Pharmaceutical packaging serves several important functions:
1. It protects pharmaceutical products from external factors like moisture, light, and contamination.
2. Different types of packaging materials are used including glass, plastic, metal, paper, and closures to suit various drug forms.
3. Proper packaging helps ensure the stability, safety and efficacy of drugs by providing identification, information and tamper evidence on the product.
2. Introduction Of pharmaceutical packaging
Types of packaging
Container
Pharmaceutical packaging Material
Glass
Plastic
Metal
Pepar And Card Board
Closure
Tamper Resistant packaging
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3. Packaging is the science, art and technology of enclosing
or protecting products for distribution, storage, sale, and
use.
Pharmaceutical packaging can be defined as the
economical means of providing presentation, protection,
identification , information, convenience ,compliance ,
integrity and stability of the product .
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Introduction
Protective Function
Storage Function
Loading and Transport Function
Identification Of Product
Mechanical Protection
Environmental Protection
Chemical Protection
Biological protection
Marketing
4. Primary packaging- is the material that first envelops the product
and hold it. This usually is the smallest unit of distribution or use.
Ex. Aerosol spray can, blister packs, bottle
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• Secondary packaging -Is outside the primary packaging perhaps used
to group primary package together.
Ex. Boxes,cartons
5. Tertiary packaging- is used to bulk handling warehouse
storage and shipping.
Ex. Barrel, container,edge protector
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6. Pharmaceutical container has been defined as a device
which hold the drug and it may or may not be in direct
contact with pharmaceutical preparations.
Charecterestic of container
1. It should withstand during normal handling.
2. It have pharmaceutically elegant appearance.
3. Dose can be drawn from it conveniently.
4. It should protect product from enviormental factor.
5. Material use in production of container should be non
toxic.
6. It should be stable in temperature and pressure during
sterilization in autoclave.
7. It should not interact physically and chemically with
product.
8. Easily labelled.
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7. 1. Single dose container
2. Multi dose container
3. Light resistance container
4. Well closed container
5. Air tight container
6. Tightly closed container
7. Tamper evident container
8. Aerosol container
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8. It is use in the production of container by using
following material.
1. Glass
2. Plastic
3. Metal
4. Pepar and board
Ideal Property Of Packaging Material
1. They must protect the preaparation from
enviormental.
2. It should not react with product.
3. It should not change product taste or odour.
4. It shoud be non toxic.
5. It should be FDA approved.
6. It should produce tamper resistance requirement.
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9. Glass container commonly used in pharmaceutical
packaging.
Advantage:
1. Transparent
2. Available in various shape and size.
3. Stable in temprature and pressure during sterilisation.
4. Economical and readily available
5. Protect photosensitive medicament by light
6. Impermeable to moisture and atmosperic gases
7. Do not deteriorate with age
Disadvantages:
1. Fragile
2. Heavy in weight
3. Release alkali
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10. Sand (silicon dioxide), Soda ash (sodium
carbonate),Limestone (calcium carbonate),Cullet
(broken glass) - aluminium, boron, potassium,
magnesium, zinc, barium.
Type of glass
I. COLOURED GLASS OR AMBER GLASS
II. SULPHURED GLASS
III. BOROSILICATE GLASS
IV. TREATED SODALIME GLASS
V. REGULAR SODALIME GLASS
VI. GENERAL PURPOSE SODALIME GLASS
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11. Amber colour glass:
Use for photosensitive product.
Obtained by c,s,fe,and magnesium oxide
Sulphur glass:
It is obtained by exposing soda lime glass to moist SO2
at about 500°c to get sulphured glass.
Type I—Highly resistant borosilicate glass.
Alkalinity is removed by using boric oxide to neutralized
the oxide of potassium and sodium
It is highly resistant glass.
It has high melting point so can with stand high
temperatures.
It is more chemically inert than the soda lime glass
It can resist strong acids,alkalies and all types of
solvents. Reduced leaching action.
USES:
Laboratory glass apparatus.
For injection and water for injection
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12. Type II-treated soda lime glass:
Type II containers are made of commercial soda lime
glass that has been dealkalized or treated to remove
surface alkali
. The de-alkalizing process is know as sulphur
treatment.
Sulfur treatment neutralizes the alkaline oxides on the
surface, rendering the glass more chemically resistant.
Uses: Used for alkali sensitive products. Infusion
fluids, blood and plasma. Large volume container.
Type III-Regular soda lime glass:
It is a soda lime silicate glass with only moderate
hydrolytic resistance.
Container form this glass is used for non aquas
parenterals preparation.
Ex powder for parenterals use.
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13. Type IV-non parenterals genral purpose soda lime
glass:
Container made by this glass use for topical or oral
preparation.
MANUFACTURE OF GLASS:
The four basic processes used in the production of glass
are:
Blowing uses compressed air form the molten glass in
the cavity of metal mold.
In drawing , molten glass is pulled through dies or
rollers that shape the soft glass.
In pressing mechanical force is used to press the
molten glass against the side of a mold.
Casting uses gravity or centrifugal force to cause
molten glass to form in the cavity of mold.
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14. Plastics may be defined as any group of substances, of
natural or synthetic origins, consisting chiefly of polymers of
high molecular weight that can be moulded into a shape or
from by heat and pressure.
