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Agomelatine solid preparation

A technology of solid preparation and solid dispersion, which is applied in the directions of pill delivery, medical preparations without active ingredients, and medical preparations containing active ingredients, etc. The effect of stable, good in vitro dissolution performance

Active Publication Date: 2012-09-19
ZHEJIANG HUAHAI PHARMACEUTICAL CO LTD
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

However, the micronization of drugs requires special airflow pulverization equipment, which is cumbersome in production and requires quality control of drug particle size, which reduces production efficiency.

Method used

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  • Agomelatine solid preparation
  • Agomelatine solid preparation
  • Agomelatine solid preparation

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0033] Preparation of agomelatine solid dispersion:

[0034] 10 g of agomelatine and 5 g of povidone (model Kollidon 12PF) were weighed and mixed evenly, then added to a hot-melt extruder, and the temperature of the extruder was set at 100° C.

Embodiment 2

[0036] Preparation of agomelatine solid dispersion:

[0037] 10 g of agomelatine and 5 g of copovidone (model Kollidon VA64) were weighed and mixed uniformly before being added to a hot-melt extruder, and the temperature of the extruder was set at 130° C.

Embodiment 3

[0039] Preparation of agomelatine solid dispersion:

[0040] Weigh 10 g of agomelatine and 10 g of povidone (type Kollidon 30) and mix them evenly before adding them into a hot-melt extruder, and the temperature of the extruder is set at 160° C.

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Abstract

The invention provides an agomelatine solid preparation. Agomelatine and a carrier are subjected to hot melt extrusion to form solid dispersoid of agomelatine, and the solid dispersoid of agomelatine can be further prepared into the solid preparation. A product can be dissolved out well and is controllable in quality.

Description

technical field [0001] The invention relates to the field of pharmaceutical preparations, in particular to agomelatine solid dispersion, a preparation method and a preparation containing the solid dispersion. Background technique [0002] Agomelatine tablets (agomelatine tablets) are developed by the French company Servier, the specification is 25mg, and its trade name is Weixin. It is mainly used for the treatment of adult depression. It was approved for marketing by the European Union in February 2009. It is the world's first melatonin receptor agonist antidepressant. Its molecular structural formula is as follows: [0003] [0004] The solubility of agomelatine is poor, it is almost insoluble in hydrochloric acid solution of pH=1.0, acetate buffer solution of pH=4.5, phosphate buffer solution of pH=6.8 and water, so it needs to be used in the preparation process. Improve its dissolution rate to enhance its bioavailability. [0005] Drugs with poor solubility have b...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K9/14A61K9/20A61K9/48A61K31/165A61K47/32A61K47/34A61P25/24
Inventor 彭俊清代孔恩葛光华胡李斌李巧霞
Owner ZHEJIANG HUAHAI PHARMACEUTICAL CO LTD
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