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

IF 4.4 2区 医学 Q1 PHARMACOLOGY & PHARMACY European Journal of Pharmaceutics and Biopharmaceutics Pub Date : 2024-08-15 DOI:10.1016/j.ejpb.2024.114456
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Abstract

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.

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在 SeDeM 图的帮助下,探索湿气活化干法制粒技术,以开发胃复安片剂。
水分活化干法制粒(MADG)是一种极具吸引力的制粒工艺。然而,只有少数几项研究探讨了通过 MADG 实现的改良药物释放,而且据作者所知,没有一项研究探讨了胃保留问题。本研究的目的是在 SeDeM 图的帮助下,探索 MADG 工艺在开发具有胃保留作用的安慰剂片剂中的适用性。漂浮能力和溶胀能力被确定为关键质量属性(CQA)。经过制剂筛选步骤,浮动基质形成剂和粘合剂的类型和浓度被确定为十种制剂中最相关的关键材料属性(CMA)。针对这些变化因素进行了多元线性回归分析(MLRA),以找到设计空间。根据主成分分析(PCA)结果和多元线性回归分析,制备了一种优化产品,并对其进行了表征。粒料还通过 SeDeM 进行了评估。总之,制粒可制成浮动片剂,浮动滞后时间短(4 小时),并显示出良好的溶胀特性。迄今为止所取得的结果很有希望,足以将 MADG 视为一种有利的制粒方法,用于获得胃复安片剂,甚至是其他需要在其成分中含有相对较多吸收材料的控制给药系统。
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来源期刊
CiteScore
8.80
自引率
4.10%
发文量
211
审稿时长
36 days
期刊介绍: The European Journal of Pharmaceutics and Biopharmaceutics provides a medium for the publication of novel, innovative and hypothesis-driven research from the areas of Pharmaceutics and Biopharmaceutics. Topics covered include for example: Design and development of drug delivery systems for pharmaceuticals and biopharmaceuticals (small molecules, proteins, nucleic acids) Aspects of manufacturing process design Biomedical aspects of drug product design Strategies and formulations for controlled drug transport across biological barriers Physicochemical aspects of drug product development Novel excipients for drug product design Drug delivery and controlled release systems for systemic and local applications Nanomaterials for therapeutic and diagnostic purposes Advanced therapy medicinal products Medical devices supporting a distinct pharmacological effect.
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