In vitro methods to assess drug precipitation in the fasted small intestine – a PEARRL review

Authors: O’Dwyer PJ, Litou C, Box KJ, Dressman JB, Kostewicz ES, Kuentz M, Reppas C
Publication: J Pharm Pharmacol
Keywords: In vitro in vivo extrapolation (IVIVE), mechanistic absorption, mechanistic dissolution, PBPK modeling
Software: DDDPlus™, GastroPlus®

Objectives

Drug precipitation in vivo poses a significant challenge for the pharmaceutical industry. During the drug development process, the impact of drug supersaturation or precipitation on the in vivo behaviour of drug products is evaluated with in vitrotechniques. This review focuses on the small and full scale in vitro methods to assess drug precipitation in the fasted small intestine.