Targeting Particle Size Specification in Pharmaceutical Crystallization: A Review on Recent Process Design and Development Strategies and Particle Size Measurements,Organic Process Research & Development

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Targeting Particle Size Specification in Pharmaceutical Crystallization: A Review on Recent Process Design and Development Strategies and Particle Size Measurements
Organic Process Research & Development ( IF 3.1 ) Pub Date : 2022-11-29 , DOI: 10.1021/acs.oprd.2c00277
Fan Liu _{1,

2} , Sujay D. Bagi ₂ , Qinglin Su ₂ , Rajshree Chakrabarti ₂ , Rita Barral ₂ , Janaka C. Gamekkanda ₂ , Chuntian Hu ₂ , Salvatore Mascia ₂

Affiliation

Obtaining a particle size within the specifications for a pharmaceutical compound in an industrial crystallization can be a challenging task. The events affecting the final particle size of the product include nucleation, growth, breakage, and agglomeration, which are often convoluted. Secondary nucleation may significantly influence the particle size distribution. The strategies and techniques relevant to obtaining an in-spec particle size in crystallization are summarized and discussed from a perspective of process parameters. The effect of cooling profiles, seeding strategies, as well as mixing by agitation are reviewed, and an efficient and controlled crystallization process may be achieved using an optimized combination of these conditions. Multiple characterization methods for particle size and distribution are compared, and the discrepancies associated with the measurements are addressed.

中文翻译：

药物结晶中的目标粒度规格：近期工艺设计和开发策略以及粒度测量的回顾

在工业结晶中获得符合药物化合物规格的粒径可能是一项具有挑战性的任务。影响产品最终粒径的事件包括成核、生长、破碎和团聚，这些事件通常是复杂的。二次成核可能会显着影响粒度分布。从工艺参数的角度总结和讨论了在结晶中获得符合规格的粒径的相关策略和技术。回顾了冷却曲线、晶种策略以及搅拌混合的影响，并且可以使用这些条件的优化组合来实现高效且受控的结晶过程。比较了粒度和分布的多种表征方法，

更新日期：2022-11-29

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