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首页> 外文期刊>Organic process research & development >Statistical Design of Experiment on Contact Secondary Nucleation as a Means of Creating Seed Crystals for Continuous Tubular Crystallizers
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Statistical Design of Experiment on Contact Secondary Nucleation as a Means of Creating Seed Crystals for Continuous Tubular Crystallizers

机译：接触二次成核作为连续管式结晶器晶种生成实验的统计设计

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摘要

In the pharmaceutical industry, it is often desired to produce seed crystals with an appropriate narrow size distribution of the desired polymorph. This study describes a system that generates such crystals continuously in a small-scale tubular crystallizer at low supersaturation via contact secondary nucleation. A response surface model was constructed by conducting a statistical design of experiment that models the nucleation rate as a function of contact force, area, and frequency. This model reveals that within a certain range the nucleation rate is linearly related to all three factors in this system. A combination of in-line video analysis and off-line microscope, image analysis was used to determine the particle size distribution of seed crystals obtained in this system, and the majority of the crystals were found to be under 20 mu m. This seems to be a feature of contact secondary nuclei in general and does not vary significantly with contact force, area, and frequency. Furthermore, the seed crystals generated are of the same polymorph as the parent crystals as a result of the attrition process. This study shows that generating seed crystals with a narrow size distribution using contact secondary nucleation for a continuous tubular crystallizer can be realized at a controlled rate by quantitative variation of certain design parameters.
机译：在制药工业中，通常希望生产出具有所需多晶型物的适当窄尺寸分布的晶种。这项研究描述了一种系统，该系统通过接触二次成核作用在低过饱和度的小型管状结晶器中连续生成此类晶体。通过进行实验的统计设计，构建了响应表面模型，该模型将成核速率建模为接触力，面积和频率的函数。该模型表明，在一定范围内，成核速率与该系统中的所有三个因素线性相关。在线视频分析和离线显微镜相结合，图像分析被用来确定在该系统中获得的晶种的粒度分布，并且发现大多数晶体在20μm以下。通常，这似乎是接触次级核的特征，并且不会随接触力，面积和频率而发生显着变化。此外，由于磨损过程，所产生的种晶具有与母体晶体相同的多晶型物。这项研究表明，通过连续改变某些管状设计参数的数量，可以使用可控速率实现连续管状结晶器利用接触二次成核生成尺寸分布窄的晶种。

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