Critical quality attributes (CQA) and critical process parameters (CPP) Roles in the pilot scale up process and stability of a cosmetic cream

• Main Authors: Syed Omar, Sharifah Shakirah, Ab. Hadi, Hazrina, Doolaanea, Abd Almonem
• Format: Article
• Language: English
• Published: IIUM Press 2022
• Subjects: RS Pharmacy and materia medica
• Online Access: http://irep.iium.edu.my/103080/7/103080_Critical%20quality%20attributes%20%28CQA%29.pdf; http://irep.iium.edu.my/103080/; https://journals.iium.edu.my/ktn/index.php/jp/article/view/119/87; https://doi.org/10.31436/jop.v2i2.119

Introduction: The objective of this study was to scale up a natural based cream containing Piper betle L. extract to pilot scale and asses it’s stability over time. Method: During the scale up process, the critical process parameters (CPP) were monitored closely to ensure the critical quality attributes (CQA) are maintained within a desired range. To ensure the formulation was stable, a 6-months stability study was done where the organoleptic properties, particle size, zeta potential, viscosity, microbial limit and hydroxchavicol content were assessed. The formulation was characterized repeatedly at 0-month, 1-month, 2-month, 3-month and 6-month time point after being stored in 30°C±2 and 40°C±2 at 75%±5% RH. Results: CPPs in each process were maintained at certain values throughout to achieve CQAs. Time, speed and temperature during mixing and homogenization process were monitored and maintained. Stability study over 6 months proved the ability of the product to remain stable with pH < 5, particle size < 2µm, low span value, zeta potential < -50mV, apparent viscosity < 1.2Pa.s-¹ and no microbial growth. Conclusion: In conclusions, CPPs played a major role in enabling the formulation produced attain acceptable CQAs. Identifying CQA and CPP ensured the production of quality and stable product.