Pharmaceutical Packaging

By: Tsegaye N. (B. Pharm., MSc in pharmaceutics)

tsega1994et24@gmail.com

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 Introduction

 WHO definition: packaging is an economical means of providing:

 Presentation
 Protection
 Identification/ information
 Containment
 Convenience and compliance
 For a product during storage, carriage, display and use until such time as
the product is used or administered.

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Introduction…

 Function of a packaging for a medical preparation is to maintain:

Quality

 Safety and

 Stability of its content

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Introduction…
Packaging material
 Any material including printed material employed in the packaging of a
pharmaceutical product
 Primary packaging materials are those that are in direct contact with the product
 Secondary/tertiary packaging materials any outer packaging used for storage,
transportation or shipment
Packaging process
 All operations, including filling and labeling, that a bulk product has to undergo in
order to become a finished product

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Packaging materials

I. Container: is a device in which the drug is enclosed and is in direct

contact with the drug.
 A container which remains in contact with the drug at all times is known as
immediate container
II. Closure: is a device which seals the container to exclude oxygen, CO2 ,
moisture, microorganisms and prevent the loss of volatile substances.

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Packaging materials
III. Carton: is the outer covering which gives secondary protection against
mechanical and other environmental hazards.
IV. Box: is a device which is generally used for packing multiples of the product.
 It gives primary protections against external hazards during transport and handling.

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Desirable qualities of a Packaging materials

 Protect the contents from physical and mechanical hazards. i.e.

 Vibration, compression, shock, abrasion, punctures etc.
 No reaction with the content
 Should not release any chemical.
 No adsorption of the product.

 Should give convenient and easy withdrawal of the required dose.

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Cont…
 Be capable of withstanding extremes of temperature and humidity.
 Protect the contents from both water loss and gain.
 Protect the content from loss of volatile materials.
 Be sufficiently transparent to permit the inspection of the content.
 This may be impractical for drugs sensitive to light.

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Cont…

 The container should be able to protect light sensitive preparations.

 The closure must be easy to remove and replace.
 Easy to label and thus to identify the product.
 The container must not absorb substances from the preparation.
 It must not impart its own color, taste and odor to the preparation
 Be convenient and easy to use, and also be cheap and economical.
 Adoptable to certain high speed filling equipment
 Should be attractive.

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Types of containers

1. Well closed containers

 Protect the preparation from contamination by extraneous solids.
 Prevent the loss of potency of active constituents.
 Prevent the loss of contents during transport, storage and handling.

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Types of containers….

2. Air – tight containers

 Protects the contents from contamination with extraneous solids, liquids and
vapors, from loss of volatile constituents, and from changes
 Due to efflorescence, deliquescence and evaporation under ordinary conditions
of handling, storage and transport.

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Types of containers….

3. Hermetically – sealed containers

 Does not allow air and other gases to pass through it
 It is used for injectables
Example: a glass ampoule sealed by fusion
4. Light resistant containers
 Protect the drug which undergo decomposition in the presence of light.
Example: Amber colored or opaque containers

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Types of containers….
5. Single dose containers
 Used to supply only one dose of the medicament.
 Sealed in such a way that the contents cannot be removed without removing the
seal. E.g. ampoules.
6. Multiple dose containers
 Holds a number of doses
 Sealed in such a way that successive doses can be withdrawn easily without
changing the strength, quality or purity of the remaining contents. E.g. vials

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Types of containers….

7. Aerosol containers
 Must withstand the pressure evolved inside the container at the time of use.

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Materials used for production of containers

Containers can be made from:

I. Glass
II. Plastics
III. Metals
IV. Paper

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I. Glass

 Mostly produced by heating a mixture of silica (SiO2 ), soda ash (Na2CO3) and
limestone (CaCO3) in a furnace at about 1400 0C.
 The fused mass on rapid cooling forms glass which is soft in nature and is
used for making bottles.
 But if potassium carbonate is used instead of sodium carbonate, a hard glass is
produced which is used for the preparation of laboratory apparatuses.

