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Preclinical, Clinical, and Translational Sciences
Hot Topic

Hot Topic: Identifying Gaps and Pushing Boundaries in Mechanistic Dissolution Modeling

Wednesday, November 12, 2025
1:30 PM - 2:30 PM CT
Location:220

Preclinical & Translation Sciences Hot Topic

Dissolution is a key determinant of oral drug product bioavailability and therapeutic effectiveness, making it a common quality attribute of many poorly soluble drug products. A mechanistic understanding of dissolution aids in understanding key performance mechanisms and setting clinically relevant specifications as a function of variable drug product and physiological characteristics. This session will begin with a short overview of key assumptions limiting the effectiveness of classical dissolution models, followed by presentations by two researchers pushing these boundaries. One talk will highlight a physics based, yet easy and accurate dissolution model for non-spherical and spherical particles dissolving under different hydrodynamic conditions. The other talk will describe a comprehensive approach to modeling dissolution of ionizable drugs in gastric and intestinal fluids in reactive media representative of the gastrointestinal tract.

Learning Objectives:

  • Understand the fundamental principles behind the dissolution process of polydisperse non-spherical (e.g. elongated) and spherical particles in reactive media representative of the gastrointestinal tract under different fluid hydrodynamic conditions
  • Recognize the limitations of traditional dissolution models, particularly in predicting the dissolution of non-spherical and ionizable drugs
  • Learn how the impact of reactive media, fluid hydrodynamics, and particle shape can be integrated into models of in vitro and in vivo dissolution using easy, yet accurate approaches