Mechanistic investigation of the negative food effect of modified release zolpidem

Authors: Andreas CJ, Pepin X, Markopoulos C, Vertzoni M, Reppas C, Dressman J
Publication: Eur J Pharm Sci
Keywords: biorelevant dissolution testing, deconvolution, Food effects, PBPK modeling, Qgut, USP apparatus III (BioDis), USP apparatus IV (flow-through cell), zolpidem
Software: GastroPlus®

Aims

When administered orally as either an immediate or modified release dosage form, zolpidem demonstrates a negative foodeffect, i.e. decrease in Cmax and AUC. The aim of the study was to arrive at a better understanding of the absorption of this BCS class I compound in vivo and to simulate the observed plasma profiles using in vitro and in silico methods.