Drug Packaging Materials

Any material, including printed material, employed in the packaging of

a pharmaceutical product, excluding any outer packaging used for
transportation or shipment.
Primary packaging materials are those that are in dircct contact with
the product.
Different types of packaging materials used for Drug Packaging are
Glass
Metals
Plastics
Elastomers
Paper and
Paper board
Types of materials Uses
Cardboard Boxes, Display units
Paper Labels, Leaflets
Glass Ampoules, Bottles, Vials, Syringes,Cartridges
Plastic Closures, Bottles, Bags, Tubes,
Laminates with paper or foil/film
Rubber Closures, including plungers Vial stoppers
Metal, Collapsible tubes e.g.aluminiumn Rigid cans Foils
Needles Gas cylinders Pressurized containers
strips
Definition of Glass

An amorphous inorganic product of fusion that has been cooled to a rigid

Condition without crystallizing.

Glass is amost widely used material for Drug packaging.

Consumption of Glass
Three largest consumers:
1. glass packaging (43%)
2. domestic conmmodities
3. construction industry
elass package
43% sheet glass
30%

plants and conduits 5o Housekeping 12

elecuotechnical heeds I0
Fig. 13
National Glass Usage
hip www lua doe ov bane ooni 000727¡lan anwa hau

Types of Glass
Type I- neutral (borosilicate glass)
 by special treatment -USCd
Ype l- inner surface alkalinity neutralized
reguire an absolute neutral
pn Sensitive products which do not
glass sensitive products (e.g.
Type III- Most common, used for non-pH
pharma and dry products.)
USP Type I glass Containers--composition
Chemical Kimble Wheaton Type Kimble Amber
KG-33 IAmber 203
Si02 80 66 69
B203 13 10
A1203 3 7 6
Fe203 1 1
ZnO 0.5 0
Ti02 0 3
MnO 6
Ba0 1
CaO 0.5 1
Na,0 4 8
K20 1 2
Pkg-503 -28,29

Advantages
Impermcable to gases, moisture, odors and microorganisms
Inert
Transparent
Good compression strength
Easy to clean and sterilize
Can be molded into a variety of shapes and sizes
Ideal for high speed and hot filling lines
Made from abundant raw materials
Reusable and Recyclable
Re-sealable
Versatile
Disadvantages
Heavy (more density 2-2.5 g/cc)
Susceptible to mechanical breakage
Low thermal shock resistance
unable to withstand sudden changes in temperature
Potential hazards from glass splinters or fragments in food

Metals as Drug Packaging materials

Metal containers are used solely for medicinal products for non
parenteral administration.
They include tubes, packs made from foil or blisters, cans, and aerosol
and gas cylinders.
Aluminium and stainless steel are the metals of choice for both primary
and secondary packaging for medicinal products.
 excellent tamper-evident
They have certain advantages and provide
Containers.
Metals used in primary drug packaging are
Tinplate
aluminum. steel limits its use to
Tne p00r corrosion resistance of uncoated
galvanized or plastic-lined drums for bulk products.
Forms of Metal packaging
Cans
Tin cans
Tin-free steel cans
Aluminum cans
Aluminum foil
Aluminum foil laminates
Metallised flexible films
Metal cans : Advantages
Can be heated for sterilization and quickly cooled
Shatter proof
Physical strength, dead fold characteristics
Impervious to light, air and water
No harmful interaction with food if properly treated
Impervious tO insects and rodentS
Recyclable
Disadvantages
Costly
More denser

Materials used in cans

Tin plate
steel sheet with acoating of tin on each surface of the metal.
Coating with tin:
D Hot-dipping
DElectro-plating and the corrosion
Combines strength and formability of steel
resistance and good appearance of tin.
Easily welded, lacquered and printed.
Aluminum
Used in the form of purified alloys
Alloying metals (Cu, Mn, Mg, Zn, Si, Cr, Fe, Ti) improve formability and
Corrosion characteristics
. Lighter, weaker but more ductile as compared with tinplate and ECCS
Aluminum Foil
Athin rolled shcet of alloyed aluminum
Thickness: 4.3-150 microns
Impermeable tO gases and water vapor when thicker than 25.4 u
In the softest temper, exhibits dead-folding characteristics
Can be converted into wide range of shapes and products:
DSemi-rigid containers
DFoil lids, caps and cap liners
U Composite cans combined w/ paper, paperboard and plastics
 pressure
rolls in a mill under
Process
sheet slabs between
IPassing heated Al mills
on sheet and plate
and re-rolling rolling
DContinuous casting and cold
ols, gases,
Metallised foils produces a very good barrier to
aluminum
A thin Coating of
moisture, odors and light
Process:

vacuum environment
is unrolled through a high continuously fed pots condense on
aluminum from
U Vaporized
the fillm to form athin coating
flexible than foil laminates
Less expensive and more

