer mill, vibration (IMPACT)
1.CHILD- ✓ One that is difficult for most children under 5 4. Ball mill, pin mill, Fluid energy mill (IMPACT & ATTRITION)
RESISTANT years of age to open or gain access to the 5. Roller mill – (ATTRITION & COMPRESSION)
CONTAINER contents or obtain a harmful amount of the
contents PAN POLISHING
- A finishing method for hard gelatine capsules, wherein a
polyurethane or cheese cloth material lines the
 polishing pan. The liner is used to trap removed dust, PROPERTIES OF GRANULES FOR TABLET PRODUCTION:
imparting gloss to capsules; 1. Fluidity / Flowability
BLENDING / MIXING OF POWDERS (FHAT) 2. Compressibility
1. Tumbling mixer/blender – (YRDOT) – commonly used for larger IMPROVEMENT OF POWDER / GRANULE FLOWABILITY:
of blending or mixing of powders 1. ALTERATION OF PARTICLE SIZE AND SIZE
● Y cone, DISTRIBUTION
● Rotating cube,  Use larger particles
● Double cone,  Reduce the amount of fines
● Obliques cone, 2. ALTERATION OF PARTICLE SHAPE OR TEXTURE
● Twin shell or V mixer  The more spherical and smoother the particles, the more
2. High speed mixer granulator flowable
3. Fluid bed mixer Have the tablet granulation which it dries faster 3. ALTERATION OF SURFACE FORCES
4. Agitator mixer – ribbon and planetary mixer  Reduce/increase electrostatic charges
 Reduce moisture content
GRANULES 4. ALTERATION OF PROCESS CONDITIONS
- Aggregates of powders that adhere or bond to each other 5. USE OF FLOW ACTIVATOR (GAL)
to form larger unit particles  Use glidants, lubricants and anti-adherents
- *Common size of granules is 0.2-4 mm in diameter CAPSULES:
METHODS OF GRANULATION: HGC / HARD GELATIN SGC / SOFT GELATIN
1. WET GRANULATION aka WET MASSING CAPSULE CAPSULE
TYPES:  Aka: DRY FILLED  Has 5-8/6-10%
A. WET MASSING WITH THE USE OF WATER – (MSD) CAPSULE  Rendered plastic-like
3 STEPS OF MSD:  Has 12-16/13-15% with the addition of
1.) MOISTENING the powders to produce a wet mass moisture plasticizers (glycerin or
2.) SCREENING the wet mass to break into granules of desired  Gelatin shells are sorbitol)
size manufactured in a  Oblong, oval, spherical,
3.) DRY the granules to remove solvent separate process tube, pearl,
B. FLUID BED GRANULATION LIQUID IS SPRAYED ON (dipping pegs made of suppository-type
SUSPENDED POWDERS manganese bronze in  Filled with pumpable
*The difference between Wet Massing with the use of water and Fluid a melted gelatin solutions, suspensions,
bed granulation liquid is sprayed on suspended powders are: mixture) pasty material or
 Wet massing or MSD has 30-35% of water  Shell composed of: powders formed and
 Fluid bed granulation, this is the method of tablet production Gelatin, water, sugar, sealed in a single
wherein the granulation solution is spayed into the suspended colorants, 0.15% sulfur manufacture process
particles, so it is the more expensive type of wet granulation dioxide, titanium dioxide  Plate process and
WET GRANULATIONS: (SSSH) • Has 2 parts: rotary or reciprocating
1. Shear granulators body and die process
2. High speed mixers/granulators cap/head
3. Spray dryers • Has 8 sizes (5
4. Spheronizers/pelletizers to 000)
FLUID BED GRANULATION  Common for pin method
- A method of tablet production wherein a granulation or the reciprocating die
solution is sprayed onto the suspended particles method
which would then be dried rapidly in the suspending air FOR HARD GELATI CAPSULE:
GRANULATION PIN METHOD/RECIPROCATING DIE
 Process in which primary powder particles are made to adhere  Dipping, Spinning, Drying, Stripping, Trimming and Joining the
to form larger, multiparticle entities capsules, Polishing
SPHERONIZATION 6 COMMON STEPS:
 A multiple process used to make uniformly spherical DIPPING:
particles (for controlled release application) - Pairs of the stainless steel pins are dipped into the dipping
 *Performs to increase the flowability of the granules solution to simultaneously form the caps and bodies.
2. DRY GRANULATION - The dipping solution is maintained at a temperature of
- Particles are aggregated using high pressure about 50C in a heated, jacketed dipping pan.
TYPES: SPINNING:
A. ROLL-COMPACTION B. SLUGGING METHOD - The pins are rotated to distribute the gelatin over the pins
METHOD (RGS) (SGS) uniformly and to avoid the formation of a bead at the
 Powders are rolled into ♠ Slugging the powders capsule ends.
dense sheets (formation of a large DRYING:
 Sheets are granulated tablet called slug) - The gelatins is dried by a blast of cool air to form a hard
using a mechanical ♠ Slugs are granulated shells.
granulator using an appropriate - The pins are moved through a series of air drying kilns to
 Sieve granules to obtain equipment remove water
the desired size ♠ Sieve granules to obtain STRIPPING:
the desired size - A series of bronze jaws strip the cap and body portions of
TYPES OF GRANULES: the capsules from the pins.
A. GOOD GRANULES TRIMMING AND JOINING:
- Particles that pass through sieve 20 and are retained at - The stripped cap and body portions are trimmed to the
sieve 40 required length by stationary knives.
B. FINES particles that pass sieve 40 - After trimming to the right length, the cap and body portion
QUALITIES OF A GOOD GRANULATION: are joined and ejected from the machine.
1. As spherical as possible POLISHING:
2. Uniform in content ֎ PAN POLISHING: Acela-cota pan is used to dust and polish
3. Normal or bell-shaped distribution of particle sizes ֎ CLOTH DUSTING: Capsule are rubbed with cloth
 ֎ BRUSHING: Capsule are feed under soft rotating brush. GLIDANTS Improve flow properties of granules
FOR SOFT GELATIN CAPSULE: EX: COLLOIDAL SILICA,
PLATE PROCESS: CORNSTARCH, TALC, FUMED SILICON
GDUPF OXIDE, MG STEARATE
o Warm sheet of gelatin is poured on the mold, drug is poured LUBRICANTS Reduces friction during ejection of tablets
upper gelatin layer is added, pressure is applied to form, fill + from the machine to prevent picking
seal the capsule. EX: MG STEARATE, CA STEARATE, ZN,
ROTARY DIE: STEARATE, MINERAL OIL, CARBOWAX
GFS 400, LEUCINE, AND COLLOIDAL
o Gelatin formed into continuous ribbon, by RD machine and are SILICON DIOXIDE
consequently brought together, fill is injected between ribbon, ANTI-ADHERENTS Prevents tablet ingredients from sticking to
sealed with pressure and heat punches and dies during the production
MATERIALS FOR CAPSULE SHELL MAKING EX: MG STEARATE, TALC
1.GELATIN Partial hydrolysis of collagen from animals ADSORBENTS Agent capable of holding the molecule
Types: Gelatin A & B onto their surfaces
*Wall former for microencapsulation EX: ACTIVATED CHARCOAL
2.PLATICIZER For elasticity & flexibility COLORING AGENTS For aesthetic purposes and product
Glycerin, sorbitol DYES- WATER identification can be natural or synthetic
3.COLORANTS FD&C SOLUBLE FD&C – food, drug & cosmetics
4.PRESERVATIVES 0.15% sulfur dioxide LAKES – WATER D&C – drug & cosmetics
5.OPACIFYING Titanium dioxide INSOLUBLE EXTERNAL D&C- external use only
AGENT *For large scale glidants, lubricants and FLAVORING AGENTS Oils or dry powders are used in
surfactants may also be employed formulations color, odor and flavor must
complement one another
CAPSULE SIZES ESTIMATED (mL) EASIER VERSION SWEETENING Natural (SHS- SUCROSE, HONEY,
(mL) AGENTS STEVIA) Artificial (CAAS- CYCLAMATE,
000 1.40 1.4 ASPARTAME, ACESULFAME K,
00 0.95 1.0 SACCHARIN, SUCRALOSE)
0 0.68 0.7 COLORANTS:
1 0.5 0.5  FD&C RED NO. 2 (AMARANTH)
2 0.37 0.4 - Causes cancer in rats, unproven safety
3 0.30 0.3  FD&C RED NO. 4
4 0.21 0.2 - Found in maraschino cherries and ingested drugs; only
used in external drugs and cosmetics
5 0.13 0.1
 FD&C YELLOW NO. 5 (TARTRAZINE)
ENCAPSULATION PROCESS
- Causes allergic type reaction in many people
Preparation of formulation
 D&C RED NO. 22 (EOSINE)
Filling
 FD and C #6 (SUNSET YELLOW)
Sealing
 BRILLIANT BLUE- FD AND C BLUE NO. 2
Cleaning & Polishing
 ALLURA RED- FD AND C RED NO. 40
BLOOM STRENGTH
FLAVORANTS:
- Load in grams required to push a standard set distance
COCOA FLAVOR Combats bitter taste of the drug
into a prepared gelatin gel (6.66%) soln at 10 deg c
- *It measures the gelatin capsule’s rigidity CITRUS FLAVOR Combats acid or sour
- *The higher bloom strength the higher or more stable the RASPBERRY FLAVOR Masked salty taste of the drug
capsule is FLAVORED SYRUP:
PARTS OF A TABLET PRESS (HFPDC) ERIODICTYON Bitter taste
1. HOPPER – loads the granule GLYCYRHIZZA Saline
2. FEED SHOE – directs granules from the hopper to the side ACACIA Urea
3. PUNCH – compress granules into tab
4. DIE – control the size and shape of the tablet LMW SALTS Salty
5. CAM TRACKS – guides the movement of upper and lower HMW SALTS Bitter
punches INCREASED OH GROUP Increased bitterness
DILUENTS / FILLERS Add necessary bulk to the formulation N-CONTAINING Bitter
EX: LACTOSE, STARCH, SORBITOL, EX. Alkaloids or alkaline
KAOLIN, AVICEL (Atropine & Caffeine)
*Avicel is a microcrystalline cellulose ANIMAL SECRETION FOR FORMULATION OF FRAGRANCE:
BINDERS / Promotes adhesion of the particles  Avette – Cat
ADHESIVES EX: STARCH, ACACIA, ALGIN,  Ambergris – Sperm whale
CELLULOSE, GELATIN, LIQUID  Musk – Deer
GLUCOSE, POVIDONE, CORNSTARCH,
TRAGACANTH
DISINTEGRANTS Promotes breakup of the tablet after
administration
EX: CELLULOSE-, STARCH, ALGIN,
SODIUM STARCH GLYCOLATE
*Added to break or disintegrate the tablets
*Should breakup cause before the
absorption there 2 D’s that will be happen,
the disintegration and dissolution
*Disintegration process should have a low
particle size
*Dissolution’s goal is to produce solution
PARTS OF A TABLET PRESS (HFPDC): - ADV: No significant increase in tablet size and weight
1. HOPPER – loads the granule (storing) unlike sugar-coating
2. FEED SHOE – directs granules from the hopper to the side - About 2-5% increase in thickness only
(responsible for the distribution) 1. FILM FORMER – Produces smooth thin film
3. PUNCH – compress granules into lab (compaction) Examples: Cellulose acetate phthalate, HPMC
4. DIE – control the size and shape of the tablet 2. ALLOYING SUBSTANCE – Provides water solubility /
5. CAM TRACKS – guides the movement of upper and lower permeability to the film to ensure penetration by body fluids
punches (guide) Ex: Polyethylene glycol (PEG)
3. PLASTICIZER – Produces flexibility + elasticity during
TABLET COATING: application
A. SUGAR-COATING (PPP) EX: Castor oil, PG, Glycerin, PEG
- Successive addition of sucrose-based solutions to a tablet 4. SURFACTANT – Enhance spreadability of the film during
core application
3 PROCESSES: EX: Spans & Tweens
1. Pan Coating – most widely used 5. OPAQUANT & COLORANT - to enhance aesthetic
2. Pan Spraying qualities of the coat
3. Pan Suspension EX: TiO2, FD&C
6. SWEETENER, FLAVOR & AROMA – Enhance
A.STEPS IN SUGAR-COATING (SSSFP) acceptability of the tablet by the px
1.SEALING / WATERPROOFING – for components easily EX: Vanillin, saccharin
affected by water
7. GLOSSANT – Produces luster to tablet
2. SUBCOATING – improve bond between sugar coat and tablet
EX: Beeswax
core
8. VOLATILE SOLVENT – Allows the spread of other CMPD
3. SYRUPING / SMOOTHING – complete rounding off
over the tablet while allowing rapid evap to permit an
a. GLOSSING – establishing color safe
effective yet speedy operation
b. HEAVY SYRUPING – build a solid color base rapidly
EX: Alcohol-acetone mixture
c. REGULAR SYRUPING – to attain appropriate color
ENTERIC COATING
4. FINISHING – to attain final smoothness
- Designed to resist dissolution in the stomach but dissolve
DEBOSSED – imprinted with a mark BELOW the surface
in the less acidic environment of the small intestines.
EMBOSED – imprinted with a mark ABOVE the surface
- Ph: 4.8 or greater
5. POLISHING – for sheen or gloss
SPANSULE
- A capsule composed of hard gelatin shell containing
QUIZ:
hundreds of tiny coated beads/pellets of drugs for
1. It produces drugs for the other company
sustained release
2. Used to improve bond between sugar coat and tablet core
- Ends of both bodies and cap are highly tapered/narrowed.
3. Substance added in Sealing
- Used by Smith Kline Beecham
4. Autoclave plastic.
PULVULES
5. Cool place.
- End of the body-producing peg is tapered but the cap-
6. A process wherein warm sheet of gelatin is poured on the mold,
making peg is rounded.
drug is poured, upper gelatin layer is added, pressure is applied
- Used by Eli Lilly
to form, fill + seal the capsule.
KAPSEAL
7. A multistep process used to make uniformly spherical particles.
- This is a distinctive looking capsule because of the sealing
8. Tests the leaching potential of the glass
with a colored band of gelatin.
9. Type III glass in AKA_______
- This is used by Parke-Davis
10. Method of mixing of Divided powders.
CONI-SNAP
11. It is Cl to phenylketonuria.
- The rim of the capsule body is not straight but tapered
12. Law whicj involves the adoption of PIC/PICS.
slightly.
13. Temperature requirement of HGC.
- This eliminates splitting of the joined capsule.
14. Responsible for testing and assaying of drugs.
15. Principle of Hammer mill and vibration mill.
Question:
16. Spray dryer is used for ______
A pH-sensitive, non-digestible radiofelemettric device used as a
17. Other name of brilliant blue.
nonradioactive means of measuring gastric pH, gastric residence time
18. A syrup masking the saline taste
and gastric emptying time of solid dosage forms is called HEIDELBERG
19. Diluent of choice for moisture sensitive subs.
CAPSULE
20. A combination of org chart and job description
21. AKA Pharmaceutical glazed
22. A mill used for reduction of particle size, homogenization and CAPPING – Separation of top and bottom
production of finely divided solids. *Entrapment of air, where of tears and dyes
23. Ambergris is derived from _______ CHIPPING – separation of small portion (commonly see in friability
24. % of water in wet massing. test)
25. It improve the blood between sugar coat and tablet core LAMINATION – separation of several layers
26. It measures the capsule rigidity. PICKING - removal of top layer (punch)
27. A granulator used to produce a finely divided particles of FLAKING – removal of small portion of liquid
suspension. STICKING – Adhesion of the material to the die wall
28. A container protecting the content from extraneous solid, liquid BLISTERING – reduce adhesion of film from the tab due to improper
and vapor. drying
29. 160x – 200x as sweet as sucrose WRINKLING – reduce adhesion with many blister
30. AKA Hydrated aluminum Silicate ORANGE-PEEL – roughness of tab surface
BRIDGING – filling of the score line
B. FILM-COATING (FAPSOSGV) SWEATING – formation of oil film droplets of liquid
- The process of placing a thin, skin-tight coating of a BLOOMING – dull migration of plasticizer
plastic-like material over a tablet core SPOTTING – migration of the other ingredient
MOTTLING – migration of color
 WEIGHT VARIATION – problem with die  Gravimetric filling – for mobile and frothy solutions
HARDNESS VARIATION – problem with punches  Vacuum filling – for viscous solutions
TABLET EROSION – Is the disfiguration of the core tablet  Pressure filling – for viscous solutions
*The tablet absorbs too much water during the coating application,
where it causes the surface to become softer and less erosion GENERAL SCHEME FOR SUSPENSION:
resistant 1.ACTIVE - should be insoluble
FILMING – Slow form of sticking INGREDIENT - Must be uniformly dispersed
CRATERING – Defect of film coating whereby volcanic craters 2.DISPERSION - aqueous or non-aqueous
appear MEDIUM
BLUSHING – Whitish specks/ haziness in the film 3.WETTING AGENT - displaces the air from crevices of drug
CRACKING – due to rapid expansion of tablet particles
ROCKER BOTTOM – sunken center formation - glycerin, sorbitol solution, syrup
4.SUSPENDING - Hydrocolloids – acacia, tragacanth,
SOLUTIONS AGENT veegum, cellulose derivatives
- Homogenous one-phase system consisting 2 or more - Clays – bentonite (Native colloidal
components hydrated silicate), kaolin (Hydrated
- Most commonly used liquid dosage form aluminum silicate)
- pH: 4.8 or greater - Others: Agar, gelatin, pectin, gelatinized
1.ACTIVE Consider solubility & stability starch
INGREDIENT *Responsible for the therapeutic effect of the 5.BUFFER
drug product 6.SWEETENING
2.SOLVENT Consider clarity, toxicity, viscosity, AGENT
compatibility, palatability 7.FLAVORING
EX. Water – best solvent AGENT
3.CO-SOLVENT Used in combination with the solvent to 8.COLORANT
increase solubility of the solute 9.PRESERVATIVE
EX. Ethanol, sorbitol, glycerin, propylene
glycol, polyethylene glycol EMULSION
4.SOLUBILIZER Surfactants (Tweens)  Are dispersed systems in which the dispersed phase is
5.VISCOSITY Improves pourability and to some extent, composed of small globules of a liquid distributed throughout a
ENHANCER / palatability vehicle in which it is immiscible.
CONTROLLER Sugar, PVP, cellulose derivatives 4 TYPES:
6.BUFFER Controlling pH to maintain solubility and  OIL IN WATER EMULSION
stability  WATER IN OIL EMULSION
Most common: pH 4-7  MULTIPLE EMULSION
EX. Citric, lactic, glutaric  MICROEMULSION
7.SWEETENING *For the taste to be accepted/acceptable GENERAL FORMULATION – EMULSION
AGENT 1. Active Ingredient
8.FLAVOR *Addition of the flavorant 2. Aqueous phase (water part)
9.COLORING *To be aesthetically appealing 3. Oleaginous phase (oil part)
AGENT 4. Emulsifier
10.PRESERVATIVE Benzoic acid and its salts, parabens, - Acts as the bridge between the 2 immiscible phases
chlorobutanol, benzyl alcohol, thimerosal, (the water and the oil phase)
benzalkonium chloride - Stabilizer of the internal phase
*Addition of Benzoic acid with a conc of 0.1- - Retards coalescence of the globules
0.2% - TYPES: Refer to DDS
5. Antioxidant
GENERAL STEPS IN THE MANUFACTURE OF PHARMACEUTICAL - Protects the emulsified lipids which are susceptible to
oxidation
SOLUTIONS
- EX: BHA, BHT, tocopherol, ascorbic acid, EDTA
1. Preparation of formulation materials and equipment
2. Compounding 6. Preservative
- Charge the solute to the solvent - Should be effective for both phases
7. Sweetener
Agitate with the use of mixers until solution is homogenous
8. Flavoring agent
- Heat may be employed to increase solubility
- Ensure complete solution before further processing 9. Colorant
- Solutes in small concentrations (such as dyes and 10. Humectant
- Reduces the evaporation of moisture from the product
intensely colored materials) must be predissolved prior to
- EX. glycerin, sorbitol, propylene glycol
mixing with the whole batch
3. Storage & Aging MANUFACTURING PROCESS
To allow complete blending of all the components 1. OIL PHASE containing oil-soluble ingredients is heated at
4. Filtration & Clarification (GVPPS) about 5-10C above the melting point of the ingredient with the
- Aim for 3-5 microns or less highest melting point.
- Filter media: Cellulose nitrate, polyamide, polyvinylidene 2. AQUEOUS PHASE is heated to the same temperature.
chloride, nylon 3. THE TWO PHASES ARE MIXED.
- Classified as: 4. VOLATILE INGREDIENTS ARE ADDED AT THE LOWEST
• Gravity filtration – slow TEMPERATURE AS POSSIBLE (usually 45-55C).
• Vacuum filtration – large scale 5. ADJUST THE FINAL WEIGHT when emulsion reaches 35C.
• Pressure filtration – fast, to achieve highly EQUIPMENTS (MCH)
polished product 1.) Mechanical stirrers
2.) Colloid mills – Homogenization of viscous emulsions
• Parallel filtration – one type of filter
• Series filtration – more than one filter
5. Filling & Packaging (GVP)
 - An equipment the mixes the components of emulsions by ACTUATOR
means of various impellers on shafts, which are placed  Provides a rapid and convenient means for releasing the
directly into the system to be emulsified; contents from a pressurized container’ button that activates
3.) Homogenizers the system
- This equipment produces finely divided particles by VALVE
spraying a mist of liquid through a heated chamber,  Expels the contents from the container; regulate the flow of
drying immediately and collecting the dried powders in a product from container
clean receptable; STEM
HLB VALUE RANGE SURFACTANT APPLICATION  Part of the usual aerosol valve assembly that supports the
0-3 Antifoaming agents actuator and delivers the formulation in the proper form
4-6 W/O emulsifying agents DIP TUBE
7-9 Wetting agents  The tube that delivers the content
8-18 O/W emulsifying agents GASKET
13-15 Detergents  Placed snugly with the stem, prevents leakage of the
10-18 Solubilizing agents formulation when the valve is closed.
 HLB number usually between 1 and 20 are used as emulsifying MOUNTING CUP
agents  Part of the usual aerosol valve assembly that is attached to the
 With values 8-18 indicates hydrophilic molecule (produce o/w aerosol can or container and hold the valve in place
type of emulsion) SPRING
 Lower numbers in the range of 3 to 6 indicates lipophilic  Holds the gasket in place and is the mechanism by which the
molecules and will produce w/o emulsions actuator retracts when pressure is released, returning the valve
AEROSOL to the closed position
- Pressurized dosage forms designed to deliver drug
systematically or topically with the aid of liquefies or
propelled gas
- Product concentrate – active ingredient combined with
excipients
- Propellant – act as a solvent and diluent