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Glass types

1. Type I /Borosilicate glass

2. Type II /Treated soda – lime glass
3. Type III /soda – lime glass
4. Type NP/ non parenteral glass
5. Colored glass
6. Neutral glass

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Glass types…

Type I/Borosilicate glass

 Produced by replacing sodium oxide flux by boric oxide (B2O3) and some of lime
by alumina (Al2O3) in the basic components of glass.
 It has a high melting point and can withstand high temperatures hence it does not
crack when used for boiling the water and even for cooking.
 Resistant to chemical substances
 Mainly used for making laboratory apparatus

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 Glass types…

Type III/soda – lime glass

 It is an ordinary glass prepared from silicon dioxide, soda ash and limestone.
 It is the cheapest quality and most common form of glass.
 Contains high concentration of alkaline oxides & imparts alkalinity to aqueous
substances, which can adversely affect the quality of the product contained in it.

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 Glass types…

 Ordinary soda – lime glass

 Are not suitable for alkali sensitive products
 Should not be used for parenteral preparations.
 Generally used for solid medicaments
 Type NP/ Non – parenteral glass
 It is general purpose soda – lime glass used for oral and topical preparations.

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 Glass types…
Type II /Treated soda – lime glass
 Are Sulphur dioxide treated soda – lime glasses.
 Surface alkali de – alkalinized by sulphur dioxide and these glasses can be used
for alkali sensitive products.

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 Glass types…

Colored glass
 Used for light sensitive products
 Amber colored glass does not allow the U.V rays pass through it.
 They are not used for parenteral products because it becomes difficult to check
clarity in such preparations.

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 Glass types…

Neutral glass
 It is resistant to alkalies, weathering, and can withstand autoclaving.
 Used for manufacturing of multidose vials
 It is composed of SiO2, B2O3, Na2O, Al2O3, BaO & K2O

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Problems of glass containers

Flaking:
 During flaking the alkali is extracted from the surface of glass containers and
silica rich layer is formed which sometimes gets detached from the surface and
can be seen in the contents in the form of shining flakes.
 This is a serious problem especially in parenteral preparations.

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Problems of glass…

Weathering:
 Sometimes moisture condensed on the surface of glass container, can extract some
weakly bounded alkali, leaving behind a white deposit of alkali carbonate, this
results in loss of brilliance.
 To prevent weathering, the deposited white layer of alkali carbonates should be
removed as early as possible by washing the container with a dilute solution of
acid and then washing thoroughly with water.

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Advantages of glass container

 Allows the visual inspection of the contents

 Are chemically inert
 Quite strong & rigid
 Some are heat resistant; so, they can be readily sterilized by heat
 Impermeable to moisture and atmosphere
 Can be easily cleaned without scratching
 It is easily labeled
 It is cheap and readily available

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Disadvantages of glass container

 Are brittle and break easily

 May crack when subjected to sudden changes of temperatures.
 It may release alkali to aqueous contents

soda – lime

Treated soda

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Plastics

 Are high molecular weight polymers possessing long carbon chains.

 Are synthetic polymers which are converted into different forms.
 They are widely used
Types:
I. Thermosetting type
 Are usually hard and brittle at room temperatures but become flexible on heating.
 Used for making the closures of bottles and jars.

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Plastics
II. Thermoplastic type
 Are becoming more popular day to day
 Used for packing mixtures, tablets, capsules, ointments, etc.
 Upon heating, they often become viscous fluids while on cooling again hardens.

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Plastics

 The various thermoplastic polymers used for the manufacture of containers are:
a) Low density polyethylene (LDPE)
 For bottles, jars & collapsible tubes
b) High density polyethylene (HDPE)
 Used for bottles, jars & closures
c) Polyvinyl chloride (PVC)
 Used for bottles, tubes and films

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Plastics
Advantages of plastics
 Are flexible in nature
 Less brittle than glass
 Light weight
 Can be made into different shapes and sizes
 Suitable for both container and closure
 Readily available
 Relatively inexpensive

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Plastics

Disadvantages of plastics
 Cannot withstand heat
 Permeable to water vapour and atmospheric oxygen.
 Interact with certain chemicals
 May adsorb substances from solution.

