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Production-Scale Particle Design of a Pharmaceutical Intermediate

机译：医药中间体的生产规模颗粒设计

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Product requirements within the pharmaceutical and life sciences sector change rapidly due to new drug developments and applications linked to new formulations.This paper presents recent developments in designing an optimal crystallization process incorporating,at the design stage,customer demands regarding the physical properties of the crystalline product,notably particle size and particle size distribution.Simple laboratory-scale batch crystallization experiments were performed to extract the relevant kinetic parameters of nucleation,growth,and aggregation and to identify further mechanisms such as disaggregation and attrition.Aggregation,considering also nucleation and growth,was simulated via population balance modeling whereas disaggregation was considered by quantitative determination of the interparticle forces.Using this new design route,a production-scale crystallization process comprising a continuously operated air-jet crystallizer with an integrated clarification zone was successfully commissioned.
机译：由于新药的开发以及与新配方相关的应用，制药和生命科学领域的产品要求迅速变化。本文介绍了设计最佳结晶工艺的最新进展，该工艺在设计阶段就结合了客户对晶体物理性质的要求进行了简单的实验室规模的批量结晶实验，以提取成核，生长和聚集的相关动力学参数，并确定了进一步的机制，如分解和磨损。聚集，还考虑了成核和生长通过人口平衡模型进行模拟，而通过粒子间力的定量确定来考虑分解。使用这种新的设计路线，包括连续运行的气流结晶器和集成的澄清区的生产规模的结晶工艺得以实现。成功调试。

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