QUIZ:
1. BHA/BHT is used as _______
2. An equipment that mixes the components of emulsions by
Pressure of the propellant forces the liquid phase up the tube and out in means of various impellers on shafts
the atmosphere → propellants meets the air → evaporates dues to drop 3. Problem with punches
in pressure → leaving the product concentrate as airborne liquid droplets 4. One type of filter is use.
or dry particles, as in powders. 5. The disfiguration of the core tablet.
6. A pH-sensitive, non-digestible radiofelemettric devise used as
PROPELLANT a nonradioactive means of measuring gastric pH, gastric
residence time and gastric emptying time of solid dosage forms
1.LIQUIFIABLE GAS CFC – can degrade the ozone layer
is called _______
DICHLORODIFLUOROMETHANE,
7. A capsule with colored gelatin band
DICHLOROTETRAFLUOROETHANE,
8. End of the body-producing peg is tapered but the cap-making
TRICHLOROMONOFLUOROMETHANE
peg is rounded.
2.COMPRESSED GAS Include carbon dioxide, nitrogen, nitrous
9. Placed snugly with the stem, prevents leakage of the
oxide
formulation when the valve is closed.
10. HLB Value of Wetting agent
11. Migration of colorant
12. Part of the usual aerosol valve assembly that supports the
actuator and delivers the formulation in the proper form
13. More than 1 filter is used in filtration
14. 2 examples of film former
15. Spans can produced ____ type of emulsion
CATEGORIES: LEDDSS GRADE C AND D
- Solutions ready for injection  Clean areas for Carrying out less critical stages of the
- Dry soluble products ready to be combined with a solvent manufacture of sterile
prior to use GRADE C
- Suspensions ready for injection  Hair and where relevant beard should be covered
- Dry insoluble products ready to be combined with a  A single or two piece suit gathered at the wrist and with high
vehicle prior to use neck and appropriate shoes or overshoes should be worn
- Emulsions ready for injection should shed virtually no fibers or particulate matter
- Liquid concentrates ready for dilution prior to use GRADE D
PRODUCTION FACILITIES – EASY TO CLEAN, SAFE, STERILE ♦ Hair and where relevant beard should be covered
5 SECTIONS: ♦ General protective suit and appropriate shoes and overshoes
A. MATERIALS SUPPORT AREA should be worn
- SURFACES SHOULD BE CONTINUOUS ♦ Appropriate measures should be taken to avoid any
- CLASS 10,000 ENVIRONMENT contamination coming from outside and clean areas
• (nmt 10,000 particles or 0.5 um or larger are STERILIZATION
present in per cubic ft.) 1.) STEAM (PROTEIN DENATURATION)
B. COMPOUNDING AREA  Autoclave (121C, 15-30 mins, 15psi)
- Most stringent control 2.) DRY HEAT (OXIDATION)
Stainless steel cabinets and counters ♠ Oven (160-170C, 2-4 hrs)
- Continuous surfaces ♠ 650C in 1 minute, 250C in 45 minutes, and 180C in
- CLASS 100 ENVIRONMENT 4 hours
C. ASEPTIC FILLING AREA 3.) TYNDALLIZATION (DNA MUTATION)
- “heart” of production area  Intermittent steam sterilization exposing material to
- Laminar air flow (LAF) with HEPA filter (High Efficiency 100C for 30 min or 80C for 1 hr for 3 consecutive
Particulate Air) days
- 99.95% efficiency 4.) GAS → ethylene oxide (DENATURATION)
- Used to test efficiency of heap filter: DOP TEST 5.) IONIZING RADIATION UV (DNA UNWINDING)
D. QUARANTINE AREA  (204-280 nm); bactericidal (gamma, cathode, beta
- Storage while waiting for QC results rays)
E. FINISHING AREA 6.) BACTERIAL FILTRATION-MEMBRANE FILTERS
A. Active drug (MECHANICAL SEPARATION)
B. Solvent/Vehicle STERILIZATION
Aqueous water miscible water for injection Glycerin 1. STEAM: B. stearothermophilus
Ethanol propylene glycol PEG 400 & 600 2. DRY HEAT: B. subtilis
Vegetable oils – SPCC 3. IONIZING RADIATION UV: B. pumilus, B. stearothermophilus,
CoCoPeSe (Corn oil, Cottonseed oil, Peanut oil & Sesame oil) – B. subtilis
solvent for intra-muscular injection 4. ETHYLENE OXIDE: B. subtilis
Non-vegetable oils 5. MEMBRANE FILTRATION: P. diminuta
Benzyl benzoate ethyl oleate isopropyl myristate
Other excipients QUALITY CONTROL
Buffer acetates citrate phosphates Environment:
Preservative Blood agar plate
Chlorobutanol, benzyl alcohol, parabens RODAC contact plates
Chelating agent: EDTA Product: sterility tests, pyrogen tests
Tonicity adjusting agent
NaCl, boric acid, NaNO3, KNO3, dextrose PACKAGING & LABELING
D.Containers Methods to seal ampoules
Bottle, vial, ampule, cartridge, bag, glass, plastic 1. TIP SEAL METHOD (AKA BEAD SEAL)
Single-dose (limit: 1000 mL) - Not so efficient
Multiple-dose (limit: 30mL) 2. PULL SEAL
E.Closures/Stoppers - More efficient

MANUFACTURE OF STERILE PRODUCT LEAKERS TEST

 Should be carried out in clean areas, entry to which should - Test the integrity of strips, blisters and bottles
be through airlocks for personnel and/or for equipment and - Operation based on vacuum
materials
CLEAN AREAS PYROGEN TEST:
 An area with defined environmental control of particulate BACTERIAL ENDOTOXIN TEST
and microbial contamination, constructed and used in such  This is a test for estimating the concentration of
a way as to reduce the introduction, generation, and retention bacterial endotoxins
of contaminants within the area  Endotoxins react with enzyme Limulus Amebocyte
AIRLOCK Lysate (LAL) forming gel-clot formation
֎ An enclosed space with two or more doors, which is  LAL are obtained from aqueous extracts of the
interposed between two or more rooms circulating amebocytes of the horseshoe crab,
TYPES OF DIFFERENT GRADES: Limulus polyphemus
GRADE A The pyrogen test using rabbit is the
QUANTITATIVE FEVER RESPONSE TEST
 Local zone for high risk operations
 Involves measuring the rise in temperature of the rabbits
 EX: Filling zone, stopper bowls, open ampoules and vials,
following the intravenous injection of a test solution and
aseptic connections
measuring the temperature for 1-3 hours at 30 min interval
 Provided by a laminar air flow work station with a HEPA
 If no rabbit shows an individual rise in temperature of 0.5C or
GRADE B
more above, the product meets the requirements for the
 For aseptic prpn and filling
absences of pyrogens, otherwise use additional 5 rabbits
  If not more than three of the eight rabbits show individual rises
in temperature of 0.5C or more and if the sum of the eight
individual maximum temperature rises does not exceed 3.3C,
the material under examination meets the requirements for the
absence of pyrogens.
FINE DISPERSION 1-10 MICRONS
TRUE SOLUTION <1 microns
COLLOIDAL DISP 1-0.5 microns
COARSE DISP >0.5 microns
SUSPENSION >0.5 microns
PARENTERAL AND 1-5 microns
INHALATIONAL SUSP.
IMPALPABLE POWDER 74 microns
MICRONIZATION <5 microns
FLUID OR JET MILLING <10 microns
COLD STERILIZATION 0.2 microns
ORAL AEROSOLS Below 50 microns
MICROPULVERIZATION 10-50 microns
SPHERONIZATION 0.5-12 microns

