Containers and Closures for Pharmaceuticals MANIK

Md. Imran Nur Manik
Lecturer
Department of Pharmacy
Primeasia University

Basic principles of compounding and dispensing: Containers and closures for dispensed products
Prepared By: Md. Imran Nur Manik; M.Pharm. (R.U.) Page 1
manikrupharmacy@gmail.com; Lecturer; Department of Pharmacy; Primeasia University.
Packaging
Packaging is the process by which the pharmaceuticals are suitably packed so that they should retain their
therapeutic effectiveness from the time of their packaging till they are consumed.
It is the art and science which involves preparing the articles for transport, storage, display and use.
Container
A container may be defined as a device in which the drug is enclosed and is in direct contact with the
drug.
Closures
A closure is a device which seals the container to exclude oxygen, carbon-dioxide, moisture,
micro-organisms and prevent the loss of volatile substances.
It also prevents the loss of medicament during transport and handling.
The qualities of good containers and closures
The good packaging materials i.e. the containers and closures must meet the following criteria.
(Ideal properties of containers and closures)
1. The material must give the container sufficient strength to withstand the extremes of
temperature and pressure as well as to withstand handling while empty, while filling, closing,
sterilizing, labelling, transport, storage and use by the consumer.
2. The material should be impervious to any possible contaminants; for example solids, liquids,
gases vapours or microorganisms.
3. It should not interact with the contents. This includes migration, absorption, adsorption or
extraction. e.g. Absorption of water from creams into cardboard boxes.
4. It should protect the contents from the loss of product due to leakage, spillage or permeation.
5. The container must not impart its own colour, test or odour to the preparation.
6. They must be FDA (Food & Drug Administration) approved.
7. They must meet applicable tamper-resistance requirements.
8. They must be adaptable to commonly employed high-speed packaging equipment.
9. Must be cheap and economical i.e. they must have reasonable cost in relation to the cost of the
product.
10. They must be convenient and easy to use by the patient.
11. They must be non-toxic and biodegradable.
12. The container and closure must not react either with each other or with the preparation.
13. Apart from all these a container and closure should be attractive in appearance and must have
sale promotion and marketing value.
Md.
Imran
Nur
Manik

Types of Container
The containers can be classified into the following types.
1. Well closed containers: A well closed containers is used to protect the preparation from
contamination by extraneous solids to prevent the loss of potency of active constituents and to
prevent the loss of contents during transport, storage and handling.
2. Air-tight containers: Air-tight containers are used to protect the containers from atmospheric
contamination of liquids, solids or vapors. They prevent the drugs due to efflorescence,
deliquescence or evaporation.
3. Hermetically-Sealed containers: Hermetically sealed container is that which does not allow
the air or other gases to pass through it. They are generally used for injectables.
4. Light-resistant containers: Light resistant containers are used to protect the drugs which
undergo decomposition in the presence of light. For e.g .Amber colored glass or opaque glass.
5. Single dose containers: They are used to supply only one dose of the medicament. They are
sealed in such a way that the contents cannot be removed without removing the seal; the
contents so removed are consumed immediately. e,g. ampoules.
6. Multi dose containers: A multi dose container should hold a number of doses. It is sealed in
such a way that success doses can be withdrawn easily without changing the strength, quality or
purity of the remaining contents e.g multi dose vials.
7. Aerosol containers: Containers for aerosols must be strong enough to withstand the pressure
evolved inside the container at the time of use of preparation.
Materials used for the making of containers
I. Glass
II. Metals
III. Rubbers
IV. Plastics
V. Fibrous material
VI. Films, foils and laminates
Glass
Glass has been widely used as a drug packaging material. Glass is composed of sand, soda ash,
limestone,& cullet. Si, Al, Na, K, Ca, Mg, Zn & Ba are generally used into preparation of glass.
Advantages
1. They are hygienic and suitable for sterilization
2. They are relatively non reactive ( depending on the grade chosen)
3. They can be used on high speed packaging lines
4. They can be easily labeled.
5. They are transparent.
6. They are available in various shapes and sizes.
7. They can withstand the variation in temperature and pressure during sterilization.
8. They are economical and easily available.
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Imran
Nur
Manik

