Packaging (Dr. Indiran Pather) - Vocabulary Flashcards

Key terms and definitions extracted from the packaging lecture notes, covering container importance, moisture control, tamper evidence, compliant packaging, and modern packaging considerations.

Container (pharmaceutical packaging)

A vessel that holds medicine and protects it from contamination, physical damage, moisture, oxygen, and light.

Primary functions of the container

To contain the medicine and protect it from contamination, physical damage, and environmental factors.

Final container

The container in the finished product used for packaging and stability; stability data considered within the final container; the container is an integral part of the product.

Immediate container

The container that directly contacts and holds the product (e.g., tablet vial, liquid bottle, blister pack).

Outer container

The secondary packaging (carton or shipping container) that protects the product during transport.

Desiccant

Moisture-absorbing material placed in packaging to reduce humidity inside the package.

Silica gel

A common desiccant used to adsorb moisture in packaging.

Molecular sieve

A desiccant with pores that selectively adsorb water molecules from the package environment.

Calcium sulfate (CaSO4)

A desiccant used to control moisture in packaging.

Adsorbent capacity

The amount of moisture a desiccant can absorb at a given humidity and temperature.

Moisture permeability

How easily moisture penetrates a packaging material, reflecting its barrier properties.

Cap and bottle neck

Primary pathways through which moisture can enter a container.

Moisture ingress importance

Extreme sensitivity of some products to moisture, necessitating effective moisture barriers.

Oxygen and moisture control

Packaging strategies aimed at minimizing exposure to oxygen and moisture to preserve drug stability.

Tamper Evident Packaging (TEP)

Packaging designed to show clearly if tampering has occurred; indicators or barriers provide visible evidence.

Code of Federal Regulations (CFR) Tamper Evident regulation

Regulatory standard requiring tamper-evident packaging for OTC products, with certain exceptions.

Indicator or barrier

Feature that reliably signals tampering, such as unique patterns, logos, or seals.

Tape tamper-evident

Sealed tape that shows disrupted printing or residue change when peeled away.

Heat-shrink band

A tamper-evident band around caps or containers that shows tampering if removed.

Compliance packaging

Packaging designed to help patients follow dosing regimens, including reminders and controlled access.

Intermezzo case study

Zolpidem MOTN product case illustrating packaging designed to prevent multiple-dose taking at night.

Senior Adult User Effectiveness (SAUE)

A measure of how effectively senior adults can use/open packaging; reported as a percentage in studies.

Child Resistant Packaging Act (Poison Prevention Packaging Act of 1970)

U.S. law requiring child-resistant packaging for many medicines, with tests for children and seniors.

Child test procedures

Testing protocol with children under 5 to evaluate whether they can open packaging within a set time.

Senior adult panel

Testing packaging with older adults (e.g., 50–70 years) to assess usability and safety.

Desiccant stuffing

Filler materials (cotton wool, rayon wool, polyester wool) placed to protect contents and fill space.

21st Century Packaging

Modern packaging addressing sensitive drugs, complex dosage forms, and abuse prevention, with emphasis on guides to prevent misuse.

Protection against mis-use and diversion

Packaging features designed to limit inappropriate use or access to potent drugs.