Predictive in vitro Methods for Characterizing Product Performance, Case Study: Furosemide (U01)

This project follows after earlier CDER research projects in which in vitro furosemide dissolution and/or solubility data were collected in various dissolution media such as simulated gastric and intestinal fluids. In two different studies with different approaches and dissolution testing apparatus, furosemide dissolution was higher in medium containing milk and baby formula than that in standard buffer medium. This research project will explore additional methodology to characterize dissolution of furosemide (the model drug) in media containing milk, baby formula and Ensure Plus™. The suitability of methods including the in vitro methods using dissolution media containing milk, baby formula and Ensure Plus for predicting in vivo performance of furosemide (a poorly soluble and poorly permeable drug), classified as BCS (Biopharmaceutic Classification System) Class IV drug will be explored and determined.