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Stable compositions of fenofibrate with fatty acid esters

A technology of fatty acid ester and fenofibrate, which is applied in the field of fenofibrate composition, can solve the problems of poor water solubility of fenofibrate and limited absorption of digestive tract, etc., and achieve the effect of reducing adverse side effects

Inactive Publication Date: 2007-12-26
RELIANT PHARMACEUTICALS INC
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0006] However, fenofibrate has very poor water solubility and its absorption in the digestive tract is limited

Method used

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Examples

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Embodiment Construction

[0023] The fenofibrate is substantially completely dissolved in the fatty acid ester, which improves the administration of fenofibrate. According to the present invention, at least 90% w / w fenofibrate is dissolved in the fatty acid ester, preferably at least 95% w / w, and more preferably at least 98% w / w. At room temperature (about 23°C to 27°C), the dosage form is stable for a period of at least one month, preferably at least six months, more preferably at least one year, and most preferably at least two years. By "stable" the inventors mean that the dissolved fenofibrate does not precipitate out of solution to any appreciable extent, eg less than 10%, preferably less than 5%.

[0024] Combination products comprising a certain amount of fenofibrate and a certain amount of fatty acid esters have therapeutic utility. The present invention also provides a method for treating hypertriglyceridemia, hypercholesterolemia, mixed dyslipidemia, vascular disease, arteriosclerosis and re...

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PUM

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Abstract

A pharmaceutical composition in unit dose form of fenofibrate and a solvent system of fatty acid esters, wherein the fenofibrate is substantially dissolved in the solvent system.

Description

[0001] This application claims priority to provisional application 60 / 633,126, filed December 6,2004. This provisional application is hereby incorporated by reference in its entirety. technical field [0002] The present invention relates to a stable fenofibrate composition comprising fenofibrate and a fatty acid ester, wherein the fenofibrate is dissolved. The composition effectively treats hypertriglyceridemia, hypercholesterolemia, mixed dyslipidemia, vascular disease, arteriosclerosis and related diseases, obesity, prevents and reduces cardiovascular and vascular morbidity, reduces insulin resistance, Reduce fasting glucose level and postprandial glucose level, and / or reduce the incidence of diabetes, and / or delay the onset of diabetes. Background technique [0003] In humans, high levels of total cholesterol, low-density lipoprotein (LDL), and apolipoprotein B (the membrane complex of LDL-C) promote atherosclerosis. This high level also promotes lower levels of high-d...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K9/00
CPCA61K47/14A61K31/192A61K9/4858A61K9/08A61P3/06A61P3/10A61P9/00A61P9/10
Inventor 乔治·博博泰斯鲁洛夫·M.·L.·龙根
Owner RELIANT PHARMACEUTICALS INC