Muhammad Safadi

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

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 Cmax 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 Cmax using rasagiline as a model compound.