Continuous Sonocrystallization Process for Controlling the Polymorphs and Particle Size of Perampanel

IF 3.1 3区化学 Q2 CHEMISTRY, APPLIED

Organic Process Research & Development Pub Date : 2024-10-23 DOI:10.1021/acs.oprd.4c00293

Koji Machida, Koichi Igarashi, Hideo Kawachi, Mai Okamoto, Shumpei Yonezawa, Yuka Morishige, Masayuki Azuma, Akira Nishiyama

引用次数: 0

Abstract

Sonocrystallization is a promising technology for improving the reproducibility and productivity of the crystallization process because of the unique cavitation effect of ultrasound as well as for controlling crystal polymorphs and particle size. Despite these advantages, the use of ultrasound for crystallization has typically been limited to laboratory studies and has not been widely adopted on an industrial scale by the pharmaceutical industry. In this study, ultrasound was combined with continuous crystallization using a mixed-suspension, mixed-product removal (MSMPR) crystallizer, and this technology was applied to the crystallization of perampanel, demonstrating the effects of ultrasound and its practicality. Finally, the continuous sonocrystallization process was successfully scaled up using a 10 L ultrasonic crystallizer capable of direct ultrasound irradiation, providing a methodology for the scale-up of the continuous sonocrystallization process.

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用于控制紫杉醇多晶体和粒度的连续超声结晶工艺

超声波结晶技术因其独特的空化效应以及对晶体多晶体和粒度的控制，在提高结晶过程的可重复性和生产率方面大有可为。尽管超声波具有这些优势，但其在结晶过程中的应用通常仅限于实验室研究，尚未被制药行业在工业规模上广泛采用。在本研究中，利用混合悬浮、混合产物去除（MSMPR）结晶器将超声与连续结晶结合起来，并将这一技术应用于 perampanel 的结晶，展示了超声的效果及其实用性。最后，利用一个可直接进行超声波辐照的 10 升超声波结晶器，成功地扩大了连续超声波结晶工艺的规模，为扩大连续超声波结晶工艺的规模提供了一种方法。

本文章由计算机程序翻译，如有差异，请以英文原文为准。

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来源期刊

Organic Process Research & Development 化学-应用化学

CiteScore

6.90

自引率

14.70%

发文量

251

审稿时长

2 months

期刊介绍： The journal Organic Process Research & Development serves as a communication tool between industrial chemists and chemists working in universities and research institutes. As such, it reports original work from the broad field of industrial process chemistry but also presents academic results that are relevant, or potentially relevant, to industrial applications. Process chemistry is the science that enables the safe, environmentally benign and ultimately economical manufacturing of organic compounds that are required in larger amounts to help address the needs of society. Consequently, the Journal encompasses every aspect of organic chemistry, including all aspects of catalysis, synthetic methodology development and synthetic strategy exploration, but also includes aspects from analytical and solid-state chemistry and chemical engineering, such as work-up tools，process safety, or flow-chemistry. The goal of development and optimization of chemical reactions and processes is their transfer to a larger scale; original work describing such studies and the actual implementation on scale is highly relevant to the journal. However, studies on new developments from either industry, research institutes or academia that have not yet been demonstrated on scale, but where an industrial utility can be expected and where the study has addressed important prerequisites for a scale-up and has given confidence into the reliability and practicality of the chemistry, also serve the mission of OPR&D as a communication tool between the different contributors to the field.