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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IIUM Press, International Islamic University Malaysia
2025-01-01
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| Series: | Journal of Pharmacy |
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| Online Access: | https://journals.iium.edu.my/ktn/index.php/jp/article/view/281 |
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| author | Thazin Win Mohd. Rushdi Abu Bakar Farahidah Mohamed Muhammad Taher Md. Zaidul I. Sarker |
| author_facet | Thazin Win Mohd. Rushdi Abu Bakar Farahidah Mohamed Muhammad Taher Md. Zaidul I. Sarker |
| author_sort | Thazin Win |
| collection | DOAJ |
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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.
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| format | Article |
| id | doaj-art-2f1d2a76c98c42958eef4eb3a7355910 |
| institution | Kabale University |
| issn | 2773-5664 |
| language | English |
| publishDate | 2025-01-01 |
| publisher | IIUM Press, International Islamic University Malaysia |
| record_format | Article |
| series | Journal of Pharmacy |
| spelling | doaj-art-2f1d2a76c98c42958eef4eb3a73559102025-01-31T01:09:00ZengIIUM Press, International Islamic University MalaysiaJournal of Pharmacy2773-56642025-01-015110.31436/jop.v5i1.281Optimising Palm Olein-Based Betamethasone 17-Valerate Emulsions for Scalable Manufacturing and Stability Thazin Win0Mohd. Rushdi Abu Bakar1Farahidah Mohamed2Muhammad Taher3Md. Zaidul I. Sarker4Department of Pharmaceutical Technology, Kulliyyah of Pharmacy, International Islamic University Malaysia, Jalan Sultan Ahmad Shah, 25200 Kuantan, Pahang, Malaysia.Department of Pharmaceutical Technology, Kulliyyah of Pharmacy, International Islamic University Malaysia, Jalan Sultan Ahmad Shah, 25200 Kuantan, Pahang, Malaysia.Department of Pharmaceutical Technology, Kulliyyah of Pharmacy, International Islamic University Malaysia, Jalan Sultan Ahmad Shah, 25200 Kuantan, Pahang, Malaysia.Department of Pharmaceutical Technology, Kulliyyah of Pharmacy, International Islamic University Malaysia, Jalan Sultan Ahmad Shah, 25200 Kuantan, Pahang, Malaysia.Northern Marianas College, Finasisu Lane, Saipan, 96950, Northern Mariana Islands, USA. 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. https://journals.iium.edu.my/ktn/index.php/jp/article/view/281Palm oleinScale-upStable emulsionsFull factorial design Betamethasone 17-valerate |
| spellingShingle | Thazin Win Mohd. Rushdi Abu Bakar Farahidah Mohamed Muhammad Taher Md. Zaidul I. Sarker Optimising Palm Olein-Based Betamethasone 17-Valerate Emulsions for Scalable Manufacturing and Stability Journal of Pharmacy Palm olein Scale-up Stable emulsions Full factorial design Betamethasone 17-valerate |
| title | 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_short | 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 |
| topic | Palm olein Scale-up Stable emulsions Full factorial design Betamethasone 17-valerate |
| url | https://journals.iium.edu.my/ktn/index.php/jp/article/view/281 |
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