Module 3 Presentations

07/05/2024

How do we set Acceptance Criteria? Example: Drug Product Performance • Compound x is a BCS Class 1 compound – High solubility a across physiological pH range – Immediate Release Hard Gelatin

Capsule (wet granulation) – Rapidly Dissolving (>85% Dissolution in 15 minutes) • pH independent release

Developing Specifications for the Active Ingredient

The Organisation for Professionals in Regulatory Affairs

13

How do we set Acceptance Criteria? For Example: Drug Product Performance • Dissolution testing performed in pH 6.8 Phosphate Buffer on stability – no changes on storage • Disintegration testing performed on stability – rapid disintegration with no change on storage • Specification set to control Disintegration time in lieu of dissolution

 Possible when certain prerequisites are met • high solubility, high permeability and rapid dissolution • link between dissolution and disintegration

• Even when these prerequisites are not met it may still be possible to not perform dissolution testing routinely …

Developing Specifications for the Active Ingredient

The Organisation for Professionals in Regulatory Affairs

14