Materials used in

formulation of dosage
form containers
PREPARED BY : MUNEEB ALTAF
The containers and container components

Container components for parenteral products must be considered an integral part of the
product because they can dramatically effect product stability, potency, toxicity and safety.
 Parenteral dosage forms, especially solutions, usually require more evaluation of
packaging components as to product compatibility and stability.
 Common container components in direct contact with the product include various types of
glass, rubber, plastic, and stainless steel (needles), all of which may react with the drug.
1) Glass:

Glass is a readily available economical material which is Relatively inert, thus giving
excellent product/pack compatibility, and provides good product presentation (clarity, sparkle,
design) together with good product identification.
Glass earlier suffered some limitations associated with the production process and difficulties
in finding a satisfactory closure.
Today blown glass containers can be made at speeds of over 200 per minute with range of
neck finishes that are suitable for many types of closure.
 In spite of their weight and fragility, glass containers can be handled at high speed on
production lines.
Types of glass:

The various pharmacopoeia define the types of glass used for packaging pharmaceutical
preparation as follows:
• Type I Neutral or borosilicate
• Type II Soda glass with a surface treatment
• Type III Soda glass of limited alkalinity
• NP Soda glass (nonparenteral usage)
 Neutral glass is more expensive and is more difficult to process. It is harder, more
resistant to thermal shock, and durable, hence any likelihood of surface erosion is
considerably reduced.
Continued...

Types I, II and III are intended for parenteral preparations and type N.P. For oral, topical
products and other commercial purposes.
Type I is used for most injections and for water for injection.
Types I and II may be used for infusion fluids, blood and plasma. Because these preparations
require large volume containers, treated soda­lime glass is allowed as a less costly alternative
to boro-silicate.
 Types I and III may be used for most of the oily injections. Type III is specified for
thiopentone sodium.
Coloured glass:

 To avoid the deleterious effect of light, coloured glass containers could be used. Glass
can be coloured as follows:
 Carbon and sulfur or iron and manganese Amber
 Compounds of cadmium and sulfur Yellow
 Cobalt oxide or cupric oxide Blue
 Iron oxide , Manganese dioxide , and chromium dioxide Green.
2) Plastic:

 “Plastic” is a term used generally to describe a variety of compounds of high molecular

weight that can be molded to shape , hardness , and clarity .
 Some common plastic mateials used in medical devices are listed below :
 Polyethylene. Various densities are available (low, medium, high). It is relatively inert,
opaque material containing no plasticizer, constituting a common ingredient of plastic
syringes
 Polypropylene. Similar to polyethylene, being relatively inert, available in many grades,
and autoclavable. It is a common ingredient of plastic syringes.
Continued...

 Polyvinyl chloride. Available in a variety of formulation to produce relatively clear,

autoclavable container. When 30% to 40% of a phthalate ester is added to formula, this
product can be flexible, Polyvinyl chloride formulations are used to manufacture plastic
I.V. Bags. All l.V. Tubing administration sets are polyvinyl chloride formulations.
 Polystyrene. An inexpensive, rigid clear type of plastic material; however, being not very
inert, wilt react with paraldehyde and other materials. It has a low melting temperature
and cannot be heat sterilized.
 Nylon. A stable inert and generally opaque material, can be made and used where
hardness is necessary (e.g.. I. V sets, filters in blood sets).
Continued...

 Polymethylmethacrylate (Lucite). A relatively expensive, stable, hard material used to

make needle adaptors on l. V. Sets.
 Polyolefins (polyethylene and polypropylene).
 A mixture of two compounds produces a rigid or semi-rigid formulation containing no
plasticizer.
Additives to enhance the quality desired for
their use:

 Plasticizers to give flexibility to the package.

 Antioxidants are added to prevent discoloration.
 Plastic devices are produced with heat and pressure which may result in the need for
stabilizing agents.
 Fillers may be added to enhance the formulation.
 Anti static agents are sometimes needed to prevent clinging of the material.
 Colorants may be necessary for some devices.
 Lubricants are added to facilitate removal from the production molds.
3) Rubber:

 The basic types of polymers in rubber formulations are saturated and unsaturated
elastomers or a combination of the two. The following classification lists most of the
polymers utilized as parenteral closures:
 Unsaturated elastomers
 1. Polyisoprene-natural or synthetic.
 2. Polybutadiene
 3. Styrene butadiene rubber.
 4. Nitrile butadiene rubber.
 5. Polychloroprene.
Continued...

 Saturated elastomers
1. Copolymer of polyisobutylene and polyisoprene (butyl).
2. Ethylene propylene rubber.
3. Ethylene propylene diene rubber.
4. Silicone rubber.
Muneeb Altaf
• Department of Pharmacy.
• Faculty of Medical and Health
Sciences. Thank you
• University of Poonch,
Rawalakot.