Pharmaceutical Manufacturing Handbook: Production and

PACKAGING MATERIALS 167
of the USP container test. Incorporating oxygen adsorbents such as iron powder
into packaging units can reduce the effect of oxygen. Protection from light can be
achieved using primary packaging (packaging that is in direct contact with the
dosage forms) and secondary packaging made of light - resistant materials. May be
involved in the photolytic degradation kinetics. The velocity of the photochemical
reaction may be affected not only by the light source, intensity, and wavelength of
the light but also by the size, shape, composition, and color of the container.
Great effort should be taken to stabilize a formulation in such a way that the
shelf life becomes independent of the storage conditions. The photostability of drugs
and excipients should be evaluated at the formulation development stage in order
to assess the effects of packaging on the stability of the fi nal product. Molsidomine
tablet preparations in inadequate primary containers (blister) without secondary
containers when exposed to irradiation may produce morpholine. These results
illustrate the importance of packaging for the stability of molsidomine [19] .
Three standard tests for water vapor permeation have been established by the
USP for use with solid oral dosage forms.
1. Polyethylene containers (USP 〈 661 〉 ) [10]
2. Single - unit containers and unit - dose containers for capsules and tablets (USP
〈 671 〉 )
3. Multiple - unit containers for capsules and tablets (USP 〈 671 〉 ) [10]
The cotton and rayon used as fi llers in solid oral dosage form containers may not
meet pharmacopeial standards, but through appropriate tests and acceptance criteria
for identifi cation and moisture content, their adequacy should be shown. For
example, rayon has been found to be a potential source of dissolution problems for
gelatin capsules and gelatin - coated tablets.
Desiccants are often used to eliminate moisture in packaging when the moisture
resistance of the packaging is not suffi cient to prevent exposure. The utility of desiccants
has been assessed based on a sorption – desorption moisture transfer model
[20] .
Desiccants or other absorbent materials are primary packaging component. The
components should differ in shape and/or size from the tablets or capsules with
which they are packaged. Their composition should be provided and their inertness
should be proved through appropriate tests, and acceptance criteria should be
established.
A topical powder product may be marketed in a sifter - top container made of
fl exible plastic tubes or as part of a sterile dressing (e.g., antibacterial product). The
topical formulations in a collapsible tube can be constructed from low - density polyethylene
(LDPE), with or without a laminated material. Normally, there is no
product contact with the cap during storage. Thus usually there is no cap liner,
especially in collapsible polypropylene screw caps. Normally separate applicator
devices are made from LDPE. Product contact is possible if the applicator is part
of the closure, and therefore an applicator ’ s compatibility with the drug product
should be established, as appropriate (e.g., vaginal applicators).
Nonsolids Typical liquid - based oral dosage forms are elixirs, emulsions, extracts,
fl uid extracts, solutions, gels, syrups, spirits, tinctures, aromatic waters, and suspen-