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Features, Functions and selection of Pharmaceutical Packing Materials

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International Journal of Pharmaceuticals and

Neutraceuticals Research

IJPNR |Vol. 1 | Issue 1 | April - 2014

Journal Home page: www.ijpnr.com

Review article Open Access

Review Features, Functions and Selection of Pharmaceutical

Packaging materials
Arif Sabah , Iqbal Ahmed , Adeel Arsalan2, Aysha Arif3, Sidra Tanwir1, Atta Abbas1,
1,* 2

Farrukh Rafiq Ahmed1

1
Faculty of Pharmacy, Ziauddin University, Karachi, Sindh, Pakistan.
2
Baqai Institute of Pharmaceutical Sciences, Baqai Medical University, Karachi, Sindh, Pakistan.
3
Faculty of Pharmacy, University of Karachi, Karachi, Sindh, Pakistan.
.* Corresponding author: Arif Sabah.
E-mail id: drarif_bips1@yahoo.com.

ABSTRACT
Packaging is an important component in the development of various drug formulations in pharmaceutical industry.
Packaging of pharmaceutical dosage forms has a close relationship between a pharmaceutical preparation and its
package which is a major concern to the drug stability and safety. The selection of Packaging material is made on
the basis of its efficacy and performance characteristics in preserving the quality, potency and safety of the
pharmaceutical products. The stability testing of pharmaceutical products and compatibility testing of packaging
materials is an integral part of R&D in pharmaceutical industry. The stability of a drug in solid and liquid dosage
forms depends on the efficacy of the packaging materials to protect the drug from chemical degradation and changes
in physical characteristics such as appearance, hardness, friability, dissolution, disintegration, weight variation,
moisture contents and mechanical durability. This is particularly necessary for the storage of the products under
accelerated conditions. It has been observed that the use of substandard packaging materials by some pharmaceutical
industries leads to stability problems, packaging materials - drug interaction, poor efficacy to moisture barrier and
formation of hazardous materials. In order to study the effect of environmental factors on the packaging efficacy of
solid and liquid dosage form preparations, it is intended to study the stability of a number of selected pharmaceutical
products in packaging materials using glass, aluminum foil, plastic, paper and other materials as primary or
secondary packaging material and to determine the extent to which these materials are effective in providing
protection to the product and in maintaining its desirable physical and chemical characteristics under the proposed
storage conditions. It is intended to evaluate the shelf lives of the products stored in different packaging materials
and examine their efficacy and performance characteristics in maintaining the product integrity for a prolonged
period of storage.
Keywords: Pharmaceutical; Packaging materials; Dosage form.

