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Roflumilast solid dispersion and medicinal composition containing same

A technology of solid dispersion and roflumilast, which is applied in the field of medicine, can solve problems such as difficulty in melting-solvent method, difficulty in removing residues, difficulties, etc., and achieve the effects of reducing content uniformity, improving dissolution rate, and accelerating dissolution rate

Inactive Publication Date: 2013-03-27
WUXI HONGXING BIOMEDICAL TECH
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

The melting method is more complicated to prepare, and industrial production is currently relatively difficult. The solvent method usually contains organic solvents, which are difficult to remove residues and difficult to control the safety of the production process. The melt-solvent method is even more difficult to implement. Explosion-proof measures are required, and there are certain requirements for the solubility of the drug if there is an aqueous solvent

Method used

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  • Roflumilast solid dispersion and medicinal composition containing same
  • Roflumilast solid dispersion and medicinal composition containing same
  • Roflumilast solid dispersion and medicinal composition containing same

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0033] Example 1 Preparation of Roflumilast-Crosslinked Polyvinylpyrrolidone-Sodium Lauryl Sulfate Solid Dispersion

[0034] (1) Roflumilast 0.1g (2) Cross-linked polyvinylpyrrolidone 0.5g (3) Sodium lauryl sulfate 0.1g

[0035] Put (1) (2) (3) into a horizontal planetary ball mill (model QM-WX04, Shanghai Chubo Laboratory Equipment Co., Ltd., the same below) after mixing, add 10 10mm balls, 400 rpm Grind for 1 hour, take out the ground product and pass through a 60-mesh sieve.

Embodiment 2

[0036] Example 2 Preparation of Roflumilast-Polyethylene Glycol 6000-Sodium Lauryl Sulfate Solid Dispersion

[0037] (1) Roflumilast 0.1g (2) Macrogol 6000 1.9g (3) Sodium lauryl sulfate 0.1g

[0038] Put the mixture of (1) (2) (3) into a planetary ball mill, add 15 10mm balls, grind at 400 rpm for 1 hour, take out the ground material and pass it through a 60-mesh sieve.

Embodiment 3

[0039] Example 3 Preparation of Roflumilast-Lactose-Sodium Lauryl Sulfate Solid Dispersion

[0040] (1) Roflumilast 0.1g (2) Lactose 0.9g (3) Sodium lauryl sulfate 0.1g

[0041] Put the mixture of (1) (2) (3) into a planetary ball mill, add 10 10mm balls, grind at 400 rpm for 1 hour, take out the ground material and pass it through a 60-mesh sieve.

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Abstract

The invention discloses a roflumilast solid dispersion and a medicinal composition containing the same. The roflumilast solid dispersion comprises (1) roflumilast, (2) one or several of crosslinked polyvinylpyrrolidone, lactose, polyethylene glycol and microcrystalline cellulose, and (3) sodium dodecyl sulfate. The medicinal composition comprises the roflumilast solid dispersion and a pharmaceutically acceptable carrier. By preparing roflumilast into a solid dispersion, the solubility of a medicine is improved, the dissolution speed of the medicine is increased, and the dissolution rate of a medicinal composition containing the roflumilast solid dispersion in a dissolution medium is greatly improved; and in a grinding process, premixing of the medicine and some accessories is realized, and the problem in the content uniformity of a small dose of preparation is greatly reduced.

Description

technical field [0001] The invention relates to a roflumilast solid dispersion and a pharmaceutical composition containing the same, belonging to the field of medicine. Background technique [0002] Chronic obstructive pulmonary disease (COPD) is a fatal lung disease that hinders normal breathing. It is estimated that 210 million people worldwide suffer from COPD, and more than 3 million people died of COPD in 2005, equivalent to 5% of all deaths, and nearly 90% of COPD deaths, occur in low- and middle-income countries. According to the WHO forecast, COPD will become the third leading cause of death in the world by 2030. COPD has become an important public health problem because of its large number of patients, high mortality rate and heavy social and economic burden. [0003] The clinically used drugs for the treatment of COPD mainly include bronchodilators and corticosteroids, and roflumilast belongs to bronchodilators, but the mechanism of action is different from other...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K9/14A61K31/44A61K47/38A61P11/08
Inventor 胡君寅赵玉琴范建萍李瑞文
Owner WUXI HONGXING BIOMEDICAL TECH
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