Lecture 7

Question 1

There are essentially four environmental factors that cause pharmaceutical product instability.

Answer 1

• Water
• Heat
• Light
• Oxygen

Question 2

The Pharmacist’s first responsibility is…

Answer 2

proper storage of pharmaceutical products and to provide storage information to the consumer

Question 3

Product stability can be divided into three categories

Answer 3

• Chemical
– Potency (90% Label Claim) – Purity
– 5 year maximum expiration date

• Physical
– Product Specifications
– Pass/Fail

• Microbiological
– Preservative Effectiveness
– Sterility Testing

Question 4

Determination of chemical stability is not limited to the active ingredient.

Answer 4

• ActivePharmaceuticalIngredient
• Excipients
• Degradationproduct(s)

Question 5

Excipients are often added to…

Answer 5

• improve stability

- antioxidants may be added to liquid or solid dosage forms

Question 6

The chemical stability of liquid products may be affected by…

Answer 6

• solution pH

- buffer agents are used to control pH and stabilize the formulation

Question 7

There are many physical product attributes that are important to product quality.

Answer 7

• Appearance
• Color
• Odor
• Taste
• Dissolution
• Moisture content
• Friability
• Polymorphism
• Hydrate formation
• Solution Clarity
• Solution pH
• Aggregation
• Precipitation
• Settling/Redistribution

Question 8

Manufacturers and Pharmacists both have stability related requirements.

Answer 8

• Industry Requirement
– Product Testing
• Preclinical toxicology studies
• Clinical trials (IND phase)
• Commercial products (NDA phase)

• Pharmacist Requirement 
– Proper Storage
– Label
• Commercial products
• Extemporaneously compounded products

Question 9

Testing at elevated temperatures is used during development to…

Answer 9

accelerate reactions and predict chemical stability at lower temperatures

Question 10

Lyophilization is a manufacturing process used to…

Answer 10

• used to remove water from a solution product

- main objective is to obtain a product that has a longer shelf-life

Question 11

Pharmacist’s Responsibilities

Answer 11

• Storage Conditions
– Product
– Reconstituted product

• VisualInspection
– Discoloration
– Product Collapse

• Reconstitution Volume

• ReconstitutionVehicle
– WFI
– BWFI
– Special Diluent

• Reconstitution Procedure
– Addition of vehicle to protein products
– Time for dissolution