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INTRODUCTION
Packaging is one of the largest industrial sectors in
the world, worth $280 billion. Consumer healthcare
packaging represents 4% ($ 11.2 billion) of
packaging industry (Arif Sabah et al, 2014). As a
drug manufacturer’s approach the 21st century they
face a number of challenges that packaging can help
them to meet. (Pilchik, 2000a, 2000b) It is very
important in preserving the quality, potency and
safety of pharmaceutical products. The
pharmaceutical industry must ensure that their
products maintain the desired shelf lives during the
period of storage and consumptions under specified
conditions. It has been often observed that the
inappropriate and cheap packaging materials use by
many industries does not maintain the desired
characteristics in the formulations and therefore they
may not be able to provide the clinical efficacy of the
product. It is utmost important that depending upon
the chemical nature and stability of the solid and
liquid formulations, a judicious selection of the
packaging material be made which is not only
compatible with the product but does not allow any
effects which would cause degradation of the
chemical in the product. In the development of
packaging material for a particular formulation all the
desired tests are to be carried out to ensure its
preserving capabilities to maintain the essential
characteristics of the formulation during storage. The
consideration of economy in the selection of
packaging material may render it unfit for use for the
intended formulation and, therefore, the patient may
not derived full benefit from the use of product. In
many cases it has been observed that considerable
degradation of the drug has occurred resulting in
undesirable physical and chemical changes along
with some toxic effects which may be highly
hazardous to the patient.
Packaging has been defined in different ways,
because of its perceived numerous functions. For
instance, (Soroka, 1996) described packaging as a
coordinated system of preparing goods for transport,
distribution, storage, sales and uses. He further stated
that, it is a complex, dynamic, scientific, artistic and
business function, which in its most fundamental
form contains, protects, preserves, provides
convenience and informs the concerned people within
the acceptable environment constraints. The complex
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nature of packaging is seen in the fact that, there are a
number of aspects which have to be kept in
consideration so that one side should not be in
conflict with the other. For instance, manufacturers
should not concern themselves with only the
container that is supposed to protect the product since
the concern is on getting the product to the final
consumer. They need to consider the structural
aspects of packaging, grades of packaging, materials
of packaging and the stability of packaging in respect
of the intended pharmaceutical products. This is
necessary because of the possibility of the chemical
interaction between the packaging and the contents
and their ultimate harmful effects on the consumer.
The packaging is stated as the technology and art of
preparing a commodity for convenient transport,
storage, and sales. Packaging is the expression of the
brand identity of the product, its intrinsic qualities
and stability. Solid dosage form design and process
development depend heavily on the physical and
chemical properties of the active and excepients
components. These properties are closely linked to
the final product specification such as purity,
strength, stability, hardness, friability, disintegration
dissolution, appearance and mechanical durability.
The physico-chemical properties of the product are
heavily dependent upon the efficacy of the packaging
material (Ahmad and Sheikh, 1993, 1994a, 1994b,
1994c, 1994d).
The selection of the packaging, therefore, begins with
the determination of the product’s physical and
chemical characteristics, its protective needs and its
marketing requirements. The material selected must
be not reactive with products; protective from
environmental condition; not impart to the products
tastes or odors; non-toxic; FDA approved; meet
applicable tamper- resistance requirement; adaptable
to commonly employed high-speed packaging
equipment. (Croce et al., 1986)
Prendergast and Pitt (1996) mentioned that
“Packaging seems to be one of the most important
factors in influencing purchasing decision made at
the point of sales and it is an essential part in selling
process”. Marketing Essentials (2003) makes a
definite statement about the sales function of
packaging. It states that a package does much more
than hold a product- it is a selling tool. Packaging
types and design are the major component in the
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marketing campaign. It is often considered as the product, packaging proves temper evident, child
most important and critical sales promotional tool resistance and anti counterfeiting, correct packaging
(Essuman, 2008). prevents any wastage (such as leakage or
deterioration) which may occur during transportation
PACKAGING MATERIALS USED FOR and distribution, good packaging and presentation
SOLID AND LIQUID DOSAGE FORMS encourages consumers to buy products, good
packaging extended the shelf lives of the products.
The most commonly used pharmaceutical packaging
The inadequate packaging may be the result of: A
materials for solid dosage form are glass container,
lack of knowledge of the materials and/or the
plastic container, paper and paperboard, metal and
requirements for packaging different products. Each
aluminum foil. There are four basic components of
product has its own characteristics and packaging
pharmaceutical blister packages, strip packaging i.e.
requirements vary. In many countries the choice of
the forming film, the lidding material, the heat-seal
packaging materials may be limited for those that are
coating, strip sealing, closure sealing and the printing
available, supplies are often situated in urban areas
ink. The most common blister package, alu-alu
and this may cause problems for the rural producer in
package, strip package, film, paper, plastic or multi
terms of transportation and often in negotiating with
material backing that is adhered to the sheet of the
suppliers. Packaging can represent a large part of the
thermoformed plastic bubbles. Forming films
total cost of a processed food this may be in part the
accounts for approximately 80-85% of the blister
result of the higher unit cost when small quantities
package and lidding material make up 15-20% of the
are ordered for small-scale production, so the
total weight of the package. The pack is usually
selection of the primary packaging materials must
present in up to three layers. Primary pack or
fulfill the following important requirements like
immediate container, secondary pack, for information
moisture barrier requirements, light barrier
and additional protection and tertiary pack, added for
requirements, Gas barrier requirements, and chemical
storage and distribution.
properties. The selection of the packaging materials
The primary packaging for the product (e.g. bottle
therefore begins with the determination of the
and closure) must be fit for purpose because primary
products physical and chemical characteristics, its
package is in direct contact with the product. It must
protective needs and its marketing requirements. The
adequately protect the product from the environment
material selected must have the following
while being compatible with the product. Usually,
characteristics (Croce et al., 1986). They must not be
primary packages provide the major protective
reactive with products; they must be protective from
barrier. A secondary package usually contains several
environmental condition, they must not be imparted
primary packages, and provides the strength for
to the products tastes or odors, they must be nontoxic,
stacking in the warehouse. Like the secondary, a
they must be approved by FDA or other regulatory
tertiary package contains a number of secondary
agencies, they must meet applicable tamper-
packages. Its function is to hold together the
resistance requirement, they must be adaptable to
secondary packages during distribution.
commonly employed high speed packaging
equipment.
FEATURES AND FUNCTIONS AND
SELECTION OF PHARMACEUTICAL TYPES OF PACKAGING MATERIALS
PACKAGING MATERIALS FOR SOLID AND LIQUID DOSAGE
The pharmaceutical packaging materials contain
some important features and functions like:
FORMS
Packaging protect against all adverse external GLASS
influence that can alter the properties of the product, Glass is generally the first choice of packaging for all
Packaging protect against biological contamination, types of pharmaceutical products. Glass is the only
packaging protect physical damage, packaging carry packaging material rated 'GRAS' or 'generally
the correct information and identification of the regarded as safe' by the U.S. Food & Drug

