Controlled crystallization of an API in submicron size was enabled based on an accurate solubility profile and a growth inhibition property via semi-continuous processing, to meet special formulation requirements.

Diverse crystallization challenges encountered by CfPC (Center for Pharma Crystallization) and our clients will be analyzed systematically to provide insights into main bottleneck problems in today’s drug development programs.

Given challenges facing the pharmaceutical industry, an accelerated Drug Development greatly benefits from guidance provided by computational methods. This presentation will focus on computational support of the following important tasks related to the pharmaceutical crystallization.

Problems associated with polymorphic instability and increasingly insoluble drug candidates represent white space to innovate novel forms and processing methods with better properties in the drug product. But the journey from identifying new solid forms to creating engineered particles with optimal formulation properties has often been too inefficient to realize this goal.

Rational selection of solvents plays a critical role in solid form screening and production. On the one hand, a variety of solvents with different properties are chosen in form screening to maximize the screening space of searching for all potential solid forms because some solvents selectively favor the generation of a particular form as a result of crystallization kinetics.