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Preparation method of vortioxetine hydrobromide tablet

A technology for vortioxetine tablets and thioxetine tablets, which is applied in the field of preparation of vortioxetine hydrobromide tablets, and can solve the problems of easy cracking of tablets, slow dissolution of tablets, high defective rate, etc.

Inactive Publication Date: 2020-12-01
CSPC ZHONGQI PHARM TECH (SHIJIAZHUANG) CO LTD
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

The applicant adopts the process method in this patent, and the obtained tablets are prone to problems such as splits and missing corners, and the rate of defective products is high; the tablet with a better appearance is selected for further dissolution experiments, and it is found that the dissolution rate is only 20% at the 5min sampling point. % or so, tablet dissolution is slow

Method used

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  • Preparation method of vortioxetine hydrobromide tablet
  • Preparation method of vortioxetine hydrobromide tablet
  • Preparation method of vortioxetine hydrobromide tablet

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0050] Example 1: Influence of Inlet Air Temperature

[0051] Using the prescription in Table 1, when other parameters in the process are the same, the influence of different inlet air temperatures is investigated. The specific preparation process is as follows:

[0052] (1) Weigh the internally added raw and auxiliary materials vortioxetine hydrobromide, mannitol, and microcrystalline cellulose.

[0053] (2) Prepare an aqueous solution of 6W / W% hydroxypropyl cellulose.

[0054] (3) Add the internal raw and auxiliary materials in step (1) into the fluidized bed, set the inlet air temperature as shown in Table 4, and the air volume is 500m 3 / h, atomization pressure 3bar, spray the solution of step (2) into the fluidized bed through a peristaltic pump, control the spray speed 100-300g / min, stop the machine after spraying, and take samples to measure the moisture content of the particles.

[0055] (4) Pass the granules obtained in step (3) through a 1.5 mm sieve for sizing, an...

Embodiment 2

[0063] Embodiment 2: The influence of air volume

[0064] Using the prescription in Table 1, investigate the influence of different air volumes, the specific preparation process is as follows:

[0065] (1) Weigh the internally added raw and auxiliary materials vortioxetine hydrobromide, mannitol, and microcrystalline cellulose.

[0066] (2) Prepare an aqueous solution of 6W / W% hydroxypropyl cellulose.

[0067] (3) Add the raw and auxiliary materials in step (1) into the fluidized bed, set the inlet air temperature at 85°C, the air volume as shown in Table 6, and the atomization pressure at 3 bar, and spray the solution in step (2) into the fluidized bed through a peristaltic pump , control the spray speed of 100-300g / min, stop the machine after spraying, and take samples to measure the moisture content of the particles.

[0068] (4) Pass the granules obtained in step (3) through a 1.5 mm sieve for sizing, and add additional auxiliary materials microcrystalline cellulose and ...

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Abstract

The invention provides a preparation method of a vortioxetine hydrobromide tablet. The vortioxetine hydrobromide tablet is composed of a base sheet and a coating. In the granulation process, the air inlet temperature of a fluidized bed is controlled to be 75-85 DEG C, and the air inlet amount is controlled to be 500-700 m<3> / h, the particle bulk density is controlled to be 0.3 to 0.4 g / ml, the water content is controlled to be 1.5% to 3%. Compared with a contrast group, with the base tablet prepared through tabletting, the tablet is low in defective rate and small in tablet weight difference,is capable of solving a problem that a base tablet of the contrast group is dissolved slowly at an early stage, and possesses excellent industrial application prospect.

Description

technical field [0001] The invention belongs to the field of preparation methods, in particular to a preparation method of vortioxetine hydrobromide tablets. Background technique [0002] Vortioxetine hydrobromide tablets, an immediate-release tablet, was developed by Lundbeck Company in Denmark for the treatment of depression in adults. It was approved by the FDA on September 30, 2013 and first launched on November 21, 2017. Approved for marketing in China, the product name is Xindayue, and the specifications are 5mg and 10mg. [0003] Both the FDA and the Chinese instructions have introduced the core (backsheet) composition of vortioxetine hydrobromide tablets: mannitol, microcrystalline cellulose, hydroxypropyl cellulose, sodium carboxymethyl starch, magnesium stearate, and adopt Tablet production by fluidized bed granulation process. [0004] The patent of CN201080037699.9 applies for protection of an enteric-coated tablet. Example 5 introduces a tablet core with the s...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K9/16A61K47/26A61K47/38A61K47/36A61K47/12A61K9/28A61K31/496A61P25/24
CPCA61K9/1682A61K9/1623A61K9/1652A61K9/1617A61K9/28A61K31/496A61P25/24
Inventor 李少茹赫玉霞张茜唐琳郭阳蔡兴诗徐艺婉
Owner CSPC ZHONGQI PHARM TECH (SHIJIAZHUANG) CO LTD