Diploma in Pharmacy

(D. Pharm)
First year

PHARMACEUTICS-I
Review Questions /Comprehensive Questions
Syllabus:

UNIT - I
Introduction of different dosage forms- Their classification with examples-their relative
applications. Familiarization with new drug delivery systems. Introduction to Pharmacopoeias with
special reference to the Indian Pharmacopoeia.
Metrology- System of weights and measures. Calculations including conversion from one to
another system. Percentage calculations and adjustment of products. Use of alligation method in
calculations. Isotonic solutions.
Packaging of pharmaceuticals-Desirable features of a container and types of containers. Study of
glass & plastics as materials for containers and rubber as a material for closure-their merits and
demerits.
Introduction to aerosol packaging

UNIT - II
Size reduction- Objectives and factors affecting size reduction, methods of size reduction- study of
Hammer mill, ball mill, Fluid energy mill and Disintegrator.
Size separation- Size separation by sifting, official standards for powders, Sedimentation methods
of size separation, Construction and working of Cyclone separator.
Mixing and Homogenization-Liquid mixing and powder mixing, mixing of semisolids. Study of
silverson Mixer-Homogenizer, planetary Mixer; Agitated powder mixer; Triple Roller Mill; Propeller
Mixer; colloid Mill and Hand Homogenizer. Double cone mixer.

UNIT - III
Clarification and Filtration-Theory of filtration, Filter media; Filter aids and selection of filters.
Study of the following filtration equipments-Filter Press, sintered filters, Filter candles, Metafilter.
Extraction and Galenicals-
(a) Study of percolation and maceration and their modification, continuous hot extraction-
Application in the preparation of tinctures and extracts.
(b) Introduction to Ayurvedic dosage forms.
Evaporation-Definition-Factors affecting evaporation-study of evaporating still and Evaporating
pan.
UNIT - IV
Distillation-Simple distillation and Fractional distillation, steam distillation and vacuum distillation.
Study of vacuum still, preparation of purified water I.P. and water for Injection I.P. construction
and working of the still used for the same.
Introduction to drying process-Study of Tray Dryers; Fluidized Bed Dryer, Vacuum Dryer and
Freeze Dryer.
Sterilization-Concept of sterilization and its differences from disinfection-Thermal resistance of
microorganisms. Detailed study of the following sterilization process. Sterilization with moist heat,
Dry heat sterilization, Sterilization by radiation, Sterilization by filtration and Gaseous sterilization.
Aseptic techniques-Applications of sterilization process in hospitals particularly with reference to
surgical dressings and intravenous fluids. Precautions for safe and effective handling of
sterilization equipment.

UNIT - V
Processing of Tablets-Definition; different type of compressed tables and their properties.
Processes involved in the production of tablets; Tablets excipients ; Defects in tablets; Evaluation
of Tablets; Physical standards including Disintegration and Dissolution. Tablet coating-sugar
coating; films coating, enteric coating and micro-encapsulation
Processing of Capsules-Hard and soft gelatin capsules; different sizes of capsules; filling of
capsules; handling and storage of capsules. Special applications of capsules.
Study of immunological products like sera, vaccines, toxoids & their preparations.
UNIT – I
Multiple Choice Questions
Q.1 Which one of these is not a unit dosage form?
a) Tablets
b) Suppositories
c) Powders
d) Pellets
Q.2 International system of units (SI) includes
a) Metric system
b) Avoirduposis system
c) Apothecaries system
d) None
Q.3 one grain is equivalent to
a) 100 mg
b) 64.78 mg
c) 50 mg
d) None
Q.4 Which one of this material is commonly used for closures?
a) Rubber
b) Metal
c) Glass
d) Plastics
Q.5 Lozenges are solid dosage form intended for
a) Faster action
b) Slow dissolution
c) Slow disintegration
d) None
Q.6 one drop is equivalent to
a) 0.06 ml
b) 1.0 ml
c) 0.3 ml
d) 0.5 ml
Q.7 Soda lime glass is not suitable for parenteral solution because
a) It is mechanically weak
b) It releases alkali in solution
c) It loses its brilliancy on repeated use
d) None
Q.8 Which one of these is used as vulcanising agent in rubber?
a) Zinc oxide
b) Sulphur
c) Calcium carbonate
d) Zinc Stearate
Q.9 Propylene glycol is used in ear drop as
a) Preservative
b) Solvent
c) Additive
d) None
Q.10 In aerosols, dip tube is usually made of
a) Polyamides
b) Polypropylene
c) Metal
d) Neoprene

ANSWERS

01 02 03 04 05 06 07 08 09 10
C A B A B A B B B B
Short Answer Questions
Q.1 Discuss bulk powders for external use by giving their definitions and examples.
Ans. Bulk powders for external use: -
External bulk powders contain non-potent substances for external applications. These powders
are dispensed in glass, plastic wide mouth bottles and also in cardboard with specific method of
application.
Bulk powders for external used are of many types.
 Dusting powders
 Snuffs
 Douche powders
 Dental powder
 Insufflations
 Talcum powders
 Deodorant powders
(a) Dusting powders:
These are used externally for local application not intended for systemic action. They should
contain the ingredients giving free flow, protectiveness, absorbency, antiseptic and stickiness.
Dusting powders contain substances such as zinc oxide, starch, boric acid, kaolin or talc.
(b) Snuffs:
These are finely divided solid dosage forms of medicaments dispensed in flat metal boxes with
hinged lid. These powders are inhaled into nostrils for decongestion, antiseptic, and
bronchodilator action.
(c) Douche powder:
Preparations formulated for cleansing of vagina, nasal cavity and optic cavity. Before use, they are
required to be dissolved in water.
Zinc sulphate, Magnesium sulphate, Boric acid, Oil of lemon, Water
(d) Dental powders:
This preparation is a type of dentifrice meant for cleaning the teeth.
As such, dental powders contain detergents, abrasives, antiseptics and colouring and flavouring
agents incorporated in a suitable base. Generally the base is calcium carbonate.
(e) Insufflations:
Insufflations are a class of powders meant for application to the body cavities e.g., ear, nose,
vagina etc. The powder has to be extremely fine and must find an entry to the cavity deep enough
to bring about its action at the site.
(f) Talcum powders:
Preparations that are employed on the face. They cover the shine on the face due to moisture and
grease and conceal minor visible cuts of the face to enhance personal attractiveness.
(g) Deodorant powders:
Preparations that remove or neutralize the bad odor to sweat. This powder is mainly used to
remove or neutralize foul smelling of the skin.

