CHENG, XIU XIU,CHEN, CHIH-MING,JAN, STEVE,CHOU, JOSEPH
申请号：
ES09006402
公开号：
ES2540972T3
申请日:
1999.03.19
申请国别(地区):
ES
年份:
2015
代理人:
摘要：
A pharmaceutical controlled release tablet comprising: (a) a homogeneous osmotic core comprising metformin hydrochloride, optionally a binding agent； and optionally an absorption enhancer, (b) a semipermeable membrane wrapping the homogeneous osmotic core； and, (c) at least one pathway in the semipermeable membrane for the release of metformin, where the pathway is an opening, hole, hole, cavity, weak area or an erodible element, and where the controlled release pharmaceutical tablet shows the following dissolution profile when tested in a USP type 2 apparatus, at 75 rpm, in 900 ml of simulated intestinal fluid (phosphate buffer pH 7.5) and at 37 ° C: - after 2 hours it is released from 0 to a 25% of the drug； - after 4 hours, 10 to 45% of the drug is released； - after 8 hours, 30 to 90% of the drug is released； - after 12 hours no less than 50% of the drug is released； - after 16 hours no less than 60% of the drug is released； and - after 20 hours no less than 70% of the drug is released； for use in the treatment of hyperglycemia and provide continuous and non-pulsating therapeutic levels of metformin for periods of twelve to twenty four hours obtaining a maximum plasma level between 8 and 12 hours after administration, to be administered once daily with or after the afternoon meal.Un comprimido farmacéutico de liberación controlada que comprende: (a) un núcleo osmótico homogéneo que comprende hidrocloruro de metformina, opcionalmente un agente aglutinante； y opcionalmente un potenciador de absorción, (b) una membrana semipermeable envolviendo el núcleo osmótico homogéneo； y, (c) al menos, una via en la membrana semipermeable para la liberación de la metformina, donde la via es una abertura, orificio, agujero, cavidad, área débil o un elemento erosionable, y donde el comprimido farmacéutico de liberación controlada muestra el siguiente perfil de disolución cuando es sometido a prueba en un aparato USP tipo 2, a 75 r.p.m., en 900 ml de fluido intestinal simulado (ta
