Vortioxetine hydrobromide tablets and preparation method thereof

Abstract

The invention relates to vortioxetine hydrobromide tablets and a preparation method thereof, and belongs to the technical field of medicine. Tablet cores of the vortioxetine hydrobromide tablets are prepared from vortioxetine hydrobromide, mannitol, calcium phosphate dibasic, sodium carboxymethyl starch and magnesium stearate. A coating solution of the vortioxetine hydrobromide tablets is prepared from hydroxypropyl methylcellulose, polyethylene glycol 400, titanium dioxide, iron oxide yellow and purified water. The preparation method includes the steps that the raw materials of the tablet cores are screened, evenly mixed, directly subjected to tabletting and then subjected to coating. After the tablets are subjected to gastric-soluble film coating, the bitter taste of the tablets can be well avoided when the tablets are taken orally, and therefore compliance is improved. A film coating layer contains titanium dioxide, shading can be well achieved, it is avoided that the tablets are degraded under illumination, and therefore the stability of the tablets is improved.

Description

technical field [0001] The invention relates to a vortioxetine hydrobromide tablet and a preparation method thereof, belonging to the technical field of medicine. Background technique [0002] Vortioxetine was jointly developed by Lundbeck and Takeda Pharmaceuticals in the United States. It was approved by the U.S. Food and Drug Administration (FDA) on September 30, 2013 to be marketed in the United States. and 20mg for the treatment of major depressive disorder in adults. [0003] Chinese Patent Publication No. CN104644594A discloses a vortioxetine hydrobromide gastric dissolving tablet and a preparation method thereof, the raw materials of which include vortioxetine hydrobromide, lubricant, filler, binder and disintegrant; The method includes steps such as granulation, and the granulation process takes a long time. In the process, the drug is exposed to light to easily degrade the raw material, which has a certain impact on the stability of the drug, and the production cy...

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Problems solved by technology

[0003] Chinese Patent Publication No. CN104644594A discloses a vortioxetine hydrobromide stomach-dissolving tablet and a preparation method thereof, the raw materials of which include vortioxetine hydrobromide, a lubricant, a filler, a binder and a disintegrant; its preparation The method includes steps such as granulation, and the granulation process takes a long time. In this process, the drug is exposed to light, which easily degrades the raw materials, which has a certain impact on the stability of the drug, and the production cycle is long, so it cannot be most effectively improved. Efficiency of industrial mass production

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