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A pharmaceutical composition for oral comprising fenofibrate and preparation method thereof

A technology of fenofibrate and a composition is applied in the field of oral pharmaceutical compositions containing fenofibrate and the preparation thereof, and can solve the problems of reducing the yield of heat-labile drugs, thermal stability, adverse irritation of gastrointestinal mucosa, and the like

Inactive Publication Date: 2009-08-26
SAM CHUN DANG PHARM
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

However, fenofibrate as an active agent must be micronized for a long time according to a complicated process, thereby reducing the heat-labile drug yield and thermal stability during the micronization process.
Moreover, sodium lauryl sulfate can cause adverse irritation to the gastrointestinal mucosa

Method used

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  • A pharmaceutical composition for oral comprising fenofibrate and preparation method thereof
  • A pharmaceutical composition for oral comprising fenofibrate and preparation method thereof
  • A pharmaceutical composition for oral comprising fenofibrate and preparation method thereof

Examples

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Embodiment 1-5

[0049] Preparation of solid dispersions according to the spray-drying method

[0050] The solid dispersion containing fenofibrate of the present invention was prepared according to the composition in Table 1.

[0051] Table 1

[0052]

[0053] Fenofibrate was dissolved in a mixture of ethanol and dichloromethane at a volume ratio of 1:1, and hydroxypropylmethylcellulose was added as a water-soluble polymer to obtain a mixed solution of 8% (w / v). Poloxamer 188, Poloxamer 407, Cremophor RH-40, and soybean lecithin were added as surfactants to the mixed solution to prepare each solution. Each solution was spray-dried with a disc-type spray dryer to obtain a solid suspension in which fenofibrate was dispersed in hydroxypropylmethylcellulose. Spray drying is carried out under the following conditions: the feed temperature is 75-77°C, the combustion chamber temperature is 55-58°C, the rotary speed is 7,000-10,000rpm / min, and the flow rate is 16-20kg / h.

Embodiment 6-7

[0061] Preparation of Tablets Containing Fenofibrate Solid Dispersion

[0062] According to the dry granulation method, the solid dispersion of fenofibrate in Example 2 is made into granules, completely mixed with equal amounts of microcrystalline cellulose, lactose and cross-linked polyvinylpyrrolidone, and then mixed with colloidal anhydrous silicic acid as an enhancer. A plasticizer, magnesium stearate acts as a lubricant, and is then produced into tablets.

[0063] In Example 6, the fenofibrate solid dispersion was granulated with cross-linked polyvinylpyrrolidone as a disintegrant, while in Example 7, no cross-linked polyvinylpyrrolidone was added.

[0064] table 3

[0065]

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Abstract

The present invention relates to an oral pharmaceutical composition comprising the fenofibrate and a preparation method thereof. More specifically, the present invention is directed to an orally-administered pharmaceutical composition with improved bioavailability for treating hyperlipidemia and the preparation method thereof, where the solid dispersion is prepared by spray-drying a mixture of 100 parts by weight of fenofibrate dispersed in 20-200 parts by weight of water-soluble polymer, and 5-50 parts by weight of surfactant. The oral pharmaceutical composition has high bioavailability because of the increased solubility of amorphous fenofibrate. In addition, the spraying and drying can be performed at a time and low temperature, and thus a loss of activity of drug can be minimized, unlike the mechanical milling method.

Description

[0001] Cross-references to related applications [0002] This application claims the benefit of Korean Patent Application No. 10-2006-0072550 filed with the Korean Intellectual Property Office on Aug. 1, 2006, which is hereby incorporated by reference in its entirety. technical field [0003] The present invention relates to an oral pharmaceutical composition containing fenofibrate (chemical name isopropyl-2-(4-(4-chlorobenzoyl)phenoxy)-2-methylpropionate) and its preparation method. More specifically, the present invention provides an oral pharmaceutical composition containing fenofibrate with increased bioavailability because fenofibrate is an amorphous form and a dosage form of a solid dispersion. Background technique [0004] Fenofibrate is one of the most widely used therapeutic agents in the world for the treatment of endogenous hypercholesterolemia and hypertriglyceridemia in adults. The molecular structure of fenofibrate is C 20 h 21 ClO 4 , with a molecular we...

Claims

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Application Information

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IPC IPC(8): A61K9/14A61K31/216
CPCA61K9/146A61K9/1652A61K31/216A61K9/1617A61K9/1635A61P3/06A61K9/10A61K9/14
Inventor 白承姬韩成均辛银宗李祐荣朴俊锡
Owner SAM CHUN DANG PHARM
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