Dosage Form Stability

Question 1

Enhance Product Stability affected by Hydrolysis

Answer 1

1. Elimination of water:
2. Use of buffering agents to maintain a certain pH.
3. Protection from humidity

Question 2

Enhance Product Stability affected by Oxidation

Answer 2

1. Antioxidants: ascorbic acid and sodium sulfite.
2. Preparation and storage under oxygen free atmosphere.(vials and ampules).
3. Chelating agents (e.g calcium disodium edetate. EDTA)
4. Packaging in light resistant or opaque containers.
5. Storage of oxidizable drugs in a cool place.

Question 3

Stability Testing

Answer 3

• • Before approval for marketing product stability must be assessed with regard to*
  1. Formulation
  2. Influence of pharmaceutical ingredients
  3. Influence of container and closure
  4. Manufacturing and processing condition
  5. Packaging components
  6. Condition of storage and shipping
  7. Condition of pharmacy shelf life and patient use.

Question 4

Drug Stability

Answer 4

the extent to which a product retains within specified limit the same properties and characteristics throughout its shelf life.