(113) Physiologically Based Pharmacokinetic Modeling and IVIVC for Long-Acting Injectable Suspensions

Long acting injectable (LAI) suspensions demonstrate extended release by forming depots at the injection site (subcutaneous or intramuscular), from which poorly soluble drugs are slowly dissolved and absorbed into the systemic circulation. Developing complex generic LAIs is often challenging. Establishing mechanistic in vitro–in vivo correlations (IVIVC) based on physiologically based pharmacokinetic (PBPK) models is a valuable approach for advancing LAI drug product development. This study aimed to establish an IVIVC approach paliperidone palmitate LAI suspension formulations in rat and human