Pharmaceutical Manufacturing Handbook: Production and

166 PACKAGING AND LABELING
component and to compare this periodically to the profi le from a new batch of the
packaging component. Extractables should be identifi ed whenever possible.
Nonsterile Products
Solids The most common solid oral dosage forms are capsules and tablets. A
typical solid oral dosage forms container closure system is a plastic, usually high -
density polyethylene (HDPE), bottle with a screw - on or snap - off closure and a
fl exible packaging system such as a pouch or a blister package. A typical closure
consists of a cap, often with a liner, frequently with an inner seal. If used, fi llers,
desiccants, and other absorbent materials are considered primary packaging
components.
A change in the selection of packing materials combined with a change in storage
conditions or conditions during administration of the drug products may provoke
stability problems.
Many studies have been conducted on predicting the role of packaging in moisture
adsorption by dosage forms. Adsorption of moisture by tablets contained in
polypropylene fi lms was successfully modeled from storage temperature and the
difference in water vapor pressure between the inside and outside of the packaging
[15] .
Chemical and physical degradation of packaged dosage forms caused by moisture
adsorption has been predicted from the moisture permeability of the packaging. For
example, strength changes of lactose – corn starch tablets in strip packaging [16] and
discoloration of sugar - coated tablets of ascorbic acid [17, 18] were predicted using
the moisture permeability coeffi cient of the packaging.
Typical fl exible forms of packaging containing solid oral dosage forms are the
blister package and the pouch. A blister package usually consists of a lidding material
and a forming fi lm. The lidding material is usually a laminate which includes a
barrier layer (e.g., aluminum foil) with a print primer on one side and a sealing agent
(e.g., a heat - sealing lacquer) on the other side.
The sealing agent contacts the dosage form and the forming fi lm. The forming
fi lm may be a single fi lm, a coated fi lm, or a laminate. A pouch typically consists of
fi lm or laminate which is sealed at the edges by heat or adhesive.
Solid oral dosage forms generally need to be protected from the potential adverse
effects of the following:
1. Water vapor (e.g., moisture may affect the decomposition rate of the active
drug substance or the dissolution rate of the dosage form)
2. Incident light (e.g., in case of photosensitive products)
3. Reactive gases (e.g., oxygen could provoke oxidative reactions)
Carefully selected packaging material may help protect drug products. For
example, a blister or pouch and use of secondary packing may be used to protect
pack photosensitive material, especially when a dark polymeric fi lm with a covering
lid made of aluminum is used for blister packing. Blister packaging using multilayer
HDPE material and selection of an adequate sealing technique may help prevent
moisture in the blister system. However, plastics and glass for packaging of solid
oral dosage forms and for powders for reconstitution should meet the requirements