2. ●Packaging of pharmaceuticals
● Role of packaging
●Selection of packaging materials
●Characteristics of containers
●Glass container
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3. Packaging of pharmaceutical :-
Packaging is a process by
which the pharmaceuticals are suitably
packed so that they retain their therapeutic
effectiveness from the time of their
packaging till they are consumed.
Defination :- Packing may be defined as the
art and science which involves preparing the
articles for transport,storage,display and use.
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Types of pharmaceutical Packaging
material :
●Glass
●Plastic
●Metal
●Paper and Board
Role of packaging :-
1)protection: Against light
Against reactive materials
Against moisture
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Against physical damage
Against adulteration.
2)Presentation
3)Identification
4)Information
5)Compatible
6)Convenience
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Selection of packaging material
depends on the following factors :
●The nature of the product itself : Its
chemical activity, sensitivity to moisture
and oxygen,compatibility with packaging
materials.
●The types of patients :Is it going to be
used by an elderly or by a child?
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●The dosage form.
●Method of administrering of the
medication.
●Required shelf life.
●Dose of formulation.
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Ideal Properties 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 stability of
the product.
♦Withstand wear and tear during
normal handling.
♦Must be non toxic.
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Glass as packaging material :
Glass is commonly used in pharmaceutical
packaging because it possesses superior
protective qualities.
It is available in variety of sizes and shapes.
It is chemically inert,impermeable,strong
and rigid and has FDA clearence.
Glass dosen’t deteriorate with age.
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Coloured glass especially Ambered can
give protection agains light when it is required.
COMPOSITION OF GLASS :-
Glass is principally composed of sand,soda
ash,lime stone & cullet.
Sand:Almost pure silica(60%)
soda ash:sodium carbonate
lime stone:calcium carbonate
cullet:Broken glass that is mixed with the
batch & act as fusing agent for entire mixter
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●The most common cations found in
pharmaceutical glassware are silicon,aluminium,
boron, sodium, potassium, calcium, magnesium,
zinc & barium.
●Reduction in the proportion of sodium
ions makes glass chemically resistant.however
without sodium or other alkalies glass is difficult
and expensive to melt.
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Manufacturing of Glass :- Four basic process
A) Blowing :- It uses compressed air to give
shape to the molten glass into the cavity of
metal mold. Most commercial bottles & jars are
produced.
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1.A gob of hot glass drops into the blank
(parison) mould.
2.The mould is sealed shut by a ‘base’ part
and a plunger pushes the glass into the
mould (made from iron).
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3.The glass is shaped into a ‘blank’ and also
pushed into the neck finish by the plunger. This
part of a jar or bottle is finished to its final
shape at this stage.
4.The blank shape (parison) is removed, rotated
180°, and transferred to the blow (finishing)
mould.
5.This mould is in two halves, made from fine-
grain cast iron, and is highly polished.
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6.Air is blown into the hot parison to expand
it tightly against the mould walls.
7.The mould opens, the bottle is removed,
inspected, tested and shipped for filling.
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B) Drawing :- In this method, molten glass is
pulled through dies or rollers that shape the soft
glass, rod tubes, sheet glass & other items of
uniform diameter are usually produced by this
method.
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C) Tubing : It has thinner & more uniform wall
thickness with less distortion than blow
molded containers. Ampoules and vials drawn
from tubing.
D) Pressing & Casting : In pressing mechanical
force is used to press the molten glass against
the side of mold.
Casting uses gravity or centrifugal
force to cause molten glass to form in the
cavity of mold.
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If molten glass is sufficiently fluid, it can be
poured into a mold.
Relatively massive objects, such as
astronomical lenses and mirrors, are made by
this method.
After cooling and solidifying, the piece must
be finished by polishing.
Casting of glass is not often used except for
special jobs.
Smaller lenses are usually made by pressing.
CASTING PROCESS:
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Types of glass :-
1) Type-I Borosilicate Glass
2) Type-II Treated Soda Lime Glass
3) Type-III Regular Soda Lime Glass
4) Type-NP General Purpose Soda Lime
Glass.
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1) Type-I Borosilicate Glass :-
This is highly resistant glass, a substantial
part of the alkali and each cations are replaced by
Boron &/or Aluminum & Zinc. It is more
chemically inert than soda lime glass.
There is addition of approximately 6% of
Boron to form Type-I Borosilicate glass.
2) Type-II Soda Lime Glass :-
Type-II container is made up of commercial
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soda lime glass that has been dealkalized or
treated to remove surface alkali. The
dealkalizing process is known as Sulphur
treatment. This prevents weathering of bottles.
In this process, the glass is exposed to an
atmosphere containing water vapour & acidic
gases particularly Sulphur Dioxide at an
elevated temperature. This results in a reaction
between the acid & some of the surface alkali.
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The alkali removed from the glass appears on
the surface as a sulphate bloom, which is
removed when the containers are washed before
filling.
3) Type-III Regular Soda Lime Glass :-
These containers are untreated & made up
of commercial soda lime glass of average &
better than average chemical resistance.
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4) Type-IV General Purpose Soda Lime Glass :-
These containers are made up of soda lime
glass are supplied for non-parentral products,
those intended for oral or topical use.
ADVANTAGES OF GLASS CONTAINERS :-
◉They are transparent.
◉They are available in various shapes and sizes.
◉They can withstand the variation in temperature
and pressure.
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◉Less cost.
◉They can protect the medicament from light.
◉They are impermeable to moisture and
atmosphere gas.
DISADVANTAGES :-
◉Easily breakable.
◉Glass containers are heavy in weight.
◉They may release the alkali to aqueous
solution.
29. Flaking:
If alkali is extracted from
surface of glass container then silica rich
layer is produced which sometimes breaks
away and can form shining flakes on
surface, this process increases in higher
temperature.
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30. The moisture condensing on the surface
of the glass container, can extract some
weakly bounded alkali leaving a white
deposit of alkali carbonate. If this deposit is
allowed to remain on the surface & further
condensation of moisture leads to
formation of alkaline solution which
dissolved away some silica leading to loss
of brilliance technically termed as
“WEATHERING”.
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