Q.2 Define the term “metrology”. Which systems have been used by the pharmacists to weigh
and measures ingredients?
Ans. Metrology:-
Metrology is the study of fundamental principles of testing, manufacturing and compounding of
pharmaceutical preparations.
The systems that are being used by the pharmacist are:
a) Metric System
b) Imperial System
Now a day, Metric system is the system of choice for the measurement of mass and capacity. It
has been adopted by most of the countries of the world. It is a scientific system accepted by
scientists all over the world because of:
I. Its simplicity of tables based upon the decimal system of notation.
II. Its tables of length, volume and weighs are conveniently correlated.

Q.3 Write the advantage and disadvantages of plastic containers?

Ans.
Plastic containers are becoming very popular for packaging different sterile products including
infusion, dialysis fluid and eye drop. This popularity is due to the variety of plastic available and
their adoptability to many package forms like bottles, boxes, pouches, syringes and tubes.
They are commonly used in pharmaceutical packaging because of the following advantages:
1) They are light in weight and can be handled easily.
2) They are poor conductor of heat.
3) They are unbreakable.
4) They have sufficient mechanical strength.
5) They can be transported easily.
6) They are resistant to inorganic chemicals.
7) They have good protection power.
 8) They are available in various shapes and sizes.
Plastic containers have certain disadvantages such as:
1) They cannot withstand heat without softening or distorting.
2) They are permeable to water vapour and atmospheric gases.
3) They may absorb chemical substances, such as preservatives for solution.
4) They may interact with certain chemical to cause softening or distortion.
5) They are relatively expensive.
6) Special type of gum or adhesive required for labelling.

Q.4 Convert the following as directed-

a) 2.56 kilogram to milligrams.
b) 7038 miligram to kilograms.
c) 0.05 gram to micrograms.
d) 3.625 liters to micro liters.
Ans.
a) 2560000 mg
b) 0.007038 kg
c) 50,000 micrograms
d) 3625000 micro liters
Long Answer Questions
Q.1 Define and classify dosage forms. Discuss each of solid dosage forms by giving their
definitions with suitable examples.
Ans. Dosage forms are the devices into which a drug substance can be incorporated for the
convenient and efficacious treatment of a disease.
Drugs are rarely administered in their original pure state. They are administered in different
dosage forms after converting them into a suitable formulation.

Figure: - Dosage Forms

Solid Dosage Forms:
Tablet: These are solid dosage forms of medicament or medicaments which are prepared by
moulding or by compression. Certain excipients are also added to the medicaments in the
formulation of tablets.
Tablets are solid, flat or biconvex dishes, unit dosage form. They vary in shape and differ greatly in
size and weight, depending on amount of medicinal substances and the intended mode of
administration.
Ex. – Multivitamin tablet, Paracetamol tablet
Capsules: The capsules are solid unit dosage form in which one or more medicaments and inert
substances are enclosed within a small shell. It is prepared from a suitable form of gelatin.
Depending on their formulation, the gelatin capsule shell may be hard or soft.
Ex. – Hard gelatin capsule, Soft gelatin capsule
Powders: A pharmaceutical powder is a mixture of finely divided drug and/or chemicals in dry
form. They are available in crystalline or amorphous form.
Powders are solid dosage form of medicament which are meant for internal and external use. The
particle size of powder plays an important role in physical, chemical and biological properties of
the dosage forms.
Ex. – Dusting powders, Dentifrices, Effervescent granules
Pills: Pills are small, rounded solid dosage forms containing medicament and are intended to be
administered orally. The medicaments are mixed with excipients to form a firm plastic mass. Pills
are spherical in shape and are produced by rolling them under wooden pill rounder.
Ex. – Contraceptives pills, Sleeping pills

Q.2 Discuss functions of valve assembly of the aerosol container. Write an answer with suitable
diagram.
Ans. Valve assembly of the aerosol container:
The function of valve assembly is to expel the contents of the container in the desired form and at
the desired rate. The materials used in the manufacture of valve must be inert towards
formulation and must be approved by FDA.
 Figure: - Valve Assembly

Valve assembly consists of following parts:

