Development of Robust Crystallization Processes
Almost all active pharmaceutical ingredients (APIs) are crystallized at some stage in their preparation, and many are formulated into drug product as crystalline materials. Traditionally, API crystallization processes were optimized primarily around reactor throughput and chemical yield. Unless problems were encountered in product recovery or downstream use, consistency of solid form was often ignored.
It is now understood that a crystalline API needs to exhibit consistent physical properties when made at each stage of the development process (gram to multi-kilogram scales). In so doing formulation-development problems are minimized and regulatory requirements are met. Chemfocus is experienced in generation of crystallization methods, including the background information necessary to impart solid form control (polymorphic form, particle size, etc).