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Pharmaceutical composition with vonoprazan fumarate and preparation method thereof

A composition and drug technology, applied in the field of stable pharmaceutical compositions, can solve the problems of reducing the acidity of pharmaceutical compositions, and achieve the effect of superior storage stability

Active Publication Date: 2015-12-02
JIANGSU HANSOH PHARMA CO LTD
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

The addition of chain organic acids to the prescription reduces the acidity of the pharmaceutical composition itself, resulting in the human body being exposed to overacid drugs in the stomach after oral administration of vonoprazan fumarate tablets, before vonoprazan fumarate exerts an acid-suppressing effect Compositions that cause upset stomach

Method used

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  • Pharmaceutical composition with vonoprazan fumarate and preparation method thereof
  • Pharmaceutical composition with vonoprazan fumarate and preparation method thereof
  • Pharmaceutical composition with vonoprazan fumarate and preparation method thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0085] Embodiment 1 (sample 5)

[0086] [Table 9] Chip composition

[0087]

[0088]

[0089] ▲When necessary, use microcrystalline cellulose as an adjustment component to change the content.

[0090] [Table 10] Composition of film coating aqueous solution

[0091]

[0092] ▲Purified water accounts for 90% (w / w) of the film coating aqueous solution.

[0093] A plain tablet (core tablet) containing voronoprazan fumarate was prepared according to the composition ratio shown in the above table [9].

[0094] Dissolve 2.6 g of hydroxypropyl cellulose in 87.9 g of purified water to obtain a binder solution. Add the prepared binder solution to the excipients consisting of vonoprazan fumarate (26.72g), mannitol (130.98g) and microcrystalline cellulose (46.5g) for wet granulation. After drying, the granules were sized with a 30-mesh sieve, and magnesium stearate (2.2 g) and croscarmellose sodium (11 g) were added for total mixing. Then the obtained granules are pressed in...

Embodiment 2

[0096] Embodiment 2 (sample 6)

[0097] [Table 11] Chip composition

[0098]

[0099]

[0100] ▲When necessary, use microcrystalline cellulose as an adjustment component to change the content.

[0101] [Table 12] Composition of film coating aqueous solution

[0102]

[0103] ▲Purified water accounts for 90% (w / w) of the film coating aqueous solution.

[0104] A plain tablet (core tablet) containing vonoprazan fumarate was prepared according to the composition ratio shown in the above table [11].

[0105] Dissolve 1.3 g of hydroxypropyl cellulose and 0.75 g of fumaric acid in 43.95 g of purified water to obtain a binder solution. The prepared binder solution was added to an excipient composed of vonoprazan fumarate (13.36g), mannitol (57.99g) and microcrystalline cellulose (30g) for wet granulation. After drying, the granules were sized with a 30-mesh sieve, and magnesium stearate (1.1 g) and croscarmellose sodium (5.5 g) were added for total mixing. Then the obta...

Embodiment 3

[0107] Embodiment 3 (sample 7)

[0108] [Table 13] Chip composition

[0109]

[0110]

[0111] ▲When necessary, use microcrystalline cellulose as an adjustment component to change the content.

[0112] [Table 14] Composition of film coating aqueous solution

[0113]

[0114] ▲Purified water accounts for 90% (w / w) of the film coating aqueous solution.

[0115] A plain tablet (core tablet) containing vonoprazan fumarate was prepared according to the composition ratio shown in the above table [13].

[0116] Dissolve 3.3 g of hydroxypropyl cellulose in 43.95 g of purified water to obtain a binder solution. The prepared binder solution was added to the excipients consisting of vonoprazan fumarate (13.36g), mannitol (70.99g) and microcrystalline cellulose (15.75g) for wet granulation. After drying, the granules were sized with a 30-mesh sieve, and magnesium stearate (1.1 g) and croscarmellose sodium (5.5 g) were added for total mixing. Then the obtained granules are pr...

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PUM

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Abstract

The invention discloses a pharmaceutical composition with vonoprazan fumarate and a preparation method thereof and particularly provides a pharmaceutical composition containing an active ingredient, vonoprazan fumarate, and a method of stabilizing the pharmaceutical composition. Specifically, the pharmaceutical composition containing the vonoprazan fumarate, plasticizer and excipient has good preparation stability and has good stability during illumination.

Description

technical field [0001] The present invention relates to a stable pharmaceutical composition containing vonoprazan fumarate, an excipient and a plasticizer, and a stabilizing method thereof. The pharmaceutical composition of the invention is used for treating and maintaining non-erosive gastroesophageal reflux disease, duodenal ulcer, gastric ulcer, erosive esophagitis and other acid-related diseases. Background technique [0002] Vonoprazan fumarate (formula below), the chemical name is 1-[5-(2-fluorophenyl)-1-(pyridin-3-ylsulfonyl)-1H-pyrrol-3-yl]-N -Methylmethylamine fumarate, which belongs to a new type of PPI-potassium-competitive acid blockers (Potassium-competitive acid blockers, P-CAB), inhibits potassium in hydrogen ion / potassium ion-ATPase by competitively It is a reversible potassium ion antagonist. Compared with the traditional PPI, the acid-suppressing effect of vonoprazan fumarate has nothing to do with the activation of the proton pump, and it can significant...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K31/4439A61K47/44A61K47/10A61K47/14A61K47/26A61K47/38A61K47/12A61P1/04
Inventor 董礼常毅敏汤征闫智颖王小雷
Owner JIANGSU HANSOH PHARMA CO LTD
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