Without packaging, it would be virtually impossible to deliver pharmaceutical products to patients. Packaging helps protect,
contain, carry, dispense, and sell pharmaceuticals. It also helps drug manufacturers educate and motivate consumers.
Barrier packaging increasingly relies on new materials or combinations of materials. For maximum protection of moisture-sensitive
pharmaceuticals, Alcan Packaging Singen GmbH (Singen, Germany) incorporates a desiccant in the seal layer of its "Formpack
with Desiccant" foil laminate.
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Over the years, pharmaceutical packaging has experienced many changes. Innovations have come in four categories: design, materials
and containers, equipment, and logistics. Some advances involve more than one category.
Advances in design
Innovations in package design perform many functions. They prevent children from unwittingly taking dangerous doses of medication,
improve seniors' access to pharmaceuticals, protect consumers from malicious tampering, reduce medication errors, simplify
adherence to dosage regimens, and educate consumers about the benefits and risks of drugs.
Before the passage of the Poison Prevention Packaging Act (PPPA) in 1970, an appalling number of toddlers were sickened or
died because they accidentally ingested toxic amounts of prescription drugs or aspirin. The PPPA mandated "special packaging"
for these products that makes it difficult for a toddler to gain access to a harmful dose. In 1978, iron-containing supplements
were added to the list of products that must have child-resistant (CR) packaging. CR packaging concepts include press-and-turn
closures, squeeze-and-turn closures, and peel–push blisters.
Milestone. 30 Years of Pharmaceutical Technology
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The Consumer Product Safety Commission (CPSC, Washington, DC) credits CR packaging with saving an estimated 700 lives since
PPPA took effect (1). The packaging had one major disadvantage, however. Many designs that were difficult for kids to open
were hard for senior citizens with limited hand strength and dexterity to open. When CPSC noted a rising number of poisonings
because a grandparent transferred his or her medication to a non-CR container or didn't reclose a CR container properly, the
commission changed test protocols to ensure that CR packaging was also senior-friendly.
Several senior-friendly designs have been introduced, but there's still room for improvement. According to the CPSC, "Almost
one third of oral prescription drugs involved in accidental ingestions by children under five belongs to someone other than
the child's immediate family such as grandparents and other older adults" (2).
In addition to preventing childhood poisonings, packaging helps ensure drug products have not been tampered with and are genuine.
Tamper-evident (TE) packaging originated in 1982, when seven people died after ingesting poisoned "Tylenol" capsules. The
case, which remains unsolved, resulted in regulations that require TE packaging for most over-the-counter (OTC) pharmaceuticals.
Options include shrink bands and nonfoam inner seals with a distinctive identifying characteristic, closures with a breakable
band, and blister cards. Rules require packaging to carry information about the TE feature so consumers know what to look
for.
Pfizer's "Exubera," the world's first inhaled insulin, wouldn't be possible without packaging innovations that contain and
dispense the powdered insulin.
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In 1986, poisoned "Excedrin" capsules caused more deaths, and packaging rules were changed to require two TE features for
all capsule products. These features often entail sealing the capsules themselves and incorporating another feature such as
a shrink band.
Counterfeit pharmaceuticals have become a huge problem worldwide as well. In fact, most studies estimate that 10% of drugs
in the global supply chain are counterfeit. According to the US Food and Drug Administration (Rockville, MD), "drug products
with a high market value or that are high-priced or have high sales volume are more frequently subject to counterfeiting and
diversion" (3).
