Application of Thermodynamic and Kinetic Modeling in ASD Development for Primary Packaging Assessment

10:10 - 10:45

  • The preparation of amorphous solid dispersions (ASDs) is an established technique to increase the bioavailability of poorly water-soluble active pharmaceutical ingredients (APIs) by embedding them in polymeric excipients matrices.
  • Thermodynamic modeling can be used to understand the physical stability of ASD formulations in terms of API recrystallization and mechanical deformation of the solid drug product as well as the impact of relative humidity.
  • By combining the thermodynamic modeling with well-established kinetic models, primary packaging containers and moisture uptake modeling for physically stable ASD drug products can be assessed.

Please note that this will be a remote presentation

Kristin Lehmkemper, Senior Scientist, AbbVie