Containers and closures for dispensed products

Introduction

• 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.
• Cartons : outer covering which gives secondary protection against
mechanical and environmental hazards.
• Also display written information . (Cardboard)
• Box :a device which is generally used for packaging of products. It
gives prime protection against external hazards.
• provides containment & absorbs shocks . (Cardboard & wood)
Ideal properties of containers and closures

• It must preserve the physical properties of all dosage forms and protect
them against damage or breakage.
• It should protect the contents from the physical and mechanical
hazards. These include vibration, compression, shock, puncture,
abrasion etc.
• It must protect the product against undesirable or adulterating
chemical, biological or physical entities.
• It should protect the contents from the atmospheric factors. For e.g.
oxygen, Carbon dioxide.
• It should protect the contents from the loss of product due to leakage,
spillage or permeation.
• It should not interact with the contents. This includes migration,
absorption, adsorption or extraction.
• It should protect the contents from the loss of water and volatile
materials.
• The container must not impart its own colour, taste or odour to the
preparation.
• It should be capable of withstanding extremes of temperature and
pressure as well as to withstand handling while empty, while filling,
closing, sterilizing, labeling, transport, storage and use by the
customer.
• It must not alter the identity of the product.
• The closure must be easy to remove and replace.
• The cost of the container and closure is an integral part of overall cost
of the preparation, so it should not be high.
• Apart from all these a container and closure should be attractive in
appearance and must have sale promotion and marketing value.
Types of containers
• The containers can be classified into the following types
• 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
• Air-tight containers: Air-tight containers are used to protect the
containers from atmospheric contamination of liquids, solids or
vapours. They prevent the drugs due to efflorescence, deliquescence or
evaporation.
• 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 injectable.
• Light-resistant containers: Light resistant containers are used to
protect the drugs which undergo decomposition in the presence of
light. For e.g .Amber coloured glass or opaque glass
• 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.
• Multi dose containers: A multi dose container should hold a number of
doses. It is sealed in such a way that successive doses can be
withdrawn easily without changing the strength, quality or purity of
the remaining contents e.g multi dose vials
• Aerosol containers: Containers for aerosols must be strong enough to
withstand the pressure evolved inside the container at the time of use
of preparation.
• Child-proof containers:-A container that is fitted with a closure that
prevents opening by children.
TYPES OF PACKAGING

• Primary packaging
• is the material that first envelops the product and holds it. This usually
is the smallest unit of distribution or use and is the package which is in
direct contact with the contents.
• Examples: Ampoules,Vials ,Containers ,Dosing dropper ,Closures
(plastic, metal) ,Syringe ,Strip package, Blister packaging.
• Secondary packaging - Is outside the primary packaging perhaps
used to group primary package together. E.g. Boxes, cartons
• Tertiary packaging is used for bulk handling , warehouse storage and
transport shipping. The most common form is a palletized unit load
that packs tightly into containers.
• Apart from primary and secondary packaging, two types of special
packaging are currently in use, as follows:
• Unit-dose packaging. This packaging guarantees safer medication by
reducing medication errors; it is also more practical for the patient. It
may be very useful in improving compliance with treatment and may
also be useful for less stable products.
• “Device” packaging. Packaging with the aid of an administration
device is user-friendly and also improves compliance.
• This type of packaging permits easier administration by means of
devices such as prefilled syringes, droppers, transdermal delivery
systems, pumps and aerosol sprays. Such devices ensure that the
medicinal product is administered correctly and in the right amount.
Material Used For Manufacture Of Containers

