The Mucosal Irritative Effects of Rapidly Disintegrating Tablets on the Oral Mucosa of Hamsters and the Gastric Mucosa of Rats (6)

Accession number;04A0483482
Title;The Mucosal Irritative Effects of Rapidly Disintegrating Tablets on the Oral Mucosa of Hamsters and the Gastric Mucosa of Rats (6)
Author; KIGUCHI MASAO (Saf. Res. Inst. for Chem. Compound Co. Ltd., JPN) YOKOTANI RYO (Saf. Res. Inst. for Chem. Compound Co. Ltd., JPN) KOSHIDA MIHARU (Saf. Res. Inst. for Chem. Compound Co. Ltd., JPN) FURUKAWA MASATOSHI (Saf. Res. Inst. for Chem. Compound Co. Ltd., JPN) SAKUMA MASASHI (Saf. Res. Inst. for Chem. Compound Co. Ltd., JPN) IZAWA TOORU (Sannoba) AOKI HARUO (Sannoba) SHORIKEN KOICHI (Eisai Co., Ltd., JPN) NAKATA HIROSHI (Eisai Co., Ltd., JPN)
Journal Title;Japanese Pharmacology & Therapeutics
Journal Code:Z0947A
ISSN:0386-3603
VOL.32;NO.5;PAGE.281-290(2004)
Figure&Table&Reference;FIG.3, TBL.6, REF.13
Pub. Country;Japan
Language;Japanese
Abstract;This study was conducted to assess the mucosal irritative effects of rapidly disintegrating tablets (simvastatin 5mg, doxazosin mesilate 1mg, doxazosin mesilate 2mg) on the oral mucosa of hamsters and the gastric mucosa of rats. In the oral mucosa irritation study of hamsters, the positive control sodium lauryl sulfate (Sls) group showed irritation in the oral mucosa in visual inspections immediately (30 minutes) after discontinuing the exposure of cheek-pouch mucosa to a test substance and 24 hours after application, and in histo-pathological observations 24 hours after application. In the other where the cheek pouches were exposed to the tablets for 30 minutes under anesthesia, macro- and histo-pathological observations revealed no changes that related to the test substance at 30 minutes and 24 hours after the application. In the gastric mucosa irritation study of rats, the positive control absolute ethanol group showed irritation in the gastric mucosa in visual inspections 4 and 24 hours after administration. In the other macropathological observations revealed no changes that related to the test substance at 4 and 24 hours after the administration. These results indicate that S-SIM1-TT1-1 (simvastatin 5mg tablet), S-DOX1-TT1-1 (doxazosin mesilate 1mg tablet), S-DOX2-TT1-1 (doxazosin mesilate 2mg tablet) have no irritative effects on oral and gastric mucosae. (author abst.)
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