Packaging & Stability Lecture Review

A collection of flashcards based on the lecture notes covering key concepts on pharmaceutical packaging and its stability.

What are the learning outcomes for pharmaceutical packaging as discussed in the lecture?

Describe pharmaceutical packaging and how it is selected for individual products; correctly interpret data associated with product performance on stability.

What are the main aims and objectives of packaging in pharmaceuticals?

To understand the importance of packaging, the hazards a product can be exposed to, choose appropriate materials, discuss advantages/disadvantages of materials, define relevant hazards, and make rational packaging choices.

What is the function of primary packaging?

The primary pack has direct contact with the formulated medicine and restricts external hazards which may cause product degradation.

What are the environmental hazards that can affect pharmaceutical stability?

Moisture, temperature extremes, light exposure, pressure changes, atmospheric gases, and permeation.

What are some examples of mechanical hazards that packaging must protect against?

Shock, vibration, impact, abrasion, and puncture.

What does the term 'patient confidence' refer to in the context of pharmaceutical packaging?

Patient confidence refers to patients' trust in their healthcare providers and the effectiveness of the prescribed medicines.

Name two types of sterilization methods mentioned in the lecture.

Heat sterilization and ethylene oxide gas sterilization.

What is the significance of shelf life in pharmaceutical packaging?

Shelf life indicates the duration a medication remains stable, effective, and safe under proper storage conditions.

What do moisture changes in packaging lead to?

Loss or gain in moisture can induce physical changes, such as tablet crushing strength, and chemical changes like hydrolysis.

How can photolysis affect medications?

Photolysis can cause degradation of drugs, reducing their effectiveness due to light exposure.

What are child-resistant packaging methods?

Packaging designed to prevent accidental ingestion by children, using difficult-to-open features.

What role does aluminum play in pharmaceutical packaging?

Aluminum serves as a barrier against moisture, light, and oxygen, providing tamper resistance and promoting extended shelf life.

How does accelerated stability testing predict drug stability?

By conducting tests at elevated temperatures and humidity for a short duration, revealing how a product would react over a longer period under normal conditions.

What is hydrolysis in pharmaceuticals?

A chemical reaction in which a substance breaks down through reaction with water, commonly leading to drug degradation.

What factors must be considered for packaging selection?

Type of medication, material selection, protection requirements, compliance and safety, regulatory compliance, and sustainability.

What is the main purpose of secondary packaging?

To provide additional physical protection, convenience for wholesalers and retailers, and carry information.

What does tamper-evident packaging ensure?

That the product has not been altered or contaminated before it reaches the consumer.

What is meant by 'compliance' in the context of pharmaceutical packaging?

The ability of the packaging to facilitate patient adherence to medication regimens.

Which drug was highlighted for its sensitivity to moisture and its requisite packaging?

Glyceryl Trinitrate (GTN) tablets.

What does the FDA regulate regarding pharmaceutical packaging?

Materials used for medical purposes and labeling requirements related to dosage instructions, expiry dates, and batch numbers.

Describe the impact of particle size on stability.

Smaller particles have higher surface area, increasing exposure to moisture and acceleration of degradation; larger particles are more chemically stable.

What is the significance of light-resistant packaging?

It helps prevent photolysis by protecting drugs from harmful light exposure.