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

Syed Omar, Sharifah Shakirah and Ab. Hadi, Hazrina and Doolaanea, Abd Almonem (2022) Critical quality attributes (CQA) and critical process parameters (CPP) Roles in the pilot scale up process and stability of a cosmetic cream. Journal of Pharmacy, 2 (2). pp. 45-58. E-ISSN 2773-5664

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Abstract

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.

Item Type:	Article (Journal)
Uncontrolled Keywords:	Scale up, pilot scale, manufacturing, piper betle, cosmetic cream.
Subjects:	R Medicine > RS Pharmacy and materia medica
Kulliyyahs/Centres/Divisions/Institutes (Can select more than one option. Press CONTROL button):	Kulliyyah of Pharmacy > Department of Pharmaceutical Technology Kulliyyah of Pharmacy
Depositing User:	Dr Hazrina Ab Hadi
Date Deposited:	09 Jan 2023 10:46
Last Modified:	09 Jan 2023 10:47
URI:	http://irep.iium.edu.my/id/eprint/103080

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