PACKAGING OF

PHARMACEUTICALS

Mrs. Saba V. Shaikh.

Pharmaceutics department
M.C.E. Society’s Institute of Pharmacy,
Azam Campus, Camp, Pune-411001
Contents:
➢Desirable features of container
➢Types of container
➢Study of Glass, Plastic, Metal as material
➢Study of Rubber material for closures
➢Merits & demerits of material
➢Aerosol packaging

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 Packaging
• Packaging is outer protecting cover in
which product is enclosed in such a
manner that it becomes convenient to
handle & open from production to
administration by consumer.

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 Types of packaging
1. Primary packaging
2. Secondary packaging
3. Tertiary packaging

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Primary Packaging video 1 2 Secondary Packaging Tertiary Packaging

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 Types of packaging Material

1. Glass
2. Plastic
3. Metal
4. Paper

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 Types of container

1. Well closed Container

2. Single Dose Container
3. Multi Dose Container
4. Air tight / Hermetically sealed Container
5. Light resistant Container
6. Tamper proof / Tamper resistant
7. Aerosol Container

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 Tamper evident tape Tamper proof seal Multidose container

Aerosol container

Light resistant Single dose container Air tight container

container
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 Qualities of good container
• Neutral
• Protection to the material
• Non-toxic
• Not impart colour & taste to the product
• FDA approved
• Adaptable to high packaging speed of machines
• Elegant appearance
• Should be labeled easily
• Allow easy withdrawal of medicaments

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 Glass
• Advantages:
[Link] protective qualities
[Link]
[Link] shapes & sizes
[Link] Sterilization
[Link] & rigid
[Link]
[Link] glass
[Link] labeling
[Link]
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• Disadvantages:

[Link]
[Link]
[Link] release alkali in aqueous preparation

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 Composition of Glass
• Sand:-Pure Silica
• Soda Ash:-Sodium Carbonate
• Lime Stone:-Calcium Carbonate
• Aluminum Oxide:-Increase resistance for
chemical action
• Sodium Ions:- Increase chemical resistance
• Boron Oxide:- Useful for melting process
• Cullet:- Broken glass (Fusing agent)
mfg glass
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 Types of Glass
1. Type I Glass: Borosilicate glass is a type of
glass with the main glass-forming constituents
silica and boron oxide.

2. Type II Glass: Treated soda lime glass Soda

lime glass treated with sulfur to remove surface
alkali

3. Type III Glass: Regular soda lime glass

4. Type NP: Non parenteral glass

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 Hydrolytic resistant test I.P
Perform test on unused container

• Rinse twice with water

step1 • Rinse once with fresh D.W.

• Fill to the brim with fresh D.W. & Calculate overflow volume
• Fill the containers with 90% of calculated overflow volume of test
Step 2 solution & cover them with washed borosilicate glass dish.

• Autoclave 1000C-1210C for 20 min.

• Maintain temp for 1210C for 60 min. cool 1 hr. after removing from
Step 3 autoclave

• Titration: Test solution (Container solution) Vs 0.01 N HCL

Step 4 • Methyl red Indicator
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 Hydrolytic resistant test
Sr. No. Normal Capacity of Min. No. of Volume of test
Container container used solution

1 5 ml or less 10 50 ml

2 More than 5 ml up to 30 ml 5 50 ml

3 More than 30 ml 3 100 ml

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 Hydrolytic resistant test
Video Ampoules

Capacity of container Volume of 0.01 N HCl / 100 ml of test solution (ml)

(corresponding to 90%
average overflow
volume)
Type I & II Glass Type III Glass
NMT 1 ml 2 ml 20 ml

1-2 ml 1.8 ml 17.6 ml

20-50 ml 0.60 ml 6.1 ml

100-200 ml 0.40 ml 3.8 ml

200-500 ml 0.30 ml 2.9 ml

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 Plastic

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 Advantages of Plastic
1. Light in weight
2. Poor conductor of heat
3. Unbreakable
4. Easy transport
5. Available in various sizes & shape
6. Resistant to inorganic chemicals
7. Do not produces flakes as glass

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 Disdvantages of Plastic
1. Permeable to water vapor & atmospheric
gases
2. Do not withstand heat without softening
3. May absorb chemical substances as
preservative
4. Relatively expensive
5. Special type of adhesive req. for labeling

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 Composition of Plastic
• Polymers:
1. Polyethylene
2. Polypropelene
3. Polyvinyl chloride (PVC)
4. Polystyrene
5. Polycarbonate
6. Polyamides (Nylon)
7. Polymethyl methacrylate (PMMC)
8. Polyethylene terpthalate (PET)

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 Types / classification of Plastic
1. Thermoplastic:- on heating soften to a viscous
fluid & hardens again on cooling
eg: Nylon, PMMC

2. Thermosetting:- On heating become flexible but

not become fluid. Hard & brittle on room temp.
eg: Phenol formaldehyde resin

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 Metal
1. Aluminum 2. Stainless steel

3. Tin 4. Lead

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• Linings: If the product is not compatible with
bare metal than the inner side of metal is coated
by wax & resin solution.

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 Advantages of Metal
• They are sturdy
• Impermeable to light, moisture & gas
• Metal are useful to make rigid, unbreakable
containers.
• They are light in weight as compared to glass
• Labels can be printed directly on the surface of
metal

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 Disadvantages of Metal

• Expensive
• May shade metal particles in the product
• React with certain chemicals & drugs.

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 Paper & board
• Most widely used for outer packaging

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 Closures
• They are devices by which container can
be opened & closed.
[Link] prevents loss of material
[Link] contamination of product
[Link] detoriation of product

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 Basic design of closures
1. Screw-on / Threaded / Lug 2. Crimp-on / Crown

3. Press-on / Push-fit 4. Roll-on 5. Plug Type

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Materials used for making of closures
1. Cork: Obtain from Bark, No odour/ flavour. Mould growth
takes place in liq. Preparations. Not in use now a days.
2. Glass: Ideal but can slip during transportation. Mainly use
for reagent bottles.
3. Plastic: Commonly used. Can be tested for incompatibility
with material. Pilfer proof by using mettle seal..
4. Metal: Made up of Tin & Aluminum. Pilfer proof by using
linings.
5. Rubber: Mainly for vials, Transfusion fluid bottles etc.

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Cork is an impermeable buoyant material, obtained from the
outer layer of the bark of the cork oak.

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