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Administration. In the European and the United
States pharmacopeias various grades of glass are
classified as official based on their chemical
characteristics and efficacy within the packaging of
pharmaceuticals. Glass containers also are beneficial
from the economical point of view as glass is
abundantly present in nature and because of its
capability to be sterilized and hence be recycled. Its
distinction when compared to other packaging
materials lies in the unique combination of durability,
inertness and transparency. The container chosen for
a given preparation shall be such that the glass
material does not release substances in quantities
sufficient to affect the stability of the preparation or
to present a risk of toxicity. In justified cases, it may
be necessary to have detailed information on the glass
composition, so that the potential hazards can be
assessed. The hydrolytic stability of glass containers
for pharmaceutical use is expressed by the resistance
to the release of soluble mineral substances into water
under the prescribed conditions of contact between
the inner surface of the container or glass grains and
water.
TYPES OF GLASS CONTAINERS
According to the hydrolytic resistance characteristics,
glass containers are classified as follows:
Type I glass containers
Neutral glass, with a high hydrolytic resistance due to
the chemical composition of the glass itself.
Type II glass containers
Usually of soda-lime-silica glass with a high
hydrolytic resistance resulting from suitable
treatment of the surface.
Type III glass containers
Usually of soda-lime-silica glass with only moderate
hydrolytic resistance.
Type IV glass container
Usually lower-quality flint or soda glass (U.S) or not
for parental use.
PLASTIC
Plastics are long-chain polymers that can be melted,
formed into a desired shape, and solidified during
cooling. The general advantages of using plastic
materials in pharmaceutical packaging include
consumer acceptance, preference, excellent safety
characteristics (non fragility), less weight than other
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materials, moisture barrier properties, gas barrier
properties, good puncture resistance, low heat
conductivity, good sealant properties, and
recyclability. Plastics are inexpensive, lightweight,
strong, durable, corrosion-resistant materials, with
high thermal and electrical insulation properties,
because of these properties plastics are widely used in
the pharmaceutical packaging industry. In addition to
this it can be easily molded into the preferred shape
and provide protection against contamination and in
the storage and transportation.
TYPES OF PLASTIC CONTAINERS
POLYETHYLENE (PE)
Polyethylene is available in three different grades
including low (LDPE), medium (MDPE) and high
(HDPE) density (ranging from 0.91 to 0.96). As the
density of PE increases both physical and chemical
properties vary. The clarity and translucency depends
upon the density of PE. The low, medium and high
density PE have oxygen transmission of 500, 250-535
and 185 respectively. High density polyethylene
(HDPE) is the most crystalline material and is most
widely used for the containers by the pharmaceutical
industry for drug packaging because it offers good
barrier against moisture but a relatively poor one
against oxygen and other gases. HDPE mostly used
for solid oral medication in pharmaceutical industry.
Polyethylene is the material of choice with
polypropylene (PP) as a polymeric material used for
on line blow fill seal technology.
POLYSTYRENE (PS)
The polystyrene is the clear rigid hard material with
good tensile strength but is one of the most brittle
plastics when dropped. It is resistant to mineral oil,
water and alkali but is soluble in organic solvents. It
is fairly permeable to moisture and is generally not a
suitable packaging material for pharmaceutical
products.
POLYCARBONATE (PC)
The poly carbonate material is having good impact
resistance with excellent dimensional stability. It has
a low water absorption capacity and is heat resistant.
PC is used to make membrane filters, reusable bottles
and sterilize-able medical packaging (Jain, 2006).
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POLYVINYL CHLORIDE (PVC)
PVC used as a forming film is called rigid PVC
because it is almost free of softening agents.
Currently it is the most widely used forming film and
displays ideal forming characteristics. Its water-vapor
permeability is very low. (Patel, 2012).
The principal advantages of PVC are the low cost and
the ease of thermoforming. The main disadvantages
are the poor barrier against moisture ingress and
oxygen ingress; moreover PVC has a negative
environmental connotation due to its chlorine
content. In the case of blister packaging the PVC
sheet does not contain any plasticizer and is
sometimes referred to as Rigid PVC or RPVC. In the
absence of plasticizers, PVC blisters offer structural
rigidity and physical protection for the
pharmaceutical dosage form. On the other hand, the
blister cavity must remain accessible by the push-
through effect and the formed web may not be too
hard to collapse when pressed upon; for this reason
the PVC sheet thickness is typically chosen between
200µ to 300µ depending on the cavity size and shape.
Most PVC sheets for pharmaceutical blisters are
250µ or 0.250 mm in thickness. Typical values for
the Water Vapor Transmission Rate (WVTR or
MVTR) of a 250µ PVC film are around 3.0 g/m2/day
measured at 38°C/90%RH and the Oxygen
Transmission Rate (OTR) is around 20 ml/m2/day. In
order to overcome the lack of barrier properties of
PVC film, it can be coated with PVDC or laminated
to PCTFE or COC to increase the protective
properties. Multi-layer blister films based on PVC are
often used for pharmaceutical blister packaging,
whereby the PVC serves as the thermo formable
backbone of the structure. Also, the PVC layer can be
colored with pigments and/or UV filters. (Byett, J.,
2002). The following Factors must be considered
when PVC is uses for pharmaceutical purpose like
stabilizers, plasticizer, monomer, residue, modifiers,
lubricants, catalytic residue.
POLY VINYLIDENE CHLORIDE (PVDC)
PVDC-coated PVC has characteristics similar to
those of uncoated PVC except that the water vapor
permeability of films coated in this way is reduced by
a factor of 5-10. The coating is applied on one side
and usually faces the product and the lidding
material. PVDC is Copolymer of vinyl chloride or
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vinyl acetate and vinylidene chloride. It is an
excellent resistance to permeation by moisture and
gas and mostly widely used as a coating.
PVC and ACLAR (CTFE)
PVC-CTFE films made from PVC and ACLAR
(CTFE) have the lowest water-vapor permeability of
all the films used for blister packaging. The
environmental concerns raised about PVC also apply
to PVC-CTFE film. Poly chloro trifluoro ethylene or
PCTFE can be laminated to PVC to obtain very high
moisture barrier. Typical constructions used for
pharmaceutical products are 250µ PVC film
laminated to 15µ-100µ PCTFE film. Duplex
structures are PVC/PCTFE and triplex laminates are
PVC/PE/PCTFE. Deeper cavities can be formed by
using the triplex structures with PE. Typical WVTR
values are between 0.06 - 0.40 g/m2/day. (Clifford,
Stephanie, June 2, 2011).
CYCLIC OLEIN COPOLMERS (COC)
Cyclic olefin copolymers (COC) or polymers (COP)
can provide moisture barrier to blister packs,
typically in multilayered combinations with
polypropylene (PP), polyethylene (PE), or glycol-
modified polyethylene terephthalate (PET). Cyclic
olefin resins are generally amorphous and are noted
for good thermoforming characteristics even in deep
cavities, leading some to use COC in blister
packaging as a thermoforming enhancer, particularly
in combination with semi crystalline resins such as
PP or PE. Films can be manufactured via co extrusion
or lamination. WVTR values of commercial cyclic
olefin-based pharmaceutical blister films typically
range from 0.20 to 0.35 g/m2/day at 38C/90% RH.
Unlike PVC and other common pharmaceutical
barrier resins, cyclic olefin resins do not contain
chlorine or other halogens in their molecular
structure, being comprised solely of carbon and
hydrogen. Cyclic olefin resins are available which
comply with pharmaceutical packaging guidelines in
the US, Europe, and Japan. (Clifford, Stephanie, June
2, 2011).
POLYPROPYLENE (PP)
There is an increasing trend towards the use of PP as
