Food

Abstract

a n d m e t h o d s i n c h a r a c t e r i z a t i o n a n d d e e p s t u d i e s o n t h e polymorphic state of drug substances. The book is divided into six main sections: the first deals with thermodynamics and theoretical issues including characterization of polymorphic and solvatomorphic systems along with computational methodologies for prediction of the crystal polymorph state of drugs. The second section covers preparative methods for polymorphs and solvatomorphs, where the classical as well as High-Throughput approaches are discussed, with practical examples and the automation potential for scientific and development applications. The structural properties of polymorphs and solvatomorphs, including structural aspects and pharmaceutical co-crystal structures, are discussed in the third section. The characterization of polymorphs and solvatomorphs is a key aspect covered in the fourth section. Modern analytical approaches such as thermoanalytical and crystallographic methods, vibrational spectroscopy, solid-state NMR spectroscopy are included with brief descriptions of the effect of polymorphism and solid-state salvation on important pharmaceutical parameters such as dissolution and solubility of drugs. The fifth section encompasses the interconversion of polymorphs and solvatomorphs as well as the effects of pharmaceutical processing on the solid form of drug and excipient material. The former covers interconversions such as solid-to-solid, dehydration and desolvation, solution and vapor-mediated phase transformation. While the latter embraces processes involved in pharmaceutical manufacture such as milling, granulation, drying, hydration, lyophilization, compression and other shear stress in polymorph and solvatomorph interconversion.