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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:
RU2011148362/15
公开号:
RU2011148362A
申请日:
2010.04.29
申请国别(地区):
RU
年份:
2013
代理人:
摘要:
1. A pharmaceutical composition comprising at least 95% EPA, encapsulated in a capsule shell, wherein the composition has an initial peroxide value of not more than 5 meq / kg and when stored at 25 ° C and 60% relative humidity for 6 months, the secondary the peroxide value does not exceed 8 meq / kg. 2. The pharmaceutical composition of claim 1, wherein the EPA is ethyl EPA. 3. The pharmaceutical composition of claim 2, wherein the ethyl EPA contains less than about 1% of any individual fatty acid that is not ethylacosapentaenoate. The pharmaceutical composition of claim 2, wherein the ethyl EPA contains less than about 0.5% of any individual fatty acid that is not ethylacosapentaenoate. The pharmaceutical composition of claim 2, wherein the ethyl EPA contains less than about 0.3% DHA if it is included in the composition. The pharmaceutical composition of claim 5, wherein the ethyl EPA is substantially free of DHA. The pharmaceutical composition of claim 1, wherein the ethyl EPA contains from about 0.1 to about 1 wt.% Antioxidant. The pharmaceutical composition of claim 7, 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 secondary peroxide EPA number does not exceed 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 secondary peroxide EPA number does not exceed 6 meq / kg. The pharmaceutical composition according to claim 1, wherein when the composition is stored at 30 ° C and 65% relative humidity for 6 months, the secondary peroxide EPA number does not exceed 12 meq / kg. The pharmaceutical composition according to claim 11, where during storage1. Фармацевтическая композиция, включающая, по меньшей мере, 95% EPA, заключенную в оболочку капсулы, где композиция имеет исходное пероксидное число не более 5 мэкв/кг и при хранении
来源网站:
中国工程科技知识中心
来源网址:
http://www.ckcest.cn/home/
相关发明人
манку мехар (gb)
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