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INTERNATIONAL JOURNAL OF PHARMACEUTICAL AND CHEMICAL SCIENCES ISSN: 22775005

Review Article
Recent Trends in Pharmaceutical Packaging: A Review
Mehta Kunal C*, D. Akhilesh and B. Shyam Kumar
Shree Devi College of Pharmacy, Airport Road, Mangalore, Karnataka, India.
_________________________________________________________________________

ABSTRACT
Packaging played a significant role in the pharmaceutical field as it maintains the integrity of product
by many ways, like providing presentation, protection, identification, information. Containment,
convenience and compliance for a product during storage, carriage, display and until the product is
consumed. This article reviewing the various aspects of packaging like materials used for packaging,
types of packaging as well as recent trends of pharmaceutical packaging in pharmaceutical market.

Keywords: Packaging, Glass, Plastic, Recent trends.

INTRODUCTION climatic or biological or occasionally


Packaging can be defined as an mechanical hazards that may cause or
economical means of providing lead to product deterioration. Packaging
presentation, protection, identification must also function as a means of drug
information, containment, convenience administrations.The packaging external to
and compliance for a product during the primary package is known as the
storage, carriage, display and until the secondary packaging. The secondary
product is consumed. Packaging must packaging mainly provides the additional
provide protection against climatic physical protection necessary to endure
conditions biological, physical and the safe warehousing and for refill
chemical hazards and must be packaging.(Table1)
economical. The package must ensure
adequate stability of the product Types of container used as primary
throughout the shelf life.1The external packaging for liquid orals are:
image of the package must not only Single dose containers hold the product
compliment product confidence, but that are intended for single use like glass
provide clear and concise product and ampoule.
identification and other features included
are: Multi-dose containers hold a quantity of
 Package should provide adequate the material that will be used as two or
information related to the contents more doses. Like multiple doses vial
including legal requirements, route plastic tablet bottle.
of administration, storage
conditions, batch number, expiry Well–closed containers protect the
date, manufactures name and product from contamination with unwanted
address and product license foreign materials and form loss of contents
number. during use.
 Package should assist in patient
compliance. Airtight containers are impermeable to
 Package should preferably have solids, liquids and gases during normal
an aesthetically acceptable design. storage and use. If the container is to be
The primary packaging consist of those opened on more than one occasion it must
packaging components which have a remain airtight after re closure.
direct contact with the product (i.e. bottle,
cap, cap liner, label etc). The main Light – resistant container protect the
functions of the primary package are to contents from the effect of radiation at a
contain and to restrict any chemical, wave length between 290nm and 150nm.

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INTERNATIONAL JOURNAL OF PHARMACEUTICAL AND CHEMICAL SCIENCES ISSN: 22775005

For solid dosage forms deterioration of the product, type of patient


Tamper – evident containers are closed (baby, child, teenager, adult, elderly,
containers fitted with a device that infants etc.) must be considered while
irreversibly indicates if the container has dealing with the pharmaceutical product.
been opened.
The market:The channel of sale should
Strip packages have at least one sealed be considered, i.e. where, when, how and
pocket of material with each pocket by whom it is to be used or administered
containing a single dose of the product. (e.g. doctor, dentist, nurse, patients etc),
The package is made of two layers of film whether for home trade and/ or export.
or laminate material. The nature and level The quantity per package and follow up
of protection which is required by the sale must all be care fully considered
contained product will affect the during package design and selection.
composition of these layers.
The distribution system:The distribution
Blister packages are composed of a system should be carefully monitored, e.g.
base layer, with cavities called blisters conventional wholesale/ retail outlet or
which contain the pharmaceutical product, direct or selective outlets.
and a lid. This lid is sealed to the base
layer by heat, pressure or both. They are Manufacturing facilities:The stability of
more rigid than strip packages and are not the manufacturing facilities should be
used for powders or semi-solids. In considered due to new package,
tropical areas blister packages with an increased sale, improvements in Good
additional aluminium membrane is used Manufacturing Practice, revised product,
which provide greater protection against new product etc.
high humidity.
Function of packaging
Child Resistant Containers, commonly Protective function: Protective function
referred to as CRC's, are designed to of packaging essentially involves
prevent the child accessing the potentially protecting the contents from the
hazardous product.2 environment and vice versa. The inward
protective function is intended to ensure
Containers for semisolid and full retention of the utility value of the
pressurized products: Semi solid packaged goods. In addition packaging
dosage forms like ointments, creams etc. must essentially be able to withstand the
are packed in metallic collapsible tubes. many different static and dynamic forces
Plastic containers are also used for the to which it is subjected during transport,
packaging of creams. Pressurized handling and storage operations. The
packages expel the product through a goods frequently also require protection
valve. The pressure exerted for the from climatic conditions, such as
expulsion of the product is an important temperature, humidity etc.
consideration while selecting the
packaging for any products. Storage function: The materials used for
packaging should be stored properly so as
Factor influencing the choice of to preserve the quality of the material both
package:It is essential to have a survey before packaging and once the package
about the market, the distribution system, contents have been used.
manufacturing facilities and other
considerations before selecting the Loading and transport functions
packaging material. Packaging should therefore be deigned to
be easily handled and to permit space-
The product:The physical and chemical saving storage and stowage. The shape
characteristics of the drug entity, the and strength of packages should be such
excipients, the formulation, route of that they may not only be stowed side by

