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STABLE PHARMACEUTICAL COMPOSITIONS AND WAYS OF THEIR APPLICATION
专利权人:
ИНК. (US);АМАРИН ФАРМА
发明人:
МАНКУ Мехар (GB)
申请号:
RU2014131716
公开号:
RU2014131716A
申请日:
2014.07.30
申请国别(地区):
RU
年份:
2016
代理人:
摘要:
1. A pharmaceutical composition for treating or preventing a disease associated with the cardiovascular system in a subject in need thereof, comprising at least 95% ethyl eicosapentaenoate (ethyl EPA) encapsulated in a capsule shell comprising at least one plasticizer and a film-forming material that does not include chemically modified gelatin, where the composition has an initial peroxide value of not more than 5 meq / kg and when stored at 25 ° C and 60% relative humidity (RH) for 6 months, the composition and the second peroxide number is not more than 8 meq / kg. 2. The pharmaceutical composition of claim 1, comprising less than about 1% of any individual fatty acid that is not ethylacosapentaenoate. The pharmaceutical composition of claim 1, comprising less than about 0.5% of any individual fatty acid that is not ethylacosapentaenoate. A pharmaceutical composition according to claim 1, containing less than about 0.3% DHA (docosahexaenoic acid), if it is part of the composition. The pharmaceutical composition of claim 4, which is substantially free of DHA (docosahexaenoic acid). A pharmaceutical composition according to claim 1, containing from about 0.1 wt.% To about 1 wt.% Antioxidant. The pharmaceutical composition of claim 6, wherein the antioxidant is tocopherol. The pharmaceutical composition according to claim 1, wherein when the composition is stored at 25 ° C and 60% relative humidity for 6 months, the composition has a secondary peroxide number of not more than 7 meq / kg. The pharmaceutical composition according to claim 1, wherein when the composition is stored at 25 ° C and 60% relative humidity for 6 months, the composition has a secondary peroxide number of ethyl EPA (ethyl eicosopentanoate) no more1. Фармацевтическая композиция для лечения или предупреждения заболевания, связанного с сердечно-сосудистой системой у субъекта, нуждающегося в этом, включающая, по меньшей мере, 95% этилэйкозапентаеноата (этил-EPA), заключенного в оболочку капсулы, вк
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