PHYSICAL CHARACTERIZATION OF POLYMORPHIC DRUGS - AN INTEGRATED CHARACTERIZATION STRATEGY

The potential impact of changing crystal forms during late-stage drug development, in terms of cost and product delay, justifies systematic and early characterization of polymorphism. A thorough understanding o f polymorph characteristics also allows selection of the best form to market. The authors review the key elements of polymorph characterizat ion (identification and quantitation, structures, properties and struc ture-property relationships). The emphasis is on recent developments a nd an integrated characterization strategy for different types of poly morphs using crystallographic, spectroscopic, microscopic and thermal techniques.