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a composition

A composition and benzoic acid technology, applied in the field of medicine, can solve the problems of slow tablet disintegration, increased tablet substance, poor solubility, etc., and achieve the effects of solving low dissolution rate, improving fluidity, and solving poor fluidity

Active Publication Date: 2017-09-12
DISHA PHARMA GRP
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0003] Alogliptin benzoate is a slightly soluble drug with poor solubility and viscosity, so there are the following problems in the preparation process of the tablet: (1) the disintegration rate of the tablet is slow and the dissolution rate is low; sticky punch
At the same time, the tablet prepared by the conventional wet granulation process has the problem of the increase of related substances during storage.

Method used

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Embodiment 1

[0020] Embodiment 1, prescription: alogliptin benzoate 34g, silicon dioxide 12g, mannitol 30g, microcrystalline cellulose 62.5g, croscarmellose sodium 6g, hydroxypropyl cellulose 4g, stearic acid Magnesium 1.5g. Prepare 1000 tablets according to the preparation method described in the technical scheme, and coat the plain tablets with 10% Opadry 50% ethanol solution.

Embodiment 2

[0021] Embodiment 2, prescription: alogliptin benzoate 34g, silicon dioxide 2g, mannitol 77.5g, microcrystalline cellulose 25g, croscarmellose sodium 6g, hydroxypropyl cellulose 4g, stearic acid Magnesium 1.5g. Prepare 1000 tablets according to the preparation method described in the technical scheme, and coat the plain tablets with 10% Opadry 50% ethanol solution.

Embodiment 3

[0022] Embodiment 3, prescription: alogliptin benzoate 34g, silicon dioxide 6g, mannitol 50g, microcrystalline cellulose 48.5g, croscarmellose sodium 6g, hydroxypropyl cellulose 4g, stearic acid Magnesium 1.5g. Prepare 1000 tablets according to the preparation method described in the technical scheme, and coat the plain tablets with 10% Opadry 50% ethanol solution.

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Abstract

The invention relates to a tablet composition containing alogliptin benzoate. It is characterized in that every 1000 tablets contain alogliptin benzoate 34g, silicon dioxide 2-12g, mannitol 30-77.5g, microcrystalline cellulose 25-62.5g, croscarmellose sodium 6g, hydroxyl Propylene cellulose 4g, magnesium stearate 1.5g, Opadry coating powder appropriate amount. Through reasonable compatibility, the present invention adopts the direct compression process, which simplifies the production process, shortens the production time, improves the production efficiency and improves the product stability compared with the traditional wet granulation process.

Description

[0001] Technical field: the present invention relates to a preparation composition containing alogliptin benzoate, which belongs to the technical field of medicine. Background of the invention: [0002] Alogliptin benzoate (Alogliptin benzoate) is a serine protease dipeptidyl peptidase IV (DPP-IV) inhibitor developed by Japan's Takeda Company, which can maintain glucagon-like peptide 1 (GLP-1) and glucose dependence in the body. Insulin-promoting polypeptide (GIP) level can promote the secretion of insulin, thereby exerting the hypoglycemic effect. In April 2010, it was approved by the Ministry of Health, Labor and Welfare of Japan. [0003] Alogliptin benzoate is a slightly soluble drug with poor solubility and viscosity, so there are the following problems in the preparation process of the tablet: (1) the disintegration rate of the tablet is slow and the dissolution rate is low; When sticky punch. At the same time, the tablet prepared by the conventional wet granulation pr...

Claims

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Application Information

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Patent Type & Authority Patents(China)
IPC IPC(8): A61K9/36A61K47/38A61K31/513A61P3/10
Inventor 连艳菊许蕾龙连清
Owner DISHA PHARMA GRP
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