ORAL FILM COATING TABLET FORMULATION COMPRISING CEFUROXIME AXETIL WHICH HAS IMPROVED STABILITY FOR MOISTURE ABSORPTION BY USING STARCH SODIUM GLYCOLATE AND IS QUICKLY DISSOLVED TO IMPROVE BIOAVAILABILITY AND A MANUFACTURING PROCESS THEREOF

摘要

PURPOSE: A oral film coating tablet formulation comprising cefuroxime axetil and a manufacturing process thereof are provided, which formulation has improved stability for moisture absorption by using starch sodium glycolate and is quickly dissolved to improve bioavailability. CONSTITUTION: The oral film coating tablet formulation comprises 100 parts by weight of cefuroxime axetil and 10 to 50 parts by weight of starch sodium glycolate as a gelation inhibiting agent. The process for manufacturing the oral film coating tablet formulation comprises the steps of: (a) pressure assembling the pharmaceutical composition comprising cefuroxime axetil and starch sodium glycolate using a roller pressor to prepare rapid-dissolved granules; (b) mixing the rapid-dissolved granules with micro-crystalline cellulose and tableting the mixture; and (c) coating the tablets with a film forming composition.