Packaging Materials 605
change. For example, steroids e.g, hydrocortisone, prednisolone, and methyl-
prednisolone are susceptible to changes when exposed to light. These degradations take
place through free radical mechanism. Incorporating antioxidants in these products is
an effective measure to increase stability and shelf life. Packaging such products in
opaque containers or in containers that prevent the passage of light is a typical solution
to this problem. If the product is a liquid, or if the product must be measured from the
dispensing container, labels that have small graduated openings or windows may be
used to protect the product from mast of the environmental light to which it may be
exposed. The dyes used in formulations are in general very much sensitive to light.
Sometimes the changes in color intensity cannot be detected visually unless the change
is extreme. For example, printed materials may fade on exposure to light. The deep
color may become light and white may turn into yellowish. Colored prints on the carton
remain unprotected and can fade if stored or stacked openly for long time.
Air is a mixture of atmospheric gases. It contains mainly oxygen, nitrogen, and carbon
dioxide. Oxygen is more hazardous as it can cause oxidation. Carbon dioxide can change
the pH of a solution. Certain plastic materials, for example LDPE, are permeable to CO..
If an unbuffered solution is kept inside the container made of such material CO, can
enter into the container and shift the pH. In some cases dissolved drug can precipitate
also due to pH shift. A volatile gas (e.g., an odorous gas) or (e.g., volatile component of a
perfume, flavor, etc.) can also migrate into such container and spoil the product.
Airborne particles may contaminate plastic material. Under dry condition, plastics gain
electrical charge over their surface. The particles may be deposited on the plastics due
to the electrostatic force of attraction. Airborne particles are one of sources of microbial
contamination. Hence plastics can be contaminated.
Chemical Protection
In most cases the reactions that are responsible for change in drugs are hydrolysis and
oxidation. These are caused by environmental oxygen or other substances that remove
electrons, and light increases the energy state of a molecule to undergo change.
Packaging must stop or retard these reactions to protect the produet during its shelf-life,
and to deliver a safe and effective drug to the consumer. Most of the products are stable
for a minimum of two years from the date of manufacture.
Hydrolysis is a chemical reaction in which a molecule dissociates into two different
species by reacting with water. One of the species acquires the hydrogen ion (H") and
the other hydroxyl ion (OH). The ester or amide group is particularly susceptible to
hydrolysis. Drugs containing ester or amide functional groups can react with water. This
is different from hydration of a molecule in which water is added or absorbed from the
atmosphere by a substance, without any chemical change, Hydrolysis is the opposite of
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