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INTERNATIONAL JOURNAL OF PHARMACEUTICAL AND CHEMICAL SCIENCES ISSN: 22775005

side leaving virtually no voids but may also being to protect with a rigid outer package.
stowed safely one above the other. Top pressure or loading can distort inside.

Properties of packaging materials Vibration


Mechanical Properties:The materials Vibration consists of two variables-
used should possess sufficient mechanical frequency and amplitude. Considerable
strength to withstand while handling, vibration may occur during transport,
filling, closing and processing. Typical especially with exported items. Damage
care is needed during transport, storage may be external, such as the 'scuffing' of
and also at the time of usage by the labels, but some products may be affected
consumer especially in case of glass like the cracking of emulsions, abrasion of
containers. tablets, or segregation of mixed powders.

Physical properties Environmental hazards: Environmental


 The packaging must have a conditions encountered by the package
suitable size, thus, rubber may are likely to vary considerably, especially
presents problems if it perishes. in articles for export to the tropical areas.
 The material must protect from
light if necessary, that is, it must be Temperature:Extreme conditions may
ultraviolet absorbent. cause deterioration, low temperatures
 The container must not absorb leading to aqueous solutions freezing and,
substances from the products; e.g. hence, to fracture of containers.
absorption of water from creams in
to cardboard box. Moisture:Moisture as liquid or water
vapour may cause physical changes (e.g.
Chemical properties color fading, softening, hardening etc.) or
 The product should not react with chemical changes (hydrolysis, oxidation,
the container or closure , as might effervescence etc.).
happen if alkaline substances are
placed in aluminium containers. Pressure:Decrease in pressure, as in
 The container or closure must not mountainous regions or during flight in
yield substances to the product; for non-pressurized transport aircraft, may
example, alkali from glass, cause thin containers to burst or strip
plasticizers from plastics etc. packs to inflate.

Biological properties Biological hazards:The packaging


The material of the container must be able materials must be reasonably clean
to withstand attack by insects if this initially and when put together to form a
hazard is likely to be encountered. The finished package and restrict any further
packing should not support mould growth. contamination as much as possible. In the
case of sterile products the package and
Hazards encountered by package its closure must maintain a 100% effective
Mechanical hazards seal against microbiological contaminants
Shock or impact damage:Damage due like bacteria, moulds and yeasts.
to shock is usually caused by rough
handling, during transport etc. Cushioning Chemical Hazards:The main risk of
can be provided and a warning label may chemical hazard is due to interaction or in
be useful. Restriction of movement and compatibility between the product and
more careful handling should be made. package. These may be associated with
interaction or contamination, covering
Compression migration, absorption, adsorption,
Fragile items may be broken, or extraction, corrosion, etc.
collapsible articles crushed by
compression, the usual procedure then

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INTERNATIONAL JOURNAL OF PHARMACEUTICAL AND CHEMICAL SCIENCES ISSN: 22775005

