The morphology of crystalline active pharmaceutical ingredients (APIs) can significantly affect their product properties, so that its control during manufacturing is crucial. To address this, a newly augmented commercial milliliter-scale facility and knowledge-based workflow were developed with the aim of identifying optimal process conditions for producing more equant-shaped crystals. The design includes minimal material usage, inline imaging, and independent temperature and supersaturation control through evaporative crystallization. The methodology enables the identification of process conditions for equant-shaped crystals across diverse APIs. These findings contribute to advancing pharmaceutical research and development by providing a reliable approach to optimize crystal morphology.

中文翻译：

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活性药物成分晶体形状更均匀的综合工作流程

结晶活性药物成分 (API) 的形态会显着影响其产品特性，因此在制造过程中对其进行控制至关重要。为了解决这个问题，开发了一种新增强的商业毫升级设施和基于知识的工作流程，旨在确定生产更多等量形状晶体的最佳工艺条件。该设计包括最少的材料使用、在线成像以及通过蒸发结晶进行独立的温度和过饱和度控制。该方法能够识别不同 API 中等形晶体的工艺条件。这些发现提供了优化晶体形态的可靠方法，有助于推进药物研究和开发。