CJ
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.
, Types of Pharmaceutical Packaging Materials:
r Glass
Plastic
., Metal
, Pa
per and board
r Characteristics of Packaging Materials:-
• They must protect the preparation from
environmental conditions.
e They must not be reactive with the product.
o They must not impart to tl1e product tastes or odors.
c They must be nontoxic.
" They must be FDA approved.
< They must meet applicable tamper-resistance
requirements.
, They must be adaptable to commonly employed high
speed packaging equipment.
~ of Packaging:-
• Protection-against light
-against reacti
ve gases
-against moisture
-against microbes
-against physical damage
-against pilferage
and adulteration
C!' Presentation
.-Identification
• r nformation
, Compatible
1. Convenience
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, Selection of the Packaging Materials:-
1. On the facilities avajlable, for example, pressurized
dispenser requires special filling equipment.
2. 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.
3. On the physical form of the product. For example,
solid, semi-solid, liquids
or gaseous dosage form.
4. On the route of administration. For example, oral,
parenteral, external, etc.
5. On the stability of the material. For example,
moisture, oxygen, carbon dioxide, light, trace metals,
temperature
or pressure or fluctuation of these may
have a deleterious effect
on the product.
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~-=-=----~-=-=-====~===~~~ ~ w
~ 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 inturn the product is
affected.
7. On the cost of the product. Expensive products
usually justify expensive packaging
, Factors affecting selection of Packaging
Materials:-
1.Mechanical Factors:-
0 Shock
• Compression
• Puncture
• Vibration
2. Environmental Factors:-
•
Temperature
• Pressure
• Mois ture
• Gases
• Light
• Infestation
• Contamination
.. Containers:-
• Container is one in which the product is placed.
[J
• A pharmaceutical contai ner is defined as a device that
hoJds the drugs and is or may be in direct contact with
the preparation.
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, Ideal Requirements of Container:-
• Must be neutral towards the material which stored in
it.
• Must not interact with the substance which it holds.
• Help in maintaining the stabiJity of the product a
c Withstand \vear and tear during normal handling.
• Dose can be drawn from it conveniently.
• Able to withstand changes in pressure and
temperature.
"' Must be non-toxic.
Can be labelled easily.
c Pharmaceutically elegant appearance.
~ ypes-of Containers:
• Well- closed containers
c.. Single dose containers
• Multi dose containers
• Light-resistant containers
• Air-tight containers
• Aerosol containers
* Materials used for Making of Containers:-
1. Glass
~-Plastic
3. Metal
1 · Paper and board
CT
Glass ------=------=--=:::::::::::::;;;;;::::::= - ----..:.::::::::: ~~~
~ dvantages:-
They are transparent.
They are available in various shapes and siz es.
L 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.
o They are neutral after proper treat1nent.
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C" They are impermeable to atn1ospheric gases and moisture.
They have good protection po\ver.
• They do not deteriorate \Vith age.
They can be easily labelled.
They can be sealed hermetically or by removable closures.
Composition of Glass:--=....::-::...:::..:;.;::~~~.,__..:;~~~
~ ass 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.
□Types of Glass:-
Type
1:-Neutral or Borosilicate glass
Type 2:-Treated Sodalime glass
Type 3:-
Regular Sodalime glass
Type 4:-
General Purpose Soda lime glass
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~ uation of:Glass C ontainers:-_
~: U.S.P. and I.P. provides two testes to determine the
chemical resistance of glass containers:
• Table: Limits
of alkalinity for glass containers
• Testes Containers Limits, ml of 0.02 N
"~so
4
1.Powder glass test Type 1 1
Type 3 8.5
Type NP
15
• 2.Water attack test Type 2 (100 ml or less) 0.7
Type 2 (over 100 ml) 0.2
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• Advantages:-
They are light in weight an,d 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.
~ (s;dvantages:-
• They are permeable to water vapour and atmosphere gases.
They cannot \vithstand heat without softening or
distorting.
They may interact \Vith certain chemical to cause softening
or distortion.
-They may absorb chen1ical substances, such as
preservatives for solution.
CJ Composition of Plastic:-
• Plastics are synthetic polymers of high molecular \veight.
Plastic is made from one or more polymers together with
certain additives. The polymers commonly used are
polyethylene, polypropylene, polyvinyl chloride,
polystyrene, etc.
□Classification of Plastics:
,. Thermoplastic type
2.. Thermosetting type
□ Evaluation of Plastic:-
•
Leakage test
• Collapsibility test
• Clarity of aqueous extract
• Water vapour permeability test
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-;;-Metals
• The metals commonly used are aluminiun1, tin plated steel,
stainless steel, tin and lead.
c-Advantages:-
• They are sturdy.
• They are impermeable to light, moisture and gases.
• They can be n,ade into rigid unbreakable containers by
impact extrusion.
• They
are light in \veight as compared to glass containers.
• Disadvantages:-
~ They are expensive.
They
may shed metal particles into the pharmaceutical
product.
- CT
□Closures:-
• Closures are the devices by means of which containers
can be opened and closed.
• It
prevents loss of n1aterial by spilling or volatilization .
., It avoids conta.mination 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.
l !Types of Closures:-
• Threaded screw cap
c Lug cap
• Crown cap
• Roll on closures
• Pilfer proof closures
• Materials used for making of Closures
UMaterials used for making of Closures:-
1. Cork
2. Glass
~-PJastic
4. Metal
5. Rubber
□ Evaluation of closures:
•· Sterilization test
2. Fragmentation test
3. Self seaJibility test
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