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Severe oral stomatitis in patients treated with 5-fluorouracil (5-FU) reduces their quality of life. Here, we investigated the healing effect of rebamipide, a drug used for treatment of gastric ulcers, on the area of acetic acid-induced stomatitis in Golden Syrian hamsters treated and untreated with 5-FU. We attempted to solubilize rebamipide by ternary grinding with rebamipide, polyvinylpyrrolidone K 30 (PVPK-30), and sodium dodecyl sulfate (1:5:1) to obtain a preparation termed GMS. Application of GM5 solution, containing 3.0 mg/mL rebamipide, significantly reduced the area of acetic acid-induced oral stomatitis lesions in 5-FU-untreated animals. It also considerably reduced the lesion area of acetic acid-induced oral stomatitis in 5-FU-treated animals. In 5-FU-treated animals, the time required for 50% reduction in the area of oral stomatitis was significantly shorter in those treated with solubilized rebamipide than in those that were not thus treated (P<0.05). These results suggest that solubilized rebamipide GM5 solution is able to heal acetic acid-induced oral stomatitis in both 5-FU-treated and -untreated animals. [ABSTRACT FROM AUTHOR]