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Vortioxetine orally disintegrating tablets and preparation method thereof

A technology of vortioxetine and oxetine, which can be used in pharmaceutical formulations, pill delivery, nervous system diseases, etc., and can solve the problems of drug bitterness and low drug dissolution rate.

Inactive Publication Date: 2016-12-07
佛山市弘泰药物研发有限公司
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0008] Aiming at the deficiencies of the prior art, the present invention provides a vortioxetine orally disintegrating tablet and a preparation method thereof. Through innovative selection of excipients, optimized ratio of excipients and innovative preparation process, the low drug dissolution and bitterness of the drug are successfully solved. Sensation and other issues

Method used

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Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0044] Embodiment 1, a kind of preparation method of vortioxetine orally disintegrating tablet

[0045] 1. A vortioxetine orally disintegrating tablet, made of the following raw materials in parts by mass:

[0046] Vortioxetine

5 copies

fatty acid glycerides

10 copies

Tween 80

5 copies

white sugar

905 copies

Crospovidone

2 copies

Mannitol

10 copies

essence

0.01 part

Magnesium stearate

0.2 parts

Micropowder silica gel

0.2 parts

[0047] 2. The preparation method is as follows:

[0048] (1) Pulverize vortioxetine, pass through a 150-mesh sieve, and obtain an average particle size of 28-32 μm, and set aside;

[0049] (2) Pulverize the white sugar and polyvinylpolypyrrolidone of proportioning amount, cross 110 mesh sieves, and set aside;

[0050](3) Melt fatty acid glycerides at 60-80°C, add the proportioning amount of Tween 80 and mix well, weigh the proportioning amount of...

Embodiment 2

[0054] Embodiment 2, a kind of preparation method of vortioxetine orally disintegrating tablet

[0055] 1. A vortioxetine orally disintegrating tablet, made of the following raw materials in parts by mass:

[0056] Vortioxetine

10 copies

fatty acid glycerides

25 copies

Tween 80

8 servings

white sugar

2000 copies

Crospovidone

4 parts

Mannitol

25 copies

essence

0.04 parts

Magnesium stearate

0.4 parts

Micropowder silica gel

0.4 parts

[0057] 2. The preparation method is as follows:

[0058] (1) Grinding the vortioxetine, passing through a 160-mesh sieve, to obtain particles with an average particle size of 21-24 μm, and set aside;

[0059] (2) Pulverize white sugar and polyvinylpolypyrrolidone of proportioning amount, cross 100 mesh sieves, and set aside;

[0060] (3) Melt fatty acid glycerides at 60-80°C, add the proportioning amount of Tween 80 and mix well, weigh the pr...

Embodiment 3

[0064] Embodiment 3, a kind of preparation method of vortioxetine orally disintegrating tablet

[0065] 1. A vortioxetine orally disintegrating tablet, made of the following raw materials in parts by mass:

[0066] Vortioxetine

15 copies

fatty acid glycerides

30 copies

Tween 80

5 copies

white sugar

1000 copies

Crospovidone

3 copies

Mannitol

10 copies

essence

0.01 part

Magnesium stearate

0.2 parts

Micropowder silica gel

0.3 parts

[0067] 2. The preparation method is as follows:

[0068] (1) Grinding the vortioxetine, passing through a 155-mesh sieve to obtain particles with an average particle size of 24-28 μm, for subsequent use;

[0069] (2) Pulverize the white sugar and polyvinylpolypyrrolidone of proportioning amount, cross 120 mesh sieves, and set aside;

[0070] (3) Melt fatty acid glycerides at 60-80°C, add the proportioning amount of Tween 80 and mix well, weigh ...

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Abstract

The invention discloses vortioxetine orally disintegrating tablets and a preparation method thereof. The orally disintegrating tablets are prepared from, by mass, 5-30 parts of vortioxetine, 10-30 parts of fatty glyceride, 5-10 parts of Tween 80, 900-2,700 parts of white sugar, 2-5 parts of polyvinylpolypyrrolidone, 10-30 parts of mannitol, 0.01-0.05 part of essence, 0.2-0.5 part of magnesium stearate and 0.2-0.5 part of superfine silica powder. Vortioxetine serves as an effective medicine ingredient, and the orally disintegrating tablets are prepared through a creative process. The prepared vortioxetine orally disintegrating tablets successfully solve the problems that the medicine dissolution rate is low, and medicine is bitter and astringent, and have a good effect on functional dyspepsia.

Description

technical field [0001] The invention relates to a medicine for treating adult major depressive disorder (MDD), in particular to a vortioxetine orally disintegrating tablet and a preparation method thereof, belonging to the technical field of medicine. Background technique [0002] Vortioxetine (VORTIOXETINE, BRINTELLIX™) was approved by the FDA in September 2013 for the treatment of major depressive disorder (MDD) in adults. In October of the same year, the Human Medicines Committee (CHMP) under the European Medicines Agency (EMA) recommended that Vortioxetine be used for the treatment of major depression and issue European marketing authorization. The drug will be available in December, but is scheduled to be officially launched in January 2014. [0003] 【Market Situation Analysis】 [0004] The best-selling drugs in China’s antidepressant market are mainly dominated by imported joint venture drugs. Sino-US SmithKline’s paroxetine accounts for 84.20% of this type of drug m...

Claims

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Application Information

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IPC IPC(8): A61K9/20A61K31/495A61P25/24
CPCA61K31/495A61K9/0056A61K9/2027
Inventor 雷林芳
Owner 佛山市弘泰药物研发有限公司
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