PACKAGING OF

PHARMACEUTICALS
DR. MISBAH SULTANA
ASSISTANT PROFESSOR
PACKAGING

• It is a coordinated system of preparing goods for transport,

warehousing, logistics, sale and end use
• It is the science, art and technology of enclosing or protecting products
for distribution, storage, sale and use
• It is process of design, evaluation, and production of packages
PACKAGING

• It 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.
OBJECTIVES

• Physical protection
• Barrier protection
• Containment or agglomeration
• Security
• Convenience
• Portion control
PACKAGING TYPES

• Primary packaging
• Secondary packaging
• Tertiary packaging
PRIMARY PACKAGING

• Primary packaging is the material that first envelops

the product and holds it. This usually is the smallest
unit of distribution or use and is the package which is
in direct contact with the contents.
• For example Unit packs
PRIMARY PACKAGING

Different type of primary

packaging include

• Ampules • Closures (plastic, metal)

• Vials • Syringe
• Containers • Strip package
• Dosing dropper • Blister packaging
SECONDARY PACKAGING

• Secondary packaging is outside the primary packaging – perhaps used

to group primary packages together
SECONDARY PACKAGING

• Paper and boards

• Cartons
• Corrugated fibers
• Box manufacture
TERTIARY PACKAGING

• Tertiary packaging is used for bulk handling , warehouse storage and

transport shipping. The most common form is a palletized unit load
that packs tightly into containers.
TYPES OF PHARMACEUTICAL
PACKAGING MATERIALS
• Glass
• Plastic
• Metal
• Paper and board
CHARACTERISTICS OF PACKAGING
MATERIALS
• They must protect the preparation from environmental conditions.
• They must not be reactive with the product.
• They must not impart to the product tastes or odors.
• 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.
SELECTION OF PACKAGING MATERIALS

1. On the facilities available, 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.
SELECTION OF PACKAGING MATERIALS

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.
6. On 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
• Mechanical factors
These include Shock, Compression, Puncture and Vibration.
• Enviormental factors
These include Temperature, Pressure, Moisture, Gases, Light,
Infestation and Contamination
CONTAINERS

• Container is one in which the product is placed.

• A pharmaceutical container is defined as a device that holds the drugs
and is or may be in direct contact with the preparation.
IDEAL REQUIREMENTS OF CONTAINERS

• 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.
• Dose can be drawn from it conveniently.
IDEAL REQUIREMENTS OF CONTAINERS

• Able to withstand changes in pressure and temperature.

• Must be non-toxic.
• Can be labelled easily.
• Pharmaceutically elegant appearance.
TYPES OF CONTAINER

• Well-closed containers
• Single dose containers
• Multi dose containers
• Light-resistant containers
• Air-tight containers
• Aerosol containers
MATERIALS USED FOR MAKING
CONTAINERS
1. Glass
2. Plastic
3. Metal
4. Paper and board
GLASS

• They are transparent and available in various shapes and sizes.

• 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.
GLASS

• They are neutral after proper treatment and impermeable to

atmospheric gases and moisture.
• They have good protection power and do not deteriorate with age.
• They can be easily labelled and sealed hermetically or by removable
closures.
COMPOSITION OF GLASS

• Glass 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

For injectable and laboratory apparatus
Type 2:-Treated Sodalime glass
For alkali sensitive products, infusion fluids blood and plasma
Type 3:-Regular Sodalime glass
Type 4:-General Purpose Sodalime glass
PLASTIC

• They are light in weight and 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.
PLASTIC

• They are resistant to inorganic chemicals.