a support material for blister packages. The water-
vapor permeability of uncoated PP is lower than that
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of PVC and is comparable to the water vapor
permeability of PVDC coated PVC. Water- vapor
permeability of uncoated PP is lower than PVC, and
is comparable to PVDC coated PVC. One problem
posed by PP processing is thermoforming. The
temperature required for thermoforming PP and the
temperature of subsequent cooling process must be
precisely controlled. Another problem is warping of
package – often resulting in the requirement for PP
formed packages to be straightened before cartoning.
One problem posed by PP processing is
thermoforming. The temperature required for
thermoforming PP and the temperature of the
subsequent cooling process must be precisely
controlled. Another problem is warping of package
often resulting in the requirement for PP formed
packages to be straightened before cartoning.
(Wikstrøm E., 1999)
NEW HIGH BARRIER THERMO
FORMING FILM
There is a new high barrier thermoforming film based
on a new type of plastic granules called COC (cyclo-
olefine copolymer). It is suitable for pharmaceutical
and cosmetic packaging applications, where excellent
moisture barrier properties, outstanding transparency
and good rigidity are required.
Forming Film
Forming film is the packaging component that
receives the products in deep drawn pockets.
Consideration must be given to the height and weight
of the product, sharp or pointed edges of the final
package and the impact resistance, aging, migration
and cost of the film. The oriented polyamide (OPA)/
aluminum/PVC or nylon/ aluminum/PVC laminates
are intriguing a laminate structure consisting of 1-ml
OPA, 1.8-ml OPA and 2.4-ml PVC it is possible to
eliminate water vapor permeability almost entirely.
Moreover because of the large proportion of the
aluminum in the laminate recycling this material has
become feasible (particularly most lidding material
also contain aluminum (Pilchik, 2000a, 2000b).
Lidding material
The lidding material provides the base or main
structural component upon which the final blister
package is built. It must be selected according to the
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size, shape, and weight of the product .The surface of
the lidding material must be compatible with the
heat-seal coating process. Aluminum is used as the
material of construction for most other metered dose
aerosol suspension and emulsion. This material is
extremely lightweight and also is essentially inert;
although aluminum will react with certain
formulation (especially those that contain only active
ingredients and propellant) but many containers are
available that have an internal coating made from an
epon- or- expoxy - 0 type resin (Sciarra. 1996).
Types of lidding material
Hard aluminum is most widely used push-through
lidding material. The foil usually has a thickness of
0.8 ml. There are endeavors, however to reduce the
thickness of this foil to 0.6 ml. The hardness of the
aluminum facilitates push-through opening.
Soft aluminum (1ml) frequently is used for child
resistance push through foils. With the exception of
the type of the aluminum used the structure of this
lidding material corresponds so that of hard
aluminum (0.8ml). The softness and thickness of this
type of aluminum help prevent children from pushing
tablets through it.
Paper aluminum is the combination of paper and
aluminum, weight of the paper amount to 40-
45g/m2. In Europe the thickness of the aluminum
typically is 0.28-0.48 pm, but in the United States it
has a thickness of 0.6-1 ml.
Paper/PET/aluminum Lidding material made of
paper/PET/aluminum laminate is often called peel off
–push through foil. This kind of material is used
predominately in the United States. The concept is to
first peel off paper/PET/laminate from the aluminum
and then to push the tablet through the aluminum
(Sciarra. 1996).
Requirements for Lidding Components
The print primer should meet the following
requirements: It must withstand sealing temperatures
as high as 300°C without showing discoloration or
tackiness (blocking). It should offer sufficient
resistance to abrasion and be a substrate to which
printing inks can adhere strongly enough to withstand
the peeling force of adhesive tapes. Finally the print
primer must comply with FDA recommendations.
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The basic lidding material must meet requirements
for elasticity or inelasticity specific to the type of
machine used. It must guarantee water-vapor
transmission rate that is at least as low as that of the
forming films and it must be suitable for the type of
opening appropriate to the package e.g. push-thru or
peel-off. The heat-sealing coat must be compatible
with the plastic material of the form films and it must
ensure constant sealing for any given sealing
parameter. The sealing strength must be suitable for
push-thru or peel-off opening and of course it must
comply with FDA recommendations.
ALUMINIUM
Aluminum is the most abundant metal on the earth’s
surface, but it is one of the most costly constituents in
a laminate. Foil is obtained from metal of 99% purity
and above. The gauges range from 0.006 mm to
0.040 mm. The foil is annealed to give a soft foil with
a ‘dead fold’ property. Hard tempered (non-annealed)
foil occasionally finds special applications, i.e. push-
through lidding for blister packs. Lubricants are
removed from hard foil by either solvent washing or
controlled heating. For any nominal gauge +8%
variations is normally allowed. For solid dosage form
(i.e. tablet, capsules, and powders) aluminum foil is
the most commonly used packaging material due to
its protective characteristics with respect to the
effects of moisture, heat and light. Aluminum offers
significant saving in the product shipping costs
because of their light weight; they provide the
attractiveness to the tin at somewhat lower costs
(Croce at al., 1986).
For solid dosage forms (i.e. tablet, capsules and
powders), aluminum foil is the most commonly used
packaging material due to its protective
characteristics with respect to the effects of moisture,
heat and light. Aluminum offers significant saving in
the product shipping costs because of their
lightweight and also they provide the attractiveness to
tin at somewhat lower cost. (Croce at al., 1986).The
different types of aluminum packaging materials
include lidding aluminum foil containers, casserole,
lid punching machine, disposable kitchen foil, cling
film, lidding pharma foil, lidding packaging material,
cigarette foil, lidding blister foil, aluminum lidding
foil poly, paper laminated foil, heat sealable lidding
foil, foil lidding casserole, triple laminate for ORS
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pouch, strip packing, foil panes, aluminum foil and
alufoil lidding. A number of alufoil properties
combine to provide a convenient, safe and versatile
packaging format for tablets, creams, liquids and
powders covering an enormous variety of
pharmaceutical products. Alufoil unrivalled barrier
properties totally exclude moisture, oxygen and other
gases, microorganisms and light, thus maintaining
sensitive products in peak condition for long periods.
Important properties of aluminum foil
Barrier
Alufoil total barrier to light, atmosphere and liquids
is the principle reason for its use in pharmaceutical
applications.
Dead fold and mechanical properties
Alufoil is strong and can be laminated with other
materials. By using different alloys alufoil can be
given a choice of characteristics, which make it
suitable for ‘push through’ lids or pre-formed trays
for tablets.
Hygiene and safety
Alufoil does not harbor bacteria. It can be supplied in
a fully sterile condition. Many suppliers offer alufoil
packaging materials produced in hygienic ‘clean-
room’ facilities.
Sustainability
Alufoil is weight saving, effective and minimizes the
amount and diversity of packaging material needed.
Added to this reduction at source, it also helps to
preserve valuable pharmaceutical products, so cutting
waste of materials and energy.
Applications of aluminum and plastic as
packaging material
The various applications of aluminum as packaging
material for pharmaceutical products are given below.
Blister packs
Alufoil is particularly suitable for blister packs
because of the range of mechanical properties
available. Depending on the alloy and its treatment,
alufoil can be made more brittle, tougher or more
ductile. It can also be combined with other materials
