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Chewable tablet containing montelukast sodium and preparation method of chewable tablet

A technology of montelukast sodium and chewable tablets, which is applied in the directions of active ingredients of heterocyclic compounds, pill delivery, respiratory system diseases, etc. High quality requirements for excipients, to achieve the effect of improving medication compliance, bright appearance, uniform and stable quality

Inactive Publication Date: 2016-02-03
南京泽恒医药技术开发有限公司
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0010] Through the analysis of the related patents of Montelukast Sodium Chewable Tablets, it is found that the existing technology mainly solves the problem of sub-impurity through technical solutions such as opacifying agents, powder direct compression or dry granulation direct compression, film coating, and adding additives. Sulfone and stability problems; at the same time, most of the existing technologies improve the dissolution rate by adding additives such as polylactic acid or changing the binder; and there is no patent to improve the preparation from the treatment and optimization of raw and auxiliary materials Dissolution, impurities and stability are controlled; moreover, the dissolution uniformity in the prior art is poor, the content level of related substances is relatively high, and the quality stability needs to be improved; in addition, the prior art has high requirements on the quality of excipients, which are commonly used in China It is difficult for excipients to meet the requirements of their preparations, resulting in higher production costs and difficulties in rapid industrialization

Method used

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  • Chewable tablet containing montelukast sodium and preparation method of chewable tablet
  • Chewable tablet containing montelukast sodium and preparation method of chewable tablet
  • Chewable tablet containing montelukast sodium and preparation method of chewable tablet

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0063] Embodiment 1 montelukast sodium chewable tablet

[0064] Montelukast Sodium 5.19mg

[0065] Microcrystalline Cellulose PH101 (FMC) 65mg

[0066] Mannitol 215mg

[0067] Croscarmellose Sodium 6.0mg

[0068] Magnesium stearate 3.0mg

[0069] Allure Red Aluminum Tablets 0.4mg

[0070] Aspartame 0.6mg

[0071] Cherry essence 1.2mg

[0072] Proper amount of hydroxypropyl cellulose

[0073] Appropriate amount of absolute ethanol

[0074] Preparation process (avoid light during the process):

[0075] After the raw material of montelukast sodium is micronized, the raw material of montelukast sodium is added to mannitol, so that the raw material of montelukast sodium is evenly adsorbed and dispersed in mannitol to form a mannitol complex, and then microcrystalline Cellulose PH101 (FMC), cherry flavor, aspartame, allure red aluminum color tablets, mix well. To make soft material, granulate with 24-mesh sieve, and dry at 40°C-60°C. After granulating with 24-mesh sieve,...

Embodiment 2

[0077] Example 2 Montelukast Sodium Chewable Tablets

[0078] Montelukast Sodium 4.15mg

[0079] Microcrystalline Cellulose PH101 (FMC) 80mg

[0080] Mannitol 200mg

[0081] Croscarmellose Sodium 6.0mg

[0082] Magnesium stearate 3.0mg

[0083] Allure Red Aluminum Tablets 0.4mg

[0084] Aspartame 0.6mg

[0085] Cherry essence 1.2mg

[0086] Proper amount of hydroxypropyl cellulose

[0087] Appropriate amount of absolute ethanol

[0088] Preparation process (avoid light during the process):

[0089] After the raw material of montelukast sodium is micronized, the raw material of montelukast sodium is added to mannitol, so that the raw material of montelukast sodium is evenly adsorbed and dispersed in mannitol to form a mannitol complex, and then microcrystalline Cellulose PH101 (FMC), cherry flavor, aspartame, allure red aluminum color tablets, mix well. To make soft material, granulate with 24-mesh sieve, and dry at 40°C-60°C. After granulating with 24-mesh sieve, a...

Embodiment 3

[0090] Example 3 Montelukast Sodium Chewable Tablets

[0091] Montelukast Sodium 5.19mg

[0092] Microcrystalline Cellulose PH101 (FMC) 77mg

[0093] Mannitol 200mg

[0094] Croscarmellose Sodium 8.0mg

[0095] Magnesium stearate 3.5mg

[0096] Allure Red Aluminum Tablets 0.5mg

[0097] Aspartame 0.9mg

[0098] Cherry essence 1.2mg

[0099] Proper amount of hydroxypropyl cellulose

[0100] Appropriate amount of absolute ethanol

[0101] Preparation process (avoid light during the process):

[0102] After the raw material of montelukast sodium is micronized, the raw material of montelukast sodium is added to mannitol, so that the raw material of montelukast sodium is evenly adsorbed and dispersed in mannitol to form a mannitol-drug complex, and then added separately Microcrystalline cellulose PH101 (FMC), cherry flavor, aspartame, allure red aluminum color tablets, mix well. To make soft material, granulate with 24-mesh sieve, and dry at 40°C-60°C. After granulating...

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Abstract

The invention relates to a chewable tablet containing montelukast sodium and a preparation method of the chewable tablet. The chewable tablet consists of montelukast sodium and pharmaceutically acceptable adjuvants, and the chewable tablet is characterized in that a mannitol-pharmaceutical compound is formed from a montelukast sodium raw material which is micronized and from mannitol; and a microcrystalline cellulose source is optimized, so that the content of impurity sulfoxide and the content of total impurities are reduced, and moreover the preparation is good in dissolution consistency and uniformity in vitro and is greatly high in quality stability.

Description

technical field [0001] The invention belongs to the field of pharmaceutical preparations, and in particular relates to a stable montelukast sodium chewable tablet and a preparation method thereof. The preparation is suitable for the prevention and long-term treatment of asthma in children aged 2 to 14, including the prevention of daytime and nighttime asthma symptoms , treatment of aspirin-sensitive asthmatics and prevention of exercise-induced bronchoconstriction, relief of symptoms caused by allergic rhinitis. Background technique [0002] Asthma is one of the most common diseases in the world today, and it is also a world-recognized medical problem. It is listed by WHO as one of the four major persistent diseases. With the intensification of air pollution, the incidence of asthma is increasing year by year, which plagues nearly 10% of the population in developed countries, causing social and economic losses of tens of billions of dollars. In recent decades, the incidence...

Claims

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Application Information

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IPC IPC(8): A61K9/20A61K31/47A61K47/26A61K47/38A61P11/06A61P37/08A61P11/02A61P11/08
Inventor 谢晓燕董伦王雪敏
Owner 南京泽恒医药技术开发有限公司
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