Translational Development of Amorphous Dispersions

Abstract

This chapter demonstrates that the personnel involved in translational drug development (TDD) are integrated into each stage of discovery and development, serving as regular members of working groups, projects teams, and major steering committees. The early development of amorphous dispersions is carried out using certain aspects of telaprevir as an example. TDD charges the pharmaceutical development division with understanding a broad range of physicochemical properties as early as possible in a compound's development. In developing a suspension formulation of an amorphous dispersion, a mathematical, biopharmaceutical model that predicts absorption is created to ensure that a preclinical study will not result in inadequate exposure in vivo . An advance in the pharmaceutical industry would move us away from much of the current a posteriori trial‐and‐error empiricism and into a level of rigor one can expect in other technically intensive sectors of the society.

Overview of Extensively Employed Polymeric Carriers in Solid Dispersion Technology

“…Connely et al analyzed Incinek™, which is marketed HPMCAS-telaprevir solid dispersion prepared by spray drying and found that the DSC thermogram of the product showed multiple glass transition temperatures and a melting endotherm of the drug. This indicates that the product is a solid suspension containing multiple amorphous phases and a crystalline phase (170).…”