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.

在制药剂型的制造中，控制晶体粒度分布是必不可少的。特别是，获得窄尺寸分布对于实现Eupraxia制药公司开发的新缓释技术至关重要。目前的工作流程对新型抗炎疗法的扩大和生产提出了重大障碍。Hein实验室设计的新技术利用自动化和原位监测技术，将有助于确定最佳结晶条件，以实现活性药物成分的狭窄和可控粒度分布。此外，Hein实验室将研究如何将优化的结晶过程适应为连续结晶工作流程，使最终制造阶段更加稳健和高效。