以质量源于设计范式进行抗溶剂辅助结晶的工艺开发:结晶参数对右兰索拉唑活性药物成分颗粒形态和溶解行为的影响

IF 2.8 4区 生物学 Q3 BIOTECHNOLOGY & APPLIED MICROBIOLOGY
Manu Garg, Anurag Singh Rathore
{"title":"以质量源于设计范式进行抗溶剂辅助结晶的工艺开发:结晶参数对右兰索拉唑活性药物成分颗粒形态和溶解行为的影响","authors":"Manu Garg,&nbsp;Anurag Singh Rathore","doi":"10.1002/jctb.7665","DOIUrl":null,"url":null,"abstract":"<div>\n \n \n <section>\n \n <h3> BACKGROUND</h3>\n \n <p>In this work, a process development study for the crystallization step of dexlansoprazole API has been demonstrated under the Quality-by-Design (QbD) paradigm. Dexlansoprazole (crystalline) samples prepared under different crystallization conditions of reactor temperature and addition time of anti-solvent were subjected to solid-state characterization with variety of analytical techniques, including X-ray powder diffraction (XRPD), differential scanning calorimetry (DSC), thermogravimetric analysis (TGA), dynamic vapour sorption (DVS), scanning electron microscopy (SEM), particle size distribution (PSD) by laser diffraction and intrinsic dissolution rate (IDR).</p>\n </section>\n \n <section>\n \n <h3> RESULTS</h3>\n \n <p>The crystalline samples were observed to have identical polymorphic phase integrity but differed in their physical characteristics. The particle size distribution and microscopy data collectively elucidated the particle growth kinetics and the extent of agglomeration could be correlated to crystallization conditions, namely reactor temperature and addition time of anti-solvent. The intrinsic dissolution rate of samples was in good agreement with the morphological properties.</p>\n </section>\n \n <section>\n \n <h3> CONCLUSION</h3>\n \n <p>An empirical model has been proposed for intrinsic dissolution rate correlating with crystallization process parameters. In conclusion, it was possible to elucidate the impact of crystallization parameters on the solid-state behaviour of dexlansoprazole for development of appropriate pharmaceutical dosage forms. © 2024 Society of Chemical Industry (SCI).</p>\n </section>\n </div>","PeriodicalId":15335,"journal":{"name":"Journal of chemical technology and biotechnology","volume":"99 8","pages":"1734-1742"},"PeriodicalIF":2.8000,"publicationDate":"2024-05-28","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":"0","resultStr":"{\"title\":\"Process development in Quality-by-Design paradigm for anti-solvent aided crystallization: impact of crystallization parameters on particle morphology and dissolution behaviour of Dexlansoprazole active pharmaceutical ingredient\",\"authors\":\"Manu Garg,&nbsp;Anurag Singh Rathore\",\"doi\":\"10.1002/jctb.7665\",\"DOIUrl\":null,\"url\":null,\"abstract\":\"<div>\\n \\n \\n <section>\\n \\n <h3> BACKGROUND</h3>\\n \\n <p>In this work, a process development study for the crystallization step of dexlansoprazole API has been demonstrated under the Quality-by-Design (QbD) paradigm. Dexlansoprazole (crystalline) samples prepared under different crystallization conditions of reactor temperature and addition time of anti-solvent were subjected to solid-state characterization with variety of analytical techniques, including X-ray powder diffraction (XRPD), differential scanning calorimetry (DSC), thermogravimetric analysis (TGA), dynamic vapour sorption (DVS), scanning electron microscopy (SEM), particle size distribution (PSD) by laser diffraction and intrinsic dissolution rate (IDR).</p>\\n </section>\\n \\n <section>\\n \\n <h3> RESULTS</h3>\\n \\n <p>The crystalline samples were observed to have identical polymorphic phase integrity but differed in their physical characteristics. The particle size distribution and microscopy data collectively elucidated the particle growth kinetics and the extent of agglomeration could be correlated to crystallization conditions, namely reactor temperature and addition time of anti-solvent. The intrinsic dissolution rate of samples was in good agreement with the morphological properties.</p>\\n </section>\\n \\n <section>\\n \\n <h3> CONCLUSION</h3>\\n \\n <p>An empirical model has been proposed for intrinsic dissolution rate correlating with crystallization process parameters. In conclusion, it was possible to elucidate the impact of crystallization parameters on the solid-state behaviour of dexlansoprazole for development of appropriate pharmaceutical dosage forms. © 2024 Society of Chemical Industry (SCI).</p>\\n </section>\\n </div>\",\"PeriodicalId\":15335,\"journal\":{\"name\":\"Journal of chemical technology and biotechnology\",\"volume\":\"99 8\",\"pages\":\"1734-1742\"},\"PeriodicalIF\":2.8000,\"publicationDate\":\"2024-05-28\",\"publicationTypes\":\"Journal Article\",\"fieldsOfStudy\":null,\"isOpenAccess\":false,\"openAccessPdf\":\"\",\"citationCount\":\"0\",\"resultStr\":null,\"platform\":\"Semanticscholar\",\"paperid\":null,\"PeriodicalName\":\"Journal of chemical technology and biotechnology\",\"FirstCategoryId\":\"5\",\"ListUrlMain\":\"https://onlinelibrary.wiley.com/doi/10.1002/jctb.7665\",\"RegionNum\":4,\"RegionCategory\":\"生物学\",\"ArticlePicture\":[],\"TitleCN\":null,\"AbstractTextCN\":null,\"PMCID\":null,\"EPubDate\":\"\",\"PubModel\":\"\",\"JCR\":\"Q3\",\"JCRName\":\"BIOTECHNOLOGY & APPLIED MICROBIOLOGY\",\"Score\":null,\"Total\":0}","platform":"Semanticscholar","paperid":null,"PeriodicalName":"Journal of chemical technology and biotechnology","FirstCategoryId":"5","ListUrlMain":"https://onlinelibrary.wiley.com/doi/10.1002/jctb.7665","RegionNum":4,"RegionCategory":"生物学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":null,"EPubDate":"","PubModel":"","JCR":"Q3","JCRName":"BIOTECHNOLOGY & APPLIED MICROBIOLOGY","Score":null,"Total":0}
引用次数: 0

