Pharmaceutical packaging

PHARMACEUTICAL
PACKAGING
INTRODUCTION
Packaging is the science, art and technology of
enclosing or protecting products for distribution,
storage, sale, and use.
Packaging also refers to the process of design,
evaluation, and production of packages.
Pharmaceutical packaging can be defined as the
economical means of providing presentation,
protection, identification , information, convenience
,compliance , integrity and stability of the product .
FUNCTIONS OF PACKAGING
• Product Identification:- Packaging greatly helps in
identification of products.
• Product Protection:- Packaging protects the contents
of a product from spoilage, breakage, leakage, etc.
• Facilitating the use of product:- Packaging should be
convenience to open, handle and use for the
consumers.
• Product Promotion:- Packaging is also used for
promotional and attracting the attention of the people
while purchasing.
TYPES OF PACKAGING
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
Secondary packaging -
Is outside the primary packaging perhaps used to group
primary package together.
Ex. Boxes, cartons
Tertiary packaging- is used to bulk handling and shipping.
Ex. Barrel, container, edge protector
PACKAGE TESTING
Drop test
Vibration test
Shock test
Inclined impact test
Revolving drum test
TYPES OF PACKAGING MATERIALS USED FOR
PHARMACEUTICAL PACKAGING
Glass
Plastics
Rubbers
Paper/card boards
Metals
THE CHOICE OF PACKAGING MATERIAL
WILL DEPEND UPON:
The degree of protection required
Compatibility with the dosage form
Customer convenience e.g. size, weight of dosage
form,
Filling method
Sterilization method to be employed and cost
GLASS:
Glass has been widely used as a drug packaging material
Advantages
They are transparent.
 They have good protection power.
 They can be easily labelled.
Economical
 Variety of sizes and shapes
Disadvantages
Glass is fragile so easily broken.
Release alkali to aqueous preparation
COMPOSITION OF GLASS
 Sand (silicon dioxide) Soda ash (sodium carbonate) Limestone
(calcium carbonate) Cullet (broken glass) - aluminium, boron,
potassium, magnesium, zinc, barium,
Amber: light yellowish to deep reddish brown, carbon and
sulphur or iron and manganese dioxide
Yellow: Compounds of cadmium and sulphur
Blue: Various shades of blue, cobalt oxide or occasionally
copper (cupric) oxide
Green: iron oxide, manganese dioxide and chromium dioxide
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.
TYPES OF GLASS
Type I—Highly resistant borosilicate glass
Type II—Treated soda lime glass
 Type III—soda lime glass
 NP—soda glass (non parenteral usage)
Type I-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.
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.
PLASTIC
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 form by heat and
pressure.
Advantages
Less weight than glass,
 flexible
 Variety of sizes and shapes
 Essentially chemically inert, strong, rigid Safety use, high quality,
various designs
Extremely resistant to breakage
Disadvantages
Absorption permeable to moisture
 Poor printing, thermostatic charge
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)
METALS :
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
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.
RUBBER:
 Rubber is used mainly for the construction of closure meant for vials, transfusion fluid
bottles, dropping bottles and as washers in many other types of product.
BUTYL RUBBER:
Advantages:
 Permeability to water vapour .
 Water absorption is very low.
 They are relatively cheaper compared to other synthetic rubbers.
Disadvantages:
 Slow decomposition takes place above 130 ▫ C.
 Oil and solvent resistance is not very good.
NITRILE RUBBER:
Advantages : Oil resistant due to polar nitrile group. Heat resistant.
Disadvantages:
Absorption of bactericide and leaching of extractives are considerable.
CHLOROPRENE RUBBERS :
Advantages: Oil resistant. heat stability is good.
SILICON RUBBERS:
Advantages:
Heat resistance.
Extremely low absorption and permeability of water.
Excellent aging characteristic.
Disadvantages:
They are very expensive.
TAMPER RESISTANT PACKAGING:
The requirement for tamper resistant packaging is now one of
the major considerations in the development of packaging for
pharmaceutical products.
Tamper resistant package is one having an indicator to entry in
which, if missing, can reasonably be expected to provide
visible evidence to consumers that tampering has occurred.
FDA approves the following configurations as tamper resistant
packaging: Film wrappers, Blister package, Strip package,
Bubble pack, Shrink seals, and bands Oil, paper, plastic
pouches, Bottle seals, Tape seals, Breakable caps, Aerosol
containers
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:
End folded wrapper
 Fin seal wrapper
Shrink wrapper
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.
 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
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 .
BLISTER PACKAGE: 
Blister package provides excellent environmental protection, and 
efficacious appearance.
 It also provides user functionality in terms of convenience , child 
resistance and tamper resistance
 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
Peel able backing material is used to meet the requirements of child 
resistance packaging.
 The material such as polyester or paper is used as a component of 
backing lamination.
 Materials commonly used for the thermo formable blister are PVC, 
polyethylene combinations , polystyrene and polypropylene.
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 in general.
The strip of packets is cut into desired number of packets.
Different packaging materials used are: 
paper/polyethylene/foil/PVC.
BOTTLE SEALS 
A bottle may be made tamper resistant by bonding and inner 
seal to the rim of the bottle in such a way that the product can 
only be attained by destroying the seal . 
Typically glassine liners are two ply laminations use in two 
sheet of glassine paper bounded together with wax or adhesive
. For pressure sensitive inner seals pressure sensitive adhesive 
is coated on the surface of the inner seal as an encapsulated 
adhesive.
TAPE SEALS
 It involves the application of glued or pressure sensitive tape 
or label around or over the closure of the package which is to 
be destroyed to obtain the product. 
The paper used must often is a high density light weight paper 
with poor tear strength.
 BREAKABLE CAPS
 Breakable closures come in many different designs. 
The roll-on cap design of aluminium shell used for carbonated 
beverages. 
The bottom portion of the cap is rolled around the bottle neck 
finish. 
The lower portion of the cap blank is usually perforated so that 
it breaks away when the cap is unscrewed. The bottom portion 
of the closure has a tear away strip.
SEALED TUBES
 Collapsible tubes used for packaging are constructed of metal, 
plastic or lamination of foil, paper and plastic.
 Metal tubes are still used for products that required high 
degree of barrier protection 
. Most of these are made of aluminum .
 Extruded plastic tubes are widely used for products that are 
compactable and limited protection of plastic.
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