Exploring Bioequivalence of Dexketoprofen Trometamol Drug Products with the Gastrointestinal Simulator and Precipitation Pathways Analyses

This paper describes work aimed to explain the differences in oral performance in fasted humans for three different dexketoprofen trometamol (DKT) salt formulations, using a combination of in vitro techniques and pharmacokinetic analysis. This work demonstrated the importance of excipients and purity of salt phase on the evolution and rate of salt disproportionation pathways. Moreover, the data clearly showed the usefulness of the gastrointestinal simulator (GIS) apparatus as a discriminating tool that can highlight the differences in formulation performance when physiologically relevant media and experimental conditions are used with microscopy. To learn more, please view our publication.