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Chewable tablet containing montelukast sodium

A technology of montelukast sodium and chewable tablets, which is applied in the field of chewable tablets containing montelukast sodium, which can solve the problems of no mention of other effects of coloring agents, the easy discoloration of montelukast sodium when exposed to light, and the inconvenience of mass production in the workshop and other problems, to avoid photodecomposition, improve operability, and facilitate production operations

Active Publication Date: 2010-07-14
LUNAN PHARMA GROUP CORPORATION
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

But still there are following problems at present: 1) montelukast sodium is easy to change color and decompose when seeing light, so it must be shaded all the time during production, which causes inconvenience to the batch production in the workshop; 2) the lubricant magnesium stearate commonly used during production is harmful to The stability of this product has obvious influence
Among them, paragraph 4 on page 6 of the description discloses that the coloring agent iron oxide (red, yellow or black) focuses on improving the appearance of the pharmaceutical preparation, and / or makes it easier for patients to identify the preparation, but does not mention other aspects of the coloring agent. effect

Method used

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  • Chewable tablet containing montelukast sodium
  • Chewable tablet containing montelukast sodium
  • Chewable tablet containing montelukast sodium

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0030] Example 1 Montelukast sodium chewable tablets

[0031] Montelukast Sodium 5.2g

[0032] Microcrystalline cellulose 30g

[0033] Mannitol 60.7g

[0034] Iron oxide red 1.5

[0035] 4% PVPK30 ethanol solution 40g

[0036] Zinc stearate 1.0g

[0037] Preparation process: Pass the montelukast sodium and iron oxide red through a 120-mesh sieve, microcrystalline cellulose and mannitol through a 100-mesh sieve, and then mix the iron oxide red and the montelukast sodium by equal volume addition. After mixing, pass through a 100-mesh sieve twice, and then mix the above-mentioned mixed powder with mannitol in equal increments, and pass through an 80-mesh sieve after each mixing, and then add all the added raw and auxiliary materials to 4% PVPK 30 Alcohol solution is granulated, and after drying, the prescription amount of zinc stearate is added and mixed uniformly, and the tablet is obtained.

Embodiment 2-6

[0038] Example 2-6 Montelukast Sodium Chewable Tablets

[0039] For the convenience of description, Table 1 describes Examples 2-6 below. The preparation process of Examples 2-6 is the same as that of Example 1.

[0040] Table 1 Example 2-6 Montelukast Sodium Chewable Tablets Process Formula

[0041]

[0042] Note: "Example 2" in the table indicates the content of each cube corresponding to Example 2, in g; Example 3 to Example 6 and so on.

Embodiment 7-12

[0043] Example 7-12 Montelukast Sodium Chewable Tablets

[0044] For the convenience of description, Table 2 describes Examples 7-12 below. The preparation process of Examples 7-12 is the same as that of Example 1.

[0045] Table 2 Example 7-12 Montelukast Sodium Chewable Tablet Process Formula

[0046]

[0047] Note: "Example 7" in the table indicates the content of each cube corresponding to Example 7, in g; Example 8 to Example 12 and so on.

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PUM

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Abstract

The invention belongs to the field of medicine preparations, which particularly relates to a chewable tablet of montelukast sodium. Because the production process of the chewable tablet of the montelukast sodium needs the light shielding operation at present, the mass production is inconvenient, and the chewable tablet of the montelukast sodium has the defect of poorer stability. In the invention, zinc stearate and an opacifier of iron oxide red, iron oxide yellow and titanium dioxide are added into the auxiliary materials of a chewable tablet of montelukast, so that the content of relevant substances can be lowered, and the stability of the chewable tablet is enhanced.

Description

Technical field [0001] The invention belongs to the field of pharmaceutical preparations, and specifically relates to a chewable tablet containing montelukast sodium. Background technique [0002] Asthma is a chronic inflammatory disease characterized by tracheal hyperresponsiveness and reversible airway obstruction. As a common chronic disease, it affects nearly 10% of the population in developed countries and causes tens of billions of dollars in social and economic losses. In recent decades, the incidence of asthma at home and abroad, especially the incidence of asthma in children has been on the rise. According to the data from the "Epidemiological Survey" in Shanghai in 2000, the incidence of childhood asthma was 4.52%, an increase of 153.51% from 10 years ago, and children aged 2 to 5 accounted for 50.91%. [0003] Montelukast is a highly selective cysteinyl leukotriene receptor antagonist developed by Merck. It can competitively antagonize the binding of leukotriene D4 to ...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K9/20A61K31/47A61K47/38A61K47/14A61K47/02A61P11/06
Inventor 赵志全
Owner LUNAN PHARMA GROUP CORPORATION
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