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Metals

 Are not common for pharmaceuticals because they may react with the
preparations, have considerable weight and also they are costly.
 They are used for packing aerosols, powders, tablets and food articles.
 They exist in the form of plated steel, stainless steel, and aluminum.
 Collapsible tube made of aluminum, tin and lead are used
 Aluminum tubes are most popular because they are cheap as compared to tubes made
from tin.
 Collapsible tubes are light in weight, unbreakable and can be filled easily at a high
speed with automatic machines.

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Metals….

Advantages
 Lightness
 Robustness
 Impermeable to light, moisture and gases.
 Can be made in to rigid, unbreakable containers or into collapsible tubes or foil.
 Labels can be printed directly on to their surface.

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Metals….

Limitations of metal containers

 Their chemical and electro chemical activity.
 They may shed metal particles in to the pharmaceutical product.
 Expensive
 Not generally available for extemporaneous dispensing.

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Papers
 Widely used in pharmaceutical industries
 Cartons, boxes and envelopes made from papers.
 Their property can be modified by treating with plastic, wax or other materials.
 Such, treated paper will protect the products from atmospheric conditions.

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Types of glass containers
A. Bottles
 This can be amber medicine bottles or fluted (ribbed) oval bottles
I. Amber medicine bottles:- are used for all oral medicines including mixtures,
elixirs, syrups, emulsions and linctuses.
 A paper label is fixed to the curved front surface.

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Types of glass containers…

II. Ribbed oval bottles:- have flutes down the back

 The contents are "not to be taken "
 Used for mouth washes, gargles throat paints, liniments, lotions, inhalations and
antiseptic solutions.
 A paper label is fixed to the plain front surface.

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Types of glass containers…

III. Ear and nasal dropper bottles

 These are generally hexagonal in shape
 Fluted on four sides
 Amber colored and
 Fitted with a rubber teat and glass dropper as the closure
 The label is fixed to the plain side of the bottle.

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Types of glass containers…
IV. Containers for semi solid preparations
 These are wide - mouthed, cylindrical pots made of clear or amber glass and fitted
with a screw closure.
 Used for packing extemporaneously prepared ointments and pastes
 as well as commercial products where contamination by the patient's fingers is not
too detrimental.

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 Types of glass containers…

V. Containers for tablets and capsules

 These are manufactured in amber glass and fitted with a conventional closure or
child resistant screw closure.
 They are available in a number of sizes.
 Tablets, hard and soft capsules are adequately protected from crushing puncture,
etc.
 By packaging in glass tablet bottles

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Types of plastic…

1. Bottles
 Plastics are used to make medicine bottles
 E.g. Rigid amber PVC bottles of the same shape and design as glass medicine
bottles, as well as bottles for external preparations such as lotions.
 In the latter case, the bottle will be opaque not ribbed, and it may be flexible
enough to squeeze the lotion out through a small orifice at the top.

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Types of plastic…
2. Containers for tablets and capsules
 These can be plastic replicas of a conventional tablet bottles with a screw.
 Cap or a plastic vial with either a press in or slip - over closure.

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Types of plastic…
3. Containers for semi-solid preparations
 These are plastic vials with slip- over plastic lids or plastic replicas of glass
ointment pots.
 Alternatively, plastic tubes may be used.
 Tubes reduce contamination of the unused contents since only a narrow orifice is
presented to the patient.

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Types of plastic…
 Tubes are considered to reduce wastage by the patient.
 However, plastic tubes do not collapse after squeezing some of the contents out
but return to their original shape replacing the contents by the same volume of air.
 This disadvantage, normally termed" Suck back"
 may result in microbial contamination, oxidation, hydrolysis or dehydration of
the contents.

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Types of plastic…
Closures
 Plastics are the main materials used for closures.
 Can be in the form of screw - on, child resistant, push - on caps

Crown cap

Roll on cap
Screw on

Press on cap
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Special containers

 These are mainly used for manufactured products rather than extemporaneously
dispensed ones.
 They include
 Plastic squeeze bottles incorporating a dropper or
 Spray devices for drops (ear, eye and nose) or
 Nasal sprays, tubes with specially adapted nozzles for insertion in to body cavities
and plastic delivery devices.