1. Actuator
2. Stem
3. Gasket
4. Spring
5. Mounting Cap
6. Housing
7. Dip tube
1) Actuator:- To ensure that the aerosol product is delivered in the proper and desired form a
specially designed button or actuator must be fitted to the value stem.
There is an orifice in the actuator from that product is discharged.
Types of actuators used-
(a) Spray actuator:- This type of actuator deliver the product in spray form. In this size of
the orifice of spray actuator is in range from 0.016 to 0.040 inch in diameter.
(b) Foam actuator:- This type of actuator deliver the drug in foam form and size of orifice
is in the range of 0.070 to o.125 inch in diameter.
(c) Solid foam actuator:- This type of actuators is used for semisolid preparations and size
of orifice is also larger than foam type.
 (d) Special type actuator:- This type of actuators are designed in such a way that they
delivered the medication to the appropriate size and in appropriate amount.
2) Stem:- Stem supports the actuator and deliver the formulation in proper form in the
chamber of actuator. Stem is made of nylon or brass or stainless steel.
3) Gasket:- Gasket is attached with stem, it serves to prevent leakage of the formulation when
valve is in closed position.
Bunna-N or Neoprene rubber are commonly used materials for gasket.
4) Spring:- Spring serves not only to hold the gasket in place, when actuator depressed and
released but also it returns valve to its closed position.
Stainless steel is used to manufacture it.
5) Mounting Cap:- Mounting cap is used to attach the valve assembly in a proper position to
the chamber.
It may be coated with inert materials such as-epoxy resin or vinyl resin.
6) Housing:- Housing serves as the link between the dip tube, stem and spring. With stem its
orifice helps to determine the delivery rate and the form in which product is emitted.
It is generally made of nylon or delrin.
7) Dip tube:- It serves to bring the formulation from container to the valve. The inside
diameter of dip tube is about 0.120 inch to 0.125 inch.
UNIT – II
Multiple Choice Questions
Q.1 Hammer mill works on the principle of
a) Cutting
b) Impact
c) Attrition
d) Impact and attrition
Q.2 The limit of sieve number for coarse powder is
a) 10/44
b) 22/60
c) 44
d) 85
Q.3 Ball mill works on the principle of
a) Impact
b) Compression
c) Attrition
d) Impact and attrition
Q.4 Sieve No.10 contains
a) 10 wires per inch in each direction
b) 10 meshes per inch in each direction
c) Both a & b
d) None of the above
Q.5 Which mill is used for powdering hard crude drug?
a) Edge runner mill
b) Colloidal mill
c) Disintegrator
d) Fluid energy mill
Q.6 Decrease in particle size is associated with:
a) Increase in solubility of solid particle
b) Decrease in solubility of solid particle
c) No effect on solubility of solid particle
d) None of the above
Q.7 Roller mill works on the principle of
a) Impact
b) Compression
c) Attrition
d) None
Q.8 Moderately fine powder must pass through sieve no. :
a) 22
b) 44
c) 60
d) 120
Q.9 Which is the example of solid-liquid mixing?
a) Aluminum hydroxide gel
b) Complex elixir
c) Cod liver oil emulsion
d) Ephedrine syrup
Q.10 The mechanism of mixing in silverson mixer is:
a) Connective mixing
b) Laminar mixing
c) Molecular diffusion
d) Turbulent mixing

ANSWERS

01 02 03 04 05 06 07 08 09 10
B A D B C A C B A D
Short Answer Questions
Q.1 What are the various factors which affect the size reduction of drugs?
Ans. Factors Affecting Size Reduction:-
The following factors affect the process of size reduction:
1) Hardness: The hardness of the material affects the process of size reduction. It is easier to
break soft material to a small size than hard material.
2) Toughness: Size reduction of soft and tough material having high moisture content is more
difficult than the hard but brittle substances. For example, chalk stick, which is hard and
brittle, can be broken easily and while rubber being a soft and tough material is very
difficult to break.
3) Stickiness: This is due to the fact that material adheres to the grinding surfaces or sieve
surface of the mill. It is difficult to powder a drug of having gummy or resinous nature, if
the method used for size reduction generates heat. Complete dryness of material may help
to overcome this difficulty.
4) Material structure: Materials which show some special structure may cause problem during
size reduction e.g. vegetable drugs which have cellular structure, generally produce long
fibrous particles on its size reduction.
5) Moisture content: The presence of moisture in the material influences a number of its
properties such as hardness, toughness or stickiness which in its turn affects the particle
size reduction. The material should be either dry or wet. The material having 5% moisture
in case of dry grinding and 50% moisture in wet grinding does not create any problem.
6) Softening temperature: Waxy substances such as Stearic acid or drugs containing oils or
fats become softened during the size reduction processes, if heat is generated.
7) Purity required: Various mills used for size reduction often cause the grinding surfaces to
wear off and thus impurities come in the powder. The mills should be thoroughly cleansed
between batches of different materials in order to maintain purity.
8) Physiological effect: Some drugs are very potent. During their particle size reduction in a
mill, dust is produced which may have an effect on the operator. In such cases, the
enclosed mills may be used to avoid dust.
9) Ratio of feed size to product size: To get a fine powder in a mill, it is required that a fairly
small feed size should be used. Following scheme is adopted if a piece of a crude drug is
powdered to fine particles:
A piece → small pieces → coarse powder → fine powder → very fine powder (product)
 10) Bulk density: The output of the size reduction of material in a machine depends upon the
bulk density of the substance.

Q.2 Enumerate various grades of powders and sieve number official in pharmacopoeia.
Ans. Grades of powders and sieve number along with nominal aperture size as per IP
Sieve Nominal Sieve Nominal
through mesh through mesh
SI which all aperture which aperture
Grade of powder
No. particles size 40% size
must pass particles
pass
1 Coarse powder 10 1.7 mm 44 355 µm
2 Moderately coarse powder 22 710 µm 60 250 µm
3 Moderately fine powder 44 355 µm 85 180 µm
4 Fine powder 85 180 µm - -
5 Very fine powder 120 125 µm - -

Q.3 Define “Viscosity”. Write its application in pharmacy.

