发明名称 |
Pharmaceutical composition containing fenofibrate and method for the preparation thereof |
摘要 |
Disclosed is the use of a composition of fenofibrate containing micronized fenofibrate, a surfactant and a binding cellulose derivative as a solubilization adjuvant, said composition containing an amount of fenofibrate greater than or equal to 60% by weight for the preparation of a medicament for treating hypertriglyceridemias, hypercholesterolemias or hyperlipidemias while reducing the food effect on the bioavailability of fenofibrate, wherein said composition is in the form of granules comprising: (d) a neutral core; (e) an active layer, which surrounds the core; and (f) an outer layer; wherein said active layer comprises micronized fenofibrate, a surfactant and a binding cellulose derivative; and wherein said formulation has a dissolution profile of less than 10% at 5 minutes and more than 80% at 20 minutes according to the European Pharmacopoeia in a dissolution medium constituted by water with 0.025 M sodium lauryl sulphate.
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申请公布号 |
NZ546692(A) |
申请公布日期 |
2010.03.26 |
申请号 |
NZ20040546692 |
申请日期 |
2004.10.01 |
申请人 |
ETHYPHARM |
发明人 |
CRIERE, BRUNO;SUPLIE, PASCAL;CHENEVIER, PHILIPPE;OURY, PASCAL;ROTENBURG, KEITH S;BOBOTAS, GEORGE |
分类号 |
A61K31/216;A61K9/16;A61K9/50 |
主分类号 |
A61K31/216 |
代理机构 |
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代理人 |
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主权项 |
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地址 |
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