Product Testing Stability

Question 1

Routes of degradation

Answer 1

Oxidation
Photodegradation
Heat
Solvents degradation
Acid and base catalysis

Question 2

What to do if drug can hydrolysis in water

Answer 2

Replace water with another solvent

Question 3

How can you store unstable drugs

Answer 3

Penicillin
Store as free dried powders and then reconstitute before use

Question 4

How to protect from uv light

Answer 4

Use a tinted glass container or opaque outer container like cardboard

Question 5

To protect from oxygen

Answer 5

Flush with inert gas (N2)

Question 6

To prevent oxidation

Answer 6

Add a chelating agent (EDTA) to bind to metal and prevent catalytic activity
Also add an antioxidant (removes oxygen)

Question 7

Disadvantages of liquid dosage forms

Answer 7

Shedding of particles from glass container
Loss of drug to container
Extraction of material from container into liquid= possible toxicity or change in ph
Evaporation of volatile components = poor taste

Question 9

Stability testing

Answer 9

Hydrolysis = heat in acid/ basic conditions
Oxidation= with/without oxygen flushing
Light= with/ without exposure to artificial daylight lamps

Question 10

Stress testing

Answer 10

Store drug at elevated temperatures to accelerate aging and use Arrhenius eq to back calculate rate of degradation

Question 11

Advantages to stress testing

Answer 11

Speeds up the degradation process

Question 12

Disadvantage to stress testing

Answer 12

Prediction of degradation rates not always accurate as different reactions may occur at elevated temp
Dissolved oxygen concentration decline on heating and so does moisture levels