2. CONTENTS
• Introduction
• Functions of packaging
• Types of packaging
• Different types of dosage forms and their packaging
• FDA Regulation
• Recent trends in pharmaceutical packaging in industry
• Conclusion
• References
3. INTRODUCTION
• The pharmaceutical packaging can be defined as an economical means of providing
presentation, protection, identification, information, containment, convenience
and compliance for a product during storage, carriage, display and until the product
is consumed.
• Packaging must provide protection against climatic conditions biological, physical
and chemical hazards and must be economical. The package must ensure adequate
stability of the product throughout the shelf life.
Some factors that may influence the pharmaceutical pack:
• The type of dosage form
• The route or mode of administration
• The type of pack
4. • The type of dosage form: It is related to the physical state i.e solid, liquid, gas.
Solid may be regular, irregular i.e powders, tablets, capsules etc
Liquid may be based on water, alcohol, solvents i.e solutions, suspension, emulsion etc
Gas may be liquefied, pressurized i.e inhalational, aerosols.
• Route or mode of administration : The route of administration may make certain packaging
features desirable or necessary :
Oral: dispensing, dosing,with absorption occurring between mouth & colon.
Local: topical application to the skin hair
Parentrals (large & small volume):sterile products administered intrvaneously, intramuscularly,
intrathecally , subcutaneously etc, in single or multi-dose packs.
Orifice introduction: ear, eye, nose, rectal, vaginal,etc
• Type of pack / material : it refers to either the basic materials employed i.e glass, plastic ,
metal etc, or the pack style / type e.g bottle, tube, sachet, blister.
5. • A pack has a number of functions to perform during its life, including storag, carriage ,
display ,sale , etc.
Choice of packaging
The choice of packaging for any specific pharmaceutical product is dependent on the following
principle factors :
• The nature of product itself- its chemical activity, moisture sensitivity, effect oxygen and its
compatibility with possible packaging materials
• The type of patient- e.g. Child, elderly adult, male or female, ethnic origin
• The form of the dose- free flowing granules ,aqueous solution, cream, ointment, inhalation
etc.
• Method and site of administering the medication i.e topical, parenteral, ear, eye, nose, skin
etc .whether a dispensing devices is to be used e.g.syringe, dropper etc.
• Method of distribution- Ethical through pharmacies and hospitals or OTC through retail
outlets.
• Required shelf life and likely sales areas
6. FUNCTIONS OF PACKAGING
The various functions of packaging are
1. Protective function
2. Storage function
3. Loading & Transport functions
4. Identification
1. Protective function
Protective function of packaging essentially involves protecting the contents from the
environment and vice versa.
2. Storage function
The materials used for packaging should be stored properly so as to preserve the quality of the
material both before packaging and once the package contents have been used.
3. Loading and transport functions
Packaging has a crucial impact on the efficiency of transport, handling and storage of goods.
Packaging should therefore be deigned to be easily handled and to permit space-saving storage.
7. 4. Identification
The packaging should give clear identification of the product at all stages. The life
of the patient may depend upon rapid and correct identification in emergencies.
It covers some of the points:
• type of product
• product trade name
• strength
• quantity
• batch number
• expiry date
• storage instruction
8. TYPES OF PACKAGING MATERIALS:
Major packaging types are:
• Primary and intermediate packaging.
• Secondary packaging.
Primary and Secondary packaging material
Material Type Example of use
Plastic Primary infusion fluid container, dropper
bottle
Glass Primary Metric medical bottle, ampoule, vial
Metal Primary Aerosols, collapsible tube, blister
packaging
Paper Secondary Labels, patient information leaflet
Cardboard Secondary Box to contain primary pack
Gas
Cylinders
Primary Pressurized containers
Rubber Primary Closures, including plungers
9. Paper & board based packaging materials and their use in pack security system
Paper and boards are used in the following pharmaceutical packaging applications :
• Labels & leaflets
• Wrapping materials
• Bags & sacks
• Collapsible & cartons & boxes
• Shipping & transit outers
• Gummed tapes
• Composite tube & drums
• Paper liners & lamination
10. Glass container used as packaging material
Glass has been an efficient container in the pharmaceutical & cosmetic industries. It is
economical & can be handled at high speeds in production line, is inert and provide good
product representation.
Advantages:
1. Superior protective qualities
2. Economical
3. Readily available in a wide variety of sizes & shapes
4. Essentially chemically inert
11. Type of glass containers:
Type 1 —Borosilicate Glass:
Borosilicate Glass is a highly resistant glass.
Type 2 —Treated Soda-Lime Glass
Type II containers are made of commercial soda-lime glass that has been de-alkalized, or
treated to remove surface alkali. The de-alkalizing process is known as "sulfur treatment“.