70-72 deg C Avoid breaking in semisolid

2-8 deg C Storage of biologic
40-45 deg C Temp. Thermally bond capsule’s
cap and body
-34.5 - -40 deg C Propellant in aerosol liquifies
650 deg C for 1 min Destroyed pyrogen
250 deg C for 45 min contaminating glasswares
180 deg C for 4 hrs
>49 deg C Aerosol container burst
100 deg F Empty HGC should be stored

-Ira (03/28/22)
 LEGAL PHARMACY AND ETHICS An act Regulating and Modernizing the Practice of Pharmacy in the
PSMB 411 Philippines , Repealing for the purpose Republic act number five
JURISPRUDENCE thousand nine hundred twenty one (R.A. No. 5921), otherwise known
 is defined as a system of laws as the Pharmacy Law
 is the science of philosophy of laws Signed into law on July 21, 2016
ETHICS *Repeal means binabago
 is the science of morality ARTICLE I: GENERAL PROVISIONS
 It refers to the moral principles of practice SECTION 3 OBJECTIVES:
THREE TYPES OF LAW SYSTEM: This act provides for and shall govern the:
STATUTORY LAW REGULATORY COMMON LAW  Standardization and regulation of pharmacy education
LAW  Administration of licensure examination, registration and
✓ Passed by the  Supports the ➢ Principle: STARE licensing of Pharmacists
Senate or the Statutory law DECISIS - the policy  Supervision, control, and regulation of the practice of pharmacy
Congress wherein this has of courts to stand by in the Philippines
✓ Dictate the been created for the precedent  Development and enhancement of professional competence of
activities of the proper regulation ➢ Allowing the state pharmacists through continuing professional development,
person and to decide research, and other related activities
✓ Provide penalties implementation of  Integration of the pharmacy profession
for those who do not the former law ARTICLE 1: SECTION 4
comply *Ex. Administrative SCOPE OF THE PRACTICE OF PHARMACY:
*Ex. Republic acts order  Compounding
UNIVERSAL PRINCIPLES OF BIOMEDICAL ETHICS:  Dispensing and Counseling
 AUTONOMY – *Allow ourselves to choose what we want. In  Teaching
medical field, allow the patient to choose or decide  Physico-chemical, Biological Microbiological Analyses
 VERACITY – *The patient is honest to the doctor (truth  Vaccine Administration
between them)  Research
 BENEFICENCE - *Do good to our fellow people ARTICLE II: SECTION 7
 NONMELEFICENCE - *Hindi gagawa ng masama QUALIFICATIONS OF THE CHAIRPERSON AND MEMBERS OF THE
 CONFIDENTIALITY - *The patient’s record should be kept BOARD: (Board of Pharmacy)
confidential  Filipino citizen
 JUSTICE - *Fairness among citizens  RPh or MS degree holder
 ROLE FIDELITY - *Doing our own roles  10 years-experience
LAWS:  Have not been convicted of a crime
RA 5921 PHARMACY LAW JUNE 23,1969  At least 5 years membership in APO
RA3720 FOOD, DRUG, DEVICES AND JUNE 22, 1963  Not affiliated in any school, review center or similar institution
COSMETICS ACT (*to avoid leakage)
RA 6675 GENERICS ACT SEPTEMBER 13, ARTICLE II: SECTION 9
1988 TERM OF OFFICE: 3 YEARS
● May be reappointed for another term
RA 7432 SENIOR CITIZEN ACT OF 1992 APRIL 23, 1992
● *Max of 6 years
RA 9257 EXPANDED SENIOR CITIZEN FEBRUARY 26,
● New set of office-in-charge: ANTHONY ALDRIN C.
ACT OF 2003 2004
SANTIAGO (Chairman)
RA 9994 EXPANDED SENIOR CITIZEN FEBRUARY 15,
● Members: MIDRED B. OLIVEROS & ADELINA C. ROYO
ACT OF 2010 2010
ARTICLE III: SECTION 14
RA 9165 COMPREHENSIVE JUNE 7,2002
QUALIFICATIONS FOR THE LICENSURE:
DANGEROUS DRUG ACT OF
Applicant for the Pharmacist Licensure Examination:
2002
 Filipino citizen or of a foreign country which has a law or policy
RA 6425 DANGEROUS DRUG ACT OF APRIL 4, 1972
on reciprocity or the practice of the pharmacy profession
1972
 Of good moral character and reputation
RA 8423 TRADITIONAL AND DECEMBER  Degree holder of Bachelor of Science in Pharmacy
ALTERNATIVE MEDICINE ACT 9,1997  Has completed an internship program
(TAMA) OF 1997 ARTICLE III: SECTION 15
RA 8203 SPECIAL LAW ON JULY 22, 1996 SCOPE OF EXAMINATION:
COUNTERFEIT DRUGS  Inorganic Pharmaceutical Chemistry,
RA 7394 CONSUMER’S ACT APRIL 13, 1994  Organic Pharmaceutical Chemistry,
RA 7581 THE PRICE ACT MAY 7, 1992  Qualitative and Quantitative Pharmaceutical Chemistry,
RA 9502 UNIVERSALLY ACCESSIBLE JUNE 6, 2008 Pharmacognosy and Plant Chemistry,
CHEAPER AND QUALITY  Pharmaceutical Biochemistry,
MEDICINES ACT OF 2008  Microbiology and Parasitology,
RA 9711 FDA ACT OF 2009 AUGUST 18,2009  Physical Pharmacy,
 Biopharmaceutics,
R.A. NO. 10918  Pharmacology and Toxicology,
THE PHILIPPINE PHARMACY LAW  Manufacturing,
 Quality Assurance and Instrumentation,
  Pharmaceutical Calculations,  Ensure that all pharmaceutical products conform to standards
 Drug Delivery Systems, of safety, quality and efficacy, as provided for in this Act and
 Hospital Pharmacy, other pertinent rules and regulations and issuances. (Article
 Clinical Pharmacy, IV, section 32)
 Dispensing and Medication Counseling,  Must be members of the APO and must maintain membership
 Pharmaceutical Administration and Management, throughout the duration of the practice of the profession
 Public Health, (Article V, section 42)
 Legal Pharmacy, and Ethic ARTICLE IV: SECTION 31
ARTICLE III: SECTION 16 PHARMACIST REQUIREMENT:
 The Pharmacist Licensure Examination shall be given two (2) Establishments/outlets which are required to employ and/or retain and
times a year in places and dates as the PRC may designate maintain the professional services of duly registered and licensed
in the Resolution providing for the master schedule of all pharmacists shall be classified as follows:
licensure examinations pursuant to Section 7(d) of Republic (a) Category A (b) Category B
Act No. 8981. Pharmaceutical establishments Pharmaceutical establishments
 *Where did the Pharmacist Licensure Examination take place? /outlets where the direct and /outlets where the supervision
In schools where it doesn’t offer pharmacy program immediate control and and oversight of a duly
ARTICLE III: SECTION 17 supervision of a duly registered registered and licensed
 In order to be registered and licensed as a pharmacist, a and licensed pharmacist is pharmacist is required under
candidate must obtain a general weighted average of required, per establishment, pertinent provisions of law
seventy-five percent (75%), with no rating lower than fifty whether in-store or online
percent (50%) in any of the subjects. *Full time pharmacist (24/7) *Part time pharmacist only
 An applicant who failed in the licensure examination for the should be on duty should be on duty
third (3rd) time shall not be allowed to take the next succeeding *RONPDS – Retail Outlet Non-
examinations without having undertaken a refresher program Prescription Drugs
in a duly accredited institution. The Board shall issue guidelines (1) Pharmaceutical (1) Retail outlets selling
on the refresher program requirement. establishments/outlets selling household remedies and OTC
SUCCESSFUL CANDIDATES IN THE LICENSURE EXAMINATION: or otherwise making available to drugs as differentiated from the
ARTICLE III: SECTION 19 the consuming public pharmacist-only OTC medicines;
 shall take their Oath of Profession prescription/ethical medicines,
ARTICLE III: SECTION 2 combination products (medical
 Will receive Certificate of Registration and Professional device and drugs) classified as
Identification Card (subject to compliance with the registration drugs according to the primary
requirements and payment of the prescribed fees.) intended mode of action,
PIC (PROFESSIONAL IDENTIFICATION CARD pharmacist-only OTC medicine,
will include the following ✓ issued to every registrant, whether owned by the
information: upon payment of the prescribed government or by a private
 registration number, fees. person or firm, whether sold at
 dates of its issuance and ✓ shall be renewed every three wholesale or retail;
expiry, (3) years, upon presentation of (2) Establishments involved in (2) Satellite institutional
 Signature of the Chairperson the following: the manufacture, importation, pharmacies providing
of the PRC exportation, distribution, and medicines solely to employees of
Certificate of Good Standing sale of combination products their respective companies or the
(COGS) from the APO and proof (medical device and drugs) employees’ qualified
of completion of the CPD classified as drugs according to dependents, or both; or members
requirements the primary intended mode of of a duly registered organization
*Now, before renewal should action; or institution;
have CPD units (45 units before (3) (3) Fourth, fifth and sixth class
now 15 units nalang) Departments/Divisions/Units municipal health units involved
Excemption: of pharmaceutical in the procurement, distribution,
*In abroad laboratories, pharmaceutical dispensing, and storage of
*Newly RPH (1st renewal) no manufacturing laboratories, or pharmaceutical products;
CPD units required but for the 2nd other establishments with
and so on needed na ung 15 processes involving the
CPD units preparation, manufacture, assay,
regulation, product research and
REGISTERED AND LICENSED PHARMACIST: development, quality control,
 have the right to affix to one’s name, the "RPh". (Article IV, repacking, importation,
section 26) *after the oath taking exportation, distribution, sale or
 When employed he/she should display the original copy of transfer of pharmaceutical
one’s COR in a prominent and conspicuous place in the drug products in quantities greatly in
establishment (Article IV, section 29) excess of single therapeutic
 The only one to fill, compound and dispense Prescription drugs doses; and
and pharmacist-only OTC medicines (Article IV, section 30
and section 33)
 (4) Government units, including (4) Institutions providing (k) Illegal manufacture, sale, possession, dispensing of dangerous
local government, city, first to telepharmacy services; and (5) drugs and other acts in violation of Republic Act No. 9165, and
third class municipal health units, Nontraditional outlets of other applicable laws and issuances;
nongovernment organizations pharmaceutical products: (l) Committing acts in violation of Section 6 of Presidential Decree
and/or associations involved in Provided, that no prescription No. 881, entitled "Empowering the Secretary of Health to
the procurement, distribution, medicines and pharmacist-only Regulate the Labeling, Sale and Distribution of Hazardous
dispensing and storage of OTC medicines are sold. Substances" and Section 11 of Republic Act No. 3720, as
pharmaceutical products; amended;
PHARMACIST REQUIREMENT (CONT.) (m) Practicing pharmacy with a suspended COR or expired PIC;
A pharmacist working in a Category A establishment may be (n) Unauthorized dispensing of pharmaceutical products through
allowed to simultaneously work or render pharmacy services in unregistered online services or direct selling businesses;
Category B establishments, the maximum number of hours of (o) Being found guilty of immoral, unprofessional, or dishonorable
which shall be determined, in accordance with such guidelines as conduct by the Board.
may be established therefore by the Board, in coordination with the ARTICLE VII:
FDA, and other agencies, establishments, institutions, and regulatory 45 -PENAL PROVISIONS:
bodies. Any person who shall commit any of the acts stated in this section, upon
*For Category B, max of 15 RONPDS ang pwedeng mahawakan ng conviction, be sentenced (For major penalties)
isang registered pharmacist ֎ to pay a fine of not less than two hundred fifty thousand pesos
*Kailangan nasa 25 km radius lang ang lahat ng RONPDS na (₱250.000.00), but not exceeding five hundred thousand pesos
hinahawakan ng isang registeres pharmacist (₱500.000.00)
ARTICLE V: ֎ or imprisonment of not less than one (1) year and one (1) day
ACCREDITED PROFESSIONAL ORGANIZATION: but not more than six (6) years, or both, at the discretion of the
Sec 41. A pharmacist duly registered with the Board shall automatically court.
become a member of the integrated and accredited professional 46- OTHER PENALTIES:
organization of pharmacists, and shall receive the benefits and Any person who shall commit any of the acts stated in this section, upon
privileges appurtenant thereto upon payment of the required fees and conviction, be sentenced (For minor penalties)
dues.  to pay a fine of not less than one hundred thousand pesos
ARTICLE VI: (₱100,000.00), but not exceeding two hundred thousand pesos
VIOLATIONS, ADMINISTRATIVE SANCTIONS, AND PROCEDURES: (₱200,000.00)
The Board shall have the power, upon notice and hearing, to revoke or  or imprisonment of not less than thirty (30) days but not more
suspend the COR of a registered pharmacist or to cancel an STP of a than one (1) year, or both, at the discretion of the court
foreign pharmacist on any of the following grounds: (GIC-FAM-FIVA- * The owner/operator of the pharmaceutical establishments/outlets and
AMIP) the duly registered and licensed pharmacists/pharmacy support
*Revoke -tatanggalin personnel are jointly liable for the willful violation of any provision of this
*Suspend – kukunin of a period of time Act
(a) Violation on the policies and regulations in the practice of REPUBLIC ACT NO. 3720
pharmacy (AS AMENDED BY E.O. NO. 175, MAY 22,1987)
(b) Conviction of an offense involving moral turpitude by a court of "An act to ensure the safety and purity of foods and cosmetics, and the
competent jurisdiction; purity, safety, efficacy and quality of drugs and devices being made
(c) Unprofessionalism, immorality, malpractice, incompetence, available to the public, vesting the bureau of food and drugs with
gross negligence, or imprudence in the practice of the authority to administer and enforce the laws pertaining thereto, and for
profession; other purposes."
(d) Fraud or deceit in the acquisition of the COR, PIC or STP, or SECTION 3:
renewal thereof; DECLARATION OF POLICIES:
(e) Allowing the COR to be used or displayed in establishments The government shall:
where the pharmacist is not actually employed and practicing;  Establish standards and quality measures (FDDC)
(f) Addiction to alcoholic beverages or to any habit-forming drug  Adopt measures to ensure pure and safe supply of FDDC
rendering a pharmacist incompetent to practice the profession  Adopt measures to ensure the rational use (of FDDC) such as
as provided for in Section 23 hereof; banning, recalling or withdrawing – also adoption of an official
(g) Aiding or abetting the illegal practice of a non-registered and National Drug Formulary – use of generic names in labels
licensed person;  Strengthen the Bureau of Food and Drugs (aka FDA)
(h) Insanity or any mental disorder that would render the person CREATION OF THE FOOD AND DRUG ADMINISTRATION:
incompetent to practice pharmacy;  Created to carry out provision of this act
(i) False, extravagant, or unethical advertisements and  It is an office inside the Department of Health
endorsements of pharmaceutical products, pharmaceutical  It shall be under the Secretary of Health
outlets and establishments where the pharmacist’s name or the SECTION 4:
pharmacist’s professional organization and similar information, POWERS, DUTIES, RESPONSIBILITIES:
or both, are used; 1. To administer and supervise the implementation of this Act and
(j) Manufacture, sale, offering for sale of counterfeit, spurious, of rules and regulations
substandard and falsified pharmaceutical products and 2. To provide for the collection of samples of FDDC
committing other acts in violation of Republic Act No. 9165 and 3. To analyze and inspect FDDC
Republic Act No. 8203, otherwise known as the "Special Law 4. To establish analytical data to serve as basis for the
on Counterfeit Drugs"; preparation of FDDC standards - and recommend standards of
identity, purity, quality and fill of container.
 5. To issue certificate of compliance  Composition of such drug
6. To collect fees for inspection, analysis and testing of products  Description of the methods, facilities used for manufacture
and materials  Drug samples
7. To certify batches of antibiotic and insulin preparations  Label specimen
SECTION 5:  Other which would be required
DIVISIONS: SECTION 22:
AMENDED BY RA 9711 CERTIFICATE OF DRUGS CONTAINING ANTIBIOTICS:
 Inspection and Licensing Division 1. The Secretary provide for the certification of antibiotic
 Laboratory Division 2. Whenever the requirements not necessary to ensure, safety
SECTION 6: and efficacy of use and good quality, the Secretary shall
HEAD: promulgate regulations exempting such drug or class of drugs
FDA ADMINISTRATOR from such requirements.
 Head 3. Secretary shall promulgate regulations
 Appointed by the Secretary of Health  drugs which are to be stored, processed, labeled,
 *OIC-Director General → OSCAR GUTIERREZ or repacked at establishments other than those
SECTION 7: where manufactured, on condition that such drugs
 Secretary may add more personnel as may be needed comply with all such requirements upon removal from
SECTION 11: such establishments
PROHIBITED ACTS AND PENALTIES:  drugs which confirm to applicable standards of
1. Manufacture, importation, exportation, sale, offering for sale, identity, strength, quality, and purity prescribed by
distribution or transfer of any food, drug, device or cosmetic these regulations and are intended for use in
that is adulterated or misbranded. manufacturing other drugs
*Adulterated means naglagay pa ng ibang substances  drugs which are intended for investigational use by
*Misbranded means more on sa label experts qualified by scientific training and experience
2. The adulteration or misbranding of any food, drug, device, or to investigate the safety and efficacy of drugs
cosmetic. SECTION 23, 24:
3. The refusal to permit entry or inspection as authorized by ADULTERATED AND MISBRANDED COSMETICS:
Section Twenty-seven hereof or to allow samples to be COSMETICS:
collected. 1. If it contains poisonous or deleterious substance
4. The giving of a guaranty or undertaking which is false Except hair dyes if:
5. Forging, counterfeiting, simulating, or falsely representing or  It contains: "Caution: This product contains ingredient
without proper authority using any mark, stamp tag, label, or which may cause skin irritation on certain individuals
other identification device “
6. Revealing information which is a trade secret  It contains “This product must not be used for dyeing
7. The alteration, mutilation, destruction, obliteration, or removal the eyelashes or eyebrows; to do so may cause
of the whole or any part of the labeling of, the doing of any other blindness”
act with respect to, a food drug, device, or cosmetic 2. Others are same with FDD
8. The use of any representations in suggesting an application 3. Misbranded cosmetics are also the same with FDD*
which is false (in labeling and advertisement SECTION 26:
9. Use of report of analysis from FDA without authorization 1 ADMINISTRATIVE SANCTIONS, REGULATIONS, HEARING, AND
10. The manufacture, importation, exportation, sale, offering for INSTITUTION OF CRIMINAL ACTION:
sale, distribution, or transfer of any drug or device which is not  Report products to the FDA
registered with the FDA.  FDA would conduct testing
11. The Manufacture, importation, exportation, sale, offering for  If the product is indeed adulterated, misbranded, not
sale, distribution, or transfer of any drug or device by any registered, the Director shall:
person without the license from the FDA  Give notice to the complained parties
12. The sale or offering for sale of any drug or device beyond its  Issue a hearing to impeach the correctness of the
expiration or expiry date. findings
13. The release for sale or distribution of a batch of drugs without ADMINISTRATIVE ORDERS
batch certification AO 42 Drug Registration Of Herbal and/or Traditional
WHAT ARE THE PENALTIES FOR VIOLATING ANY OF THE AO 4 Availing of Compassionate Special Permit (CSP)
PROVISIONS OF SECTION ELEVEN? AO 27 Licensing Local Manufacturers Of Vaccines And
 Imprisonment of nlt 1 year but not more than 5 years Fine of nlt Biologic Products
5k – nmt 10k (amended) A0 55 Labelling Requirement
SECTION 21: AO 56 Licensing to operate
LICENSING AND REGISTRATION: -UPDATED: A0 34
1. No person shall Manufacture, sell, offer for sale, import, export,
EO 302 Adopting PNDF as immediate reference of standards
distribute or transfer any drug or device:
EO 119 Reorganizing BFAD
 Unless an application is filed for (License application
MC 15 Exemption from Requiring one pharmacist every area
or LTO/ License To Operate)
MC 17 Pharmacist Monitoring Hours
REQUIREMENT FOR THE APPLICATION UNDER OATH:
AO 62 Prescribing Requirement
 Investigations showing drug or device is safe, efficacious and
AO 63 Dispensing Requirement
of good quality (according to clinical trials)
 Full list of the articles used as components AO 67 Registration of Pharmaceutical Products
 SECTION 6:
FOOD AND DRUG ADMINISTRATION (FDA) ACT OF 2009” Section 5 of Republic Act No. 3720, as amended, is hereby further
R.A. 9711 amended and new subsections are added to read as follows:
An act strengthening and rationalizing the regulatory capacity of the (A) CENTERS AND (B) EACH CENTER
Bureau of Food and Drugs (BFAD) renaming it the Food and Drug OFFICES: SHALL BE HEADED BY
Administration (FDA) A DIRECTOR. THE
DATE OF APPROVAL: AUGUST 18, 2009 CENTERS SHALL BE SO
SECTION 1: ORGANIZED SUCH
A LAW THAT RENAMED THE BUREAU OF FOOD AND DRUGS THAT EACH WILL HAVE,
(BFAD) TO FOOD AND DRUG ADMINISTRATION(FDA). AT LEAST, THE
SECTION 3: FOLLOWING DIVISIONS
It is hereby declared a policy of the State to adopt, support, establish,  Regulation and  Product Research and
institutionalize, improve and maintain structures, processes, Research (veterinary Standards
mechanisms and initiatives that are aimed to: medicine, vaccines and Development Division
PROTECT AND PROMOTE HELP AND MAINTAIN biologicals);  Licensing and
SECTION 4:  Food Regulation and Registration Division
OBJECTIVES: Research  Laboratory Support
Enhance and Ensure the FDA’s Provide coherence  Cosmetics Regulation Division
strengthen the monitoring and in the FDA’s and Research
administrative and regulatory coverage regulatory system (household
technical capacity hazardous/urban
FUNCTIONS, POWERS AND DUTIES: substances)
 Implementation  Device Regulation,
 Collection of samples Radiation Health, and
 Analyze and inspect Research
 To maintain bonded warehouses
 Ban, recall, and/or withdrawal of product “These Centers shall regulate
 Verification of complaints the manufacture, importation,
 Establish analytical data exportation, distribution, sale,
 To prescribe standards, guidelines, and regulations offer for sale, transfer, promotion,
 Appropriate authorizations advertisement, sponsorship of,
 Post market surveillance system and/or, where appropriate, the
 Issuance of certificates use and testing of health
products. The Centers shall
likewise conduct research on
the safety, efficacy, and quality of
health products, and to institute
standards for the same.
(C) THE (D) the policy and
ADMINISTRATION AND planning office which
FINANCE OFFICE shall be under the Office
headed by the deputy of the Director-General
director-general for shall have, at least, a
administration and finance training, advocacy and
communications division
(E) THE FIELD (F) THE LEGAL
REGULATORY SERVICES SUPPORT
OPERATIONS OFFICE CENTER shall provide
headed by the deputy legal services to the entire
director-general FDA and shall be directly
under the Office of the
Director General."
SECTION 7:
Section 6 of Republic Act No. 3720, as amended, is hereby further
amended, to read as follows:
DOH (secretary)
FDA (Director General)
 Two (2) Deputy Directors general,
 Deputy Director-general For Field Regulatory Operations
 Deputy Director-general For Administration And Finance
SECTION 10:
"SEC. 11. The following acts and the causing thereof are hereby
prohibited:
“(a) The manufacture, importation, exportation, sale, offering for sale,  The owner, proprietor, administrator or manager of the
distribution, transfer, non-consumer use, promotion, advertising, or drugstore, hospital pharmacy or dispensary, laboratory or other
sponsorship of any health product that is adulterated, unregistered or outlets or premises where the counterfeit drug is found who
misbranded. induces, causes or allows the commission of any act herein
“(b) The adulteration or misbranding of any health product. prohibited;
“(d) The giving of a guaranty or undertaking  The registered pharmacist of the outlet where the counterfeit
drug is sold or found, who sells or dispenses such drug to a
Section 11, subsections (a), (b), (d), (g), (j),(k) and (l) of Republic Act third party and who has actual or constructive knowledge that
No. 3720, as amended, are hereby further amended to read as follows: said drug is counterfeit; and
 Should the offense be committed by a juridical person the
“(g) The alteration, mutilation, destruction, obliteration, or removal president, general manager, the managing partner, chief
“(j) not registered health product. operating officer or the person who directly induces, causes or
“(k) The manufacture, importation, exportation, sale, offering for sale, knowingly allows the commission of the offense shall be
distribution, transfer, or retail without the license to operate penalized.
“(l) any health product beyond its expiration or expiry date, if applicable. SECTION VII:
ADMINISTRATIVE SANCTIONS:
Section 11, subsections (a), (b), (d), (g), (j),(k) and (l) of Republic Act Upon finding that the drugs examined are counterfeit and the
No. 3720, as amended, are hereby further amended to read as follows: determination of the parties liable thereof, the Bureau shall impose any
or all of the following sanctions:
SECTION 11:  Permanent closure and revocation of its license
Section 12, subsection (a) of Republic Act No, 3720, as amended, is  Fine of nlt ₱100,000 and nmt ₱500,000
hereby further amended to read as follows:  Forfeiture, confiscation, and destruction of products found to
“SEC.12.(a) Any person who violates any of the provisions of be counterfeited and the equipment used
Section eleven hereof shall, upon conviction, suffer the penalty of  Forfeiture, confiscation, and destruction of products found to
imprisonment ranging from (1) year - (10) years or a fine of (P50,000.00) be counterfeited and the equipment used
- (P500,000.00), or both, at the discretion of the court.  Cancellation of the license of the pharmacist
That if the offender is a manufacturer, importer or distributor of  Permanent disqualification of the person engaged in any
any health product, the penalty of (5 to 10) years imprisonment and a business activity
fine of (P500,000.00) -(P5,000,000.00) SECTION VIII:
SECTION 13: PENALTIES:
Section 29-A of Republic Act No. 3720, as amended, is hereby further The commission of any of the acts prohibited under section 4 and 6 of
amended, and new subsections are added to read as follows: this Act shall be punished by:
"SEC. 29-AMENMMENT: ADMINISTRATIVE SANCTIONS:  Imprisonment of not less than six (6) months and one (1) day;
(1) Cancellation of any authorization but not more than six (6) years for more possession of
(2) A fine of P50,000.00-P500,000.00). An additional fine of counterfeit drugs as provided for in section 4
(P1,000.00) shall be imposed for each day of continuing  Imprisonment of six (6) years and one (1) day, but not more
violation than ten (10) years or a fine of not less than one hundred
(3) Destruction and/or appropriate disposition of the subject health thousand pesos (p100,000) but not more than five hundred
thousand pesos (p500,000) or both such imprisonment and
SPECIAL LAW ON COUNTERFEIT DRUGS fine at the discretion of the court in any other case mentioned
R.A. NO. 8203 in section 4 hereof;
An act of prohibiting counterfeit drugs, providing penalties for violations  Imprisonment of not less than six (6) months and one (1) day,
and appropriating fund therefor. but not more than two (2) years and four (4) months if the
Signed into law on September 1996 counterfeit drug is intended for animals;