Plastics as Drug Packaging materials.

from the availability of a range of polymers,
Plastics packaging benefits
each
chemical properties,
with its own combination of physical and
Processing characteristics and cost.
polymers; an international standard,
There are many different plastic more.
ISO 1043-1 of 1987, lists 92, and there are many
few main polymers are used.
But for the majority of packaging needs, a
The polymers can be used alone,
with other materials such as
in combination with other polymers, or
aluminium or cardboard.
flexible or rigid.
In cach of these cases, the package can be
Polymers are classificd broadly as again.
º thermoplastic: form after heat. Over and over reform
Can't
º thermoset: set after heat. Only sets once.
Thermoplastics
crystalline: polymers arranged in a regular order
º amorphous: polymers arranges randomly like coil
º Thermosets
º low molecular weight monomers that crosslink and polymerize to
for polymer network
º Elastomers
º Can be either thermoplastic and thermoset
º Thermoset elastomers: natural and synthetic rubbers
º Thermoplastic elastomers: plastics that mimic rubber
(EPDM, TPO, TPE)
LDPE --- 0.91 to 0.93 g/cc , HDPE --- 0.94 to 0.97 g/cc
The advantages that plastics have over glasS and metal.
1.Light in weight. The density of plastics is 1-1.5 g/cc vs. glass at 2-2.5,
aluminum at 2.7 and tinplate at 8.5.
2. A lightweight package is casier for consumers to handle: lifting,
carrying and dispensing are all simplified.
 3.Plastics have ease of
Crcate shapes and stylesfabrication. This allows
that incorporate built indesianers the freedom to
as squeeze administration aids Suci
bottles,
4. Closely related todroppers, etc.
design freedom is a unigue option that plastics
the designer: using thin flexible films to offer
low cost packages. create the ultimate in lightweigt,
5. Like metal and unlike glass, plastic
O. LIKe glasS and unlike metal. plastiCscontainers are shatterproOT.
can be crystal clear or totally
opaque. transparent.
7. Heat sealing of plastic films, provides an easily
closure opened hermetic
at lower COst.
8. Plastics can be readily treated to accept printing inks and can be casIly
metalised; from the graphiCs standpoint, they are superior to glass or
metals.
9. Aluminum is the only compctitive drug packaging material that is
produced in film form. However, aluminum foil is much more expensive
than plastic fil m and is inferior in toughness and strength.
10. Foil is used in packaging drugs to provide a gas barrier, but coated
plastic films can provide an equally effective barrier at lower cost.
ELASTOMER as Drug Packaging materials
Elastomers are polymers that can be stretched to at least twice their
unstretched length and return to their original length when the
stretching force is released.
This high stretchability differentiates elastomers from other materials
Uscd in drug packaging;
rmetal and plastics are elastic only over a very small deformation
range. container
In drug packaging, elastomers are used mainly for parenteral
closures.
This use arises from two unique physical properties of elastomers
- Compressability and -resealability.
in mating
Their compreSsability allows them to seal small irregularities
Surfaces such as the inside of the neck of a parenteral vial.
Reclosability allows them to close completely after a hypodermic
needle has been withdrawn.
Properies of Elastormers for pharmaceutical applications are:
impermeability to gases penetrated by a
Coring resistance (resistance to fragmentation when
needle)
Compression recovery
shelf life
solvent resistance Elastomer Structure
resilience
resistance to 0Zone and radiation
contents
resistance to interaction with the package
Typical Elastomers in Pharma Packaging are
Elastomers
Butyl Rubber
Halo Butyl Rubber
Ethylene propylene Rubber
 Silicone Rubber
Fluroelastomers
Natural Rubber
Neoprene Rubber
Nitrile Rubber
Styrene Butadiene Rubber
Poly butadiene

various types of elastomers, butyl and chlorobutyl rubbers

OT these closure market Since they offer the
share 80% of the overall parenteral
vapor.
best resistance to permeation by oxygen and water contact lens vials
Silicone based elastomers are used largely for multiple autoclaving for re
becauSe their good heat resistance allows and then replaced.
sterilization after the lens has been removed materials precludes their
these
However, the high gas permeability of closure applications.
Natural Rubber in other pharmaceutical