CONTROLLED RELEASE PREPARATION CONTAINING CILOSTAZOL AND PROCESS FOR THE PREPARATION THEREOF

摘要

A controlled-release preparation containing cilostazol is provided to minimize side effects such as headache due to immediate release of cilostazol, and improve compliance of patient by maintaining effective blood concentration of cilostazol and reducing dosage frequency. A controlled-release preparation contains 10-80 wt.% of cilostazol or its pharmaceutically acceptable salt, 0.1-50 wt.% of solubilizer and 5-80 wt.% of erodible hydrogel-forming material selected from polyethylene oxide, hydroxyalkylcellulose, hydroxypropylalkylcellulose, polyvinylalcohol, polyvinylpyrrolidone, sodium carboxymethylcellulose, propyleneglycol alginate, carbopol, sodium alginate, xanthan gum, locust bean gum, cellulose gum, gellan gum, tragacanth gum, karaya gum, guar gum, acacia gum and a mixture thereof. A method for preparing the controlled-release preparation containing cilostazol comprises the steps of: (1) mixing cilostazol or its pharmaceutically acceptable salt with solubilizer and granulating the mixture by solid dispersion to prepare solubilized drug granules; and (2) mixing the solubilized drug granules with erodible hydrogel-forming material and granulating the mixture.