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.

中文翻译：

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连续声波结晶工艺控制吡仑帕奈多晶型物和粒径


由于超声波独特的空化效应，声波结晶是一种很有前途的技术，可以提高结晶过程的可重复性和生产率，以及控制晶体多晶型物和粒度。尽管有这些优点，但超声结晶的使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。本研究采用混合悬浮混合产物去除 （MSMPR） 结晶器将超声与连续结晶相结合，并将该技术应用于吡仑帕奈的结晶，证明了超声的效果及其实用性。最后，使用能够直接超声照射的 10 L 超声结晶器成功放大了连续声波结晶工艺，为连续声波结晶工艺的放大提供了一种方法。