It is hereby the policy of the State to protect and promote the right to GENERICS ACT OF 1988 RA 6675
health of the people and instill health consciousness among them as APPROVED DATE: SEPTEMBER 13, 1988
provided in Section 15 Article 11 of the Constitution. AN ACT TO PROMOTE, REQUIREAND ENSURE THE
PRODUCTION OF AN ADEQUATESUPPLY, DISTRIBUTION, USE
SECTION IV: AND ACCEPTANCEOF DRUGS AND MEDICINES IDENTIFIED
PROHIBITED ACTS: BYTHEIR GENERIC NAMES.
The following acts are declared unlawful and therefore prohibited:
 The manufacture, sale, or offering for sale, donation, SECTION 2:
distribution, trafficking, brokering, exportation, or importation or STATEMENT OF POLICY:
possession of counterfeit drugs  To promote, encourage and require the use of generic
 Possession of any such counterfeit drugs terminology
 Forging, counterfeiting, simulating or falsely representing, or  To ensure the adequate supply of drugs with generic names at
without proper authority. the lowest possible cost
 Photocopying, duplicating, altering, printing, transferring, REPUBLIC ACT OF 6675
obliterating or removing the approved label “GENERICS ACT OF 1988”
 Making, selling, or concealing any instrument Dapat gamitin ng doctor ang generic name sa tuwing magrereseta
SECTION V: ng gamot mapapubliko man o probado.
PARTIES LIABLE:  To encourage the extensive use of drugs with generic names
The following Persons shall be liable for violation(s) of this act: through rational system of procurement and distribution
  To emphasize the scientific basis for the use of drugs, in SECTION 8:
order that health professionals may become more aware and REQUIRED PRODUCTION:
cognizant of their therapeutic effectiveness Subject to the rules and regulations promulgated by the Secretary of
 To promote drug safety by minimizing duplication in Health, every drug manufacturing company operating in the Philippines
medications and/or use of drugs with potentially adverse drug shall be required to produce, distribute and make available to the
interact ions. general public the medicine it produces, in the form of generic drugs.
SECTION 4: SECTION 11:
THE USE OF GENERIC TERMINOLOGY FOR ESSENTIAL DRUGS EDUCATION DRIVE:
ANDPROMOTIONAL INCENTIVES:
 In the promotion of the generic names for pharmaceutical
products, special consideration shall be given to drugs and
medicines which are included in the Essential Drugs List.
 The exclusive use of generic terminology in the manufacture,
marketing and sales of drugs and medicines, particularly those
in the Essential Drugs List.
3 FACTS ABOUT GENERIC DRUGS
Generics provide the same quality, safety and efficacy as original SECTION 12:
branded medicines. PENALTY:
They contain the same active substance and thus are 1st : REPRIMAND
interchangeable with the original product. 2ND : NLT P2,000.00 but NMT P5,000.00
All medicines, whether branded or generic, must be registered and 3RD : CONVICTION
approved by BFAD.  NLT P5,000.00 but NMTP10,000.00
 Suspension for 30 days
This ensures the public of their quality and safety, and is a
4TH : CONVICT ION AND SUBSEQUENT
requirement before they can be sold to the market.
 NLT P10,000.00
Doctors must indicate the generic name of all drugs in their
 Suspension for 1 year or longer
prescriptions.
ANY JURIDICAL PERSON WHO VIOLATES SEC 6(C), 6 (D), 7 OR 8
The Generics Act of 1988 requires all doctors to indicate first the
SHALL:
generic name, then indicate the brand name in parenthesis when
PENALTY:
prescribing.
 NLT P5,000.00 but NMTP10,000.00
SECTION 5:
 And Suspension or revocation of license to operate
POSTING AND PUBLICATION:
 Or imprisonment of NLT 6months NMT 1 year
The Department of Health shall publish annually in at least two (2)
DEPARTMENT MEMO 2009-0009
newspapers of general circulation in the Philippines the generic names,
 Generics Only Prescribing
and the corresponding brand names under which they are marketed, of
 Issued on January 7, 2009
all drugs and medicines available in the Philippines.
 This prohibits government physicians to prescribe branded
SECTION 6:
medicines.
WHO WILL USE GENERIC TERMINOLOGY:
A.O. 62 s. 1989
GOVERNMENT MEDICAL, ORGANIZATION
Subject: Rules and Regulations to Implement Prescribing Requirements
AGENCIES & DENTAL, OR COMPANY (6C)
under RA 6675
PERSONNEL (6A) VETERINARY Shall indicate
SEC 3:
Shall use generic PRACTITIONERS prominently the
 Generic names shall be used in all prescript ions.
names in all (6B) generic name of
 The generic name must be written in full but the salt may be
transaction Shall write product labels
abbreviated.
prescriptions using (advertising and
 The generic name of the drug must be clearly written on the
generic names, promotion materials)
prescript ion immediately after the Rx symbol
Brand name may be
SEC 4:
included
INCORRECT PRESCRIPTIONS:
SECTION 7:
 Erroneous prescription
PROVISION ON QUALITY, MANUFACTURER’S IDENTITY AND
 Violative prescription
RESPONSIBILITY:
 Impossible prescription
 2. Violative prescription UNIVERSALLY ACCESSIBLE CHEAPER AND QUALITY
MEDICINES ACT OF 2008,
REPUBLIC ACT 9502
APPROVAL DATE: JUNE 6, 2008
An Act Providing for Cheaper and Quality Medicines, Amending for the
Purpose Republic Act No. 8293or The Intellectual Property Code,
Republic Act No. 6675 or The Generics Act of 1988, and Republic Act
No. 5921or The Pharmacy Law and for Other Purposes.
CHAPTER 1. GENERAL PROVISIONS.
SECTION 2:
DECLARATION OF POLICY:
 It is the policy of the State to protect public health and when the
public interest or circumstances of extreme urgency so require,
*No substitutions and no generic name it shall adopt appropriate measures to promote and ensure
3. Impossible Prescription access to affordable quality drugs and medicines for all.
 Pursuant to the attainment of this general policy, an effective
competition in the supply and demand of quality affordable
drugs and medicines is recognized by the State as a primary
instrument.
SECTION 3:
CONSTRUCTION IN FAVOR OF PROTECTION OF PUBLIC HEALTH:
All doubts in the implementation and interpretation of the provisions of
this Act, including its implementing rules and regulations, shall be
resolved in favor of protecting public health.
CHAPTER 3. DRUGS AND MEDICINES PRICE REGULATION.
SECTION 17:
DRUGS AND MEDICINES PRICE REGULATION AUTHORITY OF
THEPRESIDENT OF THE PHILIPPINES:
The President of the Philippines, upon recommendation of the Secretary
*Brand name is different from generic of the Department of Health.
A.O. 90 S. 1990 SECTION 18:
 Subject: Amendment to A.O. 62 s. 1989 DRUGS AND MEDICINES PRICE MONITORING AND REGULATION
 Rules and Regulations to Implement Prescribing Requirements AUTHORITY OF THE SECRETARY OF THE DEPARTMENT OF
 As amended A.O. 62, permit s the writing of the generic names HEALTH:
of more than one drug product in one prescript ion form. DOH Secretary
A.O. 63 S. 1989 SECTION 19:
Subject: Rules and Regulations to Implement Dispensing Requirements FUNCTIONS AND RESPONSIBILITIES OF THE SECRETARY OF
under RA 6675. THE DEPARTMENT OF HEALTH:
SEC 4: No retailer shall sell drugs and medicines at a retail price exceeding the
GUIDELINES ON WHAT TO DO WITH VIOLATIVE, ERRONEOUS, maximum retail price approved by the President of the Philippines.
AND IMPOSSIBLE RX: POWER TO IMPOSE ADMINISTRATIVE FINES AND PENALTIES:
VIOLATIVE AND IMPOSSIBLE ERRONEOUS RX DOH Secretary
RX . No case shall be less than Php50,000.00 not more than
The prescript ions shall be kept The prescript ions shall be filled, Php5,000,000.00 for violations of the maximum retail price
and reported by the pharmacist but it shall also be kept and SECTION 23:
or other interested parties to the reported to the nearest DOH LIST OF DRUGS AND MEDICINES THAT ARE SUBJECT TO PRICE
nearest DOH office for office for appropriate act ion. REGULATION:
appropriate act ion a. For chronic and life0threatening conditions.
SEC 5: b. Drugs and medicines indicated for prevention of diseases.
VIOLATIONS ON THE PART OF DISPENSERS AND OUTLETS: c. Drugs and medicines indicated for prevention of pregnancy
 Imposing a particular brand or product on the buyer d. Anesthetic agents
 Inaccurate dispensing SECTION 26:
 Failure to post or make accessible required up- to- date info on DISPLAY OF MAXIMUM RETAIL PRICE FIXED AND APPROVED BY
drug product ORDER OF THE PRESIDENT OF THEPHILIPPINES FOR DRUGS
 Failure to adequately inform the buyer on available product s AND MEDICINES SUBJECT TO PRICE REGULATION.
that meet then prescription.
 Failure to indicate the generic name "RETAIL PRICE NOT TO EXCEED _____________ UNDER DRUG
 Failure to record and keep prescriptions filled. PRICE REGULATION
 Failure to report to the nearest DOH office cases of violative,
erroneous, and/or wrong prescriptions within 3 months after CHAPTER 4. STRENGTHENING OF THE BUREAU OF FOOD AND
receipt of such prescript ions. DRUGS.
SECTION 31:
The Bureau of Food and Drugs shall submit a yearly performance report
to the Quality Affordable Medicines Oversight Committee,
SECTION 32:
The Bureau of Food and Drugs shall take the necessary steps to ensure
that all drugs authorized for marketing in the country shall conform to
international standards.
AO 55
Principal display panel- refers to the part of a label that is most likely
to be displayed, presented, shown or examined under customary
condition of display for retail use
✓ If brand name is presented using a special typeface exclusively MANDATED PRICE CEILING:
designed and used for it, the generic name shall be rendered (1) The impendency, existence, or effects of a calamity;
in Helvetica Medium (2) The threat, existence, or effect of an emergency;
✓ The Rx symbol should be printed in a type size NO LESS (3) The prevalence or widespread acts of illegal price manipulation
THAN one fifth (1/5) of the height of the PDP DETERMINATION OF PRICE CEILING:
✓ Alcohol content when present must be expressed in % (1) The average price, in the last three (3) months immediately
✓ Expiration date-shall be expressed in terms of the month and preceding the proclamation of the price ceiling, of the basic
the year. (Last day of the MONTH) necessity or prime commodity under consideration;
DEFINITION OF TERMS (2) The supply available in the market;
WARNINGS refers to statements regarding the (3) The cost to the producer, manufacturer, distributor or seller
occurrence of potential hazards and side including but not limited
effects associated with the use of the
product and the limitation of its use.
CONTRAINDICATIONS refers to statements regarding the
conditions wherein the use of the product
may cause harm to the patient.
PRECAUTIONS refers to the instruction and special care
required in the used of the product to
avoid undesired effects and to ensure the
safe and effective use of the drug.

