A Two-Phase Dissolution-Partition Test for Characterization of BCS II/IV Drugs and Formulations

11:15 - 11:45

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      • Characterize the aqueous super-saturation resulting from dissolution of amorphous solid dispersions
      • Use the aqueous media with pH alteration for ionic drugs
      • Assess the interplay among three kinetic processes: dissolution, precipitation and partition
      • Facilitate evaluation of key formulation variables and functional excipients
      Demonstrate IVIVC for several BCS II and IV products

This presentation will focus on characterization of dissolution and partition profiles of poorly water soluble drugs and related formulations using a biorelevant two-phase dissolution-partition test. This test is designed to evaluate the dissolution of BCS II/IV drugs in an aqueous, biorelevant compartment that allows physiologically relevant pH changes with simultaneous partitioning (absorption) into a water immiscible organic phase. Case studies will be presented to demonstrate the utility of this method for evaluation of the super saturation and its relevance to in vivo exposure in humans. The presence of the “absorptive phase” in this the two-phase test appears to overcome shortcomings of conventional single-phase in vitro dissolution methods and therefore presents a great opportunity for establishing quantitative IVIVC in drug product development.