Ans. Viscosity:-
Every liquid has its own flow rate. Liquids like water, alcohol, chloroform and acetone move fast,
whereas syrup, honey and glycerin flow slowly.
In other words, the property of a liquid which gives its resistance to flow is called viscosity.
Viscosity of liquid decreases with rise in temperature, while it increases with fall in temperature.
Applications of viscosity in pharmacy:
a) Viscosity plays an important role in the stability of emulsions and suspensions.
b) Ophthalmic preparations are made viscous to prolong the contact time of the drugs e.g.
methyl cellulose is used for this purpose.
c) Certain pharmaceutical formulations are standardized on the basis of its viscosity e.g. liquid
extract of liquorice.
d) Paints are made more viscous so that they may remain in contact with skin for long time
e.g. glycerin is included in paint formulation to increase the viscosity.
e) Fats, waxes and other viscous substances are filtered at higher temperature.
f) The viscosity of certain liquid preparations is increased in order to improve pourability or to
make the preparation more palatable.
Q.4 Describe the working of a silverson mixer with the help of a labeled diagram.
Ans. SILVERSON MIXER - EMULSIFIER

Figure: - SILVERSON MIXER - EMULSIFIER

Working: The emulsifier head is placed in the vessel containing immiscible liquids, in such a way
that it should get dipped into liquids. When the motor is started, the liquids are sucked through
the fine holes and the oil is reduced into fine globules due to the rotation of the blades.
So a fine emulsion is produced which is then expelled out. The intake and expulsion of the mixture
set up a pattern of circulation.
Long Answer Questions
Q.1 Describe the principle, construction, working, advantages and disadvantages of fluid
energy mill with the help of suitable diagram.
Ans. Fluid Energy Mill

Figure: - Fluid Energy Mill

Principle: It works on the principle of impact and attrition.

Construction: It consists of a loop of pipe, which has a diameter of 20 to 200 mm, depending on
the overall height of the loop, which may be upto about 2m. There is an inlet for the feed and a
series of nozzles for the inlet of air or an inert gas. It also has an outlet with a classifier which
allows the air to escape but prevents the particles to pass until they become sufficiently fine.
Working: The air or inert gas is introduced with a very high pressure through the nozzles. Solids
are introduced into air stream through inlet. Due to high degree of turbulence, impact and
attritional forces occurs between the particles. The fine particles are collected through a classifier.
Fluid energy mill reduces the particles to 1 to 20 micron.
Advantages of Fluid Energy Mill:
1) The mill is used to grind the material to fine powder
2) The particle size of powder can be controlled due to the use of a classifier.
3) Since there is no wear of the mill, contamination is not possible.
 4) It is useful for grinding heat sensitive substances such as sulphonamides, vitamins and
antibiotics.
Disadvantages of Fluid Energy Mill:
1) Fluid energy mill is not suitable for milling of soft, tacky and fibrous materials.
2) The equipment is expensive, because it needs additional accessories particularly fluid
energy source and dust collection equipment.

Q.2 Describe the principle, construction, working and uses of a cyclone separator with the help of
suitable diagram.
Ans. Cyclone Separator

Figure: - Cyclone Separator

Principle: In cyclone separator, centrifugal force is used to separate the solids from fluids. The
separation process depends not only on the particle size, but also on the density of particles.
Depending on the fluid velocity, the cyclone separator can be used to separate all types of
particles. It is also possible to allow fine particles to be carried by the fluid.
Construction: It consists of a cylindrical vessel with a conical base. In the upper part of the vessel is
fitted with a tangential inlet and a fluid outlet and at the base it is fitted with solid outlet.
Working: The suspension of a solid in gas (usually air) is introduced tangentially at a very high
velocity, so that rotary movement takes place within the vessel. The fluid is removed from a
central outlet at the top. The rotatory flow within the cyclone separator causes the particles to be
acted on by centrifugal force. The solids are thrown out to the walls, thereafter it falls to the
conical base and discharged out through solids outlet.
Uses:
1) Cyclone separator is used to separate the solids from gases.
2) It is also used for size separation of solids in liquids.
3) It is used for separating the heavy or coarse fraction from fine dust.
UNIT – III
Multiple Choice Questions
Q.1 The rate of filtration is expressed in the form of:
a) Fick’s law
b) Darcy’s equation
c) Strok’s law
d) None of the above
Q.2 Which one of these for bacterial filtration?
a) Membrane filter
b) Sintered glass filter
c) Filter paper
d) None of the above
Q.3 Which one of these does contain any filter medium?
a) Filter leaf
b) Metafilter
c) Filter press
d) None of the above
Q.4 The rate of filtration is increased by:
a) Decreasing the viscosity of filtrate
b) Increasing the area of filter medium
c) Increasing the pressure drop across the filter medium
d) All of the above
Q.5 Liquid extracts contain drug and menstrum in the ratio of:
a) 1 : 1
b) 1 : 2
c) 2 : 1
d) None
Q.6 Unorganized drugs are usually extracted by a process, called:
a) Maceration
b) Percolation
c) Decoction
d) Infusion
Q.7 Which of these process use soxhlet extractor?
a) Simple percolation
b) Continuous hot percolation
c) Infusion
d) Double and triple maceration
Q.8 The rate of evaporation depends on:
a) Surface area
b) Temperature
c) Viscosity
d) All of the above
Q.9 What is the source of heat in most of the evaporators?
a) Coal
b) Hot water
c) Oil bath
d) Steam
Q.10 The rate of evaporation can be increased by:
a) Removing the vapours above the evaporating liquids surface
b) Increasing the viscosity of liquid
c) Decreasing the surface area
d) None

ANSWERS

01 02 03 04 05 06 07 08 09 10
B A B D A A B D D A
Short Answer Questions
Q.1 What are the filter aids? Name the filter aids commonly used in pharmacy practice.
Ans. Filter Aids:
These are substances which reduce the resistance of the filtrate to flow. These are added to the
preparation in concentration from 0.1 to 0.5 percent before filtration. An ideal filter aid should
possess the following qualities:
1) Low specific gravity, so that filter aids remain suspended in the liquid.
2) It should be free from impurities.
3) It should be inert to the liquid being filtered.
4) It should have a structure that permits formation of porous cake.
5) It should have a particle size distribution suitable for the retention of solids as required.
Examples of filter aids are:
Kieselguhr, Talc, Charcoal, Asbestos, Paper pulp, Bentonite, Fullers earth

Q.2 Explain the factors which affect the rate of filtration.