Type 3—Regular Soda-Lime Glass
Containers are untreated and made of commercial soda-lime glass of average or better than-
average chemical resistance.
12. • General-Purpose Soda-Lime Glass
Containers made of soda-lime glass are supplied for non-parenteral products, those
intended for oral or topical use.
• Ampoules
Ampoules are thin-walled glass containers, which after filling, are sealed by either tip
sealing or pull sealing. The contents are withdrawn after rupture of the glass, or a single
occasion only.
These are great packaging for a variety of drugs. The filed – in product is in contact with
glass only and the packaging is 100% tamper proof.
• Bottles, vials and syringes
These are more or less thick walled containers with closures of glass or of material other
than glass such as plastic materials or elastomers.
13. Plastics used as a packaging materials
Plastics are mainly produced by the process of polymerization which may be either
addition or condensation polymerization.
Polymers used for production of plastics:
Commonly used
polymers
Less commonly used
Polymers
Polyethylene Polymethylmethacrylate
Polypropylene Polyethylene terephthalate
Polyvinylchloride Polytrifluoroethylene
Polystyrene Aminoformaldehydes
14. Advantages of Plastic Containers
• Low in cost
• Light in weight
• Durable
• Pleasant to touch
• Flexible facilitating product dispensing
• Odorless and inert to most chemicals
• Unbreakable
• Leak proof
• Able to retain their shape throughout their use
Metal container used as packaging materials
Metals are the choice for both primary & secondary pharmaceutical packaging.
Form ,excellent tamper-evident containers, metals are strong, impermeable to gasses.
Metals are ideal packaging material for pressurized containers
15. Tin
Tin containers are preferred for foods, pharmaceuticals
Aluminum
Aluminum tubes offer significant savings in product shipping costs because of their light weight.
They provide good appearance.
Aluminum foil used as laminations for blisters, strips & sachet packs.
Lead
Lead has the lowest cost of all tube metals and is widely used for nonfood products such
as adhesives, inks, paints,
Linings
If the product is not compatible with bare metal, the interior can be flushed with wax-type
formulations or with resin solutions,
16. Rubbers used in packaging
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.
o BUTYL RUBBER
They are relatively cheaper compared to other synthetic rubbers
o NITRILERUBBER
Oil resistant due to polar nitrile group. Heat resistant
o CHLOROPRENE RUBBERS
Oil resistant. Heat stability is good
o SILICON RUBBERS
Heat resistance. Extremely low absorption and permeability of water.
17. DIFFERENT TYPES OF DOSAGE FORMS AND THEIR PACKAGING
Solid dosage forms : Tablets , Capsules
Liquid dosage forms : Solution , suspension , emulsion
Semisolids : Ointment , gels, creams
Parentrals / sterile products
Meter dose products: Aerosols, inhalers
Opthalmics preparations
Biotechnological products
Transdermal products
Temper resistant packaging
Contraceptives
18. Solid dosage forms packaging :
It includes different types of packaging like blister packaging, strip packaging, sachet
packaging, aluminum foil ( alu alu) packaging.
• Blister packaging :
Blister packs originally consisted of a thermoformed plastic tray with a lidding material made
from plastic, paper, foil or a combination of these.
It is a packaging configuration capable of providing excellent environmental protection.
Fig : Blister packaging process
The blister is prepared from:
polyvinylchloride (PVC)
PVC / polyethylene combinations
Polypropylene& polystyrene.
19. Fig: Unit dose packaging of tablet & capsules
Liquid dosage form packaging:
Traditionally glass has been the material of choice for the packaging of liquids, but a variety of
plastics is now also widely used as they have little or no permeability for liquids.
• Glass / polyethylene bottles are used for liquid packaging.
They can be be as follows:
(i) Narrow mouth
(ii) Wide mouth
(iii)Coloured mouth
20. (i)Wide mouthed bottles: These are used for high viscosity liquids or for
suspensions.
(ii) Narrow mouthed bottles: For low viscosity liquids e.g. gargles, mouth washes,
mixtures, elixirs narrow mouthed bottle is used.
(iii)Coloured flutted bottles: Liquid preparations for external uses like lotion,
liniments, paints etc. are supplied in coloured fluted bottles in order to distinguish
them from preparations meant for internal use.
Fig: Liquid dosage form packaging
21. Semisolids products packaging:
Semisolids products like creams, gels , ointments , pastes should be packed in jars of wide
mouth made from either glass or plastic.
Collapsible tubes are use for packaging of semisolids. Ointments, pastes, gels are packed in
plastic or metal tube ( aluminum)
Fig: Semisolids products packaging
22. Parentrals / Sterile products:
The efficacy, stability and safety of a parenteral drug on storage and administration
depends largely on the nature and performance of the packaging components.
