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Montelukast sodium chewable tablet and preparation method thereof

A technology of montelukast sodium and chewable tablets, which is applied in the field of preparation of montelukast sodium chewable tablets, can solve the problem of not giving stable montelukast sodium preparations and the like, and is suitable for industrial production and production operations. Simple, effective in reducing the risk of bioinequivalence

Active Publication Date: 2018-06-22
SHANGHAI ANBISON LAB
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0008] But the prior art does not provide a more stable montelukast sodium preparation

Method used

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  • Montelukast sodium chewable tablet and preparation method thereof
  • Montelukast sodium chewable tablet and preparation method thereof
  • Montelukast sodium chewable tablet and preparation method thereof

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preparation example Construction

[0033] A preparation method of montelukast sodium chewable tablets, the preparation method comprises the following steps:

[0034] After the montelukast sodium and hydroxypropyl cellulose are dissolved in the ethanol solution, the coloring agent is added to suspend uniformly to obtain a binder solution;

[0035] Spray the binder solution onto the surface of the pharmaceutical excipient mixture in a fluidized state, and dry after granulation;

[0036] The dried particles are then uniformly mixed with other pharmaceutically acceptable excipients and compressed into tablets to prepare montelukast sodium chewable tablets.

[0037] The pharmaceutical excipient mixture is a mixture of microcrystalline cellulose and spray-dried lactose. The ratio of microcrystalline cellulose to spray-dried lactose is 1:2-12. The mass dosage ratio of montelukast sodium to hydroxypropyl cellulose is 1:0.4-2. The coloring agent is selected from iron oxide red or iron oxide yellow, and the mass dosage ratio o...

Embodiment 1

[0047]

[0048] Preparation Process:

[0049] Binder solution: Weigh the prescribed amount of hydroxypropyl cellulose and add it to 30 g of ethanol, stir until the solution, and let stand to defoam. Weigh the prescribed amount of montelukast sodium and add it to 20 g of ethanol, and stir until dissolved. The montelukast sodium ethanol solution was added to the hydroxypropyl cellulose ethanol solution and stirred uniformly, and then the prescription amount of iron oxide red was added to the above solution and suspended uniformly.

[0050] The mixture of spray-dried lactose and microcrystalline cellulose is placed in a fluidized bed to maintain a fluidized state. The binder solution is sprayed for granulation, and after drying, a prescription amount of croscarmellose sodium, aspartame, and cherry are added. The flavor and magnesium stearate are evenly mixed and compressed into tablets.

Embodiment 2

[0052]

[0053] Preparation Process:

[0054] Binder solution: Weigh the prescribed amount of hydroxypropyl cellulose and add it to 30 g of ethanol, stir until the solution, and let stand to defoam. Weigh the prescription amount of montelukast sodium into 20 g of ethanol, and stir until it dissolves. The montelukast sodium ethanol solution was added to the hydroxypropyl cellulose ethanol solution and stirred uniformly, and then the prescribed amount of iron oxide red was added to the above solution and suspended uniformly.

[0055] The mixture of spray-dried lactose and microcrystalline cellulose is placed in a fluidized bed to maintain a fluidized state, and the binder solution is sprayed to granulate. After drying, a prescription amount of croscarmellose sodium, aspartame, and strawberry are added. The flavor and magnesium stearate are evenly mixed and compressed into tablets.

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Abstract

The invention relates to a montelukast sodium chewable tablet. The tablet is composed of montelukast sodium, gamma-cyclodextrin, a binder, a disintegrant, a filler and a lubricant. According to the method, a special cavity structure and non-toxic excellent properties of the gamma-cyclodextrin and the characteristic that the gamma-cyclodextrin can be combined with various objects are used for preparing a montelukast sodium clathrate compound, so that the montelukast sodium is protected from light, oxygen and the like due to a cyclodextrin clathrate compound, and the stability of the montelukastsodium tablet is improved. The montelukast sodium is dispersed in the gamma-cyclodextrin, compared with the commonly used direct mixing tabletting process, the risk of uneven distribution of the montelukast sodium in granules is reduced during the production process, and content uniformity of the tablet is obviously improved.

Description

Technical field [0001] The invention relates to a montelukast sodium chewable tablet, and also relates to a preparation method of montelukast sodium chewable tablet. Background technique [0002] Montelukast sodium appeared as Merck's third-generation fourth leukotriene receptor antagonist drug candidate. Its safety and effectiveness have been confirmed. In pediatric clinical studies, the chewing dosage form also showed good results in infants and young children, and did not affect the growth rate of infants and young children. Everyone eventually called it "Montelukast" to commemorate its birthplace-Montreal. Montelukast (trade name Shun Er Ning) was launched in February 1998 and was approved for adults and children between 6 and 14 years old. In June 2000, Shun Erning was further approved by the US Food and Drug Administration for infant asthma patients over 1 year old. [0003] Montelukast sodium, as an oral leukotriene receptor antagonist, can specifically inhibit cysteyl le...

Claims

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Application Information

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IPC IPC(8): A61K9/36A61K9/28A61K47/02A61K31/47A61P11/06A61P11/02A61P37/08
CPCA61K9/0056A61K9/2813A61K9/2866A61K31/47
Inventor 谭然然沙平雷继峰施钰文
Owner SHANGHAI ANBISON LAB
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