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GALENE COMPOSITION INCLUDING ALISKIREN AND METHOD FOR PRODUCING IT WITH EXTRUSION MELT GRANULATION FROM MELT
专利权人:
НОВАРТИС АГ (CH)
发明人:
ГХОШ Индраджит (US),КОВАЛЬСКИ Джеймс (US),СНАЙДЕР Дженнифер (US),ТОН Вэйцинь (US),ВИППАГУНТА Судза (US)
申请号:
RU2011116122/15
公开号:
RU2011116122A
申请日:
2009.09.23
申请国别(地区):
RU
年份:
2012
代理人:
摘要:
1. A solid oral dosage form comprising aliskiren or a pharmaceutically acceptable salt thereof, alone or in combination with another active agent, wherein the aliskiren or its pharmaceutically acceptable salt is prepared by melt granulation, optionally in admixture with one or more granulation excipients, said granulation is an extrusion process where the temperature of the extrudate is at least equal to the melting point, is in the melting range, is equal to the softening temperature, or is It is in the softening range of aliskiren, or its salt, or higher. ! 2. The solid oral dosage form according to claim 1, wherein aliskiren or its salt is converted to an amorphous form as a result of extrusion. ! 3. The solid oral dosage form according to claim 1, wherein the aliskiren is prepared by melt granulation in a mixture with one or more polymers. ! 4. The solid oral dosage form according to claim 3, wherein the polymer is N-vinylpyrrolidone or cellulose. ! 5. The solid oral dosage form according to claim 4, wherein the polymer is selected from hydroxypropyl methylcellulose, hydroxypropyl cellulose and polyvinylpyrrolidone. ! 6. The solid oral dosage form according to claim 1, wherein the dosage form further comprises valsartan or a pharmaceutically acceptable salt thereof. ! 7. The solid oral dosage form according to claim 6, in which aliskiren or its pharmaceutically acceptable salt is physically separated from valsartan, or its pharmaceutically acceptable salt. ! 8. The solid oral dosage form according to claim 6 in the form of a two-layer tablet comprising a layer containing aliskiren or its1. Твердая пероральная лекарственная форма, включающая алискирен или его фармацевтически приемлемую соль, в отдельности или в комбинации с другим активным агентом, причем алискирен или его фармацевтически приемлемую соль получают грануляцией из расплава, необязательно в смеси с одним или более эксципиентов для грануляции, причем указанная грануляция представляет собой экструзионн
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中国工程科技知识中心
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