MANNION, RICHARD OWEN,HUANG, HAIYONG HUGH,MCKENNA, WILLIAM HENRY,ODONNELL, EDWARD
申请号：
ES11157003
公开号：
ES2411696T3
申请日:
2007.08.24
申请国别(地区):
ES
年份:
2013
代理人:
摘要：
A pharmaceutical, oral, solid dosage prolonged release comprising a formulaciónmatricial extended release comprising matrix extended release formulation unacomposición comprising at least one active agent and at least one polyethylene oxide having, based on rheological measurements, an approximate molecular weight of at least 1,000,000 where matrix laformulación prolonged release is cured at a temperature of at least about 60 ºCdurante a period of time of at least about 1 minute as a omultiparticulados tablet, wherein the tablet or the individual multi particulates can at least flattened without breaking, characterized by a thickness of the tablet or the individual multi particulate after the flattening which secorresponde with no more than about 60% of the thickness of the tablet or individualantes multiparticulate flattening, and wherein said flattened tablet or the flattened multi unavelocidad provide dissolution in vitro, when measured in a USP apparatus 1 (basket) at 100 rpm in 900 ml simulated fluidogástrico without enzymes (SGF) at 37 ° C, characterized by the percent amount of active agent released A0,5 hours of dissolution that deviates no more than about 20 percentage points deviates from the dissolution rate corresponding in-vitro of a tablet or reference multi referenciano flattened.Forma de dosificación farmacéutica, oral, sólida, de liberación prolongada, que comprende una formulaciónmatricial de liberación prolongada, comprendiendo la formulación matricial de liberación prolongada unacomposición que comprende por lo menos un agente activo y por lo menos un óxido de polietileno que tiene,basándose en mediciones reológicas, un peso molecular aproximado de por lo menos 1.000.000 en donde laformulación matricial de liberación prolongada se cura a una temperatura de por lo menos aproximadamente 60 ºCdurante un periodo de tiempo de por lo menos aproximadamente 1 minuto, en forma de un comprimido omultiparticulados, en donde el comprimido o los multiparticul
