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

Area of Science:

• Pharmaceutical Sciences
• Formulation Development
• Quality by Design (QbD)

Background:

• Quality-by-Design (QbD) is a regulatory-endorsed approach for medicinal product development.
• QbD is infrequently utilized in compounding pharmacy practices.
• This study addresses the application of QbD to optimize APF cream formulations.

Purpose of the Study:

• To apply the Quality-by-Design (QbD) approach to optimize compounding processes.
• To determine optimal processing parameters for APF aqueous cream and cetomacrogol cream.
• To enhance the quality and reproducibility of compounded creams.

Main Methods:

• A three-level factorial design was employed to vary process parameters (temperatures, stirring speed).
• Viscosity, spreadability, and creaming index were assessed as critical quality attributes.
• Stat-Ease 360 software was used for data analysis and model prediction.

Main Results:

• Optimal conditions were identified for both aqueous cream (e.g., 60°C oil, 80°C water, 250 rpm stirring) and cetomacrogol cream (e.g., 70°C oil, 75°C water, 220 rpm stirring).
• Compounded creams met all specified quality targets, exhibiting uniform or acceptably heterogeneous droplet sizes.
• Optimized creams demonstrated stability through freeze-thaw testing with no phase separation.

Conclusions:

• A systematic, QbD-based experimental approach yields high-quality, stable, and reproducible compounded creams.
• Adoption of QbD principles can improve standardization of compounding instructions in pharmacy practice.
• Formulary guidelines could benefit from integrating QbD for enhanced pharmaceutical compounding.