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Indacaterol solid dispersion and pharmaceutical composition containing same

A solid dispersion and composition technology, applied in the field of medicine, can solve the problems of difficulty in removing residues, difficulty, and high equipment requirements, and achieve the effects of reducing the problem of content uniformity, accelerating the dissolution rate, and improving the dissolution rate.

Inactive Publication Date: 2014-06-04
熊妲妮
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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 melting-solvent method is even more difficult to achieve. 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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Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0034] Preparation of Indacaterol-Crosslinked Polyvinylpyrrolidone-Sodium Lauryl Sulfate Solid Dispersion

[0035] (1) indacaterol 0.1g; (2) cross-linked polyvinylpyrrolidone 0.5g; (3) sodium lauryl sulfate 0.1g; put (1) (2) (3) into the horizontal planet after mixing Type ball mill (model QM-WX04, Shanghai Chubo Laboratory Equipment Co., Ltd., the same below), add 10 10mm balls, grind at 400 rpm for 1 hour, take out the ground material and pass through a 60-mesh sieve.

Embodiment 2

[0037] Preparation of Indacaterol-Polyethylene Glycol 6000-Sodium Lauryl Sulfate Solid Dispersion

[0038](1) Indacaterol 0.1g; (2) Polyethylene glycol 6000 2.5g; (3) Sodium lauryl sulfate 0.1g;

[0039] 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

[0041] Preparation of Indacaterol-Lactose-Sodium Lauryl Sulfate Solid Dispersion

[0042] (1) Indacaterol 0.1g; (2) Lactose 1.0g; (3) Sodium lauryl sulfate 0.1g;

[0043] 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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PUM

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Abstract

The invention provides an indacaterol solid dispersion and a pharmaceutical composition containing the same. The indacaterol solid dispersion comprises (1) indacaterol, (2) one or more of crosslinked polyvinylpyrrolidone, lactose, polyethylene glycol and microcrystalline cellulose; (3) sodium dodecyl sulfate. The pharmaceutical composition comprises the indacaterol solid dispersion and a pharmaceutically acceptable carrier. By making the indacaterol into a solid dispersion, the drug solubility is improved, the dissolution speed of the drug is increased, and the dissolution rate of the pharmaceutical composition containing the solid dispersion is greatly improved in a dissolving medium; moreover, in a grinding process, the premixing of the drug and partial accessories is realized, and the problems in the content uniformity of a small-dose preparation are remarkably reduced.

Description

field of invention [0001] The invention belongs to the field of medicines, and in particular relates to indacaterol solid dispersions and pharmaceutical compositions containing them. Background of the invention [0002] Indacaterol is a bronchodilator that belongs to the long-acting inhaled β2-adrenergic receptor agonist (LABA) class and is suitable for the maintenance treatment of adult patients with chronic obstructive pulmonary disease (COPD). It takes effect in 5 minutes and lasts for 24 hours. Indacaterol is produced by Swiss Novartis Pharmaceuticals and has been listed in more than 70 countries and regions around the world since 2009; it was approved by the State Food and Drug Administration in June 2012 to be listed in China. It is the first LABA approved for the treatment of COPD in my country class of single preparations. Clinical trials have shown that taking indacaterol once a day can cause bronchodilation for more than 24 hours, and its bronchodilation time is l...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K9/20A61K9/48A61K9/16A61K9/14A61K9/12A61K31/4704A61K47/38A61K47/34A61K47/32A61K47/26A61K47/20A61P11/08
Inventor 熊妲妮孙文娟夏美华黄永文梁林
Owner 熊妲妮
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