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like paper or plastics. Blister packs are tamper-
evident and can be designed to be ‘child-proof’ or to
provide more secure access. Most blister packs
consist of a preformed plastic tray with an aluminum
foil closure manufactured to facilitate the necessary
‘push-through’ characteristic. A recent development
is the all-aluminum blister pack.
Strip packs
Strip packs can be produced from Aluminum or in
combination with paper or plastics. A key
requirement is that they should be easy to tear open.
Alufoil is readily printed and its malleability and
dead fold characteristic are important in these
applications, allowing the metal to closely form to the
shape of the tablet. Strip packs provide economical
high barrier performance and can be filled at high
speeds on modern, sterile, filling lines (Damman
foils, technical literature).
Sachets and pouches
The sensitive nature of most pharmaceutical
preparations demands that the packaging provides a
perfect barrier to moisture, and often to light. Alufoil
laminated sachets provide an effective packaging
solution for many products whether in powder, cream
or liquid form (Damman foils, technical literature).
Heat-sealed membranes and closures
Many medicines are supplied in glass, plastic or
metal containers. Alufoil, laminated with paper or
plastic, is frequently used as a heat-sealed membrane
hermetically closing the container, usually under a
plastic screw cap. The localized heat needed to affect
the sealing process is generated by an electrical
induction process after the screw caps are applied on
the filling and capping line. The resulting alufoil
membrane provides excellent barrier properties
preventing moisture or gas transmission and
providing tamper evidence (Damman foils, technical
literature).
PAPER AND PAPERBOARD
Paper and cardboard is a pillar of traditional
packaging materials, consumption of large, wide
range of applications, its output accounts for about
45% of the total output value package. Paper and
paperboard must be appropriate strength, impact
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resistance and wear resistance; good sealing and easy
to clean; excellent shape and fold, easy to use various
processing methods; should be in the mechanization
and automation of packaging; have the best printable,
easy introduction and landscaping products; lower
prices, and light weight, can reduce packaging costs
and transportation costs; easy to handle after use,
reuse and recycling of recyclable and will not pollute
the environment and conserve resources; paper and
cardboard containers are mainly large cardboard
boxes, cartons, paper bucket, paper bags, paper cans,
paper cups, paper plates, etc., are widely used in
transport packaging sales packaging. (Yam, K. L.,
"Encyclopedia of Packaging Technology", John
Wiley & Sons, 2009).
METAL CONTAINERS
Metal is the most adaptable of all the materials used
in the packaging; however it is used to dispense only
the non parental medicinal products since it poses the
threat of possible shedding of metal particles into the
product. Different metals like tin, aluminum and
tinplate are used in pharmaceutical industries. Metals
provide superior protection against contamination as
they impervious to light, moisture and gases. They
are also lighter in weight when compared to most
materials. The containers made from metals include
tubes, packs made from foil or blisters, cans, and
aerosol and gas cylinders (World Health Organization
WHO, 2002).
The major disadvantage that they pose is that they are
highly expensive. The collapsible metal tube is an
attractive container that permits controlled amounts
to be dispensed easily, with good re closure and
adequate environmental protection to the product.
The risk of contamination of the portion remaining in
the tube is minimal, because the tube does not "suck
back." It is light in weight and unbreakable, and it
lends itself to high-speed automatic filling operations.
The ductile metals used for collapsible tubes are tin
(15%), aluminum (60%), and lead (25%). Tin is the
more expensive than lead. Tin is the most ductile of
these metals. Tin containers are preferred for foods,
pharmaceuticals, or any product for which purity is
an important consideration. Tin is chemically inert of
all collapsible tube metals. Laminates of tin-coated
lead provide better appearance and will be resistant to
oxidation. They are also cheaper compared to tin
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alone. The tin that is used for this purpose is alloyed
with about 0.5% copper for stiffening. When lead is
used, about 3% antimony is added to increase
hardness. Lead has the lowest cost of all tube metals
and is widely used for nonfood products such as
adhesives, inks, paints, and lubricants. Aluminum
work hardens when it is formed into a tube, and must
be annealed to give it the necessary pliability
(Aulton, 2005; [SHA, web link: www.sha.org], 2012;
[DDL, web link: www.testedandproven.com], 2012).
CAPS AND CLOSURES
Closures that form part of the container-closure
system are an important component in the packaging
of sterile products (Tim Sandle, 2012). They are also
known as stoppers or bungs. Most commonly an
elastomeric closure is used. An elastomer is any
material that is able to resume its original shape when
a deforming force is removed, which is known as
viscoelasticity (Rockville, 2009). The primary
function of the closure system is to retain or contain
the contenet, safety and security may be necessary to
prevent hazards resulting in leakage, seepage,
spillage, pilferage, loss of quality, purity, etc. The
ideal closure prevents exposure of the sterile product
to both moisture and oxygen thus ensuring the
stability of the product and also prevents the contents
from escaping the container. The adequacy of the seal
is dependent on a number of factors; these include the
flexibility of the liner and the torque which is applied.
For a closure system to be effective it is essential to
consider the nature of material of container,
properties of the product and the stability
requirements. Closures may be manufactured by a
number of means of combination of pressure,
temperature and adhesion. The materials used for the
formation of closures include:
Metals like aluminium, aluminium alloys, tinplate, tin
free steel, stainless steel. Glass is used for formation
of stoppers. Rubbers and plastics are also and very
commonly and widely used for cap and closures.
Caps or overseals are used to secure the rubber
closure to the container in order to maintain the
integrity of the seal under normal condition of
handling and storage. These caps are usually made of
aluminium and may be equipped with plastic top to
facilitate opening.
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FUNCTIONS OF CLOSURES
The functions of closures in both plastic and glass
containers include inviolability, non refill ability,
measuring and pouring facilities, child resistance,
sales appeal or two or more of these functions in
combination (Frank, 1996). They can also assist in
the dispensing of product.
TYPES OF CLOSURES
The basic types of caps and closures include:
Thread Screw
This provides physical and chemical barrier to the
contents in the container. They are either made of
plastic or made of metal.
Lug Cap
This differs from the thread screw closure due to the
presence of continuous thread on the container. It is
more commonly used in food industries rather than
pharmaceutical industry.
Crown Cap
It is a crimped closure more commonly used in
beverage industry.
Rubber Closures
Rubber consists of several ingredients one of which is
an elastomer. Rubber compounds used in
pharmaceutical packaging contain only limit number
of ingredients which are difficult to extract. These
closures do not pose any problem and can be used in
contact with a large number of drug preparations.
Roll on Closure
Pilfer proof; reseal able and non reseal able type of
roll on closures are available. These are dimension
specific. Roll on closure hence require an easy to
mould material such as aluminum.
Pilfer Proof Closure
This differs from standard roll on closure in that it
has a longer skirt length. When this closure breaks at
the bridge, the bank remains at the neck of the
container. The closure can be resealed but the broken
bank indicates the seal has been broken. It requires
torque to remove the cap.
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friability, dissolution, disintegration, weight