There are mainly four types of material used in manufacture of

containers:-
I) GLASS
II) PLASTIC
III) METAL
IV) RUBBER
V) Fibrous material
VI) Films, Foils and laminate
GLASS
• Advantages of Glass Containers
• 1. It allows easy inspection of the containers contents.
• 2. It also have the great advantage of preserving a certain temperature
for a longer period of time. They do not dilate when it is too warm or
shrink when exposed to lower temperature
• 3. They are available in various shapes and sizes
• 4. They are economical and readily available
• 5. They can protect the photosensitive medicaments from light during
their storage
• 6. They do not deteriorate with age.
Disadvantages of Glass Containers
1. They are brittle and break easily
2. They may crack when subject to sudden changes in temperatures
3. They are heavier in comparison to plastic containers
4. They can cause light transmission
• 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.
• 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
Type I-borosilicate glass (neutral glass)
• It is highly inert type of pharmaceutical glass.
• It has high melting point so can with stand high temperatures range
• It can resist strong acids, alkalis and all types of solvents
• Reduced leaching action.
• (Note: leaching, movement of components of a container into the
contents. )
USES
• Laboratory glass apparatus.
• For injection and water for injection
• Widely used as glass ampoule and vials.
• Note:- Except for type I glass containers, glass containers for
pharmaceutical preparations are not to be re-used.
• Containers for human blood and blood components must not be re-
used.
• Type II-treated soda lime glass
• Type II containers are made of commercial soda lime glass that has
been Dealkalised or treated to remove surface alkali.
• The de-alkalizing process is know as sulphur treatment.
• Sulphur treatment neutralizes the alkaline oxides on the surface,
rendering the glass more chemically resistant.
• USES
• Used for alkali sensitive products.
• Infusion fluids, blood and plasma.
• Large volume container.
• Used to produce container for eye preparations
• Type-III regular soda lime glass
• Containers are untreated, are made of commercial soda lime glass.
• It contains high concentration of alkaline oxides and imparts alkalinity
to aqueous substances
• Flakes separate easily
• Uses
• For all solid dosage forms.
• For oily injections.
• For non aqueous parenteral products.
• Type 4 NP-general purpose soda lime glass
• Containers are made of soda lime glass supplied for non parenteral
products, intended for oral or topical use.
• USES:
• For oral use.
• For solid, liquid preparations
Plastic
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:

• They are impermeable to light, moisture and gases.

• They are sturdy (strong)
• They are made into rigid unbreakable containers by impact extrusion.
• They are light in weight compared to glass containers.
• Labels can be printed directly on to their surface.
• Disadvantages:
• They are expensive.
• They react with certain chemical
COLLAPSIBLE TUBES METAL
• The collapsible metal tube is an attractive container that permits
controlled amounts to be dispensed easily, with good reclosure, 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
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 of lead poisoning .
• 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
• They are light in weight than glass and can be handled easily.
• They are poor conductor of heat.
• They have sufficient mechanical strength.
• They can be transported easily.
• Extremely resistant to breakage
• They are available in various shapes and sizes.
• They are resistant to inorganic chemicals.
• They have good protection power.
• Flexible
• Essentially chemically inert.
Disadvantages
• Permeability: A process of solution and diffusion, with the penetrant
dissolving in the plastic on one side and diffusing through to the other
side. Glass containers are less permeable than plastic containers.
• Porosity: Minute holes or cracks in the plastic allow gas or moisture
vapour to move through directly.
• Leaching: Movement of components of container in to the contents.
• Sorption: The binding of molecules to polymer materials, includes
both adsorption and absorption.
• Poor printing
• Transmission of light through the container
• They cannot withstand heat without softening or distorting
• They may interact with certain chemical to cause softening or
distortion
Classes of plastics:
• There are two classes of plastics, reflecting the behaviour 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.
• Thermoset or thermosetting plastics
• 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.
• (note: thermoplastics can be remelted back into a liquid while
thermoset plastics always remain in a permanent solid state.)
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
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.
• Butyl rubber Nitrile rubber Chloroprene rubbers Silicon rubbers
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.
• Fibreboard 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
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.
• Material used for closures are;
• 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.
• 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 moulded into various shapes and sizes.
• Metal: Tin plate and aluminium are mostly commonly used for the
manufacture of closures but aluminium is mostly used for this
purpose.
SYMBOLS USED ON PACKAGES AND LABELS
• Many types of symbols for package labelling are nationally and
internationally standardized. For product certifications, trademarks,
proof of purchase, etc. identification code
Unit Dose packaging

• Blister Packing: In blister packing the unit dosage forms are enclosed
in between transparent blisters and suitable backing material usually
aluminium foil.
• Strip Packing: In strip packing the unit dosage of drugs are
hermitically sealed in between strips of aluminium foil and/or plastic
film.
• Advantages of blister packaging
• 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 pre-packaged 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. 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
STRIP PACKING
• 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 packet 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