首页> 外国专利> PHARMACEUTICAL DOSAGE FORM COMPRISING NIFEDIPINE OR NISOLDIPINE AND AN ANGIOTENSIN-II ANTAGONIST AND/OR A DIURETIC

PHARMACEUTICAL DOSAGE FORM COMPRISING NIFEDIPINE OR NISOLDIPINE AND AN ANGIOTENSIN-II ANTAGONIST AND/OR A DIURETIC

机译:包含尼非地平或尼司西定与血管紧张素II拮抗剂和/或利尿剂的药物剂型

摘要

The invention relates to a pharmaceutical dosage form comprising a biologically active ingredient combination of nifedipine and at least one angiotensin-II antagonist selected from candesartan and telmisartan and/or at least one diuretic selected from hydrochlorothiazide and chlorthalidone, comprising a core and a mantle coating around the core, wherein at least 85% of the nifedipine (based on the declared total amount of each biologically active ingredient) are released over a period of 24 hours, from 5 to 17% of the nifedipine are released over a period of 4 hours and from 43 to 80% of the nifedipine are released over a period of 12 hours, and at least 60% of the angiotensin-II antagonist and/or the diuretic (based on the declared total amount of each biologically active ingredient) are released over a period of 30 minutes according to the USP release method using apparatus 2 (paddle) at 75 rpm in 900 ml of a suitable medium, and also to a method for production thereof.
机译:本发明涉及一种药物剂型,其包含硝苯地平和至少一种选自坎地沙坦和替米沙坦的血管紧张素-II拮抗剂和/或至少一种选自氢氯噻嗪和氯噻酮的利尿剂的生物活性成分组合,该药物活性剂组合物周围具有核和覆盖层核心,其中至少85%的硝苯地平(基于每种生物活性成分的声明总量)在24小时内释放,5%至17%的硝苯地平在4小时内释放,并且在12个小时内释放了43%至80%的硝苯地平,并且在至少12%的时间内释放了至少60%的血管紧张素II拮抗剂和/或利尿剂(基于每种生物活性成分的声明总量)根据USP释放方法,使用装置2(桨)在75 rpm下于900 ml合适的介质中进行30分钟的干燥,及其制备方法。

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