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Crystalline form iv of agomelatine, a process for its preparation and pharmaceutical compositions containing it

A technology of composition and crystal form, applied in the field of new crystal form IV of N-[2-ethyl]acetamide, can solve problems such as no specific description

Inactive Publication Date: 2007-02-07
SERVIER LAB
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

However, the document does not specify the conditions under which agomelatine exhibiting these properties can be obtained in a reproducible manner

Method used

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  • Crystalline form iv of agomelatine, a process for its preparation and pharmaceutical compositions containing it
  • Crystalline form iv of agomelatine, a process for its preparation and pharmaceutical compositions containing it

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0018] Example 1: Form IV of N-[2-(7-methoxy-1-naphthyl)ethyl]acetamide

[0019] 2θ angle (°)

Embodiment 2

[0020] Embodiment 2: pharmaceutical composition

[0021] Prepare a prescription for 1000 tablets, each containing a 25mg dose:

[0022] The compound of Example 1……………………………… 25g

[0023] Lactose monohydrate…………………………………………… 62g

[0024] Magnesium stearate…………………………………………… 1.3g

[0025] Corn starch…………………………………………………………… 26g

[0026] Maltodextrin mixture……………………………………9g

[0027] Anhydrous colloidal silicon dioxide……………………………………… 0.3g

[0028] Sodium Starch Glycolate Type A………………………………… 4g

[0029] Stearic acid……………………………………………………… 2.6g

Embodiment 3

[0030] Embodiment 3: pharmaceutical composition

[0031] Prepare a prescription for 1000 tablets, each containing a 25mg dose:

[0032] The compound of Example 1……………………………… 25g

[0033] Lactose monohydrate…………………………………………… 62g

[0034] Magnesium stearate…………………………………………… 1.3g

[0035] Povidone……………………………………………………9g

[0036] Anhydrous colloidal silicon dioxide……………………………………… 0.3g

[0037] Sodium carboxymethylcellulose………………………………………………………………………………………………………30g

[0038] Stearic acid …………………………………………………… 2.6g.

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PUM

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Abstract

The crystalline form IV of a compound of formula (I) is characterised by the X diffraction diagram thereof on a powder.

Description

technical field [0001] The present invention relates to agomelatine or a new crystal form IV of N-[2-(7-methoxy-1-naphthyl)ethyl]acetamide of formula (I): [0002] [0003] Its preparation method and pharmaceutical composition containing it. Background technique [0004] Agomelatine, or N-[2-(7-methoxy-1-naphthyl)ethyl]acetamide, has valuable pharmacological properties. [0005] It does have a dual profile, on the one hand, it is an agonist of receptors of the melatonergic system, on the other hand, it is a 5-HT 2C receptor antagonists. These properties make it active in the central nervous system, more particularly in severe depression, seasonal affective disorder, sleep disturbances, cardiovascular diseases, digestive disorders, insomnia and fatigue due to jet lag, appetite disturbances active in the treatment of obesity. [0006] Agomelatine, its preparation and its therapeutic use are described in European patent specification EP 0 447 285 . [0007] In view of t...

Claims

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Application Information

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IPC IPC(8): C07C233/18A61K31/165A61P25/00A61P25/24A61P25/18A61P9/00A61P1/00A61P25/20A61P3/04C07C217/60C07C233/22C07C233/60C07C233/73
CPCC07C233/18C07C231/24C07C2102/10C07C2602/10A61P1/00A61P15/00A61P15/08A61P15/10A61P25/00A61P25/06A61P25/08A61P25/16A61P25/18A61P25/20A61P25/22A61P25/24A61P25/28A61P3/00A61P3/10A61P35/00A61P3/04A61P37/00A61P37/02A61P43/00A61P9/00
Inventor G·科克雷尔J·里诺尔J-C·苏维
Owner SERVIER LAB
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