Amorphous Solid Dispersions

Written by a team of experts in industry, academia and government agency, this book provides a comprehensive guide for pharmaceutical research scientists on the fundamentals of amorphous systems, the theoretical aspects of amorphous solid dispersion (ASD), and details on ASD manufacturing technologies, including spray drying, hot melt extrusion, fluid bed layering and a novel solvent controlled micro-precipitation technology. Each technology is illustrated with specific case studies. In addition, dedicated sections covers the analytical tools and technologies in characterization of the amorphous solid dispersions, prediction of long term stability, developing suitable dissolution methods, as well as regulatory aspects in ASD formulation and technologies. The book also discusses the future technologies on the horizon such as supercritical fluid processing, mesoporous silica, Kinetisol, as well as use of non-salt forming organic acids and amino acids for the stabilization of amorphous systems. Whether for manufacturing or stabilization, the emerging technologies are expected to provide pharma with the tools that will further enhance its ability to handle more challenging compounds.