Tamper – Evident Closures
Tamper evident closures are designed to prevent
accident and and intentional tampering to create safe
packaging. The main concept of the tamper- evident
packaging is increasingly being recognized in
pharmacopoeias. Various types of tamper evident
packaging are used in pharmaceutical industries are:
Bottles with inner mouth seals, tape seals, Breakable
cap ring system etc.
Child Resistant Closures
Child-resistant packaging or C-R packaging is
special packaging used to reduce the risk of children
ingesting dangerous items. This is often
accomplished by the use of a special safety cap. It is
required by regulation for prescription drugs, over-
the-counter medications (Sanbar, Shafeek, 2007). In
some jurisdictions, unit packaging such as blister
packs is also regulated for child safety (Smith, 2005).
CONCLUSION
Packaging is the most important component for
various drug formulations in pharmaceutical industry
and packaging of pharmaceutical dosage forms has
close relationship between a pharmaceutical
preparation and its package concern to the drug
stability and safety. The stability of pharmaceutical
drugs in solid and liquid dosage forms depends on the
efficacy of the packaging materials to protect from
chemical degradation and changes in physical
characteristics such as appearance, hardness,
variation, moisture contents and mechanical
durability. Glass, plastics, metal and paper are the
most commonly used packaging materials in
pharmaceutical industries. The selection of Packaging
material to pack pharmaceutical dosage forms are
made on the basis of its efficacy and performance
characteristics to preserve the quality, potency and
safety of the pharmaceutical products. Packaging
should provide protection, identification, information,
convenience and compliance for a product during
storage, carriage, display and until such time the
product is consumed. It has been observed that
considerable degradation of the drug resulting in
undesirable physical and chemical changes along
with some toxic effects which may be highly
hazardous to the patient. So the material selected for
packing pharmaceutical drugs must be not reactive
with products; protective from environmental
condition; not impart to the products tastes or odors;
non-toxic; FDA approved; meet applicable tamper-
resistance requirement; adaptable to commonly
employed high-speed packaging equipment. It is
intended to evaluate the shelf lives of the products
stored in different packaging materials and examine
their efficacy and performance characteristics in
maintaining the product integrity for a prolonged
period of storage.
CONFLICT OF INTERESTS
The authors declare no conflict of interests exists.