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Special containers

Tamper-evident closures
 Tampering includes three aspects, namely
 Altering, pilfering and falsifying the pharmaceutical product

 To prevent tragic accidents and especially malicious tampering, manufacturers try

to create safe packaging
 Such tamper-evident containers can allow the visual inspection of the medicinal
product before use, and this may serve as a first stage in detecting counterfeit
drugs

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Types of Metal containers

 Collapsible tubes for semi solid preparation:

 These tend to shed metal particles near their screw - treads.
 Tin: Are the most acceptable container for pharmaceutical and food packaging
B/c-Very inert and Compatible
 Aluminum (Al): Low cost, attractive but not as such strong.
 Lead (Pb): very flexible and cheap but, lead is toxic
 So, lead alone can not be used for oral and parenteral formulations, but can be used
in combination with other metals.

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Metal containers…
Metal containers for tablets and capsules:
 These are made from aluminum thus producing a light, robust and unbreakable
container.
 Metal foil may be used for wrapping individual molded suppositories or pessaries.
However, its main use is in strip packaging or blister packs.

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Paper and paper board

 Paper board is used extensively as an outer container to provide additional

mechanical protection to other containers.
 For example, strip and blister packs of tablets, capsules, suppositories and
pessaries may be packed in an outer paper board carton.
 Also tubes of ointments, creams and gels can be packed in carton.

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Child - resistant containers (CRCs)
Child-resistant closures
 Tragic accidents involving the drug intoxication of children has led to new
legislation making it difficult for drug packaging to be opened by young children
 While allowing adults easy access.
 Such packaging is designated as child-resistant
 Give greater protection of child from accidental, as opposed to deliberate
poisoning
 "Keep out of reach of children"

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Unit dose packaging

Advantages of unit dose packaging

 Hygienic
 Temper evident
 light weight
 Child resistant
 Protects solid dose forms from moisture and abrasion.
 Wastage is reduced
 Accurate volumes can be administered

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Unit dose pack…
The disadvantages are:
 Expensive
 Machinery is required which may be suitable for industrial or hospital use only.

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Types of unit dose packaging

Types of unit dose packaging for oral medicines include:-

 Strip packaging,
 Blister packaging and oral liquid containers and dispensers.

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Blister packs

 These consist of a lid and a blister (usually transparent).

 The lid material has to satisfy certain criteria.
Protect the pack contents.
Seal to the blister material and retain the medicament with in the blister.

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Blister packs…
 Act as a barrier to moisture and atmospheric gases.
 Accept printing to label and identify the product.
 Tear easily when the blister content is pushed through it.
 Blister materials include polyvinyl chloride (PVC), polypropylene and many other
new laminates as well as aluminum

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Strip packaging

 Flexible packaging materials can be produced from laminates formed from

combination of paper, foil, plastics and cellulose films.
 Strip packaging is invariably flexible, as opposed to blister packs which are rigid.

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Original pack dispensing

 The pharmacist does not measure or count out manufactured products for
repacking in other container.
Advantages
 All the packs bear complete product identification data, including the batch
number and source of manufacture
 The pack remains closed until opened by the patient.
 The manufacturer's pack allows for the inclusion of more information for the
patient.

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Original pack…

 The dispensing process becomes more efficient thus allowing the pharmacist
greater opportunity for counseling patients.
 The dispensing process will be cheaper to the pt.

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Original pack…
Disadvantages of Originally Packed Dispensing
 Pack design and manufacture may be more costly.
 Storage space required for OPDs may be greater than for an equivalent amount of
stock in bulk packs.
 Difficult to open ( for elderly patients)
 Emergency supplies of small quantities may be a problem.

