Packaging of Pharmaceutical
Products
Prepared by:
Badri Karki
Quality of a good container:
a. Container should be attrative
b. Water and air can easily be absorbed
c. Material of construction may be toxic
d. Container should help maintain stability of the package product
Introduction
• The art and science of, and the operations
involved in, enclosing or protecting the
products for transport, storage, sale and use.
• Also encorporates the process of design,
evalutaion, and protection of packages.
Stages of Packaging:
• Transport
• Storage
• Display
• Use
Functions of Packaging
• Protection
• Identification
• Presentation
• Convenience
• Economical
Types of Packaging
• Primary
• Secondary
• Tertiary
Primary Packaging:
• The material that first envelops the product and hold
it.
• Smallest unit of distribution or use
• Examples: bister pack, ampules, vial, bottle
Secondary Packaging:
• covering outside the primary packaging
• Facillates the grouping of the primary packaging together
• Examples: box, cartons
Tertiary Packaging:
• Packaging used for bulk handling
• Useful for transportation, storage
• Examples: Barrel, container, wood boxes, sacks
The package that comes in direct contact with the formulation directly
is called:
a. Primary packaging
b. Secondary packaging
c. Tertiary Packaging
d. None
Types of Packaging Materials in
Pharmaceuticals
• Metals
• Plastics
• Glass
• Paper and board
• Rubber
Metals:
• Used mainly for dry products
• Commonly used metals: Aluminium,stainless steel, tin-plated steel, tin
and lead
• Aluminium
• Collapsible tubes for creams and ointments
• Sachets and unit pack of tablets
• Because of light weight, saves shipping costs
• Tin
• Most chemically inert of all collapsible tubes
• Preferred for food, pharmaceuticals and any product for which purity is considered.
• Lead
• Has the lowest cost of all tube metals but should never be used alone for anything
taken internally
• Widely used for non-food prducts such as adhesives, paints, inks and lubricants
Advantages:
• Impermeable to light, moisture and gases
• Resistant to impact
• Light in weight compared to glass container
• Labels can be printed directly on their surface.
Disadvantages:
• Expensive
• reactive
• Aerosol containers are manufactured using :
a. Tin
b. Aluminium
c. Brass
d. All of the above
Plastics:
• Polyethene, polystyrene, polypropylene
• Polyethene- widely used for flexible containers, closure, bags
• Polystyrene- tubes for tablets
• Polypropylene is similar to polyethylene but has greater transparency
and better heat resistance; and more expensive
Advantages:
• Less weight than glass
• Flexible
• Variety of sizes and shapes
• Chemically inert, strong and rigid
Disadvantages:
• Absorption permeable to moisture, leaching
• Poor printing, thermostatic charge
Types of Plastics:
a) Thermoplastic:
• On heating, gets soften to viscous liquid and on cooling again gets
harden
• Examples; polyethylene, polyvinylchloride, nylon, polysterene,
polypropylene
b) Thermosetting:
• On heating may become flexible but do not become liquid
• Examples; urea formaldehyde, phenol formaldehyde, epoxy resins,
melanine formaldehyde
• The correct property of thermoset plastics:
a. Highly recylced
b. Less resistant against high temperature
c. Can be remoulded or reshaped
d. get softened when heated
• Thermoplastics are
a. Gets softened on heating
b. Can be molded
c. Does not degraded by repeated heating
d. All of the above
Glass:
• Soda glass (silica, limestone, soda ash, magnesia, alumina)
- used for dry solids or non-aqueous liquids, for external use
- unsuitable for injections
• Neutral glass (less alkali, more aluminia and some boric oxide)
- Suitable for ampoules and injection bottles
• Borosilicate glass (even less alkali and more boric oxide)
- Excellent but expensive for packaging
• Treated glass
• Type I – Highly resistant borosilicate glass
• Type II – Treated soda lime glass
• Type III – soda lime glass
• Non Parenteral glass (NP) – soda glass
Colored glass:
• Amber
- light yellowish to deep reddish brown
- carbon and sulphur or iron and manganese dioxide
• Blue
- cobalt oxide or ocassionally copper (cupric) oxide
• Green
- iron oxide, manganese dioxide and chromium dioxide
Advantages:
• Transparent
• Good protection
• Can be easily labelled
• Economical
• Available in different shape and sizes
Disadvantages:
• Fragile
• Release of alkali to aqueous preparation
• What is the major disadvantages of glass as a packaging material?
a. Weight
b. Transparent
c. Fragility
d. Can be easily labelled
• Type II glass is called as:
a. General soda lime glass
b. NP glass
c. BS glass
d. Treated soda lime
Rubber:
• Need in a specialised form for closures for injection containers.
Types of Rubber:
• Butyl rubber
• Netrile rubber
• Chloroprene rubber
• Silicone Rubber
Chloroprene Rubbers:
• Oil resistant, and heat stable
Paper and Board:
• Has variety of uses for external packages, but limited use for primary
packaging
Tamper evident packaging:
• Film wrappers
• Blister package
• Strip package
• Bubble package
• Shrink seals
• Bottle seals
• Tape seal breakable caps
• Aerosol containers
• The packaging material that is temper resistant:
a. Aerosol
b. Blister packs
c. Bubble packs
d. All of the above
• In comparison to blister, strips occupy
a. Lesser volume
b. Greater volume
c. Same volume
d. Too less volume
Packaging tests:
• Drop test
• Vibration test
• Shock test
• Inclined impact test
• Revolving drum test
Plastic containers are sterilised using…
a. Autoclave
b. Bleach
c. Ethylene oxide
d. All of the above
