importance of packaging in pharmaceuticals

1. SELECTION AND EVALUATION OF
PHARMACEUTICAL PACKAGING
MATERIALS
PRESENTER:
MR. AMOGH P. DANDEKAR
M.PHARM FIRST YEAR
DEPARTMENT OF PHARMACEUTICAL QUALITY ASSURANCE
REG.NO: NH0117005
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2. CONTENTS
 Characteristics of Packaging materials
 Role of Packaging
 Selection of the Packaging materials
 Containers
 Ideal requirements of container
 Types of containers
 Materials for making of containers
 Closures
o Types of closures
o Materials for making of closures
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3. PACKAGING
 Packaging is the process by which the pharmaceuticals
are suitably packed so that they should retain their
therapeutic effectiveness from the time of their packaging
till they are consumed.
 Packaging may be defined as the art and science which
involves preparing the articles for transport, storage,
display and use.
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4. Types of Pharmaceutical Packaging Materials:-
 Glass
 Plastic
 Metal
 Paper and board
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5. Characteristics of Packaging Materials:-
They must protect the preparation from environmental
conditions.
They must not be reactive with the product.
They must not impart to the product tastes or odors.
They must be nontoxic.
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6. Characteristics of Packaging Materials:-
They must be FDA approved.
They must meet applicable tamper-resistance
requirements.
They must be adaptable to commonly employed
high speed packaging equipment.
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7. Role of Packaging
Protection-against light
i. against reactive gases
ii.against moisture
iii.against microbes
iv.against physical damage
v.against pilferage and adulteration
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8. Role of Packaging
 Presentation
 Identification
 Information
 Compatible
 Convenience
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9. Selection of the Packaging Materials
On the facilities available, for example, pressurized
dispenser requires special filling equipment.
On the ultimate use of product. The product may be used
by skilled person in hospital or may need to be suitable for
use in the home by a patient.
On the physical form of the product. For example, solid,
semi-solid, liquids or gaseous dosage form.
On the route of administration. For example, oral,
parenteral, external, etc.
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10. Selection of the Packaging Materials
On the stability of the material. For example , moisture, oxygen,
carbon di oxide, light, trace metals, temperature or pressure or
fluctuation of these may have a deleterious effect on the product.
On the contents. The product may react with the package such as the
release of alkali from the glass or the corrosion of the metals and intern
the product is affected.
On the cost of the product. Expensive products usually justify
expensive packaging
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11. Factors affecting selection of Packaging
Materials
Mechanical Factors:-
1. Shock
2. Compression
3. Puncture
4. Vibration
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12. Factors affecting selection of Packaging
Materials
Environmental Factors:-
 Temperature
 Pressure
Moisture
Gases
Light
Infestation
Contamination
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13. Containers
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 Container is one in which the product is placed.
 A pharmaceutical container is defined as a device that
holds the drugs and is or may be in direct contact with
the preparation.

14. Ideal Requirements of Containers
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• Must be neutral towards the material which stored in
it.
• Must not interact with the substance which it holds.
• Help in maintaining the stability of the product
• A Withstand wear and tear during normal handling.
• Dose can be drawn from it conveniently.

15. Ideal Requirements of Containers
• Able to withstand changes in pressure and temperature.
• Must be non-toxic.
• Can be labelled easily.
• Pharmaceutically elegant appearance.
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16. Types of Containers
Well-closed containers
Single dose containers
Multi dose containers
Light-resistant containers
Air-tight containers
Aerosol containers
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17. Materials used for Making of Containers
1. Glass
2. Plastic
3. Metal
4. Paper and board
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18. GLASS
• Advantages:-
They are transparent.
They are available in various shapes and sizes.
They can withstand the variation in temperature and
pressure during sterilization.
They are economical and easily available.
They can protect the photosensitive medicaments from
light during their storage.
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19. GLASS
They are neutral after proper treatment.
They are impermeable to atmospheric gases and
moisture.
They have good protection power.
They do not deteriorate with age.
They can be easily labelled.
They can be sealed hermetically or by removable
closures. 19

