Prediction of in vivo supersaturation and precipitation of poorly water-soluble drugs: Achievements and aspirations.

Abstract This review focuses on options available to a pharmaceutical scientist to predict in vivo supersaturation and precipitation of poorly water-soluble drugs. As no single device or system can simulate the complex gastrointestinal environment, a combination of appropriate in vitro tools may be utilized to get optimal predictive information. To address the empirical issues encountered during small-scale and full-scale in vitro predictive testing, theoretical background and relevant case studies are discussed. The practical considerations for selection of appropriate tools at various stages of drug development are recommended. Upcoming technologies that have potential to further reduce in vivo studies and expedite the drug development process are also discussed.