Rheology of Complex Topical Formulations: An Analytical Quality by Design Approach to Method Optimization and Validation.

ABSTRACT: Analytical method validation ensures that a method provides trustworthy information about a particular sample when applied in accordance with the predefined protocol. According to regulatory standards, the rheological characteristics of topically applied semisolid formulations are one of the key elements involved in microstructure equivalence documentation. Therefore, for generic drug product manufacturers, it is a dire need to take a step forward in rheology method development and validation procedures. This paper aims to apply Analytical Quality by Design (AQbD) principles towards the development and validation of rheology methods for topical creams, as complex semisolid formulations. Risk assessment was carried out through an Ishikawa diagram and an estimate failure mode, effects, and c

SUBMITTER: Chiarentin L 

PROVIDER: S-EPMC10385475 | biostudies-literature | 2023 Jun

REPOSITORIES: biostudies-literature