Tailoring the crystal size distribution of an active pharmaceutical ingredient by continuous antisolvent crystallization in a planar oscillatory flow crystallizer

An active pharmaceutical ingredient is currently produced in a traditional batch antisolvent crystallization process. Although well-established, this process lacks flexibility to control the crystal size distribution (CSD). Therefore, new was developed enable of CSD according different specifications. This implemented continuous planar oscillatory flow crystallizer (planar-OFC). In work, main goal production small crystals meet very specific formulation requirements and, simultaneously, promote aggregation these particles optimize filtration operation. First, operating conditions were optimized for Then, planar-OFC divided into two spatially independent sections, nucleation zone (where dominant) and growth dominant), so as function residence time each zone. particular, formation aggregates could be promoted by increasing Ultimately, able produce smaller with significantly narrower CSDs than particularly important when particle sizes are required, thus reducing manufacturing costs.