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Ch5.packaging of pharmaceuticals
1. 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]
2. Out Line:
Packaging and Storage of Parmaceuticals byAliyi Gerina
Bule Hora University
2
Introduction (definitions and terminologies)
Packaging materials
Closures
Labeling pharmaceutical dosage forms
Storage, stability of pharmaceuticals and
Beyond use date
3. Introduction
3
Packaging
is defined as the collection of different
components
which surround the pharmaceutical product from the
time of production until its use.
Packaging and Storage of Parmaceuticals byAliyi Gerina
Bule Hora University
4. 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
Packaging and Storage of Parmaceuticals byAliyi Gerina
Bule Hora University
5. 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.
Packaging and Storage of Parmaceuticals byAliyi Gerina
Bule Hora University
6. 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 and Storage of Parmaceuticals byAliyi Gerina
Bule Hora University
7. 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.
Packaging and Storage of Parmaceuticals byAliyi Gerina
Bule Hora University
8. 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.
Packaging and Storage of Parmaceuticals byAliyi Gerina
Bule Hora University
9. 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
Packaging and Storage of Parmaceuticals byAliyi Gerina
Bule Hora University
10. 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.
Packaging and Storage of Parmaceuticals byAliyi Gerina
Bule Hora University
11. Types of glass containers
Dropper bottles Jars
11
Packaging and Storage of Parmaceuticals byAliyi Gerina
Bule Hora University
12. Types of glass containers
Ampoules Vials
12
Packaging and Storage of Parmaceuticals byAliyi Gerina
Bule Hora University
13. 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.
Packaging and Storage of Parmaceuticals byAliyi Gerina
Bule Hora University
14. 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
Packaging and Storage of Parmaceuticals byAliyi Gerina
Bule Hora University
15. 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.
Packaging and Storage of Parmaceuticals byAliyi Gerina
Bule Hora University
16. 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.
Packaging and Storage of Parmaceuticals byAliyi Gerina
Bule Hora University
17. 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.
18. 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
Packaging and Storage of Parmaceuticals byAliyi Gerina
Bule Hora University
19. 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.
Packaging and Storage of Parmaceuticals byAliyi Gerina
Bule Hora University
20. 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.
Packaging and Storage of Parmaceuticals byAliyi Gerina
Bule Hora University
21. Collapsible tubes
21
These are used to contain semisolid and liquid
based products.
They are made of metal or plastic.
Packaging and Storage of Parmaceuticals byAliyi Gerina
Bule Hora University
22. 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.
Packaging and Storage of Parmaceuticals byAliyi Gerina
Bule Hora University
23. 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
Packaging and Storage of Parmaceuticals byAliyi Gerina
Bule Hora University
24. 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
Packaging and Storage of Parmaceuticals byAliyi Gerina
Bule Hora University
25. 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.
Packaging and Storage of Parmaceuticals byAliyi Gerina
Bule Hora University
26. 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
Packaging and Storage of Parmaceuticals byAliyi Gerina
Bule Hora University
27. Labeling………….
27
Information should be:
Legible
Concise
Adequate
Intelligible
Accurate
Packaging and Storage of Parmaceuticals byAliyi Gerina
Bule Hora University
29. 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.
Packaging and Storage of Parmaceuticals byAliyi Gerina
Bule Hora University
30. Types of drug stability
Packaging and Storage of Parmaceuticals byAliyi Gerina
Bule Hora University
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
31. Types of drug stability,…
Packaging and Storage of Parmaceuticals byAliyi Gerina
Bule Hora University
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
32. Reason for studying stability
Packaging and Storage of Parmaceuticals byAliyi Gerina
Bule Hora University
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
33. Reason for ,….
Packaging and Storage of Parmaceuticals byAliyi Gerina
Bule Hora University
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!”
34. Types of stability studies
Packaging and Storage of Parmaceuticals byAliyi Gerina
Bule Hora University
34
Accelerated stability study
Long term stability study
35. Accelerated stability study
Packaging and Storage of Parmaceuticals byAliyi Gerina
Bule Hora University
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.
36. Accelerated stability,...
Packaging and Storage of Parmaceuticals byAliyi Gerina
Bule Hora University
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. Accelerated stability,...
Packaging and Storage of Parmaceuticals byAliyi Gerina
Bule Hora University
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. Accelerated stability,...
Packaging and Storage of Parmaceuticals byAliyi Gerina
Bule Hora University
38
Drug substances - intended for storage in a Refrigerator
Drug substances/Product- intended for storage in Freeze
Study Storage condition
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
Study Storage condition
Minimum time period
covered by data at
submission
Long term -20°C ± 5°C 12 months
Accelerated 5°C ± 3°C 6 months
39. 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
Packaging and Storage of Parmaceuticals byAliyi Gerina
Bule Hora University
40. Storage Condition,…
Packaging and Storage of Parmaceuticals byAliyi Gerina
Bule Hora University
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. Storage Condition,…
Packaging and Storage of Parmaceuticals byAliyi Gerina
Bule Hora University
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. Storage Condition,…
Packaging and Storage of Parmaceuticals byAliyi Gerina
Bule Hora University
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.
44. 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.
Packaging and Storage of Parmaceuticals byAliyi Gerina
Bule Hora University
45. Beyond-use date,…
Packaging and Storage of Parmaceuticals byAliyi Gerina
Bule Hora University
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> .