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

IF 2.8 4区生物学 Q3 BIOTECHNOLOGY & APPLIED MICROBIOLOGY

Journal of chemical technology and biotechnology Pub Date : 2024-05-28 DOI:10.1002/jctb.7665

Manu Garg, Anurag Singh Rathore

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Abstract

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).

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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

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）。

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来源期刊

Journal of chemical technology and biotechnology 工程技术-工程：化工

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.