Sen, Himadri,Velhal, Avinash K.,Jayanthi, Suryakumar,Raghavan, Vineeth
申请号:
AU2006274565
公开号:
AU2006274565B2
申请日:
2006.08.01
申请国别(地区):
AU
年份:
2012
代理人:
摘要:
A controlled release pharmaceutical composition of a selective serotonin reuptake inhibitor. The composition essentially comprises of a core comprising the active ingredient, one or more controlled release polymer(s) and one or more pharmaceutically acceptable excipients. The composition optionally will have a coating comprising one or more controlled release polymers. The composition is prepared by mixing the active ingredient with one or more controlled release polymers and one or more pharmaceutically acceptable excipients. Thereafter the mixture is granulated, dried, lubricated and compressed into tablets. The composition is used in the manufacture of a medicament, for treating and/or preventing the disorders. The active is released between about 2-8 hours with about 10-25% of active is released in vitro in 2 hours in 0.1N HCl, 750 ml dissolution medium using USP Dissolution tester, paddle method at 150 rpm. About 20-55%, 50-75% and 70-95% of active is released in vitro in 4,6 and 8 hours respectively in pH 7.5 Tris buffer, 1000 ml dissolution medium using USP Dissolution tester, paddle method at 150 rpm.