Vortioxetine sustained-release capsules and preparation method of vortioxetine sustained-release capsules

A technology of vortioxetine and sustained-release capsules, which is applied in the field of vortioxetine sustained-release capsules and their preparation, and can solve the problems of small market share and the like

Inactive Publication Date: 2017-05-31
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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Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0019] Preparation of pill cores

[0020] 1. Preparation of the main drug coating solution: add 15 g of ethyl cellulose and 1 g of vortioxetine accurately weighed into the 60% ethanol solution, stir evenly, and filter the resulting suspension with a 80-mesh sieve to form a solid content 55% coating liquid, keep stirring when spraying liquid.

[0021] 2. Pour 21g of sucrose blank core into the coating pan and preheat it. When the internal temperature of the sucrose blank core reaches above 45°C, adjust the speed in the coating pan to about 20rpm, turn on the peristaltic pump and spray gun to start coating, The spray flow rate is controlled at 70-80g / min. After coating the main drug, open the air exhaust and air intake valves, the coating pan rotates at 5 rpm, and the drying heating temperature is 50°C, and is dried for 5 hours, and the pellets are passed through 12-mesh and 20-mesh sieves to obtain the product.

[0022] Preparation of isolation coating layer

[0023] 1. Add ...

Embodiment 2

[0033] Preparation of pill cores

[0034] 1. Preparation of the main drug coating solution: Add 20g of hypromellose and 1g of vortioxetine accurately weighed in purified water, stir evenly, and filter the resulting suspension with an 80-mesh sieve to form a solid content of 50%. coating solution, keep stirring while spraying.

[0035] 2. Pour 21g of sucrose blank core into the coating pan and preheat it. When the internal temperature of the sucrose blank core reaches above 45°C, adjust the speed in the coating pan to about 20rpm, turn on the peristaltic pump and spray gun to start coating, The spray flow rate is controlled at 70-80g / min. After coating the main drug, open the air exhaust and air intake valves, the coating pan rotates at 5 rpm, and the drying heating temperature is 50°C, and is dried for 5 hours, and the pellets are passed through 12-mesh and 20-mesh sieves to obtain the product.

[0036] Preparation of isolation coating layer

[0037] 1. Add 3g of polyethyle...

Embodiment 3

[0047] Preparation of pill cores

[0048] 1. Preparation of the main drug coating solution: Add 10 g of polyethylene glycol 4000 and 2 g of vortioxetine accurately weighed in purified water, stir evenly, and filter the resulting suspension with an 80-mesh sieve to form a solid content of 45%. coating solution, keep stirring while spraying.

[0049] 2. Pour 21g of sucrose blank core into the coating pan and preheat it. When the internal temperature of the sucrose blank core reaches above 45°C, adjust the speed in the coating pan to about 20rpm, turn on the peristaltic pump and spray gun to start coating, The spray flow rate is controlled at 70-80g / min. After coating the main drug, open the air exhaust and air intake valves, the coating pan rotates at 5 rpm, and the drying heating temperature is 50°C, and is dried for 5 hours, and the pellets are passed through 12-mesh and 20-mesh sieves to obtain the product.

[0050] Preparation of isolation coating layer

[0051] 1. Add 2g...

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PUM

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Abstract

The invention discloses vortioxetine sustained-release capsules as well as a preparation method and application of the vortioxetine sustained-release capsules. The vortioxetine sustained-release capsules are prepared by loading vortioxetine sustained-release micro-pills into hollow capsules. Each vortioxetine sustained-release micro-pill is composed of a medicine-carrying pill core, an isolation type coating layer, a sustained-release coating layer and a protective coating layer from inside to outside, wherein the medicine-carrying pill core is composed of vortioxetine, an adhesive and a sucrose hollow pill core, and the specific weight percent is as follows: 0.1 percent to 10 percent of the vortioxetine, 10 percent to 30 percent of the adhesive and 10 percent to 60 percent of the sucrose hollow pill core. A sustained-release preparation can be used for prolonging the holding time of treatment concentration of the vortioxetine in a body to 12h and reducing the side effect caused by the fact that the fluctuation of plasma drug concentration is too great; meanwhile, the number of times of orally taking drug is reduced, and the vortioxetine sustained-release capsules have remarkable effect on patients with depressive disorder, who need to be treated, and are convenient to use.

Description

technical field [0001] The invention relates to the technical field of pharmaceutical preparations, in particular to a vortioxetine sustained-release capsule and a preparation method thereof. Background technique [0002] Vortioxetine hydrobromide can inhibit the reuptake of serotonin, and has the functions of 5-HT1A receptor agonist, 5-HT1B receptor partial agonist and 5-HT3', 5-HT1D and 5-HT7 receptor antagonist. The diversity of vortioxetine's action makes it regulate neurotransmission in several systems, mainly regulating serotonin, and it is speculated that it can also regulate norepinephrine, dopamine, histamine, acetylcholine, GABA and glutamate system. The relative contribution of each mechanism of action has not been determined. Vortioxetine is the first antidepressant with such diverse pharmacological activities. [Overseas marketing status] Vortioxetine (VORTIOXETINE, BRINTELLIX™) was approved by the FDA in September 2013 for the treatment of major depressive dis...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K9/58A61K9/62A61K31/495A61K47/32A61K47/38A61P25/24A61P29/00
CPCA61K9/0002A61K9/5026A61K9/5047A61K31/495
Inventor 雷林芳
Owner 佛山市弘泰药物研发有限公司
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