Ans. Factors Affecting the Rate of Filtration:
1) Pressure: The rate of filtration can be increased by applying pressure on the liquid being
filtered or by decreasing the pressure beneath the filter.
2) Viscosity: Liquids which are very viscous get filtered slowly in comparison to liquids with low
viscosity.
3) Surface area of filter media: Pleating the filter paper or using a fluted funnel increases the
effective surface area of filter paper for filtration.
4) Temperature of liquid to be filtered: Viscosity is reduced by a rise in temperature and the
filtration of viscous oils, syrups etc.
5) Particle size: It is easier to filter a liquid having coarse particles than that having finely
divided particles because coarse filtering medium can be used to filter liquid having coarse
particles and hence it increases the rate of filtration.
6) Pore size of filter media: The rate of filtration is increased when a coarse filter medium is
used for filtration.
7) Thickness of cake: As the filtration process proceeds, the solid particles start depositing on
the filter medium, and thus, it increases the thickness of the cake and decreases the rate of
filtration.
 8) Nature of the solid material: The rate of filtration is directly proportional to the porosity of
the filter cake. The porosity of the filter cake depends on the nature of the solid particles to
be removed from the liquid.

Q.3 Write about the application of extraction.

Ans. Applications of Extraction:
Extraction is frequently used in pharmaceutical sciences in the following areas:
1) Medicinal constituents are extracted from plant and animal tissues with organic solvents.
2) Drugs are frequently extracted from blood, tissue and urine in clinical practice.
3) Antibiotics are isolated from bacterial cultures by liquid-liquid extraction.
4) Leaching of soybean oil from flaked soybeans with hexane.
5) Leaching of sugar from sugar beets with hot water.
6) During drug synthesis too, the products are subjected to extraction to make the products
free from reactants and other reagents.
7) Aromatic compounds are recovered from paraffin fractions of the petroleum oil.
8) Sulphur compounds are removed from gasoline by caustic (alkali) extraction.
9) Vegetable oil is refined using furfural as a solvent.

Q.4 Describe the factors influencing the evaporation.

Ans. Factors Affecting Evaporation:
The following are the factors which affect the rate of evaporation of a liquid:
Temperature: The rate of evaporation is directly proportional to the temperature of the liquid.
The evaporation can be accelerated by increasing the temperature but it will cause decomposition
of heat sensitive principles of many drugs.
Time of evaporation: If the time of exposure is longer, greater will be the evaporation, provided
the constituents are thermostable.
Moisture content of the feed: Some drug constituents decompose more readily in the presence of
moisture if heated at a high temperature. This is due to the hydrolysis of the active constituents.
Types of product required: On evaporation of the liquid the concentrated liquid, semisolid and
solid are formed. The selection of the method and the equipment required for evaporation
depends upon the type of the product required.
Effect of concentration: During evaporation the upper layer of the liquid under evaporation has a
tendency to form a film and formation of precipitate in the product which results in lowering
down of the rate of evaporation.
Surface area: The rate of evaporation is directly proportional to the surface area of the
evaporator, in which the liquid is evaporated. The larger the surface area of the evaporator, the
shorter is the time it takes to evaporate the liquid.
Vapour pressure of the liquid to be evaporated: The rate of evaporation is directly proportional
to the vapour pressure of the evaporating liquid. The liquid has the maximum vapour pressure at
its boiling point.

Long Answer Questions

Q.1 Explain the principle, construction, working and uses of Meta filters with the help of
labeled diagram.
Ans. Meta Filters:

Figure: - Meta Filters

Principle: Metafilter functions as a surface filtration for the separation of particles. In this method,
metal rings contain semicircular projections, which are arranged as a nest to form channels on the
edges. This channels offer resistance to the flow of solids. The clear liquid is collected into a
receiver from the top.
Construction: It consists of a grooved, drainage rod on which are packed a number of metallic
rings. These rings are usually of stainless steel and have 0.8 mm thickness, 15 mm inside diameter
and 22 mm outer diameter. These rings have a number of semicircular projections on one surface
and when they are packed on the rod, the opening between the rings is about 0.2 mm.
Working: The entire assembly is placed inside a pressure vessel, containing the liquid to be
filtered. When vacuum is applied, liquid will flow from outside to inside. In this form a Metafilter
can only be used as strainer for coarse particles. But for separation of finer particles, Kieselguhr is
used. In this way the pack of rings acts as a base on which the true filter medium is supported.
Uses: The Meta filters are mostly used for clarification of syrups, elixirs and parenteral solutions.

Q.2 Describe the factors influencing the extraction.

Ans. Factors influencing the extraction:
Extraction is the processes in which the animal or plant tissues are treated with specific solvent
where by the medicinally active constituents are dissolved out whereas cell tissue and most of
inactive or inert components remain undissolved.
Factor affecting choice of the extraction process:
1) Characters of drug: The knowledge of Pharmacognosy of the drug is essential to select the
right method of extraction process.
Soft drug → Infusion
Hard and woody → Decoction
Hard and tough → Percolation
2) Therapeutic value of the drug: When the drug has considerable therapeutic value, the
maximum extraction is required, so the percolation process is used.
Example: Belladonna
In case the drug has little therapeutic value, the efficiency of extraction is unimportant and
maceration process can be used to extract the drug.
3) Cost of drug: The costly drugs are extracted by using the percolation process whereas cheap
drugs are extracted by maceration process.
4) Stability of drug: Continuous hot process should be avoided when the constituent of drug
are Thermolabile in nature. In that case, maceration or percolation process may be used.
5) Solvent: If water is used as a solvent, the maceration process should be recommended. The
percolation process should be preferred if non-aqueous solvent are used.
6) Concentration of product: The dilute products such as tinctures can be made by using
maceration or percolation process depending on the other factors.
For semi concentrated preparations, such as concentrated infusion, double or triple
maceration process can be used.
UNIT – IV
Multiple Choice Questions
Q.1 Volatile oil is separated from crude drugs by:
a) Simple distillation
b) Distillation under reduced pressure
c) Boiling with solvent
d) None
Q.2 Fractional distillation is carried out for separating:
a) Miscible liquids
b) Immiscible liquids
c) Volatile oils
d) Hormones
Q.3 Aromatics waters are prepared by:
a) Simple distillation
b) Steam distillation
c) Boiling with water
d) None
Q.4 Which one of the following dryers is known as lyophiliser?
a) Fluidized bed dryer
b) Freeze Dryer
c) Spray Dryer
d) Vacuum Dryer
Q.5 Enzyme preparations are dried by:
a) Vacuum drying
b) Freeze drying
c) Keeping in warm air
d) None
Q.6 In tabletting operation, granules are dried by:
a) Fluidized bed dryer
b) Spray Dryer
c) Tunnel Dryer
d) Vacuum Dryer
Q.7 Which condition is highly critical for drying operation?
a) Moisture
b) Pressure
c) Temperature
d) Volume
Q.8 Temperature and time used in moist heat sterilization is:
a) 1200C for 30 minutes
b) 1250C for 15 minutes
c) 1500C for 15 minutes
d) 1000C for 30 minutes
Q.9 Surgical dressings are sterilized by:
a) Dry heat sterilization
b) Gaseous sterilization
c) Radiation sterilization
d) Moist heat sterilization
Q.10 Temperature used in hot air oven for sterilization:
a) 1800C for 45 minutes
b) 1200C for 30 minutes
c) 1600C for 1 hour
d) 1600C for 2 hours

