Vonoprazan fumarate pharmaceutical composition

A composition and drug technology, applied in the directions of drug combination, pharmaceutical formula, organic active ingredients, etc., can solve the problems of reducing productivity, affecting the final appearance of film-coated tablets, etc., and achieving the effect of excellent storage stability

Active Publication Date: 2017-10-03
JIANGSU HANSOH PHARMA CO LTD
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

CN 102743330 also pointed out that the removal of PEG from the film coating component would reduce the productivity and affect the final appearance of the film coated tablet

Method used

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  • Vonoