Simultaneous API Particle Size Reduction and Polymorph Transformation Using High Shear

This case-study outlines the development and scale-up of a novel solvent-mediated process for producing small crystals. The process combines polymorph transformation with high shear to produce API with a desirable crystal phase and morphology that meets the particle size acceptance criteria ( d 90 < 75 μm). The impact of process parameters was investigated, and suitable scaling parameters were identified. Subsequently, the process was successfully scaled up to generate 100 kg of the API of the target crystallographic form with the desired powder properties.