Staff View: Optimising palm olein-based betamethasone 17-valerate emulsions for scalable manufacturing and stability

Optimising palm olein-based betamethasone 17-valerate emulsions for scalable manufacturing and stability

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...

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Main Authors:	Win, Thazin, Abu Bakar, Mohd Rushdi, Mohamed, Farahidah, Bakhtiar, M. Taher, Sarker, Zaidul Islam
Format:	Article
Language:	English
Published:	IIUM Press 2025
Subjects:	RS Pharmacy and materia medica RS192 Materia Medica-Pharmaceutical Technology TP155 Chemical engineering TP200 Manufacture and use of chemicals
Online Access:	http://irep.iium.edu.my/119213/7/119213_Optimising%20palm%20olein-based%20betamethasone%2017-valerate%20emulsions.pdf http://irep.iium.edu.my/119213/ https://journals.iium.edu.my/ktn/index.php/jp/article/view/281
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spelling	my.iium.irep.1192132025-02-06T00:47:24Z http://irep.iium.edu.my/119213/ Optimising palm olein-based betamethasone 17-valerate emulsions for scalable manufacturing and stability Win, Thazin Abu Bakar, Mohd Rushdi Mohamed, Farahidah Bakhtiar, M. Taher Sarker, Zaidul Islam RS Pharmacy and materia medica RS192 Materia Medica-Pharmaceutical Technology TP155 Chemical engineering TP200 Manufacture and use of chemicals 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. IIUM Press 2025-01-31 Article PeerReviewed application/pdf en cc_by_nc http://irep.iium.edu.my/119213/7/119213_Optimising%20palm%20olein-based%20betamethasone%2017-valerate%20emulsions.pdf 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 https://journals.iium.edu.my/ktn/index.php/jp/article/view/281 10.31436/jop.v5i1.281
institution	Universiti Islam Antarabangsa Malaysia
building	IIUM Library
collection	Institutional Repository
continent	Asia
country	Malaysia
content_provider	International Islamic University Malaysia
content_source	IIUM Repository (IREP)
url_provider	http://irep.iium.edu.my/
language	English
topic	RS Pharmacy and materia medica RS192 Materia Medica-Pharmaceutical Technology TP155 Chemical engineering TP200 Manufacture and use of chemicals
spellingShingle	RS Pharmacy and materia medica RS192 Materia Medica-Pharmaceutical Technology TP155 Chemical engineering TP200 Manufacture and use of chemicals Win, Thazin Abu Bakar, Mohd Rushdi Mohamed, Farahidah Bakhtiar, M. Taher Sarker, Zaidul Islam Optimising palm olein-based betamethasone 17-valerate emulsions for scalable manufacturing and stability
description	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.
format	Article
author	Win, Thazin Abu Bakar, Mohd Rushdi Mohamed, Farahidah Bakhtiar, M. Taher Sarker, Zaidul Islam
author_facet	Win, Thazin Abu Bakar, Mohd Rushdi Mohamed, Farahidah Bakhtiar, M. Taher Sarker, Zaidul Islam
author_sort	Win, Thazin
title	Optimising palm olein-based betamethasone 17-valerate emulsions for scalable manufacturing and stability
title_short	Optimising palm olein-based betamethasone 17-valerate emulsions for scalable manufacturing and stability
title_full	Optimising palm olein-based betamethasone 17-valerate emulsions for scalable manufacturing and stability
title_fullStr	Optimising palm olein-based betamethasone 17-valerate emulsions for scalable manufacturing and stability
title_full_unstemmed	Optimising palm olein-based betamethasone 17-valerate emulsions for scalable manufacturing and stability
title_sort	optimising palm olein-based betamethasone 17-valerate emulsions for scalable manufacturing and stability
publisher	IIUM Press
publishDate	2025
url	http://irep.iium.edu.my/119213/7/119213_Optimising%20palm%20olein-based%20betamethasone%2017-valerate%20emulsions.pdf http://irep.iium.edu.my/119213/ https://journals.iium.edu.my/ktn/index.php/jp/article/view/281
_version_	1827438744923275264
score	13.251813

Optimising palm olein-based betamethasone 17-valerate emulsions for scalable manufacturing and stability

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