Crystallization technology applications for the process development of Active Pharmaceutical Ingredients

ORGN 622

Peter R. Rose, peter.r.rose@pfizer.com, Chemical Research and Development, Pfizer, Inc, MS 8156-65, Eastern Point Road, Groton, CT 06340
Crystallization is the most common isolation and purification method for intermediates and final products synthesized in the pharmaceutical industry. Knowledge of the underlying science of crystallization can result in more robust crystallization processes from the laboratory to commercial scale. Phase diagrams such as solubility curves for a single crystalline phase or an enantiotropic polymorph system provide understanding of the crystallization thermodynamics and a roadmap to crystallization development. In addition, Process Analytical Technologies (PAT) offer an opportunity to evaluate the kinetics of crystal nucleation and growth in real time. This paper will show examples where crystallization development and engineering tools in conjunction with an understanding of the thermodynamics and kinetics of crystallization have improved isolation and purification of compounds currently in development at Pfizer.