Is it possible to achieve bio-equivalence between an oral solid immediate-release and an analogue enteric-coated formulation?

摘要

Objectives While bioequivalence between enteric-coated and immediate-release formulations can be achieved in terms of AUC, gastric emptying of enteric-coated dosage forms is a stochastic event, usually leading to lower C-max values than those observed with the corresponding immediate release. This article examines challenges of developing enteric-coated dosage forms which are bioequivalent to the corresponding immediate-release formulations in terms of both AUC and C-max using rasagiline as a model compound.