Varenicline tablet composition

A technology of varenicline and varenicline tartrate, applied in the field of medicine, can solve the problems of reduced dissolution rate, substandard content uniformity, etc., and achieve the effect of uniform content

Inactive Publication Date: 2018-03-06
WEIHAI GUANBIAO INFORMATION TECH
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0004] Purpose of the invention: the purpose of the present invention is to solve the problem that the content uniformity of the prior art is not up to standard and the dissolution rate decreases during storage

Method used

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Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0017] Example 1, D 50 0.5g of varenicline tartrate of 50 microns, 50g of lactose, 26g of microcrystalline cellulose, 6g of calcium hydrogen phosphate, 0.8g of sodium lauryl sulfate, 0.8g of magnesium stearate, prepared according to the preparation method described in the technical scheme 1000 piece.

Embodiment 2

[0018] Example 2, D 50 1g of varenicline tartrate of 76 microns, 70g of lactose, 12g of microcrystalline cellulose, 12g of calcium hydrogen phosphate, 1.6g of sodium lauryl sulfate, 1.5g of magnesium stearate, prepared 1000 tablets according to the preparation method described in the technical scheme .

Embodiment 3

[0019] Example 3, D 50 0.5g of varenicline tartrate of 65 microns, 66g of lactose, 20g of microcrystalline cellulose, 9g of calcium hydrogen phosphate, 1.2g of sodium lauryl sulfate, 1.0g of magnesium stearate, prepared according to the preparation method described in the technical scheme 1000 piece.

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PUM

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Abstract

The invention relates to a varenicline tablet composition, which belongs to the technical field of medicine. The technical scheme of the present invention is: the composition of unit dose contains: D50 is 0.5-1mg of varenicline tartrate of 50-76 microns, lactose 50-70mg, microcrystalline cellulose 12-26mg, calcium hydrogen phosphate 6-12mg, Sodium lauryl sulfate 0.8-1.6mg, magnesium stearate 0.8-1.5mg. The technical solution of the present invention obtains a varenicline tartrate tablet with uniform content and stable dissolution.

Description

technical field [0001] The invention relates to a varenicline tablet composition, which belongs to the technical field of medicine. Background technique [0002] Varenicline tartrate (also known as: Varenicline), English name: Varenicline tartrate, chemical name: 7,8,9,10-tetrahydro-6,10-methylene-6H-pyrazinamide [2, 3-h][3]Benzazepine-(2R,3R)-2,3-dihydroxysuccinate, trade name Champix, is a smoking cessation drug developed by Pfizer. Champix is ​​effective in relieving nicotine cravings and withdrawal symptoms, and can help reduce the high from smoking during a 12-week treatment. Varenicline tartrate is commercially available in two specifications of 0.5 mg and 1.0 mg, which belong to small-scale preparations. [0003] There are following problems in the process of preparing varenicline tartrate tablet: the one, the content uniformity of tablet is not up to standard, the 2nd, in the process of storing, the dissolution rate of tablet shows the trend of decreasing with the ...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K9/20A61K47/20A61K47/02A61K31/55A61P25/34
CPCA61K9/2095A61K9/2009A61K9/2013A61K31/55
Inventor 孙爱梅
Owner WEIHAI GUANBIAO INFORMATION TECH
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