Dissolution testing combined with computer simulation technology to evaluate the bioequivalence of domestic amoxicillin capsule

Authors: Pan RX, Gao Y, Chen WL, Li YL, Hu CQ
Publication: Yao Xue Xue Bao
Software: GastroPlus®


Re-evaluation of bioequivalence of generic drugs is one of the key research focus currently. As a means to ensure consistency of the therapeutic effectiveness of drug products, clinical bioequivalence has been widely accepted as a gold standard test. In vitro dissolutiontesting based on the theory of the BCS is the best alternative to in vivo bioequivalence study. In this article, the conventional dissolutionmethod and flow-through cell method were used to investigate the dissolution profiles of domestic amoxicillin capsules in different dissolutionmedia, and the absorption behavior of the drugs with different release rates (t85% = 15-180 min) in the gastrointestinal tract was predicted by Gastro Plus. The flow-through cell method was thought better to reflect the release characteristics in vivo, and amoxicillin capsules with regard to the release rates up to 45 min (t85% = 45 min) were having a satisfied bioequivalence with the oral solution according to the C(max) and AUC. Although two different dissolution profiles of domestic amoxicillin capsules were found by flow-through cell methods, prediction results revealed that domestic capsules were probably bioequivalent to each other.