Packaging and Stability

Question 1

What is the importance of packaging?

Answer 1

1. Presentation
2. Protection
3. Identification
4. Information
5. Containment
6. Convenience
7. Compliance

Question 2

What is packaging used for?

Answer 2

Storage, carriage and display until product is administered

Question 3

When presenting packaging of a medicine, what is important?

Answer 3

1. Functional
2. Regulatory aspects
3. Patient safety
4. Product integrity
5. Ease of use

Question 4

What is the primary pack of packaging? What is its function?

Answer 4

Has direct contact with formulated medicine e.g. bottle or cap
Restricts external hazards which can lead to product degradation

Question 5

What is the secondary pack in packaging? What is its function?

Answer 5

Packaging external to primary pack e.g. box
Additional physical protection, convenience for wholesaler/retailer/customer

Question 6

What makes an ideal pack?
Scientific
Functional
Information
Aesthetic

Answer 6

1. Protect drug and maintain stability/shelf life
2. Dosage form, assist patient compliance
3. Legal requirements, route, storage, batch no., expiry
4. Patient confidence, presentation

Question 7

What is patient confidence?

Answer 7

Patient tryst and assurance in healthcare providers and treatments
Encompasses belief in competence and empathy

Question 8

Functions of packaging:
Mechanical
Environmental
Biological
Chemical

Answer 8

1. Vibration, shock, impact, puncture, abrasion
2. Temperature, moisture, light, permeation, pressure, atmospheric gases (N2 used to prevent oxidation)
3. Microbiological (sterile), infestation (protect against insects, rodents), humans (tampering)

Question 9

Steps in sterile packaging: sterilisation

Answer 9

Eliminate microbial organisms
Heat sterilisation (high temp. to kill germs, NOT in heat-sensitive products)
Ethylene oxide gas sterilisation: preferred

Question 10

Steps in sterile packaging: packaging

Answer 10

Shelf life: remain sterile for expected life
Storage: packaging withstands environmental and storage conditions without breaking sterile barrier
Material: must prevent microbial contamination while safe, compliant and easy to open

Question 11

Application of packing:
Contamination
Tampering
Degradation

Answer 11

1. Protects from bacteria, dust and harmful substances
2. Secure seals prevent alteration
3. Shields from enivronmental factors like moisture, air, light and temp.

Question 12

Application of packaging:
Counterfeiting
Accidental ingestion
Dosage errors
Loss of potency

Answer 12

1. Unique holograms and QR codes to prevent fakes
2. Child-resistant packaging
3. Blister packs and unit-dose reduce overdosing
4. Protects active ingredients from breaking down due to external conditions

Question 13

What features does GTN tablet packaging (dark bottle) have that reduce packaging errors?

Answer 13

Protection from moisture (highly sensitive and cause degradation)
Medication stability
Preserving potency
Prevention of contamination
Proper dosage and handling
Expiration date