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Labeling pharmaceutical dosage forms

 Label: a small piece of paper, fabric, etc. attached to a container and giving
information about it.
 Package inserts for patients (patient information leaflets)
 Inner label affixed to an immediate container of the drug product
 Outer label includes any label affixed to the drug product packaging, such as a
pouch, card, accordion label, or other construct
 More than one outer label in a multiple packaging scheme (e.g., a vial packaged in a pouch,
pouch enclosed in a carton, several cartons enclosed in a larger carton)

 Label must carry all the information required on the inner and
outer labels

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Labeling pharmaceuticals…

 All finished drug products should be identified by labelling bearing at least the
following information:
a) The name of the drug product
brand name vs. Proper or Common Name
 USP proper name for an ingredient i.e. proper name: aspirin
 Acetylsalicylic Acid is the prescribed name (for this ingredient )
b) A list of the active ingredients (if applicable, with the International
Nonproprietary Names (INNs)),
showing the amount of ach present, and a statement of the net contents, e.g. number
of dosage units, mass or volume

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Labeling pharmaceuticals…
 Some illustrative examples of proper names for ingredients versus products in
final dosage form include the following:
 Proper name of ingredient: Acetaminophen
 Proper name of drug product in final dosage form: Acetaminophen Capsules
 Proper name of a drug product combination: Acetaminophen and
Pseudoephedrine Hydrochloride Tablets

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Labeling pharmaceutical dosage forms

c) The batch number assigned by the manufacturer

d) The expiry date in an uncoded form
 Must be on the inner and outer labels of all drug products
e) Any special storage conditions or handling precautions that may be necessary
f) The directions for use, and any warnings and precautions that may be necessary
g) The name and address of the manufacturer or the company or person responsible
for placing the product on the market

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Storage and stability of pharmaceuticals

 Pharmaceutical drug products should be stable in the drug product for the
proposed shelf life duration of the drug product and the proposed duration of the
shelf life of the individual components.
 USP defined stability as the extent to which a product retains, within specified
limits and throughout its period of storage and use (i.e., its shelf life), the same
properties and characteristics that it possessed at the time of manufacture.

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Storage and stability…

 Stability applies to chemical, physical, microbiological, therapeutic, and

toxicological properties
 Chemical stability: each active ingredient in a drug product retains its chemical
integrity and label potency within the specified limits
 Physical stability: the original physical properties, appearance, palatability,
uniformity, dissolution, and suspendability, are retained

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Storage and stability…
 Microbiological stability: if the sterility or resistance to microbial growth is
retained according to the specified requirements
 The therapeutic effect of the drug should remain unchanged and no significant
increase in toxicity should occur during the shelf life if the product is stable

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Storage and stability…

• Store as recommended by manufacturer

• Keep medicines in their original outer packaging
• All medicines should be stored in a cool and dry place
Store at room temperature below 25°C
Store between 2 and 8 °C (under refrigeration, no freezing)
Store below 8 °C (under refrigeration)
Store between -5 and -20 °C (in a freezer)
Store below -18 °C (in a deep freezer)
The expiry date can change once opened.
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Storage and stability…
Beyond use date
 The active drug becomes chemically unstable
 The effectiveness of the drug may change
 The breakdown of the drug may be toxic and harmful to the patient
 Increased risk of contamination from bacteria and other microbes

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Storage and stability…
Expiry after opening
 The manufacturer’s expiry on a container is the unopened expiry date
TABLETS AND CAPSULES
 Blister Packed/Single Unit Dose: Manufacturer's Expiry
 Bulk Packs: 1-Year from date of opening
LIQUIDS
 Preserved: 6-Months
 Diluted Preserved liquids: 2-Weeks
 Extemporaneously Prepared: 4-Weeks from date of manufacture

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Storage and stability…

CREAMS OINTMENTS
 Packed in Tubes: 3-Months  Packed in Tubes 6-Months
 Packed in Jars/Pots : 1-Month  Packed in Jars/Pots : 3-Month
 Diluted Commercial Preparations:2-  Diluted Commercial Preparations:4-
Weeks Weeks
 Extemporaneously Prepared: 4-Weeks  Extemporaneously Prepared: 8-Weeks
from date of manufacture from date of manufacture

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 Thank you
Q???

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