Vortioxetine pharmaceutical composition and preparation method thereof

A technology of vortioxetine hydrobromide and its composition, which is applied in the field of vortioxetine hydrobromide pharmaceutical composition and its preparation, can solve the problems of extremely high requirements for production equipment, high cost, and difficult industrialization implementation, etc. Achieve high bioavailability, no allergic reaction, and stable product quality

Inactive Publication Date: 2015-05-27
TIANJIN HANKANG PHARMA BIOTECH
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0014] The vortioxetine hydrobromide pharmaceutical composition produced by the prior art has extremely high requirements on production equipment, most of which are imported from abroad, and the cost is high, so it is not easy to implement the project in industrialization

Method used

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  • Vortioxetine pharmaceutical composition and preparation method thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0051] Every 1000 described vortioxetine hydrobromide pharmaceutical compositions, its formula consists of:

[0052] Vortioxetine Hydrobromide 5g

[0053] Beta Cyclodextrin 25g

[0054] Lactose 50g

[0055] Microcrystalline Cellulose 70 g

[0056] Magnesium Stearate 1g

[0057] Preparation Process:

[0058] 1) Preparation: dry microcrystalline cellulose, lactose, and magnesium stearate at 80°C for 4 hours, and set aside;

[0059] 2) Put the prescribed amount of beta-cyclodextrin and vortioxetine hydrobromide in a container, mix well, grind until the particle size is 80±10um, and set aside;

[0060] 3) Mix item 2) with the prescribed amount of microcrystalline cellulose and magnesium stearate evenly;

[0061] 4) Tablet compression: adjust the appropriate hardness and tablet weight, and perform tablet compression;

[0062] 5) Packing: packed by aluminum-plastic blister packaging machine;

[0063] 6) Storage.

Embodiment 2

[0065] Every 1000 described vortioxetine hydrobromide pharmaceutical compositions, its formula consists of:

[0066] Vortioxetine Hydrobromide 10g

[0067] Beta Cyclodextrin 50g

[0068] Lactose 100g

[0069] Microcrystalline Cellulose 140 g

[0070] Magnesium Stearate 2g

[0071] Preparation process: with embodiment 1.

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Abstract

The invention discloses a vortioxetine pharmaceutical composition and a preparation method thereof. The vortioxetine pharmaceutical composition contains hydrobromic acid vortioxetine, betadex, lactose, microcrystalline cellulose and magnesium stearate. The vortioxetine pharmaceutical composition is characterized in that the weight ratio of hydrobromic acid vortioxetine to betadex to lactose is 1 to 5 to 10. The vortioxetine pharmaceutical composition is good in stability and has obvious superiorities that the product yield is increased, the cost is lowered, the industrialization is realized, and the relatively good clinic application is achieved; the dissolution rate can be effectively increased, and the bioavailability is obviously improved. The vortioxetine pharmaceutical composition can be used for treating major depressive disorder.

Description

technical field [0001] The invention belongs to the technical field of medicine, and in particular relates to a vortioxetine hydrobromide pharmaceutical composition and a preparation method thereof. Background technique [0002] Vortioxetine [0003] English name: vortioxetine; [0004] Chemical name: 1-[2-(2,4-methylphenylthio)phenyl]piperazine; [0005] Structural formula: [0006] [0007] Molecular formula: C18H22N2S; [0008] Molecular weight: 298.45; [0009] Pharmacological type: Phosphodiesterase 4 (PDE-4) inhibitors. [0010] Mechanism of Action: Vortioxetine is thought to act through a combination of 2 mechanisms of action: modulation of receptor activity and inhibition of reuptake. In vitro studies have shown that vortioxetine is a 5-HT3 and 5-HT7 receptor antagonist, a 5-HT1B receptor partial agonist, a 5-HT1A receptor agonist, and a 5-hydroxytryptamine transporter (SERT) inhibitor. In vivo nonclinical studies have shown that vortioxetine can enhance th...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K31/495A61K47/40A61P25/24
Inventor 严洁李轩
Owner TIANJIN HANKANG PHARMA BIOTECH
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