Physical Stability of Pharmaceutical Hydrates – Impact on Chemical and Pharmaceutical Development

摘要

Hydrate formation has been one of the most often encountered phenomena during drugrndevelopment and processing and causes almost as many problems as different polymorphs, if notrnmore so. Selection criteria for either the hydrate or anhydrous form depend on the performancernof the solid form during processing and storage, and the stability under ICH specified conditions.rnThis presentation explores the new development of humidity controlled DSC and its applicationrnin characterizing pharmaceutical hydrates. The physical stability of pharmaceutical hydraternunder different temperature and humidity conditions will be essential information for decisionmaking.rnThis presentation also discusses the theoretical background for constructing a physicalrnstability phase diagram for hydrates.