Physical stability of pharmaceutical formulations: solid-state characterization of amorphous dispersions

The acceptable stability of the drug formulations is one of the basic requirements for pharmaceutical development and commercialization. The increasing application of enabling delivery techniques poses even more challenge to the drug physical stability of pharmaceutical formulations. After a brief review of regulatory requirements and recent drug recalls due to physical instability, we discuss the physical stability of the solid-state drug in amorphous dispersions with focus on analytical techniques, amorphous molecular mobility, drug-excipient interaction, and the effect of water. (C) 2013 Elsevier Ltd. All rights reserved.