Module 3 Presentations

07/05/2024

Performance Testing: Scenario

Clinical formulation dry granules in capsules • Commercial formulation wet granulated in capsule • T max 6 hours, T ½ 14 – 16 hours • Proposed approach to Performance BA/BE Strategy • Understand the effect of storage on dissolution performance •

Understand effect of DP release (In-vitro dissolution) on In-vivo performance • Leads to demonstration of satisfactory In-vivo performance of a wide range of dissolution profiles • These effects can be modelled using commercially available software In the scenario above it was predicted that dissolution curves with 80% release in 6 hours would have no effect on BE

Developing Specifications for the Active Ingredient

The Organisation for Professionals in Regulatory Affairs

15

Example: Dissolution Design Space

Q: In such a scenario would the use of Disintegration (surrogate test) add value?

Developing Specifications for the Active Ingredient

The Organisation for Professionals in Regulatory Affairs

16