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Agomelatine-containing orally disintegrating tablet

An oral disintegrating tablet and disintegration time technology, which is applied in the directions of medical preparations containing active ingredients, medical preparations without active ingredients, organic active ingredients, etc., can solve the problems of large differences, increased drug costs, and high equipment requirements

Inactive Publication Date: 2010-09-22
万全万特制药江苏有限公司
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

The implementation of this technology requires a complete and complex industrial method, and the equipment requirements are very high, resulting in a significant increase in the cost of the manufactured drug
[0005] Pharmacokinetic studies have shown that the bioavailability of agomelatine administered orally relative to the parenteral route is very low and varies considerably within the same individual and between individuals

Method used

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Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0014] Preparation prescription of orally disintegrating tablets:

[0015] components

percentage(%)

agomelatine

20

Mannitol

50

starch

15

Low-substituted hydroxypropyl cellulose (external)

10

Sucralose

2

Magnesium stearate

3

[0016] Preparation Process:

[0017] Weigh the prescribed amount of agomelatine, mannitol, and starch and mix well. Use starch slurry as a binder to make soft materials and granulate with 16 mesh. Blast-dried at 50°C, sieved with 24-mesh sieve. Add low-substituted hydroxypropyl cellulose, magnesium stearate and sucralose in the prescribed amount, mix well, and make Φ7mm shallow concave punched tablets.

Embodiment 2

3

[0021] Preparation Process:

[0022] Weigh the prescribed amount of Eudragit L100 and disperse it in 95% ethanol. After stirring evenly, slowly add the main drug agomelatine, and stir for inclusion for 15 minutes. Dry under reduced pressure to obtain clathrate. Weigh the prescribed amount of agomelatine inclusion compound and mannitol and mix evenly. Use starch slurry as a binder to make soft materials and granulate with 16 mesh. Blast-dried at 50°C, sieved with 24-mesh sieve. Add the prescribed amount of sodium carboxymethyl starch, magnesium stearate and stevioside, and mix well. Φ10mm tablet.

Embodiment 3

[0024] Preparation prescription of orally disintegrating tablets:

[0025] components

percentage

agomelatine

6

Eudragit E100

36

Mannitol

25

starch

15

Low-substituted hydroxypropyl cellulose

13

Sucralose

2

Magnesium stearate

3

[0026] Preparation Process:

[0027] Weigh the prescribed amount of EudragitE100 and disperse it in 95% ethanol. After stirring evenly, slowly add the main drug agomelatine, and stir for inclusion for 15 minutes. Dry under reduced pressure to obtain the inclusion compound, weigh the prescription amount of agomelatine inclusion compound, mannitol, starch

[0028] well mixed. Use starch slurry as a binder to make soft materials and granulate with 16 mesh. Blast-dried at 50°C, sieved with 24-mesh sieve. Add the prescribed amount of low-substituted hydroxypropyl cellulose, magnesium stearate, and sucralose, and mix well. Φ10mm tablet.

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PUM

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Abstract

The invention provides an agomelatine-containing orally disintegrating tablet, which is characterized in that the inclusion technology is adopted to prepare the agomelatine-containing orally disintegrating tablet. The invention effectively covers up the tingling of agomelatine, improves the dissolution of the agomelatine, and is suitable for industrial production.

Description

technical field [0001] The invention provides an orally disintegrating tablet containing agomelatine, which is prepared by inclusion of agomelatine, which can effectively solve the taste of the main drug and improve its dissolution rate. Background technique [0002] Agomelatine, N-[2-(7-methoxy-1-naphthyl)ethyl]acetamide is a selective agonist of melatoninergic system receptors. On the other hand, it is 5-HT 2c Antagonist of the receptor, which makes it active in the central nervous system. It is active in the treatment of major depression, seasonal depressive disorder, sleep disturbance, cardiovascular disease, digestive system disease, insomnia and fatigue due to jet lag, appetite disturbance and obesity. [0003] Orally disintegrating tablets have the advantage that they can rapidly increase the blood drug concentration of the drug, and at the same time avoid the rapid metabolism of the drug caused by the hepatic stress effect, and improve the bioavailability. Mouthfe...

Claims

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Application Information

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IPC IPC(8): A61K9/20A61K31/165A61K47/48A61K47/32A61P25/24A61P25/20A61P9/00A61P3/04A61P1/00A61K47/61
Inventor 任霞刘海丽郭夏
Owner 万全万特制药江苏有限公司
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