RA 7581
THE PRICE ACT
DECLARATION OF BASIC POLICY:
(1) Develop, adopt and promulgate measures to promote
productivity in basic necessities and prime commodities;
(2) Develop an improved and efficient transport and distribution PRICE COORDINATING COUNCIL:
system; One representative from:
(3) Develop, adopt and promulgate measures to stabilize prices at  the consumers’ sector;
reasonable levels;  the agricultural producers’ sector;
(4) Institute appropriate penalties for illegal price manipulation and  the trading sector; and
other violations of this Act; and  the manufacturers’ sector.
(5) Establish a mechanism that will readily protect consumers from IMPLEMENTING AGENCIES:
inadequate supply and unreasonable price increase on Based from the RA 7581, what are the functions of price coordinating
occasions of calamities, emergencies and like occurrences. council?
a. Price stabilization programs
b. Report and Advise the president
c. Conduct hearings
d. Publicize
e. Dissemination of the prevailing prices and price ceilings
ROLE OF THE NATIONAL STATISTICS OFFICE:
♣ shall conduct independent periodic surveys and studies of
the selling prices of all basic necessities and prime
commodities all over the country
♣ for purposes of serving as data base for government efforts
to stabilize prices, as well as evaluating the effectivity of the
same.
PENALTY FOR ACTS OF ILLEGAL PRICE MANIPULATION:
Penalty of imprisonment for a
ILLEGAL PRICE period of not less than five (5)
MANIPULATION years nor more than Fifteen (15)
years
Imposed a fine of not less than
Five thousand pesos (P5,000)
 nor more than Two million pesos the DOH, in coordination with the Philippine Health Insurance
(P2,000,000) Corporation (PhilHealth);
PENALTY FOR VIOLATION OF PRICE CEILING: (5) in actual fare for LAND transportation travel in public utility
Penalty of imprisonment for a buses (PUBs), public utility jeepneys (PUJs), taxis, Asian utility
VIOLATION OF PRICE period of not less than one(1) vehicles (AUVs), shuttle services and public railways, including
CEILING year nor more than ten(10) years Light Rail Transit (LRT), Mass Rail Transit (MJGFDRT), and
A fine of note less than Five Philippine National Railways (PNR);
thousand pesos(P5,000) nor (6) transportation fare for domestic AIR transport services and
more than One million SEA shipping vessels and the like, based on the actual fare
pesos(P1,000,000), or both, at and advanced booking;
the discretion of the court (7) discount on hotels, restaurants and recreation centers.
VIOLATION BY ALIENS: (8) Discounts on theaters, cinemas, concerts, leisure and
In case of aliens, in addition to the penalty provided in Section 15 or 16 amusement
of this Act, the offender shall, upon conviction and after service of (9) on funeral and burial services for the death of senior citizens;
sentence, be immediately deported without need of any further
proceedings. (B) Exemption from the payment of INDIVIDUAL INCOME TAXES
VIOLATION BY GOVERNMENT OFFICIALS OR EMPLOYEES: of senior citizens who are considered to be minimum wage
Any public official or employee who, by reason of his office, with or earners in accordance with Republic Act No. 9504
without consideration, conspires in the commission or knowingly (C) the grant of a minimum of five percent (5%) discount relative
conceals violations of any of the provisions of this Act shall likewise be to the monthly utilization of water and electricity supplied by
principally responsible for the violation and shall suffer the additional the public utilities. (100 kWh & 30 m3)
penalty of permanent disqualification to hold public office. (D) exemption from training fees for socioeconomic programs. ▷
(E) FREE medical and dental services, diagnostic and laboratory
EXPANDED SENIOR CITIZENS ACT OF 2010 fees
RA 9994 (F) the DOH shall administer FREE vaccination
RA 7432 (G) educational assistance to senior citizens to pursue post -
 Senior Citizen Act of 1992 secondary, tertiary, post tertiary, vocational and technical
 Date Signed: April 23, 1992 education,
RA 9257 (H) to the extent practicable and feasible, the continuance of the
▪ Expanded Senior Citizens Act of 2003 same benefits and privileges given by the Government Service
▪ Date Signed: February 26, 2004 Insurance System (GSIS), the Social Security System (SSS)
RA 9994 and the PAG-IBIG, as the case may be, as are enjoyed by
o Expanded Senior Citizens Act of 2010 those in actual service;
o Date Signed: February 15 2010 (I) retirement benefits
o *Most current (J) to the extent possible, the government may grant special
SECTION 2: discounts in special programs for senior citizens on purchase
DECLARATION OF POLICIES AND OBJECTIVES: of basic commodities, subject to the guidelines to be issued for
To recognize the rights of senior citizens. the purpose by the Department of Trade and Industry (DTI) and
To give full support to the improvement of the total well-being the Department of Agriculture (DA);
of the elderly (K) provision of express lanes for senior citizens in all commercial
To motivate and encourage the senior citizens to contribute to and government establishments; in the absence thereof,
nation building; priority shall be given to them;
To encourage their families and the communities in caring for (L) death benefit assistance of a minimum of Two thousand
the senior citizens; pesos (Php2, 000.00) shall be given to the nearest surviving
To provide a comprehensive health care and rehabilitation relative of a deceased senior citizen which amount shall be
system subject to adjustments due to inflation in accordance with the
To recognize the important role of the private sector in the guidelines to be issued by the DSWD.
improvement of the welfare of senior citizens. HOW TO AVAIL?
SECTION 4: PRESENT ANY OF THE FOLLOWING:
PRIVILEGES FOR THE SENIOR CITIZENS:
(A) the grant of twenty percent (20%) discount and exemption from
the value –added tax (VAT), if applicable, on the sale of the
following goods and services from all establishments, for the
exclusive use and enjoyment or availment of the senior citizen:
(1) on the purchase of medicines and such other essential
medical supplies to be determined by the Department of
Health (DOH).
(2) on the professional fees of attending physician/s in all private
hospitals, medical facilities,
(3) on the professional fees of licensed professional health
providing home healthcare services *Senior citizen’s ID
(4) on medical and dental services, diagnostic and laboratory fees *Booklet
in accordance with the rules and regulations to be issued by
SECTION 6: o Rank of secretary
THE OFFICE FOR THE SENIOR CITIZENS AFFAIRS (OSCA): o 6-year term
 2 OTHER MEMBERS
o Both ranks as undersecretary
o 1 member to serve for 4 years
o Other member to serve for 2 years
ENUMERATE THE 12 EX OFFICIO MEMBERS OF THE BOARD:
1. DOJ SECRETARY
2. DOH SECRETARY
3. DEFENSE SECRETARY
SECTION 7: 4. FINANCE SECRETARY
PENALTIES: 5. DOLE SECRETARY
PENALTY FINE IMPRISONMENT 6. DILG SECRETARY
FIRST 50,000 PHP – 2-6 YEARS 7. DSWD SECRETARY
CONVICTION 100,000 PHP 8. DFA SECRETARY
SUBSEQUENT 100,000 PHP – 2-6 YEARS 9. DEPED SECRETARY
CONVICTION 200,000 PHP 10. CHED CHAIRMAN
ABUSERS 50,000 PHP – NLT 6 MONTHS 11. CHAIRMAN OF NATIONAL YOUTH COMMISSION
100,000 PHP 12. PDEA DIR. GEN.
2 PERMANENT MEMBERS:
REPUBLIC ACT 9165 1. The president of the Integrated Bar of the Philippines
COMPREHENSIVE DANGEROUS DRUGS ACT OF 2002 2. The chairman or president of a non-government
AN ACT INSTITUTING THE COMPREHENSIVE DANGEROUS organization involved in dangerous drug campaign to be
DRUGS ACT OF 2002, repealing R.A. 6425, otherwise known as the appointed by the President of the Philippines.
THE DANGEROUS DRUGS ACT OF 1972, as amended, providing
funds therefor, and for other purposes. PHILIPPINE DRUG ENFORCEMENT AGENCY (PDEA)
 Implementing arm of the Board
Signed into law on June 7, 2002  Responsible for the efficient and effective law enforcement of
by Pres. Gloria Macapagal-Arroyo all the provisions on any dangerous drug and/or controlled
POLICY OF THE STATE: precursor and essential chemical as provided in this Act.
 to safeguard the integrity of its territory and the well-being of  Headed by a Director-General (undersecretary)
its citizenry particularly the youth, from the harmful effects of  Appointed by the President of the Philippines
dangerous drugs on their physical and mental well-being, and  Assisted by two (2) deputies director general with the rank of
 to defend the same against acts or omissions detrimental to Assistant Secretary
their development and preservation. UNLAWFUL ACTS & PENALTIES:
 to provide effective mechanisms or measures to re-integrate IMPRISONMENT FINE
into society individuals who have fallen victims to drug abuse 1P LIFE IMPRISONMENT TO 500K- 10M
or dangerous drug dependence through sustainable programs DEATH
of treatment and rehabilitation *RECLUSION PERPETUA
ARTICLE IX: 2P 12 YRS 1 DAY – 20 YRS 100K-500K
DANGEROUS DRUGS BOARD AND PHILIPPINE DRUG 3P 6 MOS 1 DAY – 4 YRS 10K-50K
ENFORCEMENT AGENCY: MAXIMUM PENALTY (The maximum penalty reflects parliament’s
DANGEROUS DRUG BOARD: view on the seriousness of the offence. Maximum penalties for many
 Implementing Agency of this Act that would be in charge of offences, including all offences in the Crimes Act 1958, are set
planning and creating programs for the pursuance of this Act according to a penalty scale, as outlined in the Sentencing Act 1991)
 Shall be composing of 17 members
 *taga plano -DDB, taga-action - PDEA 1P: LIFE IMPRISONMENT TO DEATH (RECLUSION PERPETUA)
FINE: PHP 500,000 TO 10 MILLION
 Importation of Dangerous Drugs
 Manufacture of Dangerous Drugs
 Unlawful Prescription
 Possession of Dangerous Drugs
 Sale of Dangerous Drugs
 Cultivation or Culture
 Maintenance of Den, Dive or Resort of Dangerous Drugs
POSSESSION OF DANGEROUS DRUGS:
1) 10 grams or more of opium;
2) 10 grams or more of morphine;
3) 10 grams or more of heroin;
4) 10 grams or more of cocaine or cocaine hydrochloride;
3 PERMANENT MEMBERS: 5) 50 grams or more of methamphetamine HCl or “shabu”;
AT LEAST 7-YEAR TRAINING 6) 10 grams or more of marijuana resin or marijuana resin oil;
 1 CHAIRMAN 7) 500 grams or more of marijuana;
o appointed by the President
 8)
10 grams or more of other dangerous drugs such as, but not 2) Name, address and license of the manufacturer, importer or
limited to MDMA or “ecstasy”, PMA, TMA, LSD, GHB. wholesaler from whom the dangerous drugs have been
2P: IMPRISONMENT OF 12 YEARS 1 DAY TO 20 YEARS FINE: PHP purchased;
100,000 TO PHP 500,000 3) Quantity and name of the dangerous drugs purchased or
 Importation of Controlled precursor or Essential chemicals acquired;
 Manufacture of Controlled precursor or Essential chemicals 4) Date of acquisition or purchase;
(Ex. Nitric acid) 5) Name, address and community tax certificate number of the
 Unnecessary Prescription buyer;
 Illegal diversions of any Controlled precursor or Essential 6) Serial number of the prescription and the name of the
chemicals physician, dentist, veterinarian or practitioner issuing the same;
 Sale of Controlled precursor or Essential chemicals 7) Quantity and name of the dangerous drugs sold or delivered;
 Coddler / Protector and
 Maintenance of Den, Dive or Resort of Controlled precursor or 8) Date of sale or delivery
Essential chemicals
3P: IMPRISONMENT OF 6 MONTHS 1 DAY TO 4 YEARS FINE: PHP
10,000 TO PHP 50,000
 Possession of Equipment, Instrument, Apparatus and Other
Paraphernalia for Dangerous Drugs
 Drug Users
MAXIMUM PENALTY:
 Possession of Dangerous Drugs during Parties, Social
Gatherings or Meetings. *Yellow prescriptions- drugs that are in Intravenous (demerol, morphine,
 Bringing any Dangerous Drugs, Controlled Precursors or opioids, fentanyl inj.)
Essential Chemicals through the use of Diplomatic Passport. *Triplicate – 3 copies of white prescription with header of the doctor and
 Selling, Trading, Distributing Illegal substances 100 meters name of the patient and the prescribed drugs and signature of the
away from school. prescriber (Tablets only)
 Financer and Drug Sellers who use Mentally deranged *Always check the S2 license (can prescribed dangerous drugs)
people and Minors.
Death penalty and 1M - 15M (1) year and one (1) day to six WHAT ARE THE CHEMICALS CONTROLLED UNDER RA 9165?
pesos: maintainer, owner (6) years and a fine ranging TABLE I+ TABLE II+
and/or operator. 10K - 50K ACETIC ANHYDRIDE ACETONE
Should any dangerous drug be Violates or fails to comply with N-ACETYLANTHRANILIC ACID ANTHRANILIC ACID
the proximate cause of the the maintenance and keeping ERGOMETRINE ETHYL ETHER
death of a person using the of the original records of ERGOTAMINE HYDROCHLORIC ACID
same in such den, dive or resorts transactions on any dangerous ISOSAFROLE METHYL ETHYL KETONE
drug and/or controlled precursor LYSERGIC ACID PHENYL ACETIC ACID
and essential chemical 3,4- PIPERIDINE
METHYLENEDIOXYPHENYL-2
SECTION 36: PROPANONE
AUTHORIZED DRUG TESTING: NOREPHEDRINE SULFURIC ACID
Applicants for Applicants for Students of 1-PHENYL-2-PROPANONE TOLUENE
driver's license firearm's license secondary PIPERONAL ** THIONYL CHLORIDE
and for permit to and tertiary POTASSIUM PERMANGANATE
carry firearms schools. SAFROLE
MANDATORY

