From In Vitro Dissolution Testing to In Vivo Clinical Pharmacokinetic Prediction Using PBPK Models for Oral Cavity Drug Products

Authors: Plait F, Kalra P, Le Merdy M, Subhami S, Lukacova V, Dwivedi P, Alam K, Tsakalozou E, Pauletti GM, Zhou H
Conference: AAPS
Keywords: AAPS 2025, dissolution, gastroplus, in silico in vitro–in vivo extrapolation (IVIVE), in vitro, oral cavity drug delivery, PBPK modeling

Purpose

This work develops a novel in vitro to in vivo extrapolation (IVIVE) method for the prediction of in vivo pharmacokinetic (PK) for oral cavity drug products (DP). This IVIVE uses in vitro dissolution measurements in artificial saliva; in vitro permeability measurements from EpiOral assays 1,2; and physiologically based PK (PBPK) modellingto bridge the critical gap between laboratory testing and clinical performance for sublingual (SL) DPs.

By Fiona Plait, Priyata Kalra, Maxime Le Merdy, Saima Subhami, Viera Lukacova, Pankaj Dwivedi, Khondoker Alam, Eleftheria Tsakalozou, Giovanni Pauletti, Haiying Zhou

American Association of Pharmaceutical Scientists (AAPS) PharmSci360, November 9-12, 2018, San Antonio, TX