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Agomelatine orally disintegrating tablet

An orally disintegrating tablet and hot-melt extrusion technology, which is applied in the field of medicine, can solve the problems of low decompression drying efficiency, cumbersome process, and difficulty in realizing industrial production, and achieve the effects of good taste, simple preparation method, and stable quality

Active Publication Date: 2014-05-28
ZHEJIANG HUAHAI PHARMA CO LTD
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

The process is relatively cumbersome, and in industrial production, the efficiency of vacuum drying is low, and it is difficult to realize industrial production

Method used

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  • Agomelatine orally disintegrating tablet
  • Agomelatine orally disintegrating tablet
  • Agomelatine orally disintegrating tablet

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1-3

[0022] The present invention will be further described in detail below in conjunction with the examples, but not limited to the following examples.

[0023]

[0024] Process: Mix the materials in Comparative Example 1 and Examples 1 to 3 according to the above ratio, and extrude them with a Thermo Process II twin-screw hot-melt extruder to obtain extrudates, and extrude them by mechanical Crusher for crushing.

[0025] In the comparative example, during the pulverization process, the pulverized material is easy to agglomerate and sticky, which makes the pulverization process extremely difficult. And in embodiment 1~3, owing to adding antisticking agent in the prescription, the material after pulverizing is not sticky.

Embodiment 4-5

[0027] The mouthfeel, disintegration, dissolution and other indicators of orally disintegrating tablets prepared without hot-melt technology and hot-melt extrusion technology were compared.

[0028] The prescription is as follows:

[0029]

[0030]

[0031] The preparation process of agomelatine orally disintegrating tablets is as follows:

Embodiment 4、5

[0033] Embodiment 4, 5: using the extrudate prepared in Example 2, according to the above ratio, the crushed extrudate was mixed with mannitol, lactose, crospovidone, sodium carboxymethyl starch, sucralose, Magnesium stearate etc. are mixed and compressed into tablets.

[0034] Test results: examine the mouthfeel and disintegration time.

[0035]

[0036] Test conclusion: After using the extrusion process, the excipients can cover up the irritation of the drug. And in the dissolution medium, the drug can dissolve rapidly. However, if the medicine has not been processed by the extrusion process, it is difficult to cover up the stimulation of the medicine only by adding flavoring agents.

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PUM

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Abstract

The invention provides an agomelatine orally disintegrating tablet. According to the agomelatine orally disintegrating tablet, agomelatine and a carrier are subjected to hot melting and extrusion to obtain an agomelatine extrudate and the extrudate is further prepared into the orally disintegrating tablet. The orally disintegrating tablet is good in taste and controllable in quality.

Description

technical field [0001] The invention belongs to the technical field of medicine, and in particular relates to an orally disintegrating agomelatine tablet and a preparation method thereof. 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] Orally disintegrating tablets are more convenient to take than ordinary tablets, but agomelatine itself has a certain irritation, which is difficult to mask with conventional taste-masking techniques. Therefore, no orally disintegrating tablets of agomelatine are currently on the market. Commonly used taste-masking techniques include: adding flavoring agents...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K9/20A61K31/165A61K47/32A61K47/10A61K47/04A61P25/24
Inventor 彭俊清黄丹曹宇
Owner ZHEJIANG HUAHAI PHARMA CO LTD