De-Risking Development: Guiding Formulation Strategy with MacroFlux to Predict Human Outcomes of KinetiSol-Processed Etravirine

KinetiSol™ Technology enables formulation of poorly soluble compounds, but predicting human performance remains a key challenge in early development. In this session, Daniel Davis, Ph.D. (Director of Business Development, AustinPx), presents a case study on developing a generic equivalent for Intelence (Etravirine) using MacroFlux™ to establish in-vitro/in-vivo correlation and optimize formulation strategy.

By linking dissolution data to canine and human PK results, the team fine-tuned excipient levels and matched the reference product’s performance under both fed and fasted conditions. This session highlights how predictive tools like MacroFlux™ can de-risk development, guide formulation decisions, and estimate in-vivo absorption outcomes using in-vitro data.