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2024-10-01

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cc-by-nc-nd (c) Anna Nardi Ricart, et al., 2024
Si us plau utilitzeu sempre aquest identificador per citar o enllaçar aquest document: https://hdl.handle.net/2445/229020

Exploration of moisture activated dry granulation for the development of gastroretentive tablets aided by SeDeM diagram

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Recurs relacionat

https://doi.org/10.1016/j.ejpb.2024.114456

Resum

Moisture activated dry granulation (MADG) is an attractive granulation process. However, only a few works have explored modified drug release achieved by MADG, and to the best of the authors knowledge, none of them have explored gastroretention. The aim of this study was to explore the applicability of MADG process for developing gastroretentive placebo tablets, aided by SeDeM diagram. Floating and swelling capacities have been identified as critical quality attributes (CQAs). After a formulation screening step, the type and concentration of floating matrix formers and of binders were identified as the most relevant critical material attributes (CMAs) to investigate in ten formulations. A multiple linear regression analysis (MLRA) was applied against the factors that were varied to find the design space. An optimized product based on principal component analysis (PCA) results and MLRA was prepared and characterized. The granulate was also assessed by SeDeM. In conclusion, granulates lead to floating tablets with short floating lag time (<2 min), long floating duration (>4 h), and showing good swelling characteristics. The results obtained so far are promising enough to consider MADG as an advantageous granulation method to obtain gastroretentive tablets or even other controlled delivery systems requiring a relatively high content of absorbent materials in their composition

Matèries

Comprimits (Medicina), Sistemes d'alliberament de medicaments, Malalties del tracte gastrointestinal

Matèries (anglès)

Tablets (Medicine), Drug delivery systems, Gastrointestinal system diseases

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Articles publicats en revistes (Farmàcia, Tecnologia Farmacèutica i Fisicoquímica)

Citació

NARDI RICART, Anna, et al. Exploration of moisture activated dry granulation for the development of gastroretentive tablets aided by SeDeM diagram. European Journal of Pharmaceutics and Biopharmaceutics. 2024. ISSN 0939-6411. [consulted: 3 of June of 2026]. Available at: https://hdl.handle.net/2445/229020

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