Advantages
Less weight than glass,
flexible
Variety of sizes and shapes
Extremely resistant to breakage
Transport easily and have mechanical strength
Disadvantages
Absorption permeable to moisture
Poor printing, thermostatic charge.
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15. TYPES OF PLASTICS
Thermosetting type –
When heated they may become flexible but they do not
become liquid
e.g. Urea formaldehyde (UF),Phenol formaldehyde ,Melamine
formaldehyde (MF), Epoxy resins (epoxides),
Polyurethanes (PURs)
Thermoplastics type-
On heating they are soften to viscous fluid which harden
again on cooling.
e.g. Polyethylene{HDPE – LDPE},
Polyvinylchloride(PVC),Polystyrene Polypropylene,
Nylon(PA), Polyethylene terepthalate(PET) ,Polyvinylidene
chloride(PVdC), Polycarbonate Acrylonitrile butadiene
styrene(ABS)
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16. Metals are used for construction of containers. The metals
commonly used for this purpose are aluminium ,tin
plated steel, stainless steel, tin and lead
Advantages:
They are impermeable to light, moisture and gases.
They are made into rigid unbreakable containers by
impact extrusion.
They are light in weight compared to glass containers.
Labels can printed directly on to their surface.
Disadvantages:
They are expensive.
They react with certain chemicals
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17. COLLAPSIBLE TUBES METAL
The collapsible metal tube is an attractive container that
permits controlled amounts to be dispensed easily, with
good reclosure, and adequate protection of the product.
It is light in weight and unbreakable and lends itself to
high speed automatic filling operations.
Most commonly used are tin, aluminium and lead.
Paper And Board
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•Use in various form of packaging of pharmaceutical
products.
•Use for preaparing outer container
•Ex carton,boxes,envelopes and fiber drums.
18. Closures are device by means of container
can be opened and closed.
Types of closures
1. Plug type
2. Crown type
3. Push fit cap
4. Screw closure
Material for closure making
1. Cork
2. Glass
3. Plastic
4. Metal
5. Rubber
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19. 1. Film wrappers
2. Blister package
3. Strip package
4. Shrink seals
5. Aerosol containers
1.Film wrapper
Film wrapping has been used extensively over the years
for products requiring package integrity or environmental
protection.
It is categorizes into following types:
1. End folded wrapper
2. Fin seal wrapper
3. Shrink wrapper
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20. 1.End folded wrapper
The end folded wrapper is formed by passing the product
into a sheet of over wrapping film, which forms the film
around the product and folds the edges in a gift wrap
fashion.
The folded areas are sealed by pressing against a
heated bar. The materials commonly used for this
purpose are cellophane and polypropylene.
2.Fin seal wrapper
The seals are formed by crimping the film together and
sealing together the two inside surfaces of the film,
producing a fin seal.
Fin sealing is superior than end folded wrapper With
good seal integrity the over wrap can removed or
opened by tearing the wrapper.
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21. 3.Shrink wrapper
The shrink wrap concept involves the packaging of the
product in a thermoplastic film that has been stretched
and oriented during its manufacture.
An L shaped sealer seals the over wrap
The major advantage of this type of wrapper are the
flexibility and low cost of packaging equipment .
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22. 2.BLISTER PACKAGE:
Blister package provides excellent environmental protection, and
efficacious appearance.
The blister package is formed by heat softening a sheet of
thermoplastic resin and vacuum drawing the soften sheet of plastic
into a contoured mold .
After cooling the sheet is released from the mold and proceeds to
the filling station of the machine. It is then lidded with heat
sealable backing material.
Material use for themoformable blister is PVC, polyethylene
combinations , polystyrene and polypropylene.
Material for back cover is polyster or paper.
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23. 3.STRIP PACKAGE
A strip package is a form of unit dose packaging that is
commonly used for the packaging of tablets and capsule .
A strip package is formed by feeding two webs of a heat
sealable flexible through heated crimping roller.
The product is dropped into the pocket formed prior to
forming the final set of seals. A continuous strip of packets is
formed.
The strip of packets is cut into desired number of packets.
packaging materials used are: ,polyethylene,PVC.
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24. 4.SHRINK SEAL PACKAGE
Shrink wrap, also shrink film, is a material made up
of polymer plastic film. When heat is applied, it shrinks tightly
over whatever it is covering after passing through heat tunnel.
PVC, Polyethylene, Polypropylene .
5.AEROSOL PACKAGING
Aerosol is defined as "An Aerosol is a disperse phase system, in
which very fine solid drug particles or liquid droplets get
dispersed in the propellants (gas), which acts as continuous
phase.
1. Container
2. Valve
3. Actuator
4. Dip tube
Packaging of Aerosol
1. Cold fill process
2. Pressure fill process
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25. Packaging is very important to protect the
product as well as it maintain the
pharmaceutical products stability.
If the attractive packaging has been done
then it is beneficial for marketing purpose
to improve the sale of product.
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26. References
I. Lachman leon, Lieberman Herbert A., Kanig Joseph
L., “The theory & practice of industrial pharmacy”
published by Varghese publishing house, bombay,
3rd edition,1991,page no. 711-732 .
II. D K Tripathi Indudtrial Pharmacy a comprehensive
approach,pharmamed press page no. 602 to 664.
III. Mehta R.M., “Pharmaceutics- 1”Published by vallabh
prakashan, delhi, 2nd edition, page no . 73-93.
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