ANSWERS

01 02 03 04 05 06 07 08 09 10
B A A B B A A A D C
Short Answer Questions
Q.1 Describe the principles and applications of steam distillation.
Ans. Steam Distillation:
Steam distillation is a method of distillation carried with the aid of steam and is used for the
separation of high-boiling substances from non-volatile impurities.
Principle: A mixture of immiscible liquids begins to boil when the sum of their vapour pressures is
equal to the atmospheric pressure. In case of a mixture of water and turpentine, mixture boils
below the boiling point of pure water, though the turpentine boils at a much higher temperature
than that of water.
Applications:
1) It is used for the preparation of volatile oils such as clove, anise and eucalyptus.
2) Camphor is distilled by this method.
3) It is useful in purification of liquid with high boiling point, for example essential oil of
almond.
4) Aromatic waters are prepared by this method.

Q.2 Write about the applications of distillation.

Ans. Applications of distillation:
1) Separation of volatile oils: Volatile oils are separated from cloves, anise seeds and
eucalyptus leaves by the method of steam distillation.
2) Purification of organic solvents: Normally, simple distillation method is used for the
purification of liquids having single component as a major fraction. Absolute alcohol (100%
ethanol) can be obtained by azeotropic distillation.
3) Manufacture of official preparations: Spirits of nitrous ether and aromatic spirit of
ammonia are prepared by simple distillation.
4) Refining of petroleum products: In the petroleum industry, the crude oil is refined into
different fractions using flash distillation.
5) Recovery of solvents: Solvents are used for extraction of drugs from plant parts and
synthetic reaction mixtures. The recovered solvent may be recycled for further use.
6) Quality control methods: Distillation method is used for determining alcohol content in
liquid dosage forms such as elixirs, as per IP 1996.
7) Separation of drugs obtained from plant and animal sources: Drugs of natural origin are
normally extracted using maceration or percolation methods. The menstrum used for
extraction is distilled off and the active constituents are separated.
 8) Purification of drugs obtained from chemical process: Many chemical processes involve the
conversion of raw materials into products. The products are separated from the reaction
mixture and purified using the methods of distillation.

Q.3 Explain the principle and working of fluidized bed dryer.

Ans. Fluidized bed dryer:
Principle: In fluidized bed dryer, hot air is passed at high pressure through a perforated bottom of
the container containing granules to be dried. The granules are lifted from the bottom and
suspended in the stream of air. The hot gas is surrounding every granule to completely dry them.
Thus, materials or granules are uniform dried.
Working: The wet granules to be dried are placed in the detachable bowl. The bowl is pushed into
the dryer. Fresh air is allowed to pass through a prefilter, which subsequently gets heated by
passing through a heat exchanger. The hot air flows through the bottom of the bowl. The air
velocity is gradually increased.
When the velocity of the air is greater than settling velocity of granules, the granules remain
partially suspended in the gas stream.
The residence time for drying is about 40 minutes. The material is left for some time in the dryer
for reaching ambient temperature. The bowl is taken out for discharging. The end point is free
flowing.

Q.4 Discuss various applications of sterilization processes in Hospitals.

Ans. APPLICATIONS OF STERILIZATION PROCESSES IN HOSPITALS
A hospital pharmacist must be familiar with the knowledge of sterilization processes. A central
sterile room has been found in big hospitals, which are considered as a sub-department of a
hospital.
 All kinds of items required in the surgery.
 Items like; syringes, tubing, urine collections sets, intravenous administration sets, needles,
gloves, blood collection bulb and bags.
All these items are carefully sterilized and packed in proper container so as to maintain the
sterility. Today, with the advent of the age of plastics and disposables, central supply room feels a
substantial relaxation on heavy workload of day-to-day working.
Due to heavy load and lack of facilities, sterility of all these items as not assured. Hospital
management took the advantage of plastic age and radiation technique of sterilization, to make
them available readymade sterilized disposable items.
A number of hospitals were manufacturing intravenous solutions, irrigation solution, and other
small volume parenteral. In many cases, quality control was lacking due to various factors, which
shifted the trend of parenteral manufacturing from hospital to industry.

