Composition

A composition and technology of benzoic acid, applied in the field of medicine, can solve the problems of slow tablet disintegration speed, increase of tablet substance, and low dissolution rate, and achieve low dissolution rate, improved fluidity, and small particle size. Effect

Active Publication Date: 2014-03-05
DISHA PHARMA GRP
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

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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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  • Composition

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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 an alogliptin benzoate tablet composition. The alogliptin benzoate tablet composition is characterized by comprising 34 g of alogliptin benzoate, 2 to 12 g of silicon dioxide, 30 to 77.5 g of mannitol, 25 to 62.5 g of microcrystalline cellulose, 6 g of cross-linked sodium carboxymethyl cellulose, 4 g of hydroxypropylcellulose, 1.5 g of magnesium stearate and a suitable amount of opadry coating powder in every 1,000 tablets. Through reasonable compatibility and by the adoption of a direct pressing process, the production process is simplified, the production time is shortened, the production efficiency is improved and the product stability is improved compared with the conventional 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; Time 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 Applications(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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