Ch5.packaging of pharmaceuticals

Bule Hora University
College of Health and Medical Sciences
Department Of Pharmacy
INTEGRATED PHYSICAL PHARMACY AND PHARMACEUTICS I
CHAPTER 5
Packaging and storage of
pharmaceuticals
By: Aliyi Gerina [BSc, B.pharm]

Out Line:
Packaging and Storage of Parmaceuticals byAliyi Gerina
2
 Introduction (definitions and terminologies)
 Packaging materials
 Closures
 Labeling pharmaceutical dosage forms
 Storage, stability of pharmaceuticals and
 Beyond use date

Introduction
3
Packaging
 is defined as the collection of different
components
 which surround the pharmaceutical product from the
time of production until its use.

Functions of packaging
4
 Containment
 Not to leak, nor allow diffusion and permeation
 Strong enough to hold the contents during
handling
 Protection
 light
 moisture
 oxygen
 microbial contamination
 mechanical damage
 adulteration

Functions of packaging (cont’d)
5
 Information
 Labels fixed on containers provide information
about the product such as
 composition,
 appropriate use,
 storage conditions, etc.
 Identifies the product from competitors
products.

Primary and secondary package
6
 Primary packaging materials
 are in direct contact with the product.
 This also applies to the closure
 which is also part of primary pack.
 Secondary packages
 are additional packaging materials
 aid transportation and handling of the product
 Include
 cartons and
 boxes that do not make direct contact with the product.

Packaging materials
7
Glass
 It is the preferred packaging material for many
pharmaceutical products.
 It is composed principally of silicon dioxide with
varying amount of other oxides such as sodium,
potassium, calcium, magnesium, aluminium, boron
and iron.

Advantages of glasses
8
 It is inert to most medicinal products.
 It is impervious to air and moisture.
 It allows easy inspection of the container
contents.
 It can be colored to protect contents from
light.
 It is easy to clean & sterilize by heat.
 It is available in variously shaped containers.

The disadvantages of glasses
9
 It is fragile.
 Certain types of glasses release alkali into
the container contents.
 It is expensive when compared to the price
of plastic.
 It is heavy resulting in increased transport
costs

USP glass types and uses
10
Type General description General use
I Highly resistant
borosilicate
glass
Buffered and unbuffered aqueous
solutions.
All other uses.
II Treated soda –
lime glass
Buffered aqueous solutions with pH
below 7.0,
dry powders, oleaginous solution.
III Soda-lime glass Dry powders, oleaginous solutions.
NP Soda-lime glass Not for parenterals.
For tablets, oral solutions and
suspensions, ointments and external
liquids.

Types of glass containers
Dropper bottles Jars
11

Types of glass containers
Ampoules Vials
12

Plastics
13
 Chemically plastics are synthetic polymers of
high molecular weight.
 In more recent times, plastic has been
developed
 for the packaging of parenteral products
 including infusion fluids & small volume injections.

Advantages of plastics
14
 Are flexible & not easily broken
 Are low density & thus light in weight
 Can be heat sealed
 Are easily moulded into various shapes
 Are suitable for use as container, closure & as
secondary packaging
 Are cheap

Disadvantages of plastics
15
 They are not as chemically inert as type I glass.
 Some plastics undergo stress cracking &
distortion from contact with some chemicals.
 Plastics are heat sensitive.
 They are not as impermeable to gas & water
vapor as glass.
 They may possess an electrostatic charge
which will attract particles.
 Additives in the plastic are easily leached into
the product.

Metals
16
 Metals used for various pharmaceutical
packaging include
 aluminum and
 tinplate.
 Tinplate is a steel composite material that uses a
steel core coated with tin.
 Aluminum and tinplate cans need to be coated or
painted with an organic lining
 to separate the product from bare metal.

Metals……………cont’d
17
 General properties
 Metal is
 strong,
 opaque, and
 impermeable to moisture, gases, light, etc.
 Metal is resistant to high and low
temperatures.
 Disadvantages
 Metal is not inert and
 can be attacked by acids and alkalies.

Closures
18
 Any closure system should provide an effective
seal
 to retain the container contents & exclude external
contaminants.
 Child-Resistant Containers (CRCs) commonly
consist of a glass or plastic vial or bottle with a
specially designed closure.
closures

Closures (cont’d)
19
 The CRCs in most common use with dispensed
medicines
 is the push down & turn (Clic-loc® closure).
 The Clic-loc® closure are based on the
assumption that young children are unable to
coordinate two separate and dissimilar actions;
 that is, applying pressure and rotating the closure top.

Closures (cont’d)
20
 In recent years greater awareness of the
vulnerability of products has led
 to the development of tamper-evident closures.
 Tamper-evident closures are available in
various designs suitable for different containers.

Collapsible tubes
21
 These are used to contain semisolid and liquid
based products.
 They are made of metal or plastic.

Collapsible tubes (cont’d)
22
 Metal tubes
 are airtight, light-proof and impermeable to moisture
and offer superior protection.
 Plastic tubes
 are light-weight, leak-proof, and relatively non
breakable.
 In contrast to collapsible metal tubes that flatten as
the product is removed,
 plastic tubes retain their original shape after
squeezing.

Blister packs
 These are
 used for packaging unit doses of
tablets and capsules
 can act as an
 aid for patient compliance.
 The medication is placed in a
compartment in a base material
 made of plastic such as PVC lined
on the top with aluminum.
 Blister packs are rigid unlike strip
packs that are flexible.
23

Strip packaging
 With strip packaging, two webs of
material sandwich various types of
dosage forms
 such as tablets, capsules,
suppositories, and pessaries.
 Each of these dosage forms is
 contained within its own compartment.
 Aluminum foil is
 commonly used to manufacture strip
packs.
24

Labeling pharmaceutical
25
 The label on dispensed medicines has two main
functions:
 to uniquely identify the contents of the
container.
 to ensure that patients have clear & concise
information
which will enable them to take or use their
medicine in the appropriate way.