REFERENCES
[1] Ahmad, I., Sheikh, R.H. Effect of temperature and humidity on hardness and friability of packaged
paracetamol tablet formulations. Pak .J. Pharm. Sci. 1994. 7(2): 69-78 P.
[2] Ahmad, I., Sheikh, R.H. Effect of moisture on the stability of packaged paracetamol tablet formulations.
Pak. J. Pharm. Sci. 1994. 16(1): 13-16 P.
[3] Ahmad, I., Sheikh, R.H. Effect of moisture on the stability of packaged paracetamol tablet formulations.
Pak. J. Pharm. Sci. 1994. 16(1): 13-16 P.
[4] Ahmad, I., Sheikh, R.H. Effect of temperature and humidity on the disintegration time of packaged
paracetamol tablet formulations. Pak. J. Pharm. Sci. 1994. 7(1): 1-7 P.
[5] Ahmad, I., Sheikh, R.H. Prediction of shelf- life of packaged paracetamol tablet formulations. Pak. J.
Pharm. Sci. (1994). 7(1) 53-58 P.
[6] Ahmad, I., Sheikh, R.H. Stability of paracetamol in packaged tablet formulations. Pak. J. Pharm. Sci. 1993.
6(2): 37-45 P.
[7] Aulton M.E. The Science of Dosage Form Design. Second edition. 2005.
[8] Byett, J. A Handbook of Packaging Technology. Whely, NewYork. 2002.