• They have good protection power.
Disadvantages:-
• Their permeability to water vapour and atmosphere gases.
• Cannot withstand heat without softening or distorting.
• They may interact or absorb certain chemical to cause softening or
distortion.
COMPOSITION OF PLASTIC

• Plastics are synthetic polymers of high molecular weight. 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:-
1. Thermoplastic type
2. Thermosetting type
EVALUATION OF PLASTIC

Plastic can be evaluated by the following tests

• Leakage test
• Collapsibility test
• Clarity of aqueous extract
• Water vapour permeability test
USES AND PROBLEMS

• Leaching: A process in which plastic material get dissolved by the

action of liquid dosage form
• Sorption: A process by which one substance becomes attached to
another.
• Permeation: it is penetration of liquid or gas into the solid
• Chemical reaction: Plastic may react with the dosage form i.e. liquid
or semi solid
METAL

• The metals commonly used are aluminium, tin plated steel, stainless steel, tin and
lead.
Advantages:-
• They are sturdy, impermeable to light, moisture and gases.
• They can be made into rigid unbreakable containers by impact extrusion.
• They are light in weight as compared to glass containers.
Disadvantages:-
• They are expensive and may shed metal particles into the pharmaceutical product.
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
TIN

• Tin containers are preferred for food, pharmaceuticals and any

product for which purity is considered.
• Tin is the most chemically inert of all collapsible metal tubes .
ALUMINIUM

• Aluminium tubes offer significant savings in product shipping costs

because of their light weight .
• They are attractive in nature
LEAD

• Lead has the lowest cost of all tube metals and is widely used for non
food products such as adhesives, inks. paints and lubricants.
• Lead should never be used alone for anything taken internally
because of the risk lead poison .
• With internal linings, lead tubes are used for products such as chloride
tooth paste
CLOSURES

• Closures are the devices by means of which containers can be opened

and closed.
• It prevents loss of material by spilling or volatilization.
• It avoids contamination 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.
TYPE OF CLOSURE

• Threaded screw cap

• Lug cap
• Crown cap
• Roll on closures
• Pilfer proof closures
TYPE OF CLOSURE

Threaded screw cap Lug cap Crown cap Pilfer proof closures

Roll on closures
MATERIALS USED FOR CLOSURE

1. Cork
2. Glass
3. Plastic
4. Metal
5. Rubber
EVALUATION OF CLOSURES

1. Sterilization test
2. Fragmentation test
3. Self sealibility test
UNIT PACKS

• Unit packs in which individual dosage are separated from each other
are popular for many type of dosage form.
• It is done through strip packaging
BLISTER PACKAGING

• Blister packaging is a type of pre-formed plastic packaging used for

small consumer goods
• The two primary components of a blister packs are the cavity made
form either plastic or aluminum and the lidding, made from paper,
plastic or aluminum
• The cavity contain the product and the lidding seals the product in the
package
BLISTER PACKAGING: ADVANTAGES

• Product integrity
• Product protection
• Temper resistance
• Reduced possibility of accidental misuse
• Patient compliance
 Blister
Packaging

Thermo Cold
foaming foaming

Transparent amber Alu-Alu

POLYVINYL CHLORIDE (PVC)

• Very clear, stiff material

• Excellent thermoformability
• Low permeability
• Low cost
• Good chemical resistance
• Thickness of about 10-15mm
POLYVINYLIDENE CHLORIDE (COATED
PVC)
• PVDC is the most common coating in blister packaging because it can
reduce the gas and moisture permeability of PVC blister packages
• Coated PVC films have thickness of 8-10mm
• Coating is applied on one side and usually faces the product
• Excellent oxygen and moisture barrier properties as compared to
normal PVC
POLYSTYRENE

• It is perfectly compatible with the thermofoaming

• Its high water vapour permeability makes it unsuitable as a blister
material for pharmaceutical purpose
ALUMINIUM BLISTER FOIL

• Used in cold foaming technique

• Alu-Alu packaging
• Good barrier to moisture, vapour and gases
• 20-25µm thick
PACKAGING LINE

• In pharmaceutical industry packaging is a coordinated process

• All process starting from primary packaging till tertiary packaging
done in a series of process coordinated/ mounted on a single machine
• These machines are called as packaging line
PACKAGING LINE