20. Composition of Glass
Glass is composed of sand, soda ash, lime stone
and cullet.
Silicon, aluminium, boron, sodium,
potassium,calcium, magnesium, zinc and barium
are generally used in the preparation of glass.
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21. Types of Glass
• Type 1:-Neutral or Borosilicate glass
• Type 2:-Treated Soda lime glass
• Type 3:-Regular Soda lime glass
• Type 4:-General Purpose Soda lime glass
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22. Evaluation of Glass Containers
U.S.P. and I.P. provides two testes to determine the
chemical resistance of glass containers:
 Table: Limits of alkalinity for glass containers
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TEST CONTAINERS LIMITS ml of 0.02 N H2S04
Powder glass test Type 1
Type 3
Type NP
1
8.5
15
Water attack test Type 2 (100 ml or less)
Type 2 (over 100 ml)
0.7
0.2

23. Plastic
Advantages:-
They are light in weight and can be handled easily.
They are poor conductor of heat.
They have sufficient mechanical strength.
They can be transported easily.
They are unbreakable.
They are available in various shapes and sizes.
They are resistant to inorganic chemicals.
They have good protection power.
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24. Disadvantages:-
They are permeable to water vapour and atmosphere gases.
They cannot withstand heat without softening or distorting.
They may interact with certain chemical to cause softening
or distortion.
They may absorb chemical substances, such as preservatives
for solution.
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25. Composition of Plastic
Plastics are synthetic polymers of high molecular
weight.
Plastic is made from one or more polymers
together with certain additives. The polymers
commonly used are polyethylene, polypropylene,
polyvinyl chloride, polystyrene, etc.
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26. Plastics
Classification of Plastics:-
1. Thermoplastic type
2. Thermosetting type
 Evaluation of Plastics:-
• Leakage test
• Collapsibility test
• Clarity of aqueous extract
• Water vapor permeability test
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27. Metals
The metals commonly used are aluminum, tin plated
steel, stainless steel, tin and lead.
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28. METALS
• Advantages:-
 They are sturdy.
 They are impermeable to light, moisture and gases.
 They can be made into rigid unbreakable containers by impact
extrusion.
 They are light in weight as compared to glass containers.
• Disadvantages:-
They are expensive.
They may shed metal particles into the pharmaceutical
product.
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29. Closures
Closures are the devices by means of which containers
can be opened and closed.
It prevents loss of material by spilling or volatilization.
It avoids contamination of the product from dirt, micro-
organism or insects.
It prevents deterioration of the product from the effect of
the environment such as moisture, oxygen or carbon
dioxide.
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30. Types of Closures
Threaded screw cap
Lug cap
Crown cap
Roll on closures
Pilfer proof closures
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31. Materials used for making of Closures:-
• 1. Cork
• 2. Glass
• 3. Plastic
• 4. Metal
• 5. Rubber
Evaluation of closures:-
• 1. Sterilization test
• 2. Fragmentation test
• 3. Self sealibility test
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32. Reference:-
• THE PHARMACEUTICAL PACKAGING | Pharma Tutor .
Pharmatutor.org. 2017 [cited 13 November 2017]. Available
from: http://www.pharmatutor.org/articles/the-pharmaceutical-
packaging-article
• Pharmaceutical Packaging | Packaging Digest .
Packagingdigest.com. 2017 [cited 13 November 2017]. Available
from: http://www.packagingdigest.com/pharmaceutical-
packaging
• Pharmaceutics-1 by R.M.Mehta, Page No.:-74-85
• The Theory and Practice of Industrial Pharmacy by Leon
Lachman, Page No.:-711-724
• Pharmaceutical Product Development by N.K.Jain, Page No.:-341-
377
• Alton's Pharmaceutics by Michael E. Alton, Page No.:-626-638
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