A Comprehensive Workflow towards More Equant-Shaped Crystals of Active Pharmaceutical Ingredients

Abstract

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.