Long Answer Questions

Q.1 Explain the construction, operational details of freeze dryer. Describe its applications in
pharmacy.
Ans. Freeze Dryer:
In the freeze drying process, there is removal of water vapours from a frozen solution by
sublimation.
Construction: Freeze dryers are composed of the following four basic components:
1) A chamber for vacuum drying
2) A vacuum source
3) A heat source
4) A vapour-removal system
The chamber of vacuum drying is generally designed for batch operation but by using special inlet
and outlet mechanisms, continuous drying operation can be achieved. It consists of shelves for
keeping the material.
The condenser consists of a relatively large surface cooled by solid carbon dioxide mixed with
acetone or ethanol. The temperature of the condenser must be much lower than the evaporated
surface of freezed substance.
Working: The working of freeze dryer involves the following steps:
1) Pre-treatment: This step is done to reduce the volume of the solution to be introduced into
the container which has limited capacity.
2) Pre-freezing: This is done to solidify water. The ampoules, vials and bottles in which
aqueous solution is packed, are frozen in cold shelves at a temperature below -500C.
3) Primary drying: The material to be dried is spread in order to increase the surface area for
sublimation. The temperature and pressure is kept below the triple point of water for the
sublimation.
4) Secondary drying: The moisture left in the primary drying is removed by an ordinary
vacuum drying. The vacuum drying is done at a temperature of 500-600C.
5) Packing: The biological products dried by freeze drying are usually required to be in a
sterile condition for injection. The containers should be closed under the controlled
atmospheric condition and also observing aseptic conditions.
 Applications of Freeze Drying Process in pharmacy:
Freeze dryer is most commonly used in the production of dosage forms, such as injections,
solutions and suspensions. It is used for drying of a number of products.
 Blood plasma and its fractionated products.
 Bacterial and viral cultures.
 Human tissue.
 Antibiotics and plant extracts.
 Steroids, vitamins and enzymes.
Several other products such as food items, coffee and tea concentrates and citrus fruit
juices are dried.

Q.2 Write an exhaustive notes on- (Any two)

a) Membrane filters
b) Sintered glass filters
c) Laminar Air Flow
Ans.
a) Membrane filters: Membrane filters are made of thin and flat membranes of cellulose
derivatives, such as cellulose acetate and cellulose nitrate. These filters are brittle when
in dry condition and can be stored for an indefinite period. The filters are between 50
and 150µ thick and are available in sizes upto 60 cm2.
A membrane filter has 400 to 500 million pores per square centimeter of filter surface.
The pores are absolutely uniform in size and occupy about 80% of filter volume. To
avoid rapid clogging of a membrane, pre-filtration is often required.
A membrane filter is fixed in a metallic holder before its use. These filters are mainly
used for sterilization of both aqueous and oily liquids. The membrane filters cannot be
used for filtration of organic solvents, such as alcohols, ketones, esters and chloroform.
b) Sintered glass filters: These are made from borosilicate glass. The glass is powdered
and sifted to produce uniform particles. These are heated to sintered point and
moulded into a flat or convex plate, which is fitted into the glass funnel of suitable
shape and size. These filters are mainly used for the filtration of liquids meant for
parenteral use. The porosity of the filter depends upon the size of the granule used in
its preparation. They are graded from 1 to 5 grades upon the porosities.
 The main disadvantage of sintered glass filters is their fragility. Before using a sintered
glass filter, it should be washed with hot HCL or HNO3 and than rinsed thoroughly with
water.
c) Laminar Air Flow: Laminar air flow devices are superior to all other equipment and
techniques for providing sterile working environment.
The laminar air flow devices produce very clean dust free sterile air due to presence of
pre-filters and high efficiency bacterial filters. The velocity of such air is generally
maintained 90±20 FPM. These devices can be in the form of rooms, cabinets, or
benches.
The laminar air flow devices must be checked from time to time for its air flow rates
across the face of the filter by means air velometer. The filters of each laminar air flow
device should be tested at the time of installation and annually thereafter.
UNIT – V
Multiple Choice Questions
Q.1 Magnesium stearate is used as:
a) Lubricant
b) Disintegrant
c) Binder
d) Glidant
Q.2 For film coated tablet, the specified disintegration time is
a) 15 minutes
b) 30 minutes
c) 60 minutes
d) None
Q.3 Flow rate of granules from the hopper can be improve by adding
a) Disintegrants
b) Glidants
c) Lubricant
d) Binder
Q.4 Tablet is film coated with
a) Cellulose acetate phthalate
b) HPMC
c) Cellulose
d) Carboxy methyl cellulose
Q.5 Which is the largest size of capsule?
a) 000
b) 00
c) 1
d) 5
Q.6 Gelatin is a
a) Fat
b) Protein
c) Carbohydrate
d) None of the above
Q.7 Hard gelatin capsule contain ………….. of moisture.
a) 9-12%
b) 15-18%
c) 12-15%
d) None of above
Q.8 BCG vaccine is used to provide immunity against
a) Influenza
b) Polio
c) Small pox
d) Tuberculosis
Q.9 Which of this vaccine contain living or attenuated virus?
a) Small pox
b) Polio
c) Rabies
d) BCG
Q.10 BCG vaccine contains:
a) Killed bacterial suspension
b) Living bacterial suspension
c) Toxoid
d) Living viral suspension

ANSWERS

01 02 03 04 05 06 07 08 09 10
A B B B A B A D A B
Short Answer Questions
Q.1 Discuss various defects in tablets.
Ans. Defects in Tablets:
It is possible to get defects in the tablets if fault lies with either formula or the compression
equipment, or both. Commonly, defects of the tablets which have been experienced are:
1) Capping: Partial or complete separation of top or bottom surface of the tablet from the
main body is called capping. This type of problem is generally found after compression.
2) Lamination: Separation of a tablet into two or three layers is called as lamination.
3) Picking: Removal of surface material from the punch surface is called picking.
4) Sticking: Some material of tablet is adhere inside the die wall, is called as sticking.
5) Chipping: Serious problem of sticking is called chipping. The tablet produced has rough
surface due to this problem. It creates difficulty in free movement of punches.
6) Mottling: Unequal distribution of color in tablet is called mottling.
7) Poor flow: Incomplete filling of dies by the powder material due to poor flow of material
from hopper to die wall.
8) Double impression: One dark and one lighter impression on tablet surface are called
double impression.

