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ФАРМАЦЕВТИЧЕСКАЯ КОМПОЗИЦИЯ В ВИДЕ МУЛЬТИЧАСТИЦ, СОДЕРЖАЩАЯ МНОЖЕСТВО ГРАНУЛ ДВУХ ВИДОВ
专利权人:
ЭВОНИК РЕМ ГМБХ (DE)
发明人:
ДЖОШИ Шраддха Саньев (IN),ГУХА Ашиш Шарадчандра (IN),ДОКЕ Суреш Шахурай (IN),ШАХ Ашишкумар Прафулчандра (IN),ПАТИЛ Преети (IN)
申请号:
RU2015138784
公开号:
RU2015138784A
申请日:
2013.04.25
申请国别(地区):
RU
年份:
2017
代理人:
摘要:
Multiparticulate pharmaceutical composition comprising a multitude of two kinds of pellets, A and B, each comprising metoprolol or a pharmaceutically acceptable salt thereof as an active pharmaceutical ingredient, wherein the pellets A are coated with a coating layer comprising at least 30% by weight of a polymeric compound consisting of one or more (meth)acrylate copolymers polymerized from 20 to 40% by weight of ethyl acrylate, 60 to 80% by weight of methyl methacrylate and 0 or less than 5% by weight of methacrylic acid or acrylic acid, in an amount sufficient to result in an active pharmaceutical ingredient release profile according to USP in pH 6.8 test medium with a release rate of less than 20% after 4 hours, wherein the pellets B are not coated or coated with a coating layer and show an active pharmaceutical ingredient release profile according to USP in pH 6.8 test medium with an active pharmaceutical ingredient release rate of more than 40% after 4 hours, wherein the metoprolol release rate of the pellets A in pH 1.2 test medium according to USP with the addition of 40% (v/v) ethanol is &bullnot more than 15% after 15 minutes &bullmore than 15 up to 40% after 30 minutes, wherein the metoprolol release rate of the pellets B in pH 1.2 test medium according to USP with the addition of 40% (v/v) ethanol is &bullmore than 15% after 15 minutes &bullmore than 40% after 30 minutes and wherein the pellets A and B are present in the multiparticulate pharmaceutical composition in a relation resulting in a combined active pharmaceutical ingredient release profile of the multiparticulate pharmaceutical composition according to USP in pH 6.8 test medium with releases rates of &bullnot more than 25% after 1 hour &bull20 to 40% after 4 hours &bull40 to 60% after 8 hours &bullnot less than 80% after 20 hours.
来源网站:
中国工程科技知识中心
来源网址:
http://www.ckcest.cn/home/

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