Progress in evaluation/prediction of bioequivalence of solid oral preparations by dissolution test

Pharmaceutical solid oral dosage forms must undergo dissolution in gastrointestinal fluid before they can be absorbed and reach the systemic circulation. Therefore,the process of in vivo dissolution and absorption is important to the curative effect of drug. Dissolution test is an ideal in vitro method to simulate the disintegration and dissolution of oral solid dosage forms in gastrointestinal tract,and dissolution is an important indicator of the quality control and evaluation of pharmaceuticals. However,the compendial equipments are recognized as being limited in their ability to replicate the dynamic process of the dosage forms transiting through the rapidly changing and complex gastrointestinal lumenal environment. This review gives an overview of biorelevant dissolution test which provides scientists with a way of assessing product performance under physiologically relevant conditions and its application in current drug evaluation.