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首页> 外文期刊>Crystal growth & design >Polymorphic Control and Scale-up Strategy for Crystallization from a Ternary Antisolvent System by Supersaturation Control
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Polymorphic Control and Scale-up Strategy for Crystallization from a Ternary Antisolvent System by Supersaturation Control

机译：通过超饱和控制从三元抗溶剂系统结晶的多态性控制和扩大策略

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摘要

Antisolvent crystallization of indomethacin (IMC) was investigated in this work by using an acetone-methanol (66.5-33.5 wt %) mixture as solvent and water as antisolvent. Selecting the binary mixture as the solvent led to an increased yield of the batch process, as the solubility of IMC is higher in the mixed solvents. Adding methanol to the solvent system mitigated the nucleation of the acetone solvate, which is dominating in the acetone-water system. Process analytical technologies were implemented to ensure that the desired polymorph was present throughout the process. Supersaturation control (SSC) was applied as a closed-loop feedback control strategy, to achieve a rapid direct design of the crystallization process using the principles of quality by control. The antisolvent flow-rate profiles, obtained by the SSC, were implemented in open loop and used for scaling up the process by 1 order of magnitude. The results show how feedback control of crystallization from a ternary solvent mixture increases productivity and simultaneously ensures suppression of nucleation to obtain the desired particle size distribution and polymorph. The direct design approach can be applied in the design and development of crystallization processes to yield the chosen solid phase of IMC when scaling from small to large scale.
机译：通过使用丙酮 - 甲醇（66.5-33.5wt％）混合物作为溶剂和水作为抗溶剂，在该工作中研究了吲哚美辛（IMC）的抗溶剂结晶。选择二元混合物作为溶剂导致分批过程的产率提高，因为IMC的溶解度在混合溶剂中较高。向溶剂系统中加入甲醇增强丙酮溶剂化物的成核，该溶剂化物在丙酮水系统中占主导地位。实施过程分析技术以确保在整个过程中存在所需的多晶型物。将超饱和控制（SSC）应用为闭环反馈控制策略，以通过控制的质量原理实现结晶过程的快速直接设计。由SSC获得的防溶剂流速分布在开环中实现，并用于将过程缩放1级。结果表明，从三元溶剂混合物中结晶的反馈控制如何增加生产率并同时确保抑制成核以获得所需的粒度分布和多晶型物。直接设计方法可以应用于结晶过程的设计和开发，以在从小到大规模缩小时产生IMC的所选择的固相。

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