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超声波辅助连续结晶的变态多态药品在一个流管状结晶器

Huadong Liao¹, Wenfeng Huang², Ling Zhou¹

¹School of Chemical Engineering and Technology, State Key Laboratory of Chemical Engineering, Tianjin University, Tianjin 300072, PR China.

Ultrasonics sonochemistry

|October 9, 2023

概括

本研究介绍了一种超声波辅助的连续管状结晶方法,用于生产转移稳定的卡维迪醇 (CVD) 形式II晶体. 这种创新技术确保了一致的质量,并克服了转基因稳定多态药物的制造挑战.

科学领域:

制药科学制药科学
化学工程是化学工程的重要组成部分.
材料科学材料科学材料科学

背景情况:

转基因稳定的多态药物提供了改善的性能,如溶解性和生物可用性.
制造业面临的挑战仍然存在,特别是实现稳定,一致的超稳定形式的生产.
碳醇 (CVD) 形式II生产面临稳定制备方面的困难,影响产品质量和监管遵守.

研究的目的:

开发一种可靠的方法来制备转移稳定的卡维迪醇 (CVD) 形式II晶体.
解决和克服连续结晶中的运行问题,如阻塞和壁贴.
为了评估超声波辅助的连续流管状结晶方法的性能.

主要方法:

使用连续管状结晶器进行转移稳定的CVD形式II晶体制备.
集成的气泡段和超声波照射来应对运营挑战.
开发并测试了一种超声波辅助的连续流管状结晶工艺.

主要成果:

成功制备了具有高效率和强度的可变性CVD形式II晶体.
管状结晶器证明了有效生成所需的转移稳定形式.
开发的方法产生了弹性,可持续和不间断的制药晶体.
解决了连续管状结晶中常见的层问题.

结论:

一种超声波辅助的连续流管状结晶方法对于生产转移稳定的多态药物是有效的.
这种方法通过确保稳定的晶体制备来提高产品质量和监管合规性.
该方法显示出在连续制造转移稳定的晶体形式方面克服挑战的巨大潜力.

关键词:

卡尔维迪洛尔 (Carvedilol) 是一种多态转换的多态转换.声晶化声晶化声晶化管状结晶器的使用方法超声波辐射辐射的超声波辐射.

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