Packaging materials used in different packaging systems that are capable of


formulations meeting the requirements of tamper-
Paper and board:The use of paperboard resistant packaging as defined by FDA
materials remains a significant part of regulation
pharmaceutical packaging in spite of the 1. Filmwrappers
facts that paper is rarely used on its own 2. Blisterpackage
for a primary package. Cartons are used 3. Strippackage
for a high percentage of pharmaceutical 4. Bubblepack
products for a number of reasons, 5. Shrinksealandbands
increasing display area, providing better 6. Foilpaperorplasticpouches
display of stock items and the collating of 7. Bottleseals
leaflets which would otherwise be difficult 8. Tapeseals
to attach to many containers. Cartons also 9. Sealedtubes
provide physical protection especially to 10. Aerosolcontainers
items such as metal collapsible tubes. 11. Sealed cartoon
Carton therefore tend to be a traditional of
pharmaceutical packaging. Film wrapper:Film wrapping has been
used extensively over the years for
Rubber based components: Rubber products requiring package integrity or
components may be made from either environmental protection. Film wrapping
natural or synthetic sources. Natural can be accomplished in several ways and
rubber has got good resealing, varies in configuration with packaging
fragmentation and coring when compared equipment.
to synthetic rubber; but is poor in respect
to ageing and chances of moisture and Fin seal wrapper:The seal are formed by
gas permeation and the absorption of crimping the film together and sealing
preservative systems is more. Most rubber together the two inside surface of the film,
formulation are relatively complex and producing a "fin" seal Since the seals are
may contain one or more of the formed by compressing the material
vulcanizing agents, accelerators, fillers, between two heater bars rather than
activators, pigments, antioxidants, sealing against the package. When more
lubricants, softeners or waxes3. consistent and greater sealing pressure is
applied, better seal integrity can be
Tamper resistant packaging:The accomplished .For this reason, fin sealing
requirement for tamper –resistant has primarily been used when protective
packaging is now one of the major packaging is critical . Since the surface of
consideration in the development of the heat seal dose not come in contact
packaging for pharmaceutical products As with the heated sealing bars on the
defined by the FDA "a tamper –resistant packaging equipment, much more
package is one having an indicator or tenacious heat sealants such as
barrier to entry which, if breached or polyethylene can be used.
trussing ,can reasonably be expected to
provide visible evidence to consumers that Shrink Wrapper: Film over wrapping can
tampering has occurred tamper –resistant also be accomplished with the use of a
packaging may involve immediate – shrink wrapper .The shrink wrap concept
container /closure systems or secondary – involves the packaging of a product in a
container /carton systems or any thermoplastic film that been stretched and
combination thereof intended to provide a oriented during its manufacture and that
visual indication of package integrity when has the property of reverting back to its
handled in a reasonable manner during un-stretched dimension once the
manufacture ,distribution ,and retail molecular structure is "unfrozen " by the
display4. application of heat.
The following package configuration have
been identified by the FDA as examples of

