Evaluation of Gastric Mucosal Injury Model Animals of Rebamipide Formulation<br/>&mdash;Study of Therapeutic Equivalence&mdash;

Abstract

The introduction of generic drugs is promoted from the perspective of medical economics. In this context, we need to understand not only the bioequivalence of generic drugs speciˆed in``the Guidelines for Bioequivalence Studies of Generic Products'', but also formulation properties to consider their eŠect on pharmacological therapy. We evaluated the pharmaceutical characteristics of rebamipide formulations, a brand-name drug and two generic drugs, and their clinical functionality by using rat models of gastric mucosal injury induced by non-steroidal anti-in‰ammatory drugs （NSAIDs). Pharmaceutical evaluation showed signiˆcant diŠerences in hardness. The inter-lot variation was small in all rebamipide formulations. In the clinical functionality study, biochemistry test values 7 d after the administration of rebamipide showed no diŠerences among formulations. Higher levels of mucosal ‰uid secretion and antioxidative enzymes were observed in the groups administered rebamipide than in the control group. The levels of lipid peroxide were lower in the groups administered rebamipide than the control group. Multivariate analysis showed slight divergence between the brand-name and generic drugs. In future, it will be necessary to select generic drugs after careful consideration of bioequivalence, clinical functionality, and therapeutic equivalence by reviewing scientiˆc evidence such as indication and formulation design, not to mention stable provision.