Win, Thazin and Abu Bakar, Mohd Rushdi and Mohamed, Farahidah and Bakhtiar, M. Taher and Sarker, Zaidul Islam (2025) Optimising palm olein-based betamethasone 17-valerate emulsions for scalable manufacturing and stability. Journal of Pharmacy, 5 (1). pp. 16-27. E-ISSN 2773-5664
|
PDF
- Published Version
Available under License Creative Commons Attribution Non-commercial. Download (1MB) | Preview |
Abstract
Introduction: Palm olein has been used as an excipient in the formulation of topical emulsions due to its rich source of natural antioxidants that can lead to better skin health and higher stability upon storage. Despite its potential as a topical drug delivery vehicle, the practical implementation of manufacturing 20% (w/w) palm olein-in-water emulsions for commercial purposes has not been explored extensively, and obtaining experimental data on scale-up studies would be helpful in facilitating this realisation. Methods: This research work established and optimised the manufacturing process parameters for the production of cream and lotion formulations containing betamethasone 17-valerate, utilising palm olein as the vehicle, with scale-up from lab-scale 5 kg batches to pilot-scale 80 kg batches. Design of experiments (DoE) where response surface methodology as well as three-level, two-factors (32) full factorial design were used to develop statistical models for representing the possible relationships between factors: homogenisation time and speed, and responses: particle size and phase separation. Results: The findings established that the quadratic model was the most suitable model as it could predict the interactions between factors and responses in an accurate manner as well as suggest the optimum operating conditions. The optimum homogenisation time and speed were found to be 40 minutes and 3400 rpm, respectively. These conditions produced emulsions with the smallest particle size (3.2 μm ± 0.03) and the least phase separation value (29.7% ± 0.35). Conclusion: The study successfully demonstrated the potential to scale up the manufacturing of 20% (w/w) palm olein-in-water emulsions for commercial purposes. The optimised parameters, obtained through DoE, facilitate the large-scale production of stable emulsions containing betamethasone 17-valerate.
| Item Type: | Article (Journal) |
|---|---|
| Uncontrolled Keywords: | Palm olein; Scale-up; Stable emulsions; Full factorial design; Betamethasone 17-valerate |
| Subjects: | R Medicine > RS Pharmacy and materia medica R Medicine > RS Pharmacy and materia medica > RS192 Materia Medica-Pharmaceutical Technology T Technology > TP Chemical technology > TP155 Chemical engineering T Technology > TP Chemical technology > TP200 Manufacture and use of chemicals |
| Kulliyyahs/Centres/Divisions/Institutes (Can select more than one option. Press CONTROL button): | Kulliyyah of Pharmacy Kulliyyah of Pharmacy > Department of Pharmaceutical Chemistry Kulliyyah of Pharmacy > Department of Pharmaceutical Technology |
| Depositing User: | Dr Mohd Rushdi Abu Bakar |
| Date Deposited: | 05 Feb 2025 08:20 |
| Last Modified: | 06 Feb 2025 08:47 |
| URI: | http://irep.iium.edu.my/id/eprint/119213 |
Actions (login required)
 |
View Item |
Download Statistics
Download Statistics