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Solid preparation containing highly dispersed fenofibrate

A fenofibrate and solid preparation technology, applied in the field of biopharmaceuticals, can solve the problem of low bioavailability of fenofibrate

Inactive Publication Date: 2011-09-21
SHANGHAI TIANLONG PHARMA
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

According to speculation, the true bioavailability of fenofibrate is still relatively low, so there is still a lot of room for improvement

Method used

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Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0025] Preparation of the highly dispersed fenofibrate carrier of embodiment 1

[0026] Prescribe as follows:

[0027] Fenofibrate 54g

[0028] Poloxamer 188 54g

[0029] PEG6000 54g

[0030] Preparation: Weigh fenofibrate, poloxamer and PEG6000 according to the prescription amount, crush the fenofibrate through an 80-mesh sieve for later use; crush the poloxamer and PEG6000 through a 40-mesh sieve, heat in a water bath at 80-90°C Melt, slowly add fenofibrate, stir until the drug powder completely disappears, put the molten drug-containing liquid in a freezer at 4°C for 24 hours, and pulverize to obtain a highly dispersed fenofibrate carrier.

Embodiment 2

[0031] Example 2 Preparation of Tablets Containing Highly Dispersed Fenofibrate

[0032] Add the following excipients:

[0033] Microcrystalline Cellulose 80g

[0034] Hypromellose 23g

[0035] Crospovidone XL 18g

[0036] Magnesium stearate 8g

[0037] Preparation: the above-mentioned excipients were pulverized through a 80-mesh sieve, and the highly dispersed fenofibrate carrier prepared in Example 1 was pulverized through a 60-mesh sieve, mixed evenly, and pressed into tablets.

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PUM

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Abstract

The invention provides a solid preparation containing highly dispersed fenofibrate, wherein the fenofibrate stably exists in carrier materials in a highly dispersed form. The carrier materials are water-soluble carrier materials and are selected from polyethylene glycol, povidone, a surfactant containing a polyoxyethylene group, a water-soluble cellulose derivative, organic acid, organic sugar and organic alcohol. The carriers can be used separately or in a combination manner. The solid preparation containing the highly dispersed fenofibrate can be in a form of capsules or tablets. The bioavailability of the fenofibrate can be improved. The dosage of the single preparation of the fenofibrate can be reduced.

Description

technical field [0001] The invention belongs to the field of biopharmaceuticals, and specifically relates to a solid preparation containing highly dispersed fenofibrate, such as a tablet or capsule, and also relates to a preparation method of the solid preparation containing highly dispersed fenofibrate. Background technique [0002] Fenofibrate (Fenofibrate), the chemical name is 2-(4-(4-chlorobenzoyl)phenoxy)-2-methyl propionate isopropyl ester, is a kind of fibrate drug, clinical application at present The preparation forms are mainly capsules and tablets. FDA-approved fenofibrate tablet dosages are 48, 54, 145, 160 mg. Most of oral fenofibrate is metabolized into glucuronide conjugates in the prosystem and first-pass sites, and no prototype exists in plasma. Fenofibrate is a prodrug, which is rapidly metabolized into fenofibric acid by esterase in the body to lower blood lipids. It can significantly reduce serum cholesterol, triglycerides and increase high-density lipo...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K9/20A61K9/48A61K31/216A61P3/06
Inventor 裴桂君
Owner SHANGHAI TIANLONG PHARMA
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