Four main materials are used
1 glass
2 plastics
3 aluminium
4 rubber
• Glass
Glass is available in four types, i.e. types I, II, III, NP (USA)
• ampoules—single or double ended, open or closed (always single use containers)
• vials—normally produced from pregraded tubing and used as single dose or
multidose containers.
23. • Plastics
The main economical plastics used in pharmaceutical applications are the ‘four’ i.e.
polyethylene, polypropylene, polystyrene and polyvinylchloride.
• Aluminium
Aluminium is used as an overseal to effect a seal between the rubber disc or plug and
vial. An overseal must be rigid, yet sufficiently ductile and malleable to be clamped
onto the vial.
• Rubber and elastomers
Rubber components are now used extensively for many parenteral packaging and
administration applications including injection vials and prefilled syringes.
• Injections:
Injection are placed either in a single-dose or multiple-dose container.
25. Large volume parentrals:
LVP solutions are typically bags or bottles containing larger volumes of intravenous
solutions.
Common uses of LVP solutions without additives include:
1) correction of electrolyte and fluid balance disturbances;
2) nutrition;
3) vehicle for administering other drugs.
• Large volume parenteral solutions are packaged in containers holding 100 ml or more.
There are three types of containers:
a) glass bottle with an air vent tube
b) glass bottle without an air vent tube,
c) plastic bags.
26. Fig: Large volume parentrals
Opthalmics product:
Most liquid ophthalmic products on the market are packaged in plastic containers fitted with
nozzles from which, by gentle squeezing, the contents may be delivered as drops.
Materials used in plastic bottle is low density polyethylene.
Semi-solid products have been packed in collapsible tin tubes.
Fig: Eye drops
27. Fig: Eye ointment
Fig: Occular inserts
Tamper resistant packaging :
Tamper-evident packaging, or TEP, means packaging that has an indicator or barrier to entry
which, if broken or missing, provides the consumer with visible or audible evidence that
tampering may have occurred.
It helps consumers recognise if the packaging has been opened, damaged or tampered with.
28. Fig:Temper resistant packaging
Meter dose products : Aerosols, inhalers
The pressurized metered-dose products was introduced to deliver the medications in a
convenient and reliable multi-dose presentation.
29. Fig: Aerosol Products
Foam type aerosol
The key components of the meter dose device which plays important roles in the
formation of the spray, and in determining drug delivery are as follows:
Container
Propellants
Drug Formulation
Metering Valve
Actuator
30. Biologics products:
The biologics is the lyophilized products that must be stored in a freezer until it is
reconstituted with sterile water for injection & administered.
Fig: Vaccine
Transdermal products:
Transdermal products are designed to support the passage of drug substances from the surface of
the skin through its various layer & into its systemic circulation.
31. Transdermals may be made from number of layers including,
• An occlusive backing membrane ( protect the system from environment)
• A drug reservoir
• A release liner, removed before application ( enables drug release)
• An adhesive layer ( maintain contact with skin after application).
• Transdermals are packaged in an individual sealed packets to preserve & and protect them
until use.
Fig: Transdermal products
32. Contraceptives Packaging:
These medication containers are useful in assisting patients to adhere to there medication
schedule.
These containers have individual compartments for daily medication & generally hold a
week’s supply.
Fig: Plastics packaging used for oral contraceptives
33. FDA Regulation:
• Food and Drug Administration evaluates a drug and the agency must be firmly
convinced that the package for a specific drug will preserve the drug's efficacy as
well its purity, identity, strength and quality for its entire shelf life.
• Under this Act, the manufacturer has responsibility to prove the safety of a
packaging material and to get approval before using it for any pharmaceutical
product.
• The specific FDA regulation states that "containers, closures and other component
parts of drug packages, to be suitable for their intended use, must not be reactive,
additive or absorptive to an extent that the identity, strength, quality or purity of the
drug will be affected.“
34. RECENT TRENDS IN PHARMACEUTICAL
PACKAGING IN INDUSTRY
• The pharmaceutical packaging market is constantly advancing and has experienced
annual growth of at least five per cent per annum in the past few years.
• Constant innovations in the pharmaceuticals themselves (such as prefilled syringes,
blow fill seal vials, powder applications and others) also have a direct impact on
the packaging.
• Traditionally, the majority of medicines (51%) have been taken orally by tablets or
capsules, which are either packed in blister packs (very common in Europe and
Asia) or fed into plastic pharmaceutical bottles (especially in the USA).
• Powders and liquids also make up part of the oral medicine intake. However, other
methods for taking medicines are now becoming more widely used. These include
parenteral or intravenous (29%), inhalation (17%), and transdermal (3%) methods.
35. • The fastest growth in pharma packaging market is expected from prefillable
syringes and parenteral vials, which will continue to expand as advances in
biotechnology result in the introduction of new therapies that must be injected. The
increasing demand for biologics will boost the demand for innovative product
packaging solutions in the global pharma packaging market.
