Vortioxetine nanoparticles, preparation and preparation method thereof

A technology of vortioxetine and rice grains, applied in the field of vortioxetine nanoparticles, preparations and their preparation, can solve problems such as small market share, and achieve the effect of increasing specific surface area

Inactive Publication Date: 2017-01-04
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

Among the domestic antidepressant manufacturers, Reboxetine is occupied by Beijing Honglin and Chongqing Yaoyou, and bupropion is divided into the market by Wante Pharmaceutical (Hainan), Shenyang Funing Pharmaceutical and Disha Pharmaceutical, but its market relatively small share

Method used

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preparation example Construction

[0041] The present invention also provides a kind of preparation method of vortioxetine preparation, comprises the following steps:

[0042] a) mixing vortioxetine, nanocarriers and a solvent to obtain a mixed liquid;

[0043] b) drying the mixed liquid to obtain vortioxetine nanoparticles;

[0044] c) mixing the vortioxetine nanoparticles with a diluent and a lubricant to obtain a vortioxetine preparation.

[0045] The invention mixes vortioxetine, nano carrier and solvent to obtain mixed liquid. In the present invention, the source of the vortioxetine is not particularly limited, and commercially available vortioxetine well known to those skilled in the art can be used. The vortioxetine preparation provided by the present invention includes 0.5 to 1.5 parts by weight of vortioxetine, preferably 1 part by weight.

[0046]In the present invention, the solvent preferably includes one or more of water, ethanol, hydrogenated castor oil and polyethylene glycol, more preferably ...

Embodiment 1

[0055] (1) Dissolve 45g soybean lecithin and 8g povidone K30 in 50% aqueous ethanol solution, add 4g vortioxetine, place in a high-speed stirring homogenizer, and stir for 60min at a stirring speed of 3000r / min to obtain mixed liquid;

[0056] (2) The obtained mixed liquid was spray-dried using a high-efficiency spray dryer, the spray speed was 5mL / min, the inlet air temperature was 60°C, and the outlet air temperature was 25°C to obtain vortioxetine nanoparticles.

Embodiment 2

[0058] (1) Dissolve 30g of soybean lecithin and 6g of povidone K30 in 50% ethanol aqueous solution, add 4g of vortioxetine, place in a high-speed stirring homogenizer, and stir for 60 minutes at a stirring speed of 3000r / min, get mixed liquid;

[0059] (2) The obtained mixed liquid was spray-dried using a high-efficiency spray dryer, the spray speed was 5mL / min, the inlet air temperature was 60°C, and the outlet air temperature was 25°C to obtain vortioxetine nanoparticles.

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Abstract

The invention relates to the technical field of medicines and particularly relates to vortioxetine nanoparticles, a preparation and a preparation method thereof. The vortioxetine nanoparticles comprise the following components in parts by weight: 1-5 parts of vortioxetine and 10-100 parts of nano carrier, wherein the nano carrier comprises one or more of lecithin, povidone, polyalkylcyanocraylate, acrylamide, N,N-methylene bisacrylamide, polysorbate, sorbitan monolaurate, polyoxyethylene lauryl ether, sodium lauryl sulfate, poloxamer, polyethylene glycol, cyclodextrin and cyclodextrin derivative. The vortioxetine nanoparticles provided by the invention are of nanoscale particle size; and on the basis, the prepared vortioxetine preparation has high dissolubility.

Description

technical field [0001] The present invention relates to the technical field of medicines, and more specifically relates to a vortioxetine nanoparticle, a preparation and a preparation method thereof. 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) of the European Medicines Agency (EMA) recommended that Vortioxetine be used for the treatment of major depression and issue a 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 market, Denmark’s Lundbeck escitalopram oxalate acco...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K9/14A61K9/48A61K31/495A61K47/36A61K47/12A61K47/32A61K47/24A61P25/24
CPCA61K31/495A61K9/145A61K9/146A61K9/4858A61K9/4866
Inventor 雷林芳
Owner 佛山市弘泰药物研发有限公司
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