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

Analytical method validation ensures that a provides trustworthy information about particular sample when applied in accordance with the predefined protocol. According to regulatory standards, rheological characteristics of topically semisolid formulations are one key elements involved microstructure equivalence documentation. Therefore, for generic drug product manufacturers, it is dire need take step forward rheology development and procedures. This paper aims apply Quality by Design (AQbD) principles towards methods topical creams, as complex formulations. Risk assessment was carried out through an Ishikawa diagram estimate failure mode, effects, criticality analysis (FMECA). Sample application, peltier temperature control, rest time were identified critical variables (CMVs), 23 full factorial design understand their impact on rotational, creep recovery and, oscillatory measurements. The per ICH Q8-Q10, Q14 guidelines validated according Q2 (R2) guideline. demonstrated adequate precision (RSD < 15%), well selectivity. AQbD provided comprehensive framework developing reliable effective this type formulation.