• Nanotechnology, the science of very small materials, is poised to have a big impact
in pharma packaging and will enable it to bring innovative and new generation
packaging solutions to market. Increasing demand for drug delivery devices and
blister packaging will also boost the growth of pharma packaging industry.
36. CONCLUSION
• Packaging plays 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.
• It explains the various aspects of packaging like materials used for
packaging,types of packaging, different dosage forms packaging as well as
recent trends of pharmaceutical packaging used in pharmaceutical market.
39. QUALITY CONTROL TESTS FOR GLASSES
1) CHEMICAL RESISTANT OF GLASS CONTAINERS
A) POWDERED GLASS TEST:
It is done to estimate the amount of alkali leached from the powdered
glass
Procedure:
•10gm sample is added with 50ml of high purity water in a 250ml flask
.
•Place it in an autoclave at 121⁰C±2⁰C for 30min.
• Titrate immediately with 0.02N sulphuric acid using methyl red as an
indicator and record the volume.
39
40. B) WATER ATTACK TEST:
This is only for treated soda lime glass containers .Principle
involved is whether the alkali leached or not from the surface of the
container.
Procedure:
• Fill each container to 90%of its overflow capacity with water and is
autoclaved at 121⁰C for 30min
• which is titrated with 0.02N sulphuric acid using methyl red as an
indicator.
•The volume of sulfuric acid consumed is the measure of the amount
of alkaline oxides present in the glass containers.
40
41. 41
TESTS CONTAINER VOL.OF 0.02N H2SO4
Powdered glass test Type I
Type II
Type III
1.0
8.5
15.0
Water attack test Type II(100ml or
below)
Type II(above 100ml)
0.07
0.02
42. 2) THERMAL SHOCK TEST:
•Place the samples in upright position in a tray.
•Immerse the tray into a hot water for a given time and transfers to cold
water bath, temp of both are closely controlled.
•Examine cracks or breaks before and after the test.
•Small bottles withstand a temp differential of 60 to 80⁰C and 1 pint
bottle 30 to 40⁰C.A typical test uses 45C temp difference between hot
and cold water.
3)LEAKAGE TEST:
Drug filled container is placed in a container filled with coloured solution
(due to the addition of dye)which is at high pressure so that the
coloured solution enters the container if any cracks or any breakage is
present.
42
43. 4) INTERNAL BURSTING PRESSURE TEST:
The most common instrument used is American glass research
increment pressure tester .
43
The test bottle is filled with water and
placed inside the test chamber
A scaling head is applied and the internal
pressure
The bottle can be checked to a preselected
pressure level and the test continues until
the container finally bursts.
44. TEST FOR PLASTIC CONTAINERS
1.Leakage test:
2. Collapsibility test:
• Applicable to containers which are to be
squeezed in order to remove contents.
• During use it should yield 90% of its contents at
required rate of flow at ambient temp. 44
Fill 10
containers
with water
Fit with
closures
Keep them
inverted at
room temp.
24hrs
No
signs of
leakage
45. 3. Clarity of aqueous extract
Select unlabelled portion from a suitable containers
Cut these portions into strips
Wash it with extraneous matter by shaking with two separate portions
of distilled water
Transfer to flask – previously washed with chromic acid
Add 250ml d.w.
Cover the flask autoclave at 121Ċ, 30min
Colourless , free from turbidity
46. 4.WATER VAPOUR PERMEABILITY
• Fill 5 containers with nominal volume of water and heat seal the
bottles with aluminium foil.
• Weigh accurately each container and allow to stand for 14 days
humidity(60±5%) temp. 20Ċ and 25Ċ.
• Reweigh the containers. Loss in wt in each container is NMT 0.2%
46
47. REFERENCES
• Mehta Kunal C, D. Akhilesh, B. Shyam Kumar; Recent Trends in Pharmaceutical
Packaging; International Journal Of Pharmaceutical And Chemical Sciences;Sep.
2012;1 (3);1282-1292.
• Kumar Sunil ; Pharmaceutical Packaging Technology ; International Journal of
Research in Pharmaceutical and Biomedical Sciences; Dec 2013 ; Vol. 4 (4) ;1400-
1414
• Bansal B K, Sharma K., Sarraf A., Chaudhary N; Pharmaceutical Packaging –Need
and Advances ; International Journal of Pharmaceutical Erudition ; Feb. 2014,
3(4), 29-41
• Sciarra J John;Aerosols;Remington:The Science & Practice of Pharmacy;
2000;20;963-978.
• www.medidose.com/liquid.packaging aspx.
• http://gohcl.com/unit-dose-products &accessories.
• www.iip.de/index.php
• www.adelphi-hp.com/en/products/
