Optimisation of Medicine Compounding Using Quality by Design Approach: Case Studies of Two Aqueous Cream Formulations.

ABSTRACT: Background/Objectives: Quality-by-Design (QbD) is a proactive, risk-based, regulatory-endorsed approach to the development and manufacture of medicinal products but is rarely applied to medicines compounded by pharmacists. This study aims to apply the QbD approach to optimise the compounding processes for the aqueous cream and cetomacrogol cream formulations listed in the Australian Pharmaceutical Formulary and Handbook (APF). Methods: The creams were prepared by varying the process conditions, including oil and water phase temperatures, stirring speed, cooling environment temperature, and the temperature at the end of stirring. Thirty-two samples of each cream type were prepared using combinations of processing conditions defined by a three-level factorial design. The viscos

SUBMITTER: Yoo O 

PROVIDER: S-EPMC12473363 | biostudies-literature | 2025 Sep

REPOSITORIES: biostudies-literature