9. They can protect the photosensitive medicaments from light during their storage.
10. They are neutral after proper treatment.
11. They are impermeable to atmospheric gases and moisture.
12. They have good protection power.
13. They do not deteriorate with age.
14. They can be sealed hermetically or by removable closures.
Disadvantages
1. It is relatively heavy
2. Glass is fragile so easily broken.
3. Release alkali to aqueous preparation.
4. They may crack when subjected to sudden changes of temperature.
5. Some containers can impart alkalinity and insoluble flakes to the formulations.
Flaking
During flaking the alkali is extracted from the surface of the glass containers and a silica rich layer is
formed which sometimes gets detached from the surface and can be seen in the contents in the form of
shining flakes.
Fig; Flacking Fig: Weathering
Weathering
Weathering is a common problem with glass containers in which sometimes moisture condensed on the
surface of glass container, can extract some weakly bonded alkali, leaving behind a white deposit of
alkali carbonate.
Types of glass
1. Type I ( Neutral or Borosilicate Glass)
2. Type II ( Treated Soda-lime glass)
3. Type III ( Soda-lime glass)
4. Type IV- General Purpose soda lime glass
5. NP—soda glass (non parenteral usage)
6. Colored glass
7. Neutral glass
1. Type I-Borosilicate glass: Highly resistant and chemically inert glass. Alkali’s and earth cations of glass are replaced by boron
and/or aluminum and zinc. These are used to contain strong acids and alkalis.
2. Type 2-Treated soda-lime glass: These are more chemically inert than Type I glass. The glass surface is de-alkalized by “Sulfur
treatment” which prevents blooming/weathering from bottles.
3. Type III- Regular soda lime glass: Untreated soda lime glass with average chemical resistance.
4. Type IV- General Purpose soda lime glass: Glass is not used for parenterals, used only for products intended to be used orally or
topically.
Md.
Imran
Nur
Manik

Package type Type of formulation can be packed
Minimum quality of glass that
can be used
Ampoule
Aqueous Injectables of Any pH Type I
Aqueous Injectables of pH Less Than 7 Type II
Non-Aqueous Injectables Type III
Vial
Aqueous Injectables of Any pH Type I
Aqueous Injectables of pH Less Than 7 Type II
Non-Aqueous Injectables Type III
Dry Powders For Parenteral Use
(Need To Be Reconstituted Before Use)
Type IV
Bottles
and
Jars
Tablets, Capsules, Oral Solids & Other Solids For
Reconstitution
Type IV
Oral Liquids (Solutions, Suspensions, Emulsions) Type IV
Nasal & Ear Drops Type IV
Certain Types Of External Semisolids
(Rubeficients, Local Irritants)
Type IV
Blood & Related Products Type I
Dropper Auxiliary Packaging Device With Certain Kind Of Products Type IV
Aerosol container
Aerosol product
( solution, suspension, emulsion or semisolid type)
Type I
METALS
Metals are used for construction of containers. The metals commonly used for this purpose are
aluminium, tin plated steel, stainless steel, tin and lead
Advantages:
1. They are sturdy. (
2. They are impermeable to light, moisture and gases.
3. They can be made into rigid unbreakable containers by impact extrusion.
4. They are light in weight as compared to glass containers.
5. Labels can be printed directly on to their surface.
Disadvantages:
1. They are expensive.
2. They react with certain chemicals
3. They may shed metal particles into the pharmaceutical product.
COLLAPSIBLE TUBES METAL
• The collapsible metal tube is an attractive container that permits controlled amounts to be
dispensed easily, with good enclosure, and adequate protection of the product.
• It is light in weight and unbreakable and lends itself to high speed automatic filling operations.
• Most commonly used are tin, aluminium and lead.
Md.
Imran
Nur
Manik