RANDOM TESTING

outside of * PSEUDOEPHERDINE
residence * EPHEDRINE
All persons Officers and Officers and
charged before members of the employees WHAT ARE THE LICENSES ISSUED AT THE COMPLIANCE
the prosecutor's military, police of public and SERVICE, PDEA, AND THE SCOPE OF COVERAGE OF EACH
office with a and other law private LICENSE WITH THE CORRESPONDING FEES?
criminal offense enforcement offices *S1 for dealer/ S2 for prescriber/ S3 for retailer/ S4 for wholesaler/ S5
agencies depends if manufacturer (S-5), Importer (S-5I), Exporter (S-5E), Depot
All candidates for or Storage (S-5D), S6 for research, S8 for compounder
public office 1. For handlers of dangerous drug/s(DD) , dangerous drugs
preparation/s(DDP/s), Table I Controlled Chemical/s used in the
SECTION 40: manufacture of drug preparation/s &/or their preparation/s
RECORDS REQUIRED FOR TRANSACTIONS ON DANGEROUS (DP/s):
DRUG AND PRECURSORS AND ESSENTIAL CHEMICALS.
Category Annual
Maintain and keep an original record of sales, purchases,
Fee
acquisitions and deliveries of dangerous drugs, indicating therein the
(PhP)
following information:
S-1 Retail of DP/s containing Table I Controlled 500.00
1) License number and address of the pharmacist;
Chemical/s
 S-3 Retail of DD/DDP/s & /or DP/s containing Table 1,000.00 Cont’g 30% METHYL ETHYL 5 liters
I Controlled Chemical/s KETONE
S-4 Wholesale/Distribution of DD/DDP/s/Table 1 3,000.00
Controlled Chemical/s used in the manufacture WHAT ARE THE REQUIREMENTS RELATIVE TO THE SALE OF
of drug preparation/s/ &/or their preparation/s TABLE II CONTROLLED CHEMICAL THAT FALLS WITHIN THE
S-5 C Compounding/Manufacture of DD/ DDPs &/or 5,000.00 PRESCRIBED THRESHOLD ABOVE?
D P/s containing Table I Controlled Chemical/s The following are the requirements involving the sale of Table II
S-5I Importation of DD/DDP/s /Table I Controlled 5,000.00 Controlled Chemical that falls within the prescribed threshold above:
Chemical/s used in the manufacture of drug 1. The licensed seller shall ask the customer for any identifying
preparation/s &/or their preparation/s document such as driver’s license, office or voter’s
S-5E Exportation of DDP/s &/or D P/s containing 5,000.00 identification and signature of the individual;
Table I Controlled Chemical/s 2. Purchased controlled chemical shall not be resold by the
S-5D Depot/Storage for S-4 & S-5 license holder 5,000.00 purchaser;
(When such address is separate and distinct 3. Table II Controlled chemical shall not be sold to minors who
from the office address of the license holder are less than eighteen (18) years of age without the written
S-6 License to conduct laboratory analysis or 500.00 consent of his/her parents or guardian or sold for the purpose
technical research using DD/DDPs &/or DP/s of abuse;
4. Transaction will be recorded by the licensed seller in a record
2. For handlers of Precursors and Essential Chemical/s or book /register, which is subject to inspection at any reasonable
Controlled Chemical/s &/ or time by PDEA Regulatory Compliance Officer;
mixture/s (PECS) 5. Transaction will be for legitimate use by the purchaser and not
for resale.
Category Annual
Fee
WHAT ARE THE PRESCRIPTION LIMITS FOR DANGEROUS
(PhP)
DRUGS’ PREPARATIONS?
P-1 Retail of Precursor & Essential Chemicals ( 500.00
The following are the prescription limits of dangerous drugs’
PECS) &/or mixture/s
preparations that may be prescribed in a single applicable
P-3 End-Use of PECS &/or mixture/s 2,500.00
prescription by a licensed practitioner:
P-4 Wholesale/Distribution/Trading of PECS&/or 3,000.00
1. Morphine Sulfate (tablets) 3,000 mg
mixture/s
Morphine Sulfate (ampoules/ 448 mg
P-5-C Compounding/Manufacture/Repack/Recycling 5,000.00
vials)
of PECS &/or mixture/s
2. Fentanyl patch 25 ug/hour =30 patches
P-5-D Bulk Depot/Storage for P4 & P5-Holders (Such 3,000.00
Fentanyl patch 50 ug/hour =15 patches
location is deemed
Fentanyl ampoules 50 ug/mL =10 ampoules (1mL)
separate& distinct from the office address of the
=3 ampoules (2mL)
license holder)
=50 ampoules (2mL) for use in
P-5-E Exportation of PECS &/or mixture/s 5,000.00
PCA machine
P-5-I Importation of PECS &/or mixture/s 5,000.00
=10 ampoules (10mL) for use in
P-5- Importation of PECS to End-Use 5,000.00 PCA machine
IM
3.Oxycontin 1,200 mg
P-6 License to conduct laboratory analysis or 500.00 Oxycontin 10 mg 120 tablets
technical research using PECS Oxycontin 20 mg 60 tablets
Oxycontin 40 mg 30 tablets
WHAT ARE THE THRESHOLDS FOR TABLE II CONTROLLED Oxycontin 80 mg 15 tablets
CHEMICAL/S THAT CAN BE SOLD TO A REGULAR OR KNOWN
CUSTOMER IN A MONTHLY BASIS THAT WILL NOT REQUIRE A. For Cancer Patients:
PRESENTING A PDEA LICENSE? *Demerol – 3 ampoules only
The following are the prescribed thresholds:
SINGLE COMPONENT TOTAL The following are the prescription limits of dangerous drugs’
CHEMICAL preparations that may be prescribed in a single applicable
ACETONE 1 liter prescription by a licensed practitioner:
HYDROCHLORIC ACID 25 liters 1.Benzodiazepines (anxiolytic =30 tabs or caps, 10 ampoules x
SULFURIC ACID 25 liters or hypnotic or both) 1 mL, 3 ampoules x 2 mL, 2
ETHYL ETHER 1 liter ampoules x 3 mL, 2 ampoules x
TOLUENE 1 liter 5 mL, 1 ampoule x 10 mL
METHYL ETHYL KETONE 1 liter
CHEMICAL MIXTURE/ AGGREGATE Benzodiazepine (muscle =90 tablets (5 mg)
SOLUTION spasm/dystonia/tetanus)
Cont’g ACETONE 5 liters 2. Phenobarbital preparations =2 weeks supply
Cont’g HYDROCHLORIC ACID 50 liters =2 bottles (100 tablet each) for
Cont’g SULFURIC ACD 50 liters Epileptic patients
Cont’g ETHYL ETHER 5 liters 3. Sodium Pentothal 3 vials (in case of hospital use)
Cont’g 30% TOLUENE 20 liters 4. Demerol 3 Ampoules
 5. Other Dangerous Drugs (in 1 vial (in case of hospital use)
vials
6. Ephedrine (parenteral form) =1 vial
Ephedrine, pseudoephedrine, =1.6 grams of base
norepherdrine (tablet/capsule

B. For Ordinary
Circumstances:

WHAT ARE THE INFORMATION CONTAINED IN A DANGEROUS

DRUG PREPARATION’S PRESCRIPTION?
The following are the information contained in a dangerous drug
preparation’s prescription:
1. Date of prescription
2. Complete name and address of the patient
3. Complete name, address, telephone number of prescribing
practitioner.
4. Prescribing practitioner’s current S-2 license no., PRC
registration no. & PTR no., & signature
5. Brand name and generic name, total no. of units to be supplied
in words followed by its roman numeral enclosed in
parenthesis;
6. Direction for use and the words ‘NON-REPETITION.

