In Vitro – In Vivo Correlation of Pentoxifylline: A Comprehensive Kinetic Analysis

This study presents an analysis of In Vitro-In Vivo Correlation (IVIVC) for pentoxifylline modified-release tablets, with a focus on deriving robust predictive models. In vitro dissolution tests were conducted in three pH media (1.2, 4.5, and 6.8) to simulate various gastrointestinal conditions. Data was collected under fed conditions from a bioequivalence (BE) study. The modeling and calculations were performed using Phoenix WinNonlin® version 8.4 software, enabling estimation of drug absorption kinetics. A Level A IVIVC model was employed for each in vivo data to establish a direct and reliable correlation between the in vitro dissolution profiles and the in vivo pharmacokinetic data. The determination coefficient (R²) exceeded 0.97, demonstrating a high degree of predictability and robustness in the established IVIVC.