Koner, Jasdip, Rajabi-Siahboomi, Ali, Missaghi, S., Kirby, Daniel J, Perrie, Yvonne, Ahmed, J. and Mohammed, Afzal (2019). Conceptualisation, Development, Fabrication and In Vivo Validation of a Novel Disintegration Tester for Orally Disintegrating Tablets. Scientific Reports, 9 ,
Abstract
Disintegration time is the key critical quality attribute for a tablet classed as an Orally Disintegrating Tablet (ODT). The currently accepted in vitro testing regimen for ODTs is the standard United States Pharmacopeia (USP) test for disintegration of immediate release tablets, which requires a large volume along with repeated submergence of the dosage form within the disintegration medium. The aim of this study was to develop an in vivo relevant ODT disintegration test that mimicked the environment of the oral cavity, including lower volume of disintegration medium, with relevant temperature and humidity that represent the conditions of the mouth. The results showed that the newly developed Aston test was able to differentiate between different ODTs with small disintegration time windows, as well as between immediate release tablets and ODTs. The Aston test provided higher correlations between ODT properties and disintegration time compared to the USP test method and most significantly, resulted in a linear in vitro/in vivo correlation (IVIVC) (R 2 value of 0.98) compared with a "hockey stick" profile of the USP test. This study therefore concluded that the newly developed Aston test is an accurate, repeatable, relevant and robust test method for assessing ODT disintegration time which will provide the pharmaceutical industry and regulatory authorities across the world with a pragmatic ODT testing regime.
Publication DOI: | https://doi.org/10.1038/s41598-019-48859-x |
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Divisions: | College of Health & Life Sciences > Aston Pharmacy School College of Health & Life Sciences > Chronic and Communicable Conditions College of Health & Life Sciences |
Additional Information: | This article is licensed under a Creative Commons Attribution 4.0 International License, which permits use, sharing, adaptation, distribution and reproduction in any medium or format, as long as you give appropriate credit to the original author(s) and the source, provide a link to the Creative Commons license, and indicate if changes were made. The images or other third party material in this article are included in the article’s Creative Commons license, unless indicated otherwise in a credit line to the material. If material is not included in the article’s Creative Commons license and your intended use is not permitted by statutory regulation or exceeds the permitted use, you will need to obtain permission directly from the copyright holder. To view a copy of this license, visit http://creativecommons.org/licenses/by/4.0/. |
Uncontrolled Keywords: | General |
Publication ISSN: | 2045-2322 |
Last Modified: | 03 Oct 2024 07:21 |
Date Deposited: | 19 Aug 2019 09:31 |
Full Text Link: | |
Related URLs: |
https://www.nat ... 598-019-48859-x
(Publisher URL) http://www.scop ... tnerID=8YFLogxK (Scopus URL) |
PURE Output Type: | Article |
Published Date: | 2019-08-28 |
Accepted Date: | 2019-08-08 |
Authors: |
Koner, Jasdip
Rajabi-Siahboomi, Ali Missaghi, S. Kirby, Daniel J ( 0000-0002-0878-2620) Perrie, Yvonne Ahmed, J. Mohammed, Afzal ( 0000-0002-5212-3040) |
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