www.ijpnr.com
~ 10~
 Arif Sabah et al / Int. J. Pharma. and Neutra. Res. Vol-1(1) 2014 [1-12]

[9] Clifford, S. "Clamshell packaging is being tossed". The Bulletin. New York Times News Service (Bend,
OR). 2011. Retrieved from: http://www.bendbulletin.com/article/20110602/NEWS0107/106020402/.
Retrieved June 6, 2011.
[10] Croce, C., Fischer, A., and Thomas, R.H. Packaging materials science, in Lackman, L, Lieberman, H. A,
and Kang, J.L, Eds. The Theory and practice of Industrial Pharmacy, 3rd ed., Lea and Febiger,
Philadelphia, Chapter 24. 1986
[11] Tim Sandle. Closures for Pharmaceutical Preparations: A Review of Design and Test Considerations.
BioPharm International. 2012. 25(12): 32-36 P.
[12] Damman foils, in Aluminum foil, Pharma foil, Aluminum foils. [online]. Available from:
www.google.com/aluminum foil as packaging material.
[13] Essuman, K. Overview of Ghanian packaging Industry: Challenges and Opportunities. Presentation at
Department of Communication Design, KNUST. Kumasi. 2008.
[14] Guidelines on packaging for pharmaceutical Products World Health Organization WHO Technical.
[report]. Report Series, No. 902, 2002
[15] SHA. Bottle finishers and closures. [online]. Assessed on: 2012 May 2. Available from:
http://www.sha.org/bottle/closures.htm,
[16] DDL. Testing Procedures. [online]. Assessed on: 2012 May 18. Available from: http://www.
testedandproven.com /package-testing/pharmaceutical-package-testing/
[17] Patel Chirag J, Satyanand Tyagi, Patel Jaimin, Patel Pinkesh, Tarun Parashar, Soniya. Pharmaceutical
Packaging: Containers & Closures Journal of Biomedical and Pharmaceutical Research. J of Biomed and
Pharm Res. 2012. 1(3): 23-32 P.
[18] Marketing Essentials. Marketing: Contemporary Conceps and Practices.” Wall Street Journal. December
21. 2003.
[19] N.K.Jain. Pharmaceutical Product development. First edition; 2006.
[20] Pilchik R. Pharmaceutical blister packaging, Part I Rationale and materials. Pharm Tech. 2000 a. 24(11): 68-
78 P. Available from: www.pharmaportal.com.
[21] Pilchik, R.. Pharmaceutical blister packaging, part II Machinery and assembly. Pharm Tech. 2000 b. 24(12):
56-60 P. Available from: www.pharmaportal.com.
[22] Prendergast P. and Pitt L. Packaging, Marketing, Logistics and the Environment: Are There Trade- Offs?
Inter J of physical Distribution and Logistics management. 1996. 26(6): 60-72 P.
[23] Richard C. Thompson1, Charles J. Moore, Frederick S. Vom Saal and Shanna H. Swan. Plastics, the
environment and human health: current consensus and future trends. Phil. Trans. R. Soc. B. 2009.
364(1526).
[24] Frank Albert Paine. Packaging of Pharmaceuticals and Healthcare Products H. Lockhart. 1996. 125 P
[25] Sciarra, J.J. Lieberman, H.A., Rieger, M.M., Banker, J.S., Eds. Aerosol suspension and emulsion, in:
Pharmaceutical Dosage Forms, Disperse System, Marcel Dekker, New York, 1996. Volume (2): 343 P.
[26] Soroka W. Fundamentals of Packaging technology, Institute of Packaging Professionals, 1996. Naperville,
Illinois, USA.
[27] Soroka, W. Fundamentals of Packaging technology, Institute of Packaging Professionals, 2002. Naperville,
Illinois, USA.
[28] Sanbar, Shafeek S. Legal medicine. Elsevier Health Sciences. ISBN 978-0-323-03753-2. 2007. 2010. 393
P.
[29] Smith G; Barone S. 2005. "PPPA, Unit Packaging". CPSC. Retrieved 25 March 2010.
[30] Umeå-study. Doctoral thesis by E. Wikstrøm, University of Umeå, Sweden The role of Chlorine during
Waste Combustion (Wikstrøm, 1999)
[31] United States Pharmacopoeia USP vol. 32, National Formulary NF vol. 27. Rockville, MD, 2009. 4133–
4140 P.

www.ijpnr.com
~ 11~
 Arif Sabah et al / Int. J. Pharma. and Neutra. Res. Vol-1(1) 2014 [1-12]

[32] Wikstrom, E. The Role of Chlorine during Waste Combustion. Thesis - Umea University; Wikstrom E.
[report]. 2000.
[33] Yam, K. L., "Encyclopedia of Packaging Technology", John Wiley & Sons. 2009. ISBN 978-0-470-08704-
6
[34] Arif Sabah, Atta Abbas, Sidra Tanwir, Farrukh Rafiq Ahmed, Adeel Arsalan, Aysha Arif, Syed Imran Ali,
Shazia Adnan, Sarah Haroon and Syed Ata Rizvi. Consumer’s perception regarding pharmaceutical
product packaging. A survey of Pakistan. 2014. Inter J of Pharm and Analytical Res. 3(1); 118-125 P.

www.ijpnr.com
~ 12~

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