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Blister Package: This packaging mode access to the product can only be attained
has been used extensively for by irreparably destroying the seal. Various
pharmaceutical packaging for several inner seal compositions may be used, but
good reasons. It is a packaging the structures most frequently
configuration capable of providing encountered are glassine and foil
excellent environmental protection, laminations
coupled with an esthetically pleasing and
efficacious appearance. Tape Seals: Tape sealing involves the
application of a glued or pressure-
Strip Package: A strip package is a form sensitive tape or label around or over the
of unit dose packaging that is commonly closure of the package, which must be
used for the packaging of tablets and destroyed to gain access to the packaged
capsules. A strip package is formed by product. The paper used most often is a
feeding two webs of a heat-sealable high-density lightweight paper with poor
flexible film through either a heated tear strength.4
crimping roller or a heated reciprocating
plate. The product is dropped into the FDA regulation: Food and Drug
pocket formed prior to forming the final set Administration evaluates a drug and the
of seals agency must be firmly convinced that the
package for a specific drug will preserve
Bubble Pack: The bubble pack can be the drug's efficacy as well its purity,
made in several ways but is usually identity, strength and quality for its entire
formed by sandwiching theproduct shelf life. Under the provisions of the Food
between a thermoform able, extensible, or and Drug Administration Act , however, no
heat-shrinkable plastic film and a rigid specifications or standards for containers
backing material. or container closures are provided.5 Under
the Act, it is the responsibility of the
Shrink Banding:The shrink band concept manufacturer to prove the safety of a
makes use of the heat-shrinking packaging material and to get approval
characteristics of a stretch-oriented before using it for any pharmaceutical
polymer, usually PVC. The heat- product. The Food and Drug
shrinkable polymer is manufactured as an Administration does not approve
extruded, oriented tube in a diameter containers as such, but only the materials
slightly larger than the cap and neck ring used in the container are approved. A list
of the bottle to be sealed. The heat- of substances considered "Generally
shrinkable material is supplied to the Recognised As Safe" (GRAS) has been
bottler as a printed, collapsed tube, either published by the FDA. In the opinion of the
pre-cut to a specified length or in roll form qualified experts they are safe under
for an automated operation. specified conditions, assuming they are of
good commercial quality. A material that is
Foil Paper or Plastic Pouches:The not included under GRAS or prior
flexible pouch is a packaging concept sanction, and is intended to be used with
capable of providing not only a package food, must be tested by the manufacturer,
that is tamper-resistant, but also by the and the data must be submitted to the
proper selection of material, a package FDA.5The specific FDA regulation states
with a high degree of environmental that "containers, closures and other
protection.A flexible pouch is usually component parts of drug packages, to be
formed during the product filling operation suitable for their intended use, must not be
by either vertical or horizontal forming, reactive, additive or absorptive to an
fillingandsealing(f/f/s)equipment. extent that the identity, strength, quality or
purity of the drug will be affected." The
Bottle Seals: A bottle may be made packaging material must be approved for
tamper-resister by bonding an inner seal such use, along with the drug, before
to the rim of the bottle in such a way that going to the market. The drug

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INTERNATIONAL JOURNAL OF PHARMACEUTICAL AND CHEMICAL SCIENCES ISSN: 22775005

manufacturer must include data on the there is an increasing need to provide


container and package components in tailored, individual packaging solutions,
contact with the pharmaceutical product in which guarantee the effectiveness of
its New Drug Application (NDA). If the medicines. Due to degradation from
FDA can determine that the drug is safe environmental factors, such as light and
and effective, and that the package is humidity, there is often a direct link
suitable, it approves the drug and between packaging and a remedy’s
package. Once approved, however, the effectiveness.Packaging of oral medicines
package may not be altered in any generally conforms to requirements for
manner without prior FDA approval. In the easy dispensing, child resistance but
case of plastics, most resin manufacturers senior-friendliness, but packs must also be
maintain Master Files on their resins with identifiable, functional and very often
the FDA. Upon request from the resin hermetically sealed. However, some
manufacturer, the FDA uses this file as a innovations provide added benefits in one
reference to support a New Drug area but may not conform to the expected
Application that which a drug standards governing another. For
6
manufacturer files. instance, blister packs provide
convenience and ensure hygiene. They
RECENT TRENDS IN are ideal for our fast-paced lifestyles and
PHARMACEUTICAL PACKAGINGE IN the need to take medication on the go
INDUSTRY and, as a result, there has been a large
The pharmaceutical packaging market is increase in their use. Indeed, blister
constantly advancing and has experienced packaging has provided the best
annual growth of at least five per cent per worldwide growth among all
annum in the past few years. The market pharmaceutical packaging products, with
is now reckoned to be worth over $20 demand increasing 6.2 per cent annually
billion a year. As with most other to over $4 billion in 2006.Advances in the
packaged goods pharmaceuticals need packaging machines themselves has seen
reliable and speedy packaging solutions the incorporation of precise filling
that deliver a combination of product mechanisms, as the wrong dosage of a
protection, quality, tamper evidence, medicine could be life threatening. Gentle
patient comfort and security needs. handling is also essential and packs
Constant innovations in the should be hermetically sealed for higher
pharmaceuticals themselves (such as product safety. A solution to achieve
prefilled syringes, blow fill seal vials, hermetically sealed packs for blister, blow-
powder applications and others) also have fill-seal pouches, vials and other products
a direct impact on the is to overwrap them into a horizontal flow
packaging.Traditionally, the majority of wrap. These flow wraps consist of a foil
medicines (51%) have been taken orally laminate that is able to increase the shelf
by tablets or capsules, which are either life of the product as well as to ensure
packed in blister packs (very common in 100% tightness.Some packaging needs
Europe and Asia) or fed into plastic are not driven by the need for hygiene,
pharmaceutical bottles (especially in the safety or traceability. The increased focus
USA). Powders, pastilles and liquids also on marketing of pharmaceutical products
make up part of the oral medicine intake. will become even more important in the
However, other methods for taking future and will drive factors such as the
medicines are now becoming more widely need for flexibility in terms of various pack
used. These include parenteral or types and sizes. Other needs are simply
intravenous (29%), inhalation (17%), and driven by costs as pharmaceutical
transdermal (3%) methods. Oral tablets manufacturers face increased cost
themselves are also now available in a pressures throughout the entire production
wide range of different shapes and and packaging process. As a result,
sizes.These changes have made a big packaging machines have to become
impact on the packaging industry and more efficient and user friendly, offering

