Fenofibrate tablet composition and preparation method thereof

A technology of fenofibrate and composition, applied in the field of fenofibrate tablet composition, to meet the requirements of dissolution consistency evaluation, reduce adverse reactions, and overcome abdominal discomfort

Inactive Publication Date: 2020-12-25
DISHA PHARMA GRP
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0005] Purpose of the invention: to solve the common adverse reactions such as abdominal discomfort, diarrhea, and constipation after taking the existing fenofibrate tablets, and improve the comfort of patients after medication

Method used

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Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0021] Embodiment 1. 2g of fenofibrate with a particle size of 6 microns, 72g of food-grade chitosan oligosaccharide, 100g of microcrystalline cellulose, 40g of hypromellose E5, 32g of polysorbate-80, 12g of micronized silica gel, stearic acid Magnesium 2g. Prepared according to the preparation method described in the technical scheme of the manual, spray granulation using 30% ethanol aqueous solution, and prepare 2000 tablets.

Embodiment 2

[0022] Example 2. Fenofibrate 2g with a particle size of 10 microns, food-grade chitosan oligosaccharide 120g, microcrystalline cellulose 60g, hydroxypropyl cellulose E5 60g, polysorbate-80 16g, micronized silica gel 24g, stearic acid Magnesium 4g. According to the preparation method described in the technical scheme of the manual, spray granulation uses 45% ethanol aqueous solution to prepare 2000 tablets.

Embodiment 3

[0023] Example 3. Fenofibrate 2g with a particle size of 8.5 microns, food-grade chitosan oligosaccharide 100g, microcrystalline cellulose 84g, hydroxypropyl cellulose E5 52g, polysorbate-80 28g, micronized silica gel 18g, stearic acid Magnesium 3g. According to the preparation method described in the technical scheme of the manual, spray 35% ethanol aqueous solution to granulate, and prepare 2000 tablets.

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Abstract

The invention relates to a fenofibrate composition, and belongs to the technical field of pharmaceutical preparations. According to the technical scheme, every 1000 fenofibrate compound tablets contain 1 g of fenofibrate with the particle size of 6-10 microns, 36-60 g of food-grade chitosan oligosaccharide, 30-50 g of microcrystalline cellulose, 20-30 g of hydroxypropylcellulose E5, 8-16 g of polysorbate-80, 6-12 g of colloidal silicon dioxide and 1-2 g of magnesium stearate. The fenofibrate composition provided by the invention has a uniform content and a low occurrence rate of adverse reactions.

Description

technical field [0001] The invention relates to a fenofibrate tablet composition, which belongs to the technical field of pharmaceutical preparations. Background technique [0002] Fenofibrate tablets were first used clinically in 1975, mainly for the treatment of hyperlipidemia in adults with unsatisfactory diet control therapy. It is one of the first-choice drugs for lowering triglycerides. It is more effective than cholesterol, and can also reduce blood uric acid levels. It also has a good effect on the treatment of type 2 diabetes and metabolic syndrome. It is one of the most commonly used fibrates, and has good effects and tolerance. [0003] According to the biopharmaceutics classification system, fenofibrate belongs to the typical class II drugs. Fenofibrate's insoluble properties and poor dissolution rate make the bioavailability of fenofibrate low, and its oral bioavailability is only 35%. Most of the current literatures describe how to improve the bioavailability...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K9/20A61K47/26A61K47/36A61K47/38A61K47/04A61K31/216A61P3/06
CPCA61K9/2009A61K9/2018A61K9/205A61K9/2054A61K9/2095A61K31/216A61P3/06
Inventor 常海容张辉杨银花谢爱芳
Owner DISHA PHARMA GRP
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