Preparation method of orally disintegrating tablet containing vortioxetine hydrobromide

A technology of vortioxetine hydrobromide and hydrobromic acid, applied in the field of medicine

Inactive Publication Date: 2019-04-09
万全万特制药(厦门)有限公司
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

The method can improve the mouthfeel of vortioxetine hydrobromide orally disintegrating tablets, and overcome problems such as the unbearable bitterness and numbness brought by raw materials or the excessive intake of carbohydrates caused by the application of too much sweetener for flavoring. At the same time, the orally disintegrating tablet is endowed with a fast disintegration time limit, providing patients with a vortioxetine hydrobromide orally disintegrating tablet with fast absorption, high bioavailability, low side effects, and convenient administration

Method used

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  • Preparation method of orally disintegrating tablet containing vortioxetine hydrobromide
  • Preparation method of orally disintegrating tablet containing vortioxetine hydrobromide
  • Preparation method of orally disintegrating tablet containing vortioxetine hydrobromide

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Experimental program
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Effect test

Embodiment 1

[0020]

[0021] Preparation Process:

[0022] Sift and mix the silicon dioxide and the raw material drug at a ratio of 1:10 to obtain a premixed compound; then, pass the filler, disintegrating agent, and flavoring agent through an 80-mesh sieve for use; secondly, take the premixed compound , fillers, and disintegrants passed through a 60-mesh sieve and mixed evenly, then added a 10% Eudragit NE30D water dispersion, stirred evenly to obtain a soft material, granulated and dried to obtain granules; finally, the dried granules Mix evenly with flavoring agent and lubricant, and press into tablets.

Embodiment 2

[0024]

[0025] Preparation Process:

[0026] Sift and mix the silicon dioxide and the raw material drug at a ratio of 1:10 to obtain a premixed compound; then, pass the filler, disintegrating agent, and flavoring agent through an 80-mesh sieve for use; secondly, take the premixed compound , fillers, and disintegrants passed through a 60-mesh sieve and mixed evenly, then added a 20% Eudragit NE30D aqueous dispersion, stirred evenly to obtain soft materials, granulated and dried to obtain granules; finally, the dried granules Mix evenly with flavoring agent and lubricant, and press into tablets.

Embodiment 3

[0028]

[0029] Preparation Process:

[0030] Sift and mix the silicon dioxide and the raw material drug at a ratio of 1:1 to obtain a premixed compound; then, pass the filler, disintegrating agent, and flavoring agent through an 80-mesh sieve for later use; secondly, take the premixed compound , fillers, and disintegrants passed through a 60-mesh sieve and mixed evenly, then added a 10% Eudragit NE30D water dispersion, stirred evenly to obtain a soft material, granulated and dried to obtain granules; finally, the dried granules Mix evenly with flavoring agent and lubricant, and press into tablets.

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PUM

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Abstract

The invention provides a preparation method of an orally disintegrating tablet containing vortioxetine hydrobromide. The method comprises the steps of performing combined taste masking on vortioxetinehydrobromide by silicon dioxide and Eudragit NE30D, and then performing wet granulation to form the orally disintegrating tablet. The application of the method aims at improving the taste of the orally disintegrating tablet, overcoming the problem of unbearable bitter and numb feeling caused by crude drugs or intake of an excess of carbohydrate caused by application of an excess of sweetening agents for taste modifying, meanwhile endowing rapid disintegration time to the orally disintegrating tablet, and providing the orally disintegrating tablet containing vortioxetine hydrobromide which isfast to absorb, high in bioavailability, low in side effect and convenient to take for patients.

Description

technical field [0001] The application belongs to the technical field of medicine, in particular to a preparation method of an orally disintegrating tablet containing vortioxetine hydrobromide. Background technique [0002] Depression is a mental illness with high prevalence, high relapse rate, high disease burden rate and high suicide rate, which will affect people's mental and physical health. It affects about 154 million people worldwide. At present, the prevalence rate of depression in my country is 1.6%, and the lifetime prevalence rate is 3.3%. The lifetime prevalence rate of depression in American men is 5-12%. It is as high as 10-25%. Depression patients spread across all age groups, with various clinical manifestations, mainly manifested as depressed mood, slow thinking, decreased speech and movement, decreased volitional activity and physical symptoms. Depression has become an increasingly serious public health problem. [0003] The pathogenesis of depression is s...

Claims

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Application Information

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IPC IPC(8): A61K9/20A61K31/495A61K47/04A61P25/24
CPCA61K9/0056A61K9/2009A61K9/2031A61K31/495
Inventor 张迪马莉
Owner 万全万特制药(厦门)有限公司
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