Staff View: Development of a novel direct compressible co-processed excipient and its application for formulation of Mirtazapine orally disintegrating tablets

Development of a novel direct compressible co-processed excipient and its application for formulation of Mirtazapine orally disintegrating tablets

Introduction Orally disintegrating tablets (ODTs) are designed to dissolve in the oral cavity within 3 min, providing a convenient option for patients as they can be taken without water. Direct compression is the most common method used for ODTs formulations. However, the availability of single com...

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Main Authors:	Loke, Ying Hui, Chew, Yik-Ling, Ashok Kumar, Janakiraman, Lee, Siew-Keah, A.B.M. Helal, Uddin, Goh, Fu Choon, Kee, Phei Er, Ng, Hui Suan, Long, Chiau Ming *, Liew, Kai Bin
Format:	Article
Published:	Taylor and Francis Group 2024
Subjects:	QD Chemistry RS Pharmacy and materia medica
Online Access:	http://eprints.sunway.edu.my/2605/ https://doi.org/10.1080/03639045.2023.2294095
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spelling	my.sunway.eprints.26052024-05-15T06:45:39Z http://eprints.sunway.edu.my/2605/ Development of a novel direct compressible co-processed excipient and its application for formulation of Mirtazapine orally disintegrating tablets Loke, Ying Hui Chew, Yik-Ling Ashok Kumar, Janakiraman Lee, Siew-Keah A.B.M. Helal, Uddin Goh, Fu Choon Kee, Phei Er Ng, Hui Suan Long, Chiau Ming * Liew, Kai Bin QD Chemistry RS Pharmacy and materia medica Introduction Orally disintegrating tablets (ODTs) are designed to dissolve in the oral cavity within 3 min, providing a convenient option for patients as they can be taken without water. Direct compression is the most common method used for ODTs formulations. However, the availability of single composite excipients with desirable characteristics such as good compressibility, fast disintegration, and a good mouthfeel suitable for direct compression is limited. Objective This research was proposed to develop a co-processed excipient composed of xylitol, mannitol, and microcrystalline cellulose for the formulation of ODTs. Methods A total of 11 formulations of co-processed excipients with different ratios of ingredients were prepared, which were then compressed into ODTs, and their characteristics were thoroughly examined. The primary focus was on evaluating the disintegration time and hardness of the tablets, as these factors are important in ensuring the ODTs meet the desired criteria. The model drug, Mirtazapine was then incorporated into the chosen optimized formulation. Results The results showed that the formulation comprised of 10% xylitol, 10% mannitol and 80% microcrystalline cellulose demonstrated the fastest disintegration time (1.77 ± 0.119 min) and sufficient hardness (3.521 ± 0.143 kg) compared to the other formulations. Furthermore, the drug was uniformly distributed within the tablets and fully released within 15 min. Conclusion Therefore, the developed co-processed excipients show great potential in enhancing the functionalities of ODTs, offering a promising solution to improve the overall performance and usability of ODTs in various therapeutic applications. Taylor and Francis Group 2024 Article PeerReviewed Loke, Ying Hui and Chew, Yik-Ling and Ashok Kumar, Janakiraman and Lee, Siew-Keah and A.B.M. Helal, Uddin and Goh, Fu Choon and Kee, Phei Er and Ng, Hui Suan and Long, Chiau Ming * and Liew, Kai Bin (2024) Development of a novel direct compressible co-processed excipient and its application for formulation of Mirtazapine orally disintegrating tablets. Drug Development and Industrial Pharmacy, 50 (1). pp. 1-9. ISSN 1520-5762 https://doi.org/10.1080/03639045.2023.2294095 10.1080/03639045.2023.2294095
institution	Sunway University
building	Sunway Campus Library
collection	Institutional Repository
continent	Asia
country	Malaysia
content_provider	Sunway University
content_source	Sunway Institutional Repository
url_provider	http://eprints.sunway.edu.my/
topic	QD Chemistry RS Pharmacy and materia medica
spellingShingle	QD Chemistry RS Pharmacy and materia medica Loke, Ying Hui Chew, Yik-Ling Ashok Kumar, Janakiraman Lee, Siew-Keah A.B.M. Helal, Uddin Goh, Fu Choon Kee, Phei Er Ng, Hui Suan Long, Chiau Ming * Liew, Kai Bin Development of a novel direct compressible co-processed excipient and its application for formulation of Mirtazapine orally disintegrating tablets
description	Introduction Orally disintegrating tablets (ODTs) are designed to dissolve in the oral cavity within 3 min, providing a convenient option for patients as they can be taken without water. Direct compression is the most common method used for ODTs formulations. However, the availability of single composite excipients with desirable characteristics such as good compressibility, fast disintegration, and a good mouthfeel suitable for direct compression is limited. Objective This research was proposed to develop a co-processed excipient composed of xylitol, mannitol, and microcrystalline cellulose for the formulation of ODTs. Methods A total of 11 formulations of co-processed excipients with different ratios of ingredients were prepared, which were then compressed into ODTs, and their characteristics were thoroughly examined. The primary focus was on evaluating the disintegration time and hardness of the tablets, as these factors are important in ensuring the ODTs meet the desired criteria. The model drug, Mirtazapine was then incorporated into the chosen optimized formulation. Results The results showed that the formulation comprised of 10% xylitol, 10% mannitol and 80% microcrystalline cellulose demonstrated the fastest disintegration time (1.77 ± 0.119 min) and sufficient hardness (3.521 ± 0.143 kg) compared to the other formulations. Furthermore, the drug was uniformly distributed within the tablets and fully released within 15 min. Conclusion Therefore, the developed co-processed excipients show great potential in enhancing the functionalities of ODTs, offering a promising solution to improve the overall performance and usability of ODTs in various therapeutic applications.
format	Article
author	Loke, Ying Hui Chew, Yik-Ling Ashok Kumar, Janakiraman Lee, Siew-Keah A.B.M. Helal, Uddin Goh, Fu Choon Kee, Phei Er Ng, Hui Suan Long, Chiau Ming * Liew, Kai Bin
author_facet	Loke, Ying Hui Chew, Yik-Ling Ashok Kumar, Janakiraman Lee, Siew-Keah A.B.M. Helal, Uddin Goh, Fu Choon Kee, Phei Er Ng, Hui Suan Long, Chiau Ming * Liew, Kai Bin
author_sort	Loke, Ying Hui
title	Development of a novel direct compressible co-processed excipient and its application for formulation of Mirtazapine orally disintegrating tablets
title_short	Development of a novel direct compressible co-processed excipient and its application for formulation of Mirtazapine orally disintegrating tablets
title_full	Development of a novel direct compressible co-processed excipient and its application for formulation of Mirtazapine orally disintegrating tablets
title_fullStr	Development of a novel direct compressible co-processed excipient and its application for formulation of Mirtazapine orally disintegrating tablets
title_full_unstemmed	Development of a novel direct compressible co-processed excipient and its application for formulation of Mirtazapine orally disintegrating tablets
title_sort	development of a novel direct compressible co-processed excipient and its application for formulation of mirtazapine orally disintegrating tablets
publisher	Taylor and Francis Group
publishDate	2024
url	http://eprints.sunway.edu.my/2605/ https://doi.org/10.1080/03639045.2023.2294095
_version_	1800100325618614272
score	13.223943

Development of a novel direct compressible co-processed excipient and its application for formulation of Mirtazapine orally disintegrating tablets

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