In Vivo Extrapolation of Precipitation with Complex Dissolution Experiments

Authors: Mullin JM
Conference: AAPS
Division: Simulations Plus

Session Description and Objectives

  • What is DDDPlus™
  • How can it be utilized in drug development?
  • What can DDDPlus predict?
  • How do we use DDDPlus for complex precipitation assays?
  • What results can be obtained?
  • Case Study – synergy of DDDPlus and GastroPlus®
  • Biphasic and membrane dissolution experiments for determination of precipitation kinetics.
  • In Vitro to In Vivo (IVIVE) extrapolation of dipyridamole, ketoconazole, and itraconazole precipitation
  • Why is precipitation important?
  • What in vitro experiments can quantify precipitation rates?
  • How can in vitro dissolution and precipitation can be modeled using DDDPlus?
  • How can in vitro dissolution parameters translate into PBPK simulations and what are the pitfalls?

By James Mullin

Presented at American Association of Pharmaceutical Scientists (AAPS) PharmSci 360, October 17-20, 2021