Harnessing the benefits of continuous crystallization to precisely control particular size distribution of active pharmaceutical ingredients

利用连续结晶的优势来精确控制活性药物成分的特定尺寸分布

• 批准号: 508663-2017
• 负责人: Hein, Jason
• 金额: $ 1.82万
• 依托单位: University of British Columbia
• 依托单位国家: 加拿大
• 项目类别: Engage Grants Program
• 财政年份: 2017
• 资助国家: 加拿大
• 起止时间: 2017-01-01 至 2018-12-31
• 项目状态: 已结题
• 来源: https://www.nserc-crsng.gc.ca/ase-oro/Details-Detailles_eng.asp?id=640361
• 关键词: Harnessing; benefits; continuous; crystallization; precisely

Control of crystallite particle size distribution is essential in the manufacturing of pharmaceutical dosageforms. In particular, obtaining a narrow size distribution is essential to enable new sustained release technologydeveloped by Eupraxia pharmaceuticals. The present workflow presents a significant barrier to scale up andmanufacturing of a novel anti-inflammatory therapy. New techniques designed by the Hein lab, whichleverages automation and in situ monitoring technology, will help to identify optimal crystallization conditionsto achieve a narrow and controlled particle size distribution for the active pharmaceutical ingredient. Inaddition, the Hein lab will investigate adapting the optimized crystallization process into a continuouscrystallization workflow, making the final manufacturing stage robust and very efficient.

控制晶体粒径分布在制造药物剂量的过程中至关重要。特别是，获得狭窄的尺寸分布对于启用Eupraxia Pharmaceuticals开发的新的持续释放技术至关重要。目前的工作流程为扩大新型抗炎疗法的制造构成了一个重大障碍。 Hein Lab设计的新技术，即自动化和原位监测技术，将有助于确定最佳的结晶条件，以实现狭窄且受控的粒径分布，以实现活性药物成分。 hein实验室不陷入困境，将调查将优化的结晶过程适应连续的晶体化工作流程，从而使最终的制造阶段稳健且非常有效。