Tin:
Tin containers are preferred for food, pharmaceuticals and any product for which purity is considered.
Tin is the most chemically inert of all collapsible metal tubes.
Aluminium:
Aluminium tubes offer significant savings in product shipping costs because of their light weight.
They are attractive in nature
Lead:
Lead has the lowest cost of all tube metals and is widely used for non food products such as adhesives,
inks, paints and lubricants.
Lead should never be used alone for anything taken internally because of the risk lead poison.
With internal linings, lead tubes are used for products such as chloride tooth paste.
PLASTIC
Plastics may be defined as any group of substances, of natural or synthetic origins, consisting chiefly of
polymers of high molecular weight that can be moulded into a shape or form by heat and pressure.
Advantages
1. They are light in weight than glass and can be handled easily.
2. They are poor conductor of heat.
3. They have sufficient mechanical strength.
4. They can be transported easily.
5. Extremely resistant to breakage
6. They are available in various shapes and sizes.
7. They are resistant to inorganic chemicals.
8. They have good protection power.
9. Flexible
10. Variety of sizes and shapes
11. Essentially chemically inert, strong, rigid Safety use, high quality,
various designs
Disadvantages
1. Absorption permeable to moisture
2. Poor printing, thermostatic charge
3. They are permeable to water vapor and atmosphere gases.
4. They cannot withstand heat without softening or distorting( ,)
5. They may interact with certain chemical to cause softening or distortion.
6. They may absorb chemical substances, such as preservatives for solution.
Classes of plastics:
There are two classes of plastics, reflecting the behavior with respect to individual or repeated exposure
to heating and cooling.
 Thermoplastics
• Capable of being shaped after initial heating and solidifying by cooling.
• Resistant to breakage and cheap to produce and providing the right plastics are chosen will
provide the necessary protection of the product in an attractive containers.
• E.g. Polystyrene, polyethylene and polyvinyl chloride.
Md.
Imran
Nur
Manik

 Thermosets
• They need heat for processing into a permanent shape. During heating such materials form
permanent crosslinks between the linear chains, resulting in solidification and loss of plastic flow.
• E.g. Phenolic, urea and melamine are representative of thermosets.
Types of Plastics
Poly ethylene:
This is used as high and low density polyethylene.
Low density polyethylene (LDPE) is preferred plastic for squeeze bottles.
High density poly ethylene (HDPE) is less permeable to gases and more resistant to oils, chemicals and
solvents.
It is widely used in bottles for solid dosage forms.
Polyvinylchloride (PVC): Used as rigid packaging material and main component of intravenous bags.
Poly Propylene: It has good resistance to cracking when flexed. Suitable for use in closures, tablet
containers and intravenous bottles.
Polystyrene: It is also used for jars for ointments and creams with low water content.
FIBROUS MATERIALS
 The fibrous materials are the important part of pharmaceutical packaging.
 Fibrous materials include: Papers, Labels, Cartons, Bags, Outers, Trays For Shrink Wraps, Layer
Boards On Pallets, etc.
The Applications as well as Advantages of Cartons include:
 Increases display area
 Provides better stacking for display of stock items
 Assembles leaflets
 Provides physical protection especially to items like metal collapsible tubes.
 Fiberboard outers either as solid or corrugated board also find substantial application for
bulk shipments.
Regenerated cellulose film, trade names Cellophane & Rayophane, is used for either individual cartons or
to assemble a no. of cartons.
CLOSURES
Closures are the devices by means of which containers can be opened and closed.
Proper closing of the container is necessary because
– It prevents loss of material by spilling or volatilization.
– It avoids contamination of the product from dirt, microorganisms or insects.
– It prevents deterioration of the product from the effect of the environment
such as moisture, oxygen or carbon dioxide.
Md.
Imran
Nur
Manik

Material used for closures
The closures for containers meant for storage of pharmaceutical products are generally made from the
following basic materials.
 Cork
 Glass
 Plastic
 Metal
 Rubber
• Cork: Cork is essentially a wood obtained from the bark of oak tree. It is used for the
manufacture of stoppers for narrow mouth bottles.
Fig: Cork
• Glass: As compared to cork glass is an ideal material for stoppers but
they do not provide leak proof closure as well as can easily slip out of the
neck of the closure during transport and handling.
• Plastic: As compared to cork, glass, rubber and metal Plastic closures are
becoming popular day by day as they are unbreakable, light in weight and can be
easily molded into various shapes and sizes.
• Metal: Tin plate and aluminum are mostly commonly used for the manufacture of
closures but aluminum is mostly used for this purpose.
RUBBERS (Elastomers):
Excellent material for forming seals, used to form closures such as bungs
for vials or in similar applications such as gaskets in aerosol cans.
Categories of Rubbers:
Natural rubbers: Suitable for multiple use closures for injectable
products as rubber reseals after multiple insertion of needle.
Synthetic rubber: Have fewer additives and thus fewer
extractable and tends to experience less sorption of product
ingredients.
Some other types of rubber used includes: Butyl rubber;
Nitrile rubber; Chloroprene rubbers; Silicon rubbers etc.
Symbols Used On Packages and Labels
Many types of symbols for package labeling are nationally and internationally standardized. For product
certifications, trademarks, proof of purchase, etc. identification code.
Md.
Imran
Nur
Manik