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INTERNATIONAL JOURNAL OF PHARMACEUTICAL AND CHEMICAL SCIENCES ISSN: 22775005

flexibility, easy operation, robustness, from GBI's , the global pharma industry is
intelligence and protection from currently witnessing rapid expansion with
interference. It is a challenge to cover all advances in manufacturing processes,
aspects at once. technology innovation and integration,
The ongoing globalization trend with which are the main driving forces behind
extended competitive landscape in the the growth of the pharma packaging
pharmaceutical industry will lead to industry, globally. The growth is likely to
smaller batch sizes. If existing packaging be high in emerging economies like India
equipment is used, this will have a and China, primarily on account of
negative effect on productivity, as older increasing generics and contract
machines are often not designed for quick manufacturing activities in these countries.
changeovers and flexibility. New The fastest growth in pharma packaging
packaging lines will have to offer high market is expected from prefillable
flexibility while maintaining production syringes and parenteral vials, which will
levels. World demand for pharmaceutical continue to expand as advances in
packaging is forecast to rise 5.5 percent biotechnology result in the introduction of
annually through 2015. The developed new therapies that must be injected. The
countries of Western Europe, the US and increasing demand for biologics will boost
Japan will account for over 70 percent of the demand for innovative product
the amount, although China will provide packaging solutions in the global pharma
faster growth opportunities. India and packaging market. Also, with more than
Brazil will also evolve into fast-growing $120 billion worth of drugs going off-patent
markets.This study analyses the $47.2 in the next five years, generic drug
billion world drug packaging industry. It manufacturers will emerge as a major
presents historical demand data for the segment driving demand for pharma
years 2000, 2005 and 2010, and forecasts packaging.8
for 2015 and 2020 by raw material (e.g., Nanotechnology, the science of very small
plastic resins, paper and paperboard, materials, is poised to have a big impact in
glass, aluminium foil), product group (e.g., pharma packaging and will enable it to
primary containers, closures, labels, bring innovative and new generation
secondary containers, prescription packaging solutions to market. Increasing
containers, accessories), world region and demand for drug delivery devices and
for 14 countries7.Strong growth in blister packaging will also boost the
emerging markets such growth of pharma packaging industry. The
as India and China has contributed to an global market for nano-enabled packaging
increase in revenue optimism. The for blisters was $941 million in 2008 and is
packaging sector in India is growing expected to grow to $2.10 billion by 2014.
considerably and is expected to increase To conclude, India pharma packaging
over the next two years, due to the high industry has come a long way and is due
demand from industry sectors such as for more growth. With globalisation many
food and beverage and pharmaceutical MNC's in the field are setting up their
packaging. Moreover, the global market manufacturing bases in India and this will
recovery will aid growth expectations as it further revolutionise the pharma
will result in increased demand for packaging market in India. Increasing
packaging machinery. Additionally, the top availability of better quality technology and
priorities for the global packaging industry new packaging machines in the country
in 2012 are 'improving operational are some of the reasons for this rapid
efficiency', 'new products and services', growth. Also the tremendous rise in health
and 'expand in current market'. awareness amongst people will continue
Furthermore, a total of 28% of to create more demand for hygienic,
respondents from global packaging tamper resistant and use-and-throw
buyers, and 36% from suppliers, anticipate packaging in the future.9
a minimum of 2% increase in their current Global packaging industry is worth US$
workforce.According to a research report 424 billion and out of this Europe has

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INTERNATIONAL JOURNAL OF PHARMACEUTICAL AND CHEMICAL SCIENCES ISSN: 22775005

