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Montelukast orally disintegrating tablet and preparation method thereof

The technology of oral disintegrating tablet and montelukast sodium is applied in the field of montelukast sodium oral disintegrating tablet and its preparation, and can solve the problems of slow absorption and onset, easy to enter the trachea, rapid relief of adverse symptoms and the like, To achieve the effect of fast drug release, less variety and feasible process

Active Publication Date: 2014-03-26
北京华禧联合科技发展有限公司
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

Ordinary preparations are tablets, capsules or granules, which are inconvenient to take, especially when patients suffer from shortness of breath and cough, and the tablets or capsules are easy to enter the trachea; intestinal administration needs to be disintegrated and dissolved, and the absorption and onset are slow. Not conducive to rapid relief of symptoms

Method used

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  • Montelukast orally disintegrating tablet and preparation method thereof
  • Montelukast orally disintegrating tablet and preparation method thereof
  • Montelukast orally disintegrating tablet and preparation method thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 2

[0029] A kind of montelukast sodium orally disintegrating tablet, the preparation prescription comprises the following components by weight percentage:

[0030] Montelukast Sodium 5%

[0031] 400 93%

[0032] Magnesium Stearate 2%

[0033] Process:

[0034] (1) Pass the montelukast sodium through a 50-mesh sieve, and take 400 The part between the 35 mesh sieve and the 50 mesh sieve, the magnesium stearate passed through the 80 mesh sieve, and mixed evenly;

[0035] (2) Weigh the prescribed amount of montelukast sodium, 400 and magnesium stearate, mix uniformly in a mixer;

[0036] (3) Powder compression.

Embodiment 3

[0038] A kind of montelukast sodium orally disintegrating tablet, the preparation prescription comprises the following components by weight percentage:

[0039] Montelukast Sodium 4%

[0040] Spray dried mannitol ( 400) 95%

[0041] Magnesium Stearate 1%

[0042] Process:

[0043] (1) Pass the montelukast sodium through a 50-mesh sieve, and take 400 The part between the 35 mesh sieve and the 50 mesh sieve, the magnesium stearate passed through the 80 mesh sieve, and mixed evenly;

[0044] (2) Weigh the prescribed amount of montelukast sodium, 400 and magnesium stearate, mix uniformly in a mixer;

[0045] (3) Powder compression.

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Abstract

The invention discloses a Montelukast orally disintegrating tablet and a preparation method thereof. The Montelukast orally disintegrating tablet comprises Montelukast, spraying and drying mannitol (particle diameters are controlled to be between 300 mu m to 500 mu m) and a lubricant. The Montelukast orally disintegrating tablet can be rapidly disintegrated in an oral cavity without adding a disintegrating agent, the dissolving is rapid, the tablet hardness is high, and the packaging, the transporting and the storing are easy; the invention further provides the preparation method of the Montelukast orally disintegrating tablet. Direct powder compression is adopted, the operation is convenient, influences of a drying process, dampness and heat on the product quality are avoided, the prescription has few varieties of auxiliary materials, a direct powder compression process is combined, and the stability is improved remarkably.

Description

technical field [0001] The invention belongs to the field of pharmaceutical preparations, in particular to a montelukast sodium orally disintegrating tablet and a preparation method thereof. Background technique [0002] Asthma is a chronic inflammatory disease characterized by tracheal hyperresponsiveness and reversible airway obstruction. As a common chronic disease, it afflicts nearly 10% of the population in developed countries, causing social and economic losses of tens of billions of dollars. In recent decades, the incidence of asthma at home and abroad, especially the incidence of childhood asthma is on the rise. [0003] Montelukast sodium is a highly selective cysteamide leukotriene receptor antagonist developed by Merck. It is a potent oral preparation that can significantly improve asthma inflammatory indicators. Measurements have shown that montelukast sodium has high selectivity, can competitively antagonize the binding of leukotriene D4 (LTD4) to Cys-LT1 rece...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K9/20A61K31/47A61K47/26A61P11/06
Inventor 李冉庄伟平毕华
Owner 北京华禧联合科技发展有限公司
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