Labeling………..
26
 The label of a pharmaceutical product must be
 in the right place and
 contain the right information.
 The following need to be taken into
consideration:
 Appearance
• Correct position
• Clean
• Secure

Labeling………….
27
 Information should be:
 Legible
Concise
 Adequate
 Intelligible
 Accurate

Label
28

Stability of Pharmaceuticals
29
Stability
– Definition: (according to USP)
 Stability is defined as the extent to which a product
retains,
 within specified limits, and throughout its period of storage
and use (i.e. Shelf life),
 the same properties and characteristics that it possessed at the
time of its manufacture.
 Stability of drugs is the major criterion in
 determining the suitability of the dosage forms or drug
products.

Types of drug stability
30
1. Chemical stability:
 Each active ingredient retains its chemical
integrity and
 labeled potency within the specified limits
2. Physical stability:
 The original physical properties
 including appearance, palatability, dissolution,
and suspendability are retained

Types of drug stability,…
31
3. Microbiological stability:
 Sterility or resistance to microbial growth is
retained according to the specified requirements.
 Antimicrobial agents/preservatives should retain
their effectiveness
4. Therapeutic stability:
 The therapeutic effect remains unchange
5. Toxicological stability :
 No significant increase in toxicity occurs

Reason for studying stability
32
 Patient safety and acceptance
– Toxic products may be formed in the decomposition
– Substantial change in physical appearance
 Drug activity
– May lead to a substantial lowering of the quantity of
the therapeutic agent in the dosage form
– Decrease in its bioavailability
 Legal requirement
– Preparations must comply with specifications of
identity, strength, purity, and quality of the drug

Reason for ,….
33
 Bad image for the manufacturer
• Poorly formulated or unstable product
– Fading or darkening of colors
– Caking of suspensions
– Breaking of emulsions
=> Non-acceptance by the user community.
• Economy point of view:
=> Financial loss due to reformulation, non sale, withdrawal
 Patient economy
“A patient is entitled to receive what he/she is paying for!”

Types of stability studies
34
 Accelerated stability study
 Long term stability study

Accelerated stability study
35
 Accelerated stability study is designed
 to predict stability of a formulation
 by carrying out the study under accelerated conditions of T, moisture
and light.
 This information is then
 projected to predict shelf life or
 used to compare the relative stability of alternative formulations.

Accelerated stability,...
36
 Objectives of accelerated stability study
– To serve as a rapid means of selecting the best
formulation from amongst a series of similar
formulations of the product
– To predict the shelf life of the product
– To serve as a rapid means of quality control

37
Drug products - General case
Study Storage condition
Minimum time period
covered by data at
submission
Long term
25°C ± 2°C or
30°C ± 2°C
12 months
Accelerated 40°C ± 2°C 6 months

38
Drug substances - intended for storage in a Refrigerator
Drug substances/Product- intended for storage in Freeze
Minimum time period
covered by data at
submission
Long term 5°C ± 3°C 12 months
Accelerated 25°C ± 2°C / 60% ± 5% r.h. 6 months
Minimum time period
covered by data at
submission
Long term -20°C ± 5°C 12 months
Accelerated 5°C ± 3°C 6 months

Storage Condition
39
 All medicines must be stored and handled in accordance
with the manufacturer’s guidelines
 in order to maintain the quality of the product.
 Inappropriate storage and handling practices of medicines
may result in
 potential spoilage of the medicines
 consequent financial impact for the facility
 Classified into three
 Normal storage condition
 Cold storage condition
 Special storage condition

Storage Condition,…
40
Normal storage condition
 Unless special storage conditions are stated,
 it is vital that drugs be stored in
 a dry,
 adequately ventilated shady and
 cool store room
– Protect from moisture:
 Store the product in a space with no >60% relative humidity.
– Photosensitive products:
 Do not store or pack products in sunlight.

41
Cold storage conditions
 Products that may be degraded rapidly when kept at
room temperature or even at cool places.
– e.g. vaccines, insulin
 Storing in
 refrigerators(2-8oC )and
 freezers (-20oC)
 Cold chain

42
Special storage conditions
 Drugs like
 narcotic and psychotropic substances, and
 combustibles (alcohol and ether)
 Narcotic drugs, psychotropic substances, and their
documents
 should be kept in securely locked rooms or cupboards.

43

Beyond-use date
44
 Provide the date after which a compounded preparation
shall not be used.
 determined from the date when the preparation is compounded.
 Beyond-use date
 is an expiry date assigned by a pharmacist for compounded
products.
 Use of a product after beyond-use date
 may not provide the desired therapeutic effect and
 may even lead to severe side effect or death.
 All compounded preparations must contain a beyond-use
date.

Beyond-use date,…
45
Non sterile preparation Beyond use date
• Non-aqueous Formulations • Not later than 6 months.
For water-containing oral
formulations (prepared from
ingredients in solid form)
Not later than 14 days (for
liquid preparations when
stored at cold temperatures
between 2 and 8 oC ).
For all other formulations (water
containing topical liquid and
semisolid, cream, gel, ointment)
not later than the intended
duration of therapy or 30
days, whichever is earlier.
Beyond use dating for non sterile extemporaneous preparation
according to USP <795> .

46
Thank You!!

Ch5.packaging of pharmaceuticals

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