Use of an Exploratory Mechanistic In-Vitro In-Vivo Relationship (IVIVR) to Support Gastro-Retentive Formulation Development

Learn how in this project we aimed to use mechanistic IVIVR as an exploratory tool, to aid decision making whilst developing a gastro-retentive (GR) tablet. The goal was to develop a GR tablet administered once daily that would match the exposure of an immediate release (IR) tablet administered twice daily. A well-established physiological-based pharmacokinetic (PBPK) model, validated through multiple clinical studies, was used to build the IVIVR. This enabled understanding of the relationship between in vitro and in vivo release, whilst accounting for gastric retention time (GRT) estimated through scintigraphy.