Q.2 How will you differentiate between a hard gelatin capsule and soft gelatin capsule?
Ans. Differentiation between Hard gelatin capsules & Soft gelatin capsules:

Sr. No. Hard gelatin capsules Soft gelatin capsules

1 The hard gelatin capsule shell The soft gelatin capsule shell becomes a
consists of two parts: single unit after sealing the two halves of the
(a) Body; (b) Cap capsules.
2 They are cylindrical in shape. They are available in round, oval and tube
like shapes.
3 Hard gelatin capsule usually consist Soft gelatin capsule usually consist of liquids
of the medicament or mixture of or solids dissolved or dispersed in suitable
medicaments in the form of excipients to give a paste-like consistency.
powder, beads or granules.
4 These are prepared from gelatin, These are prepared from gelatin, plasticizer
titanium dioxide, colouring agent and a preservative.
and plasticizer.
5 Capsules are sealed after they are Filling and sealing of soft gelatin capsules are
filled to ensure that the done in a combined operation on machines.
medicaments may not come out of
the capsule due to rough handling.

Q.3 Discuss the in brief about B.C.G vaccine.

Ans. B.C.G Vaccine (Freeze-Dried):
BCG vaccine is in the form of white pellet which when reconstituted yields an opalescent
suspension.
It is a freeze dried preparation containing live culture of the bacillus of calmette and Guerin of
Mycobacterium tuberculosis.
Preparation: The bacilli are grown on a suitable culture media. The growth period should not be
more than 14 days in any case.
After a suitable growth, they are separated by filtration in the form of a cake. The cake is
homogenized in a grinding flask and suspended in a suitable sterile liquid medium. The suspension
is transferred into the final sterile containers and freeze dried. Then containers are sealed so as to
prevent contamination or deterioration of the vaccine.
Storage: Store in hermetically sealed light resistant glass containers at a temperature between 2 0
and 80C. The reconstituted vaccine should be used immediately after its preparation.
Uses: BCG vaccine is used as an immunizing agent which provides protection against tuberculosis.
Dose: Prophylactic, 0.1 ml as a single dose by intracutaneous injection.

Q.4 Write a detail note on storage of immunological products.

Ans. Storage of immunological products:
Immunological products lose their potency on storage. The reduction in potency is due to chemical
changes which are directly proportional to the temperature of storage.
All immunological products are required to be stored below the room temperature. Refrigerated
storage is usually necessary; many vaccines and immunoglobulin need to be stored at 2-8°C and
not allowed to freeze. The viral vaccines, such as, smallpox and oral poliomyelitis are more stable
at or below their freezing point. The bacterial vaccines and antitoxins get deteriorated if they are
allowed to freeze.
The required storage conditions are always mentioned on the label fixed on the container of the
immunological products. To maintain the potency of these products, these instructions must be
followed.
Immunological preparations should also be protected from light as it accelerates decomposition of
the products. The light resistant glass containers are not recommended for storage of
immunological products because in that case it becomes difficult to detect the changes in the
product.

Long Answer Questions

Q.1 Classify immunity. Discuss natural immunity in detail.
Ans. Immunity:
The power of the body to resist the effects of the invasion of microorganisms is called immunity.

There are two types of immunities – natural and acquired

Natural Immunity: The resistance to disease is possessed by an individual due to the following
factors.
1) Age: Majority of children in the age group between 2-5 years are susceptible to diphtheria
disease, whereas adults are immune to it.
2) Race: While the Negroes have a high resistance to yellow fever, the while races are very
susceptible to it.
3) Species: Men are susceptible to typhoid fever, whereas mice are immune to it. Fowls are
immune to plague, whereas men are susceptible to it.
4) Individuals: Some persons have more resistance against cold and skin disease than others.
Q.2 How can you evaluate the tablets for the following parameters?
a) Disintegration time
b) Dissolution rate
c) Friability
d) Weight variation
Ans.
a) Disintegration time: Disintegration is defined as the process of breakdown of tablet into
small particles. Disintegration time of a tablet is determined by using disintegration test
apparatus as per IP specifications. Place each tablet in each 6 tubes of the disintegration
apparatus a then add a disc to each tube containing 6.8 pH phosphate buffer. The
temperature of the buffer should maintain at 37 ±2°C and run the apparatus raised and
lowered for 30 cycles per minute. Note down the time taken for the complete
disintegration of the tablet without any remitants.
b) Dissolution rate: The rate of absorption depends on the dissolution of the product. It is
directly proportional to the bioavailability of the products. For dissolution study two
types of apparatus are used USP XX/NF XV, basket assembly and paddle assembly. It
contains 1000 ml of hemispherical flask temperature is maintained at 37 ± 0.5 oC, t90%
obtained within 30 min. is satisfactory.
c) Friability: Roche Friabilator is the equipment which is used for the determination of
friability. It is expressed in percentage. Note down the initial weight of the tablets
individually (W initial). Tablets are placed in a plastic chamber which revolves at 25 rpm
and they are subjected to fall from a height of 6 inches in the Friabilator for about 100
revolutions. Then measure the weight of the tablet (W final) and observe any weight
difference before tablet and after the Friabilator processing.
Limits: loss in weight less than 0.5 to 1% of the initial weight of the tablet should be
considered as acceptable limits.

Percentage of friability is calculated as:

F= {(W initial) - (W final)/ (W initial)} ×100.

d) Weight variation: Random selection of 20 tablets from each batch should be done and
note down the weight of the tablet individually and check for any variation in its weight.
According to US Pharmacopoeias small variations in the weight is negligible and can be
accepted. Below is the acceptable limit of percentage deviation in weight variation.