US$127 billion, Asia has US$114 billion, China) countries have been provided. Key
North America has US$ 118 billion, Latin cost and developmental issues have also
America has US$ 30 billion, and other been addressed. The report also provides
countries have $US 30 billion. In terms of an indepth analysis of the competitive
global market percentage, Europe is 30%, landscape, including the benchmarking of
North America is 28%, Latin America is top companies, key trends on mergers
7%, Asia is 27% and other is 8% of global and acquisitions, and licensing
packaging industry.According to the agreements involving pharma
materials used in packaging industry packaging.10(fig1)
throughout the globe, paper shares the The global pharma packaging market was
most, 36%, metal is 17%, plastic takes valued at $47.8 billion in 2010. The market
34%, glass takes 10% and other occupies is forecast to grow at a compound annual
3%.According to the type of packaged growth rate (CAGR) of 7.3 per cent from
products, Beverages take 18%, food take 2010–2017, to reach a value of $78 billion
38%, pharmaceutical products take 5%, by 2017. The global pharma industry is
cosmetic products take 3% and other currently registering rapid expansion, with
products take 36% of overall packaging advances in manufacturing processes,
industry. Global market value on food and technology innovation and integration,
packaging is 161 US$ billion, beverage which are the main factors behind the
packaging is 76 US$ billion, growth of the pharma packaging industry
Pharmaceutical packaging is 21 US$ globally. This growth is expected to be
billion, cosmetic packaging is 13.3 US$ highest in the emerging economies of
billion and other is 153 US$ billion. India and China, primarily on account of
increasing generics and contract
Global market trends manufacturing activities in these
Report also reveals the trend of global countries.(fig2)
packaging industry, which is as below: The pharma packaging industry will
2004:Total market value was 405 $US continue to grow as drugs worth $142
billion(approx.), billion go offpatent in the next five years,
2005:The total market value was 425 $US expanding the generic market and the
billion(approx.) entire pharma packaging industry. The
2006:Total market value was 440 $US fastest growth in the pharma packaging
billion(approx.) market is expected to come from
2007: Total market value expected to prefillable syringes and parenteral vials,
reach 465 $US billion (approx.) and in the which will continue to expand as advances
year 2008, it may reach 480 $US in biotechnology lead to the introduction of
billion(approx.) and by the end of the year new therapies that must be injected. The
2014 it may touch 585 $US billion increasing demand for biologics will
(approx.).Presently the average annual strengthen demand for innovative product
growth rate is nearly 3.5%, which is packaging solutions in the global pharma
expected to touch US$597Bn by 2014 packaging market. All these factors, along
Pharmaceutical Packaging Industry - 2011 with the growing pharma industry, will
Yearbook provides insights into the global continue to drive demand for packaging.
pharma packaging market, with coverage However, the packaging industry will have
of the market landscape, key market to overcome challenges, such as the
trends, market drivers and restraints. The availability and price volatility of raw
report provides market forecasts for the materials and changing health regulations,
global pharma packaging industry until in order to meet increasing demand from
2017. the growing pharma industry.11
The geographical distribution of pharma
packaging manufacturers across key CONCLUSION
geographies, such as the US, the top five The study is intended to benefit existing
countries in the European region, Japan manufacturers of pharmaceuticals who
and BRIC (Brazil, Russia, India and seek to expand market opportunities. It

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INTERNATIONAL JOURNAL OF PHARMACEUTICAL AND CHEMICAL SCIENCES ISSN: 22775005

also can serve as a reference for pharma markets around the globe. The main
packaging industry players who would like objective of this review is to understand
to expand to nano-enabled technologies the current state of nano-enabled
for drug packaging. This study also packaging in the pharmaceutical industry,
provides the most complete accounting of market opportunities, the companies
nano-enabled packaging of involved, technologies being pursued and
pharmaceutical products in various intellectual property (IP) trends.12

Fig. 1

Table: 1
Types of primary and secondary packaging material

Material Type Example of use

Glass Primary Metric medical bottle, ampoule, vial

Plastic Primary Ampoule, vial, infusion fluid container, dropper bottle

Secondary Wrapper to contain primary pack

Cardboard Secondary Box to contain primary pack

Paper Secondary Labels, patient information leaflet

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Fig. 2

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