IMPORTANT DATES:
RA 6425
 The Dangerous Drugs Act of 1972
 Date Signed: April 4, 1972
RA 9165
 Comprehensive Dangerous Drugs Act of 2002
 Date signed: June 7, 2002

-IraG. (April 26, 2022)

 PUBLIC HEALTH 12. PUBLIC HEALTH PRACTICE
PSMB 411 - Public health is an interdisciplinary field and professionals
PUBLIC HEALTH in many disciplines such as nursing, medicine, veterinary
Science of protecting and improving the health of communities medicine, dentistry, and pharmacy routinely deal with
through education, promotion of healthy lifestyles, and research for public health issues.
disease and injury prevention. EXAMPLES OF PUBLIC HEALTH:
CORE AREAS:  Vaccination programs for school-age children and adults to
1. BEHAVIORAL SCIENCE OF HEALTH EDUCATION prevent the spread of disease
- Focuses on ways that encourage people to make healthy  Regulation of prescription drugs for safety and effectiveness
choices  Safety standards and practices to protect worker health and
- *To know the cause and effect of their choices safety
2. BIOSTATISTICS  Ensuring access to clean water and air
- Identify health trends that lead to life0saving measures  Educational campaigns to reduce obesity among children
through the application of statistical procedures,  School nutrition programs to ensure kids have access to
techniques, and methodology nutritious food.
- Often utilized in tandem with epidemiology OTTAWA CHARTER FOR HEALTH PROMOTION
3. EMERGENCY MEDICAL SYSTEM ☺ First International Conference ☺ The fundamental conditions
- Ensuring that communities have trained emergency on Health Promotion and resources for health are:
medical responders always available to respond to Ottawa, 21 November 1986 ● peace;
emergencies. ☺ Health Promotion ● shelter;
- Focuses on ensuring a functioning emergency care ☺ Process of enabling people to ● education;
system increase control over, and to ● food;
4. ENVIRONMENTAL HEALTH improve, their health. ● income;
- How do the built and natural environments influence our
● a stable eco-system;
health and how can we reduce risk factors? These
● sustainable resources;
environmental risk factors can cause diseases such as
● social justice, and equity.
asthma, cancer, and food poisoning.
- Environmental health studies the impact of our ☺ Health Promotion Action Means
surroundings on our health. ☺ Build Healthy Public Policy
5. EPIDEMIOLOGY ☺ Create Supportive Environments
- Epidemiologists do fieldwork to determine what causes ☺ Strengthen Community Actions
disease or injury, what the risks are, who is at risk, and ☺ Develop Personal Skills
how to prevent further incidences. They spot and ☺ Reorient Health Services
understand the demographic and social trends that ☺ Moving into the Future
influence disease and injury and evaluate new treatments. PHARMACY EDUCATION SUFFERED FROM….
6. HEALTH SERVICES ADMINISTRATION/MANAGEMENT (Gibson, 1972)
- The field of health services administration combines  The lack of definition of PH in Pharmacy
politics, business, and science in managing the  The lack of perceived relevance to pharmacy students
human and fiscal resources needed to deliver effective  The lack of a textbook focusing on the roles of pharmacists in
public health services. PH
7. INTERNATIONAL / GLOBAL HEALTH  The lack of pharmacy faculty educated in and with appropriate
- International health professionals address health experience to teach PH
concerns among different cultures in countries  The lack of sites where students could become involved
worldwide. with PH projects and work with PH personnel.
8. MATERNAL AND CHILD HEALTH PHILIPPINE HEALTH CARE SECTOR
- Providing information and access to birth control; INSTITUTIONS
promoting the health of a pregnant woman and an unborn DEPARTMENT OF HEALTH
child; and dispensing vaccinations to children are part of  Its mission is to guarantee equitable, sustainable and
maternal; and child health. quality health for all Filipinos, especially the poor, and to lead
9. NUTRITION the quest for excellence in health.
- Promoting healthy eating and regular exercise;  *Main institution or sector for health
researching the effect of diet on the elderly; teaching the BUREAU OF FOOD AND DRUGS (BFAD)
dangers or overeating and over-dieting are the  Its main responsibility is to license and regulate the delivery
responsibility of public health nutritionists. of pharmaceuticals in the Philippines.
10. PUBLIC HEALTH LABORATORY PRACTICE  It is also tasked to test the safety of food and cosmetics
- Public health laboratory professionals such as  *Licensed and regulates drugs coming to the Philippines
bacteriologists, microbiologists, and biochemists test PHILIPPINE HEALTH INSURANCE CORPORATION
biological and environmental samples in order to  RA 7875
diagnose, prevent, treat, and control infectious  Promoted the membership of every Filipino in the healthcare
diseases in communities. program, particularly the indigent sectors of the population.
11. PUBLIC HEALTH POLICY  Consequently, it established PhilHealth
- Professionals in public health policy work to improve the PUBLIC & PRIVATE HOSPITALS
public’s health through legislative action at the local, INDUSTRY ASSOCIATIONS
state and federal levels.
SOME HEALTH PROGRAMS/CAMPAIGNS  Kuru → Infectious protein found in human brain
FOURMULA ONE (F1) - *Cannibalism
 Launched as a blueprint of reform implementation aiming  GSS → Gertsmann Straussler Scheinker
for a more responsive health system, more equitable - *It is a neurogenetic brain disorder
health financing, and better health outcomes.  FFI → Fatal Familial Insomnia
 Within the medium term 2005-2010, F1 was devised to address - *Herediatry
the issues on fragmentation of the Philippines health CHARACTERISTICS OF PRION DISEASES
system and inequity in health care. ֎ Long incubation time
 Also, F1 intended to achieve speedy, precise, and well- ֎ Gradual increase in severity leading to death within months of
coordinated critical reforms to improve the health system of the onset
country ֎ No host immune response
FOURMULA ONE (F1) COMPONENTS: ֎ Non-inflammatory process in the brain
 Health Financing ֎ Neuropathological findings:
 Health Regulation - Macroscopic: normal
 Health Service Delivery - Microscopic: spongiform changes, neural loss and amyloid
 Good Governance in Health plaques w/ accumulation of PrP
PHILHEALTH SABADO: ETIOLOGY:
 “PhilHealth Sabado Magseguro”  Inherited
DOTS (DIRECTLY OBSERVED TREATMENT, SHORT-COURSE)  Infectious
*For TB/ tuberculosis  Sporadic
ELEMENTS: TRANSMISSION:
 Political commitment with increased and sustained financing  Contaminated neural tissues
 Case detection through quality-assured bacteriology  Crosses the “species-barrier”
 Standardized treatment, with supervision and patient support  Inoculation, oral
 An effective drug supply and management system  The infectious particles are relatively resistant to heat and
 Monitoring and evaluation system, and impact measurement many commonly used chemical disinfectants as well as
YOSI KADIRI irradiation
 2009 GLOBAL ADULT TOBACCO SURVEY BSE EPIDEMIC
- Reveal that among adults 15 years or older, 28.3% or 17.3  Attributed to the practice of feeding cattle (contaminated)
million Filipinos are current tobacco smokers sheep offal → carnivores
- The average age of initiation of cigarette smoking among  Transmission from mad cows to humans → vCJD
every day smokers aged 18-34 was 17.4 for men and 19.1 KURU EPIDEMIC
for women.  Fore tribe, Papua New Guinea
 Started in the early 90’s during the term of former  Ritualistic cannibalism
undersecretary Juan Flavier  Aka LAUGHING sickness
 R.A. No. 9211, known as the Tobacco regulation Act of  sCJD
2003 → revived IATROGENIC CJD
4 O-CLOCK HABIT  Contaminated (neuro) surgical instruments, dural & corneal
 First launched in 1996 which encouraged communities to seek grafts
and destroy breeding places of mosquitoes every 4 pm daily  Cadaveric pituitary hormones
 “STOP, LOOK and LISTEN” approach
 Aksyon Barangay Kontra Dengue CLINICAL PRESENTATION
- DOH + DILG  Rapidly progressive dementia
ALCOHOLICS ANONYMOUS (AA)  Psychiatric symptoms
 Fellowship of men and women who share their experience,  Cerebellar symptoms (eg ataxia)
strength and hope with each other that they may solve their  Involuntary movements
common problem and help others to recover from alcoholism  Ultimately fatal disease
OTHER SUPPLEMENTAL TOPICS IN MICROBIOLOGY AND PUBLIC
HEALTH TREATMENT
PRIONS  …unfortunately no curative tx is currently available
 PROTEINACEOUS INFECTIOUS PARTICLES
 *It is a part of a microorganism that is infectious ANTIBIOTIC DARWINISM
 TSE (TRANSMISSIBLE SPONGIFORM Factors associated with resistance:
ENCEPHALOPATHIES) ♠ Widespread, inappropriate use of broad spectrum antibiotics
 Fatal neurodegenerative disorders of humans and other ♠ Use of antibiotics in animal husbandry & fisheries
animals ♠ Xs use of antimicrobial prep in soaps & cleaning sol’ns in non-
BEST KNOWN ANIMAL DISEASES healthcare facilities
 Scrapie: sheep & goats ♠ Inc immunocompromised px → prolonged course
 Bovine spongiform encephalopathy (BSE or MADCOW ♠ Prolonged survival of debilitated px
DISEASE): cattle ♠ International travel
4 HUMAN PRION DISEASES
 CJD → Cretzfeltt Jakob Disease
- *Is the human form of mad cow disease
- *happens when you eat the brain and spinal cord of cattle
 ♠ Poverty BROAD SPECTRUM ➢ Amoxicillin
PENICILLINS ➢ Ampicillin
(AMINOPENICILLIN) ➢ Bacampicillin
PENICILLINASE-  Cloxacillin
RESISTANT  Nafcillin
PENICILLIN (ANTI-  Methicillin
STAPHYLOCOCCAL  Dicloxacillin
PENICILLINS)  Oxacillin
EXTENDED- ☻ Carbenicillin
SPECTRUM ☻ Mezlocillin
PENICILLINS (ANTI- ☻ Piperacillin
PSEUDOMONAL ☻ Ticacillin
PENICILLINS)
GENETIC VARIABILITY BETA-LACTAMASE  Clavulanic acid
MUTATIONS INHIBITORS  Sulbactam
- AKA MICROEVOLUTIONARY CHANGE  Tazobactam
- Mutations may alter the target site of antimicrobial agent 5. BYPASS OF ANTIBIOTIC INHIBITION
→ activity  Auxotrophs
MACROEVOLUTIONARY CHANGE  Require substrates that normally are synthesized by the targets
 AKA TRANSDUCTION enzymes, thus, if enzyme is blocked & substrates are
 Rearrangement* of large segments of DNA as a single event present in the env’t, organism grow despite inh of
ACQUISITION OF FOREIGN DNA synthetic enzyme
 AKA TRANSPOSONS  Bacteria create additional pathways to meet growth reqt’s
 Carried by plasmids, bacteriophage or transposable genetic
matl’s → adapt antimicrobial activity DECREASING ANTIMICORBIAL RESISTANCE
MECHANISM OF ANTIMICROBIAL RESISTANCE  Withhold antibiotics
1. ENZYMATIC INHIBITION  Narrowest spectrum antimicrobial agents
 Staphylococcus aureus - Staph infx: Pens vs Fluoroquinolone
 Enterococci & G(-) bacilli  Base decisions about broadness of empiric antibiotic coverage
2. ALTERATION OF BACTERIAL MEMBRANES on the severity of illness
 Outer membrane permeability  Careful hygiene, handwashing
- Pseudomonas aeruginosa  Education
- G(-) have a lipid bilayer that acts as a barrier to the *Educate people to not always use antibiotic, to avoid
penetration of antibiotics into the cell resistance
- Porins → mutation AO 42
- Imipinenem  “Creating an Inter-Agency Committee for the Formulation and
 Inner membrane permeability Implementation of a National Plan to Combat Antimicrobial
- Staphylococcus Resistance (AMR) in the Philippines”.
- Electron transport (Proton motive force)
- Rare → long term therapy A. PUBLIC HEALTH
- aminoglycosides  The science of PREVENTING DISEASE, PROLONGING LIFE,
3. PROMOTION OF ANTIBIOTIC EFFLUX PROMOTING HEALTH AND EFFICIENCY through organized
 *Efflux means secrete, they promote secretions of antibiotic community effort.
 Tetracycline* → subtherapeutic conc B. INFECTION is the actual growth of an organism, particularly a
 Pseudomonas aeruginosa pathogenic one, on or within a host.
 Staphylococcus aureus C. NOSOCOMIAL infections are acquired from the hospital
4. ALTERATIONS OF BACTERIAL PROTEIN TARGETS D. COMMUNICABLE DISEASE → any diseases that spreads
 Ribosomal target sites from one host to another either directly or indirectly.
- Streptomycin* E. NON-COMMUNICABLE DISEASE
- Gentamicin, tobramycin, amikacin  AKA chronic disease
- S. aureus & Enterococci → x macrolides  Long duration
 Cell wall precursor targets  Result of combination of genetic, physiological,
- vanA gene: high res; E. coli environmental and behaviors factors.
- vanB & vanC F. CONTAGIOUS DISEASE → diseases that are easily spread
- Enterococci from one person to another
 Critical enzymes G. ZOONOSES → infectious disease which can be transmitted
- PBP: transpeptidase from an animal reservoir to human host.
- Dec affinity or dec in number H. SEPSIS → toxic inflammatory condition arising from the spread
- Beta lactam resistance of microbes, especially bacteria, or their toxins from a focus of
THE PENICILLINS infection.
NARROW ✓ Penicillin G
SPECTRUM ✓ Penicillin V SEPTICEMIA is the growth of bacteria in the blood (a.k.a.
PENICILLINS blood poisoning)
 BACTEREMIA is the presence, without multiplication, of C. RESPIRATORY DROPLETS
bacteria in the blood. →Transmitted within droplet nuclei that exit the body
TOXEMIA is the presence of toxins in the blood →Travel for less than 1 meter
VIREMIA is the presence of virus in the blood (this would 2. VEHICLE TRANSMISSION:
be in the acellular portion of the blood; recall A. AIRBORNE TRANSMISSION → involves the spread of
that viruses require cells to multiply and that pathogen more or farther than 1 meter to the respiratory
these cells are not necessarily blood cells) mucous membranes of a new host
TOXIGENICITY The capacity of an organism to produce a toxin B. WATERBORNE TRANSMISSION → pathogens are usually
INVASIVENESS The ability of the microorganism to enter a host, spread by water contaminated with untreated or poorly
grow, reproduce and spread throughout the body treated diseases
VIRULENCE Degree of pathogenicity C. FOODBORNE TRANSMISSION → involves pathogens in
EPIDEMIOLOGY The study of where and when diseases occur and on foods that are inadequately processed, undercooked
and how they are transmitted within populations. or poorly refrigerated.
A. FREQUENCY OF DISEASE 3. VECTOR TRANSMISSION:
1. INCIDENCE → number of new cases of a disease A. BIOLOGICAL VECTOR
2. PREVALENCE → total number of cases both new and - Not only transmitted pathogens but also serve as host
already existing B. MECHANICAL VECTORS
B. REQUENCY AND GEOGRAPHIC DISTRIBUTION - Passively carry pathogens to new hosts.
C. RESERVOIRS OF INFECTIOUS DISEASES OF HUMANS:
RESERVIOR → sites where pathogens are maintained as a source
of infections MICROBIAL CONTROL
1. ANIMAL RESERVOIR → many pathogens that are normally 1. STERILIZATION
infect either domesticated or sylvatic animals can also affect - Destruction of all organism on an inanimate object
humans 2. DISINFECTION
→ Human infections with zoonoses are difficult to eradicate - Most but not all microorganism are killed
2. HUMAN CARRIERS 3. DEGERMING
- Humans with active disease/s - Physical removal of organism
- Humans with no obvious signs/symptoms 4. SANITATION
(asymptomatic) - Uses antimicrobial agent on objects surfaces or living
3. NON-LIVING RESERVOIR tissue to reduce the number of disease-causing organisms
- Soil, water, food to non-threatening level
D. DEVELOPMENT OF A DISEASE 5. SEPTIC
1. EXPOSURE → introducing the pathogen - Infected with microorganism
2. INCUBATION PERIOD is the time an infection has begun 6. ASEPTIC
up to the occurrence of signs and symptoms is the period of - Practices and procedure to prevent contamination from
incubation pathogens
3. PRODROMAL PERIOD is a time when symptoms (and 7. ANTISEPTIC
signs) appear, but full-blown illness has not-yet begun - Refers to living tissue
4. INVASIVE PHASE (period of illness) is the phase during 8. PRESERVATION
which the typical signs and symptoms of the disease are - Preventing the growth of bacteria, fungi and other
apparent microorganism
5. ACME is the peak of disease symptoms (and signs) 9. PASTEURIZATION
6. DECLINE PHASE is the period during which symptoms
(and signs) decrease as the infection is brought further STERILIZATION
under control 1. MOIST HEAT/STEAM (PROTEIN COAGULATION/
7. CONVALASCENCE PERIOD → repair damaged tissue DENATURATION)
8. SEQUELAE is the inability of the body to fully repair the  Autoclave (121 °C, 15-30 mins, 15psi)
damage due to an infection. Can result in sequelae which  ADVANTAGES: for heat resistant and moisture
are persisting disease after effects. resistant, sporicidal
E. MODES OF INFECTIOUS DISEASE TRANSMISSION  EX: glass wares and surgical instruments
HOST  DISADVANTAGES: not for moisture sensitive
1. INTERMEDIATE HOST → can live for a short period of time 2. GAS—ethylene oxide (DENATURATION AND
2. RESERVOIR HOST → can live long without ill effects ALKYLATING AGENT)
3. DEFINITIVE HOST → where the parasite matures: support  ADVANTAGES: for heat and moisture sensitive
asexual reproduction  EX: plastic, gauze
VECTOR Any agent that transmit a pathogen  DISADVANTAGES: very toxic, explosive
1. CONTACT TRANSMISSION: 3. DRY HEAT (OXIDATION)
A. DIRECT CONTACT  Oven (160-170°C, 2-4 hrs), incinerators
→ AKA person to person  650°C in 1 minute, 250°C in 45 minutes, and 180°C
→ require physical contact in 4 hours
B. INDIRECT CONTACT  ADVANTAGES: for heat resistant and moisture
→Pathogens are spread from one host to another by fomites sensitive
→Inanimate object  EX: metal surgical instruments
4. RADIATION
 A. IONIZING RADIATION WAVELENGTHS shorter than 1nm PROPERTIES OF BLOOD CELLS:
 MOA: increase energy → STRIKES GRANULOCYTES Members of reticuloendothelial cell of immune
MICROORGANISM → creates ions system
 EX: ELECTRON BEAMS, GAMMA RAYS, X-RAYS First WBC involved in bacterial infection
B. NON-IONIZING and acute inflammation → NEUTROPHIL
- Wavelengths greater than 1nm BEN
- EX: UV LIGHT → UV (240-280 nm); bactericidal (gamma, NEUTROPHILS Major defense against pyogenic/pus- forming
cathode, beta rays) (DNA UNWINDING) bacteria (STAPH AND STREP) by
5. PASTEURIZATION → milk and fruit juices are exposed to 60- phagocytosis
72 degrees C for 3-4 times. MONOCYTES Member of reticuloendothelial cell which may
6. BACTERIAL FILTRATION – membrane filters (MECHANICAL become macrophage
SEPARATION) Active in phagocytosis
 For heat sensitive substances COMPLETE Antigen with EPITOPES that can induce
 EX: ANTIBIOTICS, BIOLOGICALS AND ANTIGEN / immune response
RECOMBINANT DNA PRODUCTS ALLERGEN PARATOPES – ANTIBODY
7. TYNDALIZATION (DNA MUTATION) (VIRUS, EPITOPES → RECOGNIZED BY IMMUNE
- Intermittent steam sterilization exposing material to 100°C BACTERIA, SYSTEM → ANTIBODY EPITOPE
for 30 min or at 80°C for 1 hr for 3 consecutive days PATHOGEN) ENCOUNTERS PARATOPE → IMMUNE
RESPONSE
HEALTH CARE STRATEGIES HAPTENS Antigen lacking an epitope but can react with
A. PREVENTION → measures taken to prevent disease, injuries (SMALL) antibodies
POSITIVE: reduces the incidence of the disease by addressing the *Epitope is the one who recognize by our
immediate and underlying causes at the individual level B. immune system
B. PRIMARY PREVENTION → PROMOTION It is a small molecule that by itself is not
- Process of enabling people to increase control over and to immunogenic but can act as an antigen when
improve their health it binds to a larger protein molecule
- PRIMARY MEANS: developing healthy public policy INTERFERONS First line of defense against virus →
C. SECONDARY PREVENTION → CURE HEPATITS
- Therapies provided to a px with an intent to IMPROVE Host coded-proteins that can inhibit viral
symptoms and ERADICATE the px medical problem replication
D. TERTIARY PREVENTION → REHABILITATION MEMORY CELLS Produced by both T and B cells which
- Reduces the long-term effects or the complication of a constitutes the lymphoid branch
health problems - For long term immunity
- Minimal care and increasing the physical activity OPSONIZATION Is a term that refers to an immune process
BLOOD CELLS: where particles such as bacteria are
RBC/ ERYTHROCYTES targeted for destruction by an immune cell
 Controlled by the hormone erythropoietin known as a PHAGOCYTE
 No nucleus → able to transform into different shape TOXINS Can often be inactivated using formaldehyde
 HGB → Fe (OXYGEN CARRYING CAPACITY OF THE Resulting toxoids are among the most
BLOOD) successful of all vaccines→ TOXOID
WBC/ LEUKOCYTES DENDRITIC Antigen presenter by producing cytokines that
1. GRANULOCYTE (GRANULES) MACROPHAGE stimulates the T and B cell to be involved in a
I. NEUTROPHIL → IMMEDIATE RESPONSE, 1ST specific immune response with the antigen
LINE OF DEFENSE NATURAL Capable of spontaneous cytotoxic activity
II. EOSINOPHIL → INCREASE IN PARASITIC KILLER CELLS agains a variety of target cells without the need
INFECTION for antibody
III. BASOPHIL → ALLERGIC REACTION
INTERLEUKIN 4 Cytokine secreted by helper T cell and
2. LYMPHOCYTE
stimulates production of IgE
I. B-LYMPHOCYTE → MAKING ANTIBODIES /
DIGEORGE Result of T cell deficiency
IMMUNOGLOBULIN
SYNDROME
II. T-LYMPHOCYTE → HELPING B-LYMPHOCYTE
IgD Primary B Cell receptor
 T-HELPER CELL (CD4) → HELPING B-
WART Epidermal tumor of viral origin
LYMPHOCYTE (AIDS)
IMMUNO- Use for the visual microscopic detection of
 CYTOTOXIC T-CELL (CD8) → ATTACKS
FLUORESCENCE antigen in tissue section, cell suspension and
INFECTED CELLS
monolayer
3. MONOCYTE (IRREGULAR WBC CIRCULATING IN
BLOODSTREAM) → MACROPHAGE (ENTERS THE CELL
→ PHAGOCYTOSIS)
- PLATELETS/ THROMBOCYTES → SMALL FRAGMENT
OF CELL
 *The T cells matured in THYMUS, and they are also known as
THYMOCYTE
*Beta cells they can be seen in BONE MARROW
IMMUNOLOGY & SEROLOGY
ANTIGEN
- TOXIN, usually a protein
- Part of bacteria, viruses, protozoans, fungi and
endogenous (self) cells that have become “altered”
ANTIBODY
- Immunoglobulin molecule produced by specialized B-
LYMPHOCYTES OR B-CELLS
NON-SPECIFIC/ NATURAL/ INNATE - Produced in response to a specific antigen
1. BARRIER → Skin, mucous membrane, stomach acid - Unique, specific and form a “complex” with “their” antigen,
2. INFLAMMATION → Phagocytes (WBC) with the intent to inactivate the antigen
SPECIFIC / ADAPTIVE → LYMPHOCYTES - Antibodies are also known as IMMUNOGLOBULINS
1. B-LYMP (BONE MARROW) → Humoral mediated response - Abbreviated IgG, IgM, IgA, and IgD.
(Bloodstream) THE IMMUNE SYSTEM
2. T-LYMP (THYMUS) → Cell mediated response (Inside cell) CELLS: LYMPHOCYTES and LEUKOCYTES (WBCs circulating in the
MAJOR HISTOCOMPATIBILITY COMPLEX blood), tissue MONOCYTES (which leave the bloodstream and migrate
- A protein present on the extracellular surface of the cell n the tissues)
that displays portions of the proteins that are TISSUES: BONE MARROW and the submucosa of GIT
degraded inside the cell ORGANS: THYMUS, SPLEEN, liver (fetal), lymph nodes