摘要

背景在这项工作中,根据质量源于设计(QbD)范例,对右旋兰索拉唑原料药的结晶步骤进行了工艺开发研究。利用各种分析技术,包括 X 射线粉末衍射 (XRPD)、差示扫描量热 (DSC)、热重分析 (TGA)、动态蒸汽吸附 (DVS)、扫描电子显微镜 (SEM)、激光衍射粒度分布 (PSD) 和本征溶出率 (IDR),对在反应器温度和反溶剂添加时间等不同结晶条件下制备的右兰唑(结晶)样品进行了固态表征。结果观察到晶体样品具有相同的多晶相完整性,但在物理特性上有所不同。粒度分布和显微镜数据共同阐明了颗粒的生长动力学,其团聚程度可与结晶条件(即反应器温度和反溶剂添加时间)相关联。结论 提出了一个与结晶过程参数相关的内在溶解速率经验模型。总之,可以阐明结晶参数对右兰索拉唑固态行为的影响,从而开发出合适的药物剂型。© 2024 化学工业学会(SCI)。
本文章由计算机程序翻译,如有差异,请以英文原文为准。
Process development in Quality-by-Design paradigm for anti-solvent aided crystallization: impact of crystallization parameters on particle morphology and dissolution behaviour of Dexlansoprazole active pharmaceutical ingredient

BACKGROUND

In this work, a process development study for the crystallization step of dexlansoprazole API has been demonstrated under the Quality-by-Design (QbD) paradigm. Dexlansoprazole (crystalline) samples prepared under different crystallization conditions of reactor temperature and addition time of anti-solvent were subjected to solid-state characterization with variety of analytical techniques, including X-ray powder diffraction (XRPD), differential scanning calorimetry (DSC), thermogravimetric analysis (TGA), dynamic vapour sorption (DVS), scanning electron microscopy (SEM), particle size distribution (PSD) by laser diffraction and intrinsic dissolution rate (IDR).

RESULTS

The crystalline samples were observed to have identical polymorphic phase integrity but differed in their physical characteristics. The particle size distribution and microscopy data collectively elucidated the particle growth kinetics and the extent of agglomeration could be correlated to crystallization conditions, namely reactor temperature and addition time of anti-solvent. The intrinsic dissolution rate of samples was in good agreement with the morphological properties.

CONCLUSION

An empirical model has been proposed for intrinsic dissolution rate correlating with crystallization process parameters. In conclusion, it was possible to elucidate the impact of crystallization parameters on the solid-state behaviour of dexlansoprazole for development of appropriate pharmaceutical dosage forms. © 2024 Society of Chemical Industry (SCI).

求助全文
通过发布文献求助,成功后即可免费获取论文全文。 去求助
来源期刊
CiteScore
7.00
自引率
5.90%
发文量
268
审稿时长
1.7 months
期刊介绍: Journal of Chemical Technology and Biotechnology(JCTB) is an international, inter-disciplinary peer-reviewed journal concerned with the application of scientific discoveries and advancements in chemical and biological technology that aim towards economically and environmentally sustainable industrial processes.
×
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
确定
请完成安全验证×
copy
已复制链接
快去分享给好友吧!
我知道了
右上角分享
点击右上角分享
0
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 布克学术 All rights reserved.
京ICP备2023020795号-1
ghs 京公网安备 11010802042870号
Book学术文献互助
Book学术文献互助群
群 号:481959085
Book学术官方微信