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Medical composition containing vilazodone and preparation method thereof

A technology of vilazodone and composition, which is applied in the direction of drug combination, medical preparations containing active ingredients, pharmaceutical formulas, etc. It can solve the problem of high melting point of vilazodone, unsuitability of vilazodone, and difficult removal, etc. problems, to achieve good reproducibility, reduce energy consumption, and reduce pollution

Inactive Publication Date: 2013-07-24
BEIJING VENTUREPHARM BIOTECH
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

Due to the high melting point of vilazodone and the complete removal of a large amount of organic solvents in industrial production is difficult to achieve, the two commonly used separation methods for the preparation of solid dispersions are not suitable for vilazodone

Method used

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Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0020] Vilazodone Hydrochloride 10% lactose 50% microcrystalline cellulose 39% Colloidal silica 0.5% Magnesium stearate 0.5%

[0021] Preparation Process:

[0022] The vilazodone hydrochloride, lactose, and microcrystalline cellulose passed through an 80-mesh sieve are uniformly mixed, and then colloidal silicon dioxide and magnesium stearate are added and mixed to form tablets with a weight of about 200 mg.

Embodiment 2

[0024] Vilazodone Hydrochloride 10% PEG6000 10% lactose 40% microcrystalline cellulose 39% Colloidal silica 0.5% Magnesium stearate 0.5%

[0025] Preparation Process:

[0026] Put PEG6000 in a 70°C water bath and heat to melt. Add the virazole hydrochloride dissolved in ethanol into the melted PEG6000, and mix well. Then the mixture was rapidly cooled with liquid nitrogen into a solid, and then transferred to a vacuum freeze dryer, and the solid dispersion was taken out after 24 h. The obtained solid dispersion is properly pulverized, added with lactose, MCC, colloidal silicon dioxide and magnesium stearate, mixed evenly, and then pressed into tablets, with a tablet weight of about 200 mg.

Embodiment 3

[0028] Vilazodone Hydrochloride 10% PEG6000 50% lactose 15% microcrystalline cellulose 24% Colloidal silica 0.5% Magnesium stearate 0.5%

[0029] Preparation Process:

[0030] Put PEG6000 in a 70°C water bath and heat to melt. Add the virazole hydrochloride dissolved in ethanol into the melted PEG6000, and mix well. Then the mixture was rapidly cooled with liquid nitrogen into a solid, and then transferred to a vacuum freeze dryer, and the solid dispersion was taken out after 24 h. The obtained solid dispersion is properly pulverized, added with lactose, MCC, colloidal silicon dioxide and magnesium stearate, mixed evenly, and then pressed into tablets, with a tablet weight of about 200 mg.

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PUM

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Abstract

The invention belongs to the technical field of medicines, and in particular relates to a medical composition which is high in stability, digestion and absorption and a preparation method thereof. The medical composition contains vilazodone or officinal salt of vilazodone and a solid matrix.

Description

technical field [0001] The invention belongs to the technical field of medicine, in particular to the field of solid dispersion and its preparation, in particular to a pharmaceutical composition containing a poorly water-soluble drug vilazodone or a pharmaceutically acceptable salt thereof and a solid matrix and a preparation method thereof. Background technique [0002] Vilazodone is a new antidepressant for the treatment of major depressive disorder in adults. Due to its poor solubility, vilazodone can easily lead to incomplete absorption and poor bioavailability after oral administration. Therefore preparing solid preparations such as tablets, capsules, granules, and powders of vilazodone should firstly solve the problem of low dissolution of the preparation. [0003] At present, in the practice of pharmaceutical production, most of the measures for insoluble drugs focus on improving the solubility and dissolution rate of the drug. The widely used method is drug microniz...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K9/00A61K9/16A61K9/20A61K9/48A61K31/496A61K47/34A61P25/24
Inventor 王齐齐黄雪任广智孟旻
Owner BEIJING VENTUREPHARM BIOTECH
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