Unit Dose packaging
Blister Packing: In blister packing the unit dosage forms are enclosed in between transparent blisters
and suitable backing material usually aluminum foil.
Strip Packing: In strip packing the unit dosage of drugs are hermitically sealed in between strips of
aluminum foil and/or plastic film.
Advantages of Blister Package:
1. Prevention of broken glass bottles
2. Reduced costs and higher packaging speeds relative to other packaging materials.
3. Blister packaging helps retain product integrity because drugs that are prepackaged in blisters are
shielded from adverse conditions.
4. Furthermore, opportunities for product contamination are minimal.
5. Each dose is identified by product name, lot number, and expiration date.
6. Blister packaging protects pharmaceuticals in the home better than bottles do.
7. Tamper evidence is another strength of blister packaging. The dosage units are individually
sealed in constructions of plastic, foil, and/or paper. With blister packaging, however, each tablet
or capsule is individually protected from tampering until use, so any form of tampering with a
blister package is immediately visible.
Two basic types of pharmaceutical blister packages exist
1. In one variety the cavity is constructed of clear, thermoformed plastic, and the lid is formed of
clear plastic or a combination of plastic, paper, and/or foil.
2. The other type of package contains foil as an essential component of both webs, and its cavity is
created by cold stretching.
Cold Forming Blistering machine:
In the case of cold forming, an aluminum-based laminate film is simply pressed into a mold by means of
a stamp. The aluminum will be elongated and maintain the formed shape.
Advantage of cold form foil blisters is that the use of aluminum is offering a near complete barrier for
water and oxygen, allowing an extended product expiry date.
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Imran
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Manik

The disadvantages of cold form foil blisters are the slower speed of production compared to
thermoforming and the lack of transparency of the package and the larger size of the blister card
Example: ALU-ALU Machine
Operation:
The sequence involves;
1. Installing the Aluminium Foil,
2. Cold forming it into blister cavities via punch pins,
3. Loading the blister with the product,
4. Placing lidding material over the blister,
5. And heat-sealing the package.
6. Cutting into individual blisters
Thermo-cold forming blistering machine:
In the case of thermoforming, a plastic film or sheet is unwound from the reel and guided though a pre-
heating station on the blister line. The temperature of the pre-heating plates (upper and lower plates) is
such that the plastic will soften and become moldable.
Example: ALU-Tropical Machine
Operation:
The sequence involves;
1. Heating the plastic,
2. Thermoforming it into blister cavities,
1. Bottom foil uncoiler 6. Cover foil uncoiler 11. Discharge conveyor
2. Cold forming station 7. Cooling & slitting
3. Feeding device 8. Draw Off
4. Empty checker 9. Punching
5. Sealing & Embossing 10. Waste foil coiler
Md.
Imran
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Manik

3. Loading the blister with the product,
4. Placing lidding material over the blister,
5. And heat-sealing the package.
6. Installing the aluminium foil
7. Cold forming it into blister Pouch & seal it on thermoformed blister to give extra protection,
8. Cutting into individual blisters
STRIP PACKAGE
 It is commonly used for the packaging of tablets and capsules.
A strip package is formed by feeding two webs of a heat
sealable flexible film through a heated crimping roller.
 The product is dropped into the pocket formed before forming
the final set of seals. A continuous strip of packets is formed
which is cut to the desired number of packets in length.
 The materials used for strip package are cellophane, polyester,
polyethylene, polypropylene, polyvinylchloride.
Fig: Strip Packaging Machine
Md.
Imran
Nur
Manik

Containers and Closures for Pharmaceuticals MANIK

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