Physiologically Based Pharmacokinetic Modeling and Mechanistic In Vitro-In Vivo Correlation for Long-Acting Injectable Suspension

Authors: Amaral Silva D, Lukacova V, Alam K, Tsakalozou E, Al Shoyaib A
Conference: CRS
Keywords: admet predictor, gastroplus, In vitro in vivo correlations (IVIVC), Long Acting Injectable, PBPK model
Software: ADMET Predictor®, GastroPlus®
Division: PBPK

Introduction

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 once-monthly extended-release LAI suspension formulations in rat and human.

By Daniela Amaral Silva, Viera Lukacova, Khondoker Alam, Eleftheria Tsakalozou, Abdullah Al Shoyaib

CRS 2025 Annual Meeting & Expo Philidelphia, PA, July 13-18, 2025