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Vortioxetine hydrobromide crystal and preparation method thereof

A technology of vortioxetine hydrobromide and crystals, which is applied in the field of medicine, can solve problems such as difficulty in ensuring constant environmental humidity conditions, uneven product quality, and content changes, and achieve uniform and stable product quality, low hygroscopicity, and preparation The effect of simple method

Inactive Publication Date: 2016-02-17
SHANGHAI NEOSUN PHARMA TECH CO LTD
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

In the process of raw material preparation, weighing, transportation and storage, it is usually difficult to ensure that the humidity of the environment is constant. If the content of vortioxetine hydrobromide changes due to moisture absorption and weight gain, it will lead to uneven quality of the final preparation product

Method used

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  • Vortioxetine hydrobromide crystal and preparation method thereof
  • Vortioxetine hydrobromide crystal and preparation method thereof
  • Vortioxetine hydrobromide crystal and preparation method thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0035] Add 1 g of vortioxetine hydrobromide to 10 ml of 30% by volume methanol water solution, heat to reflux to dissolve, then cool down to room temperature and stir and filter. After filtering, vacuum dry at 70°C to obtain 0.79 g of crystals. HPLC shows that the purity is 99.88%.

Embodiment 2

[0037] Add 0.7g of vortioxetine hydrobromide into 50ml of 40% by volume methanol water solution, heat to reflux to dissolve, then cool down to room temperature and stir and filter. After filtration, 0.65g of crystals are dried in vacuum at 90°C, and the purity is 99.80% as shown by HPLC. .

Embodiment 3

[0039] Add 1.0g of vortioxetine hydrobromide into 5ml of 70% by volume methanol water solution, heat to reflux to dissolve, then cool down to room temperature and stir and filter. After filtration, vacuum dry at 80°C to dry 0.83g of crystals. HPLC shows that the purity is 99.85%. .

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PUM

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Abstract

The invention discloses a vortioxetine hydrobromide crystal and a preparation method thereof. A powder X-ray diffraction pattern of the crystal shows characteristic peaks at the diffraction angle 2theta of 5.8+ / -0.2, 6.9+ / -0.2, 13.2+ / -0.2, 14.1+ / -0.2, 14.6+ / -0.2, 16.2+ / -0.2, 17+ / -0.2, 18.2+ / -0.2, 18.6+ / -0.2, 19+ / -0.2, 19.5+ / -0.2, 20.7+ / -0.2, 21.1+ / -0.2, 21.6+ / -0.2, 21.9+ / -0.2, 22.3+ / -0.2, 22.7+ / -0.2, 23+ / -0.2, 23.7+ / -0.2, 24.4+ / -0.2, 24.8+ / -0.2, 25.4+ / -0.2, 28.1+ / -0.2, 28.5+ / -0 2, and 30+ / -0.2. The vortioxetine hydrobromide crystal provided by the invention has the advantages of high purity, simple preparation method, and low hygroscopicity. The crystal is not influenced by the change of environmental humidity in raw material preparation, weighing and storage, and maintains uniform and stable quality of the final product.

Description

technical field [0001] The invention relates to the field of medicine, in particular to a vortioxetine hydrobromide crystal and a preparation method thereof. Background technique [0002] Vortioxetinehydrobromide, the chemical name is 1-[2-(2,4-dimethylphenylsulfanyl)phenyl]piperazine, the chemical structure is shown in the following formula (I), commercial named BRINTELLIX ? . [0003] Formula (I) [0004] Vortioxetine hydrobromide belongs to the new generation of antidepressants. The drug works through a combination of 2 mechanisms of action: modulation of receptor activity and inhibition of reuptake. Studies have shown that vortioxetine hydrobromide is a 5-HT reuptake inhibitor and a 5-HT 3 , 5-HT 7 , 5-HT 1D Receptor antagonist, 5-HT 1B Partial agonists of receptors, 5-HT 1A Receptor agonist, plays an antidepressant role by regulating 5-HT. In vivo nonclinical studies have demonstrated that it increases levels of the neurotransmitters serotonin, norepinephrin...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): C07D295/096
Inventor 肖莉
Owner SHANGHAI NEOSUN PHARMA TECH CO LTD
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