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Orally disintegrating tablet containing vilazodone hydrochloride solid dispersions and preparation method thereof

A technology of vilazodone hydrochloride and solid dispersion, which is applied in the field of pharmaceutical preparations, can solve the problems of poor dissolution and low solubility of preparations, and achieve the effect of improving dissolution and drug solubility

Inactive Publication Date: 2017-04-26
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

Although vilazodone hydrochloride has strong drug efficacy, its solubility is extremely low under physiological pH conditions, and the in vitro dissolution rate of the preparation is poor

Method used

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  • Orally disintegrating tablet containing vilazodone hydrochloride solid dispersions and preparation method thereof
  • Orally disintegrating tablet containing vilazodone hydrochloride solid dispersions and preparation method thereof
  • Orally disintegrating tablet containing vilazodone hydrochloride solid dispersions and preparation method thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0021] Vilazodone hydrochloride orally disintegrating tablets are prepared from the following components, in the amount of 1000 tablets

[0022]

[0023] Its preparation method comprises the following steps:

[0024] (1) Take vilazodone hydrochloride, dissolve it in 10 times the weight of ethanol solution, add the prescribed amount of PEG6000, stir to dissolve into a clear and transparent solution, and remove the solvent by rotary evaporation to obtain a solid dispersion.

[0025] (2) The obtained solid dispersion is pretreated through a 60-mesh sieve.

[0026] (3) Uniformly mix the pretreated vilazodone hydrochloride solid dispersion with the prescribed amount of lactose, microcrystalline cellulose, and internally added croscarmellose sodium, then dry granulate, add externally added croscarmellose Sodium cellulose, magnesium stearate and acesulfame K are evenly mixed and compressed into tablets.

[0027] test results:

[0028] The disintegration time is 25s, compared wi...

Embodiment 2

[0030] Vilazodone hydrochloride orally disintegrating tablets are prepared from the following components, in the amount of 1000 tablets

[0031]

[0032] Its preparation method comprises the following steps:

[0033] (1) Take vilazodone hydrochloride, dissolve it in 50 times the weight of ethanol solution, add the prescribed amount of PVPK-30, stir to dissolve it into a clear and transparent solution, and remove the solvent by rotary evaporation to obtain a solid dispersion.

[0034] (2) The obtained solid dispersion is pretreated through a 120-mesh sieve.

[0035] (3) Uniformly mix the pretreated vilazodone hydrochloride solid dispersion with the prescribed amount of mannitol, microcrystalline cellulose, and internally added low-substituted hydroxypropyl cellulose, then dry granulate, add externally added low-substituted hydroxypropyl cellulose Base cellulose, magnesium stearate and aspartame are evenly mixed and compressed into tablets.

[0036] test results:

[0037] ...

Embodiment 3

[0039] Vilazodone hydrochloride orally disintegrating tablets are prepared from the following components, in the amount of 1000 tablets

[0040]

[0041] Its preparation method comprises the following steps:

[0042] (1) Take vilazodone hydrochloride, dissolve it in 25 times the weight of ethanol solution, add the prescribed amount of PVPK-90, stir to dissolve into a clear and transparent solution, and remove the solvent by rotary evaporation to obtain a solid dispersion.

[0043] (2) The obtained solid dispersion is pretreated through a 120-mesh sieve.

[0044] (3) Uniformly mix the pretreated vilazodone hydrochloride solid dispersion with the prescribed amount of mannitol, pregelatinized starch, and internally added crospovidone, then dry granulate, add externally added low-substituted hydroxypropyl fiber Sodium stearyl fumarate and sucralose were evenly mixed and compressed into tablets.

[0045] test results:

[0046] The disintegration time is 23s, compared with the...

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Abstract

The invention belongs to the field of a medicine preparation, and particularly relates to an orally disintegrating tablet containing vilazodone hydrochloride solid dispersions and a preparation method thereof. By aiming at the problems of poor water solubility and low preparation dissolubility of the vilazodone hydrochloride, the vilazodone hydrochloride and carriers are prepared into the solid dispersions for improving the solubility. The solid dispersions are used for preparing the orally disintegrating tablet; the orally disintegrating tablet can fast disintegrate in 30s; and the main medicine dissolubility is obviously improved.

Description

technical field [0001] This application belongs to the technical field of pharmaceutical preparations. Background technique [0002] Vilazodone hydrochloride is the first new-generation indolealkylamine antidepressant developed by Trovis Pharmaceuticals Co., Ltd., which was approved by the FDA on January 21, 2011, for the treatment of major depressive disorder (Major depressivedisorder, MDD). Major depressive disorder, also known as clinical depression, major depressive disorder, unipolar depression, or unipolar disorder, is a psychiatric disorder characterized by a preoccupation with a depressive affective state, low self-esteem, and Loss of interest in activities that are fun. Major depressive disorder is a disabling condition that negatively affects family, work, school, daily eating and sleeping, and other bodily functions. In the United States, approximately 3.4% of people with depression commit suicide. Perhaps 60 percent of all suicides suffer from major depressiv...

Claims

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Application Information

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IPC IPC(8): A61K9/20A61K47/38A61K47/26A61K47/10A61K31/496A61P25/24
CPCA61K9/0056A61K9/2018A61K9/2031A61K9/2054A61K31/496
Inventor 李春马莉
Owner 万全万特制药(厦门)有限公司
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