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Solid pharmaceutical composition containing agomelatine

A technology for compositions and medicines, applied in the directions of medicine combination, medicine delivery, medicine formulation, etc., can solve the problems of difficulty in transportation and packaging, low hardness, large differences, etc.

Inactive Publication Date: 2008-04-02
BEIJING D VENTUREPHARM TECH DEV
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0004] It is worth noting that the bioavailability of agomelatine administered by the oral route in humans is very low and varies considerably within the same body and between individuals
[0005] CN 1622804A discloses an orally disintegrating composition containing agomelatine, which mainly exists in the form of tablets and is prepared by direct compression. The hardness of the tablets is 20 Newtons, and the disintegration in the oral cavity is The disintegration time is less than 3 minutes. This orally disintegrating composition may improve the bioavailability of agomelatine in the human body, but the rapid disintegration in the oral cavity may lead to the rapid release of the bad taste of the drug, reducing the Patient adaptability, and to achieve rapid oral disintegration, the hardness of the tablet is generally low, which brings difficulties to transportation and packaging

Method used

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Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0033] Element

[0034] Mix agomelatine with poloxamer 188, calcium hydrogen phosphate, microcrystalline cellulose PH101, and crospovidone xl, mix well, add water to moisten, make soft material, granulate, dry, granulate, Add sucralose and magnesium stearate, and press into tablets.

Embodiment 2

[0036] Element

[0037] Mix agomelatine with poloxamer 188, calcium hydrogen phosphate, microcrystalline cellulose PH101, and crospovidone x1, mix well, add water to moisten, make soft material, granulate, dry, granulate, Add sucralose and magnesium stearate, and press into tablets.

Embodiment 3

[0039] Element

[0040] Mix agomelatine with poloxamer 188, calcium hydrogen phosphate, microcrystalline cellulose PH101, and crospovidone xl, mix well, add water to moisten, make soft material, granulate, dry, granulate, Add sucralose and magnesium stearate, and press into tablets.

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PUM

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Abstract

The present invention provides a solid medicine combination, which comprises ago cherating as an active ingredient; a non-ionic hydrophilic surfactant which can be accepted by pharmacy. In addition, the present invention is combined with one or a plurality of medicine excipients. The present invention is mainly used for curing depression.

Description

technical field [0001] The invention relates to a novel solid pharmaceutical composition, especially a pharmaceutical composition containing agomelatine. Background technique [0002] Agomelatine is a selective agonist of melatoninergic receptors on the one hand and an antagonist of 5-HT2C receptors on the other. It is active in the treatment of major depression, seasonal depressive disorder, sleep disorders, cardiovascular disease, digestive system disease, insomnia, fatigue due to jet lag, appetite disturbance and obesity. [0003] European patent EP 0447285 discloses agomelatine, its preparation method and its therapeutic effect. [0004] It is worth noting that the bioavailability of agomelatine administered orally in humans is very low and varies considerably within the same body and between different individuals. [0005] CN 1622804A discloses an orally disintegrating composition containing agomelatine, which mainly exists in the form of tablets and is prepared by di...

Claims

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Application Information

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IPC IPC(8): A61K9/00A61K9/20A61K31/165A61K47/34A61P25/24A61K47/10A61K47/38
Inventor 莫良侃
Owner BEIJING D VENTUREPHARM TECH DEV
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