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Orodispersible pharmaceutical composition for oromucosal or sublingual administration of agomelatine

A composition and drug technology, applied in the directions of drug combination, drug delivery, sugar-coated pills, etc., can solve the problems of unresearched pharmacological properties, etc., and achieve the effect of good acceptability

Inactive Publication Date: 2007-06-20
LES LAB SERVIER
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0014] However, these various methods have disadvantages
Indeed, the use of local anesthetics or molecules capable of interacting with receptors involved in the sensation of stimulation is not satisfactory because these compounds have intrinsic pharmacological properties that have not been studied

Method used

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  • Orodispersible pharmaceutical composition for oromucosal or sublingual administration of agomelatine

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0054] Formulation: 320mg prepared tablet

[0055] components

Embodiment 2

[0057] Formulation: 350mg prepared tablet

[0058] components

Quantity (mg)

central nucleus

agomelatine

Starlac 

Magnesium stearate

coating

Powdered Anhydrous Citric Acid

Starlac 

Aspartame

acesulfame potassium

Magnesium stearate

1

48.75

0.25

10

282

3

3

2

[0059] The central core was made by mixing the components followed by direct compression. The cores of Examples 1 and 2 had a hardness of about 15 Newtons and a brittleness of less than 1%. The components of the coating layer are mixed and the coating is carried out by compression of the obtained powder mixture around the core.

[0060] The coated tablets of Examples 1 and 2 had a target hardness of 40 Newtons and a friability of about 1%. The in vitro disintegration time is less than 3 minutes (European Pharmacopoeia).

Embodiment 3

[0062] Formulation: 320mg prepared tablet

[0063] components

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PUM

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Abstract

The invention relates to a coated solid orodispersible pharmaceutical composition for oral, oromucosal or sublingual administration of agomelatine.

Description

technical field [0001] The present invention relates to novel coated solid orodispersible pharmaceutical dosage forms of agomelatine for administration by oral, oromucosal or sublingual routes. Background technique [0002] Agomelatine or N-[2-(7-methoxy-1-naphthyl)ethyl]acetamide of formula (I): [0003] [0004] As well as its hydrates, crystalline forms and pharmaceutically acceptable acid or base addition salts have valuable pharmacological properties: it is a selective agonist for receptors of the melatoninergic system, on the other hand it is a 5- HT 2C Antagonist of the receptor, which makes it active in the central nervous system. These properties provide it with activity in the central nervous system, especially in the treatment of major depression, seasonal affective disorder, sleep disturbances, cardiovascular diseases, digestive disorders, insomnia and fatigue due to jet lag, appetite disorders and obesity active in. [0005] Agomelatine, its preparation a...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K31/165A61K9/16A61K9/28A61P25/24A61P25/20A61P9/00A61P1/00A61P3/04
CPCA61K31/165A61K9/286A61K9/2826A61K9/0056A61P1/00A61P1/14A61P17/00A61P25/00A61P25/02A61P25/18A61P25/20A61P25/22A61P25/24A61P3/00A61P3/04A61P43/00A61P9/00A61P9/10A61K9/28
Inventor M·朱利安F·塔罗特J-M·佩昂P·武特里希
Owner LES LAB SERVIER
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