IMMUNITY
INNATE IMMUNITY
- Generalized
- Protects the body against all invaders
ACQUIRED IMMUNITY
- Specific
- Reacts against specific antigens

INNATE IMMUNITY
 Skin and mucous membranes → act as physical barriers to
invaders
 *Skin is the first barrier against foreign bodies
 Neutrophils and monocytes (both types of WBCs), and tissue
macrophages (WBCs which have migrated to the tissue →
engulf all invaders, PHAGOCYTOSIS AND PINOCYTOSIS
 Colostrum → preformed antibodies from the mother
 Protective secretions from the body such as mucus
 Non-pathological bacteria that normally live in the body →
inhibit the growth of pathogens
ACQUIRED IMMUNITY
→VACCINES
 Humoral immunity
 Mediated by ANTIBODIES (lymphocytes that mature in the
BONE MARROW) which are spread primarily to THE FLUID
and the BLOOD
 “B” cells produce plasma cells (response to antigen) → specific
antibodies or Ig
 Some “B” cells → memory cells → Ig
IgG  *Gahaman (palatandaan)
 *Y-shape
 “coats” the antigen and enables the destruction of
the antigen by macrophages
IgM  *Malaki, mauuna (palatandaan)
 second most common
 produces the primary immune response to “new”
antigens, efficient at neutralizing virus
IgA  *Alat (palatandaan)
 protect the body by binding to antigens in the
respiratory and GIT and not allowing the antigens to
attach and enter the body
  *Ex. luha, pawis TYPES OF VACCINES
IgE  *Ellergy (palatandaan) - All vaccines contain an active component (the antigen)
 attach to HISTAMINE RECEPTOR which generates the protective immune response.
 release of histamine and other substances that Vaccines may also contain additional components.
cause inflammation LIVE ATTENUATED VACCINES
IgD  not found in al species, they are present in low  Live vaccines are made using ‘wild’ viruses or bacteria that
concentration in primates, rodents and probably dogs have been attenuated, or weakened, before being included in
CELLULAR IMMUNITY the vaccine.
 Mediated by CELLS  *small dose
 T-lymphocytes → “activated T cells” → circulate throughout the  Rotavirus, chickenpox, and measles, mumps and rubella,
body often for months BCG
 The activated cells perform much like antibodies, by binding to INACTIVATED VACCINES
specific antigens.  Inactivated vaccines are made using ‘wild’ viruses or bacteria
INTERACTIONS BETWEEN DIFFERENT PARTS OF THE IMMUNE that have been grown in a culture medium and inactivated
SYSTEM before being included in a vaccine or made using a toxin,
TISSUE MACROPHAGES protein or polysaccharide (sugar) fragment derived from
 Inactivate antigen → circulation → lymph node and “present” it viruses or bacteria (subunit vaccines).
to MHC *which reside there  *multiple dose
HELPER T CELLS (OF CELL MEDIATED IMMUNITY)  Hepatitis A, influenza and polio vaccines are inactivated
 CD4 cell surface marker vaccines on the New Zealand Immunisation Schedule.
 Produce various substances including, AB which are essential Diphtheria, tetanus, pertussis, hepatitis B, human
in fighting viral infections papillomavirus, Haemophilus influenzae type b,
COMPLEMENT (ALSO KNOWN AS THE COMPLEMENT SYSTEM) meningococcal, and pneumococcal vaccines are subunit
 Series of enzymes that are found in the blood vaccines.
 Assist the immune system by phagocytosis, chemotaxis and SUBUNIT VACCINE
opsonization of bacteria by WBCs TOXOID VACCINES Tetanus diphtheria and
IMMUNITY pertussis toxins are inactivated
ACTIVE IMMUNITY You will make the antibodies to create toxoids for use in
PASSIVE IMMUNITY You are given with the antibodies Infanrix-hexa, Infanrix-IPV,
NATURAL You will get the antibodies naturally Boostrix, and ADT Booster
ARTIFICIAL Antibodies are artificially introduced to Schedule vaccines.
the body POLYSACCHARIDE VACCINE Are taken from the outside layer
IMMUNITY of encapsulated bacteria such as
NATURAL ACTIVE Acquire disease 23 Streptococcus pneumoniae
NATURAL PASSIVE From placenta (pneumococcal) serotypes for
use in the Pneumovax 2 special
ARTIFICIAL ACTIVE Vaccine containing antigens
groups Schedule vaccine.
ARTIFICIAL PASSIVE Vaccine containing antibodies
CONJUGATE VACCINE Are taken from the outside layer
of encapsulated bacteria and join
HYPERSENSITIVITY
the molecules to carrier proteins.
TYPE I: IMMEDIATE Mediated by IgE antibodies and can range
Polysaccharide molecules are
from minor skin irritation to fatal
taken from Haemophilus
CYTOTOXIC shock
influenzae tybe b (Hib), 13
EX: asthma
Streptococcus pneumoniae
TYPE II: CYTOTOXIC Involves the IgM and IgG, an example is
(pneumococcal) serotypes,
the blood transfusion reaction.
and either one of four Neisseria
EX: autoimmune
meningitidis (meningococcal)
TYPE III: IMMUNE Mediated by ANTIGEN-ANTIBODY serogroups and joined to carrier
COMPLEX REACTION IMMUNE COMPLEXES (precipitates) that proteins for the Schedule
are deposited in tissues and cause vaccines Act-HIB, Prevenar 1,
inflammatory reactions, including NeisVac-C and Menactra
glomerulonephritis and RA. respectively.
EX: serum sickness
RECOMBINANT VACCINE The gene segment for a protein
TYPE IV: DELAYED AKA CELL-MEDIATED IMMUNITY and is from the disease-causing
REACTION caused by T-CELL, this inflammatory organism that is known to
reaction usually ALLERGIC after stimulate a protective immune
exposure response (protein of interest) is
EX: Organ transplant rejection, inserted into the gene of
tuberculosis testing (TB), Contact another cell, such as a yeast
dermatitis cell.
Infanrix-hexa, HBvaxPRO and
Gardasil, Gardasil 9 respectively.
 H. INFLUENZAE TYPE B Contains bacterial
VACCINE polysaccharide which promotes
opsonization
HEP B VIRUS VACCINE Contains inactivated serum-
derived viral antigen
MMR / MEASLES-MUMP- Made up of live virus/living
RUBELLA attenuated vaccine
RABIES VACCINE Contains inactivated virus

-IRA G. (MAY 3, 2022)