title: [Evaluation of Gastric Mucosal Injury Model Animals of Rebamipide Formulation--Study of Therapeutic Equivalence].
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 specified in "the Guidelines for Bioequivalence Studies of Generic Products", but also formulation properties to consider their effect 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-inflammatory drugs (NSAIDs). Pharmaceutical evaluation showed significant differences 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 differences among formulations. Higher levels of mucosal fluid 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 scientific evidence such as indication and formulation design, not to mention stable provision.
authors.affiliation: Department of Pharmacy, Kochi Medical School Hospital.
authors.forename: Noriaki
authors.initials: N
authors.lastname: Abe
authors.forename: Hiroki
authors.initials: H
authors.lastname: Funato
authors.forename: Ayumu
authors.initials: A
authors.lastname: Hirata
authors.forename: Megumi
authors.initials: M
authors.lastname: Nakai
authors.forename: Michiro
authors.initials: M
authors.lastname: Iizuka
authors.forename: Hisashi
authors.initials: H
authors.lastname: Shiraishi
authors.forename: Kohei
authors.initials: K
authors.lastname: Jobu
authors.forename: Yusuke
authors.initials: Y
authors.lastname: Yagi
authors.forename: Aki
authors.initials: A
authors.lastname: Kadota
authors.forename: Kyoko
authors.initials: K
authors.lastname: Ogi
authors.forename: Junko
authors.initials: J
authors.lastname: Yokota
authors.forename: Mitsuhiko
authors.initials: M
authors.lastname: Miyamura
mesh_terms: D000409:Alanine / Q000031:analogs & derivatives* / Q000493:pharmacokinetics / Q000627:therapeutic use; D000818:Animals; D000894:Anti-Inflammatory Agents, Non-Steroidal / Q000009:adverse effects; D000897:Anti-Ulcer Agents / Q000493:pharmacokinetics* / Q000627:therapeutic use*; D004195:Disease Models, Animal; D004339:Drug Compounding; D016568:Drugs, Generic / Q000493:pharmacokinetics / Q000494:pharmacology* / Q000627:therapeutic use*; D005753:Gastric Mucosa / Q000187:drug effects / Q000378:metabolism; D007213:Indomethacin / Q000009:adverse effects; D008054:Lipid Peroxides / Q000378:metabolism; D008297:Male; D015363:Quinolones / Q000493:pharmacokinetics* / Q000627:therapeutic use*; D017208:Rats, Wistar; D013276:Stomach Ulcer / Q000139:chemically induced* / Q000188:drug therapy* / Q000378:metabolism; D013810:Therapeutic Equivalency
chemical_list: D000894:Anti-Inflammatory Agents, Non-Steroidal; D000897:Anti-Ulcer Agents; D016568:Drugs, Generic; D008054:Lipid Peroxides; D015363:Quinolones; C052785:rebamipide; D000409:Alanine; D007213:Indomethacin