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
María Ximena Origoni , Anna Nardi-Ricart , Marc Suñé-Pou , Pilar Pérez-Lozano , Miquel Romero-Obón , Josep Maria Suñé- Negre , Ana Teresa Ochoa-Andrade , Encarna García- Montoya
{"title":"Exploration of moisture activated dry granulation for the development of gastroretentive tablets aided by SeDeM diagram","authors":"María Ximena Origoni ,&nbsp;Anna Nardi-Ricart ,&nbsp;Marc Suñé-Pou ,&nbsp;Pilar Pérez-Lozano ,&nbsp;Miquel Romero-Obón ,&nbsp;Josep Maria Suñé- Negre ,&nbsp;Ana Teresa Ochoa-Andrade ,&nbsp;Encarna García- Montoya","doi":"10.1016/j.ejpb.2024.114456","DOIUrl":null,"url":null,"abstract":"<div><p>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.</p><p>In conclusion, granulates lead to floating tablets with short floating lag time (&lt;2 min), long floating duration (&gt;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.</p></div>","PeriodicalId":12024,"journal":{"name":"European Journal of Pharmaceutics and Biopharmaceutics","volume":"203 ","pages":"Article 114456"},"PeriodicalIF":4.4000,"publicationDate":"2024-08-15","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.sciencedirect.com/science/article/pii/S0939641124002820/pdfft?md5=50a0ac915de9eaaca96fbbcfe51bc5be&pid=1-s2.0-S0939641124002820-main.pdf","citationCount":"0","resultStr":null,"platform":"Semanticscholar","paperid":null,"PeriodicalName":"European Journal of Pharmaceutics and Biopharmaceutics","FirstCategoryId":"3","ListUrlMain":"https://www.sciencedirect.com/science/article/pii/S0939641124002820","RegionNum":2,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":null,"EPubDate":"","PubModel":"","JCR":"Q1","JCRName":"PHARMACOLOGY & PHARMACY","Score":null,"Total":0}
引用次数: 0

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.

Abstract Image

查看原文
分享 分享
微信好友 朋友圈 QQ好友 复制链接
本刊更多论文
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。
本文章由计算机程序翻译,如有差异,请以英文原文为准。
求助全文
约1分钟内获得全文 去求助
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.
期刊最新文献
Continuous twin-screw melt granulation of drug-loaded electrospun fibers. Homogeneity analysis of medicine tablets by laser induced breakdown spectroscopy combined with multivariate methods. Antifungal peptide-loaded alginate microfiber wound dressing evaluated against Candida albicans in vitro and ex vivo Challenges in the development of long acting injectable multivesicular liposomes (DepoFoam® technology) Comparing effects of terpene-based deep eutectic solvent and solid microneedles on skin permeation of drugs with varying lipophilicity
×
引用
GB/T 7714-2015
复制
MLA
复制
APA
复制
导出至
BibTeX EndNote RefMan NoteFirst NoteExpress
×
×
提示
您的信息不完整,为了账户安全,请先补充。
现在去补充
×
提示
您因"违规操作"
具体请查看互助需知
我知道了
×
提示
现在去查看 取消
×
提示
确定
0
微信
客服QQ
Book学术公众号 扫码关注我们
反馈
×
意见反馈
请填写您的意见或建议
请填写您的手机或邮箱
已复制链接
已复制链接
快去分享给好友吧!
我知道了
×
扫码分享
扫码分享
Book学术官方微信
Book学术文献互助
Book学术文献互助群
群 号:481959085
Book学术
文献互助 智能选刊 最新文献 互助须知 联系我们:info@booksci.cn
Book学术提供免费学术资源搜索服务,方便国内外学者检索中英文文献。致力于提供最便捷和优质的服务体验。
Copyright © 2023 Book学术 All rights reserved.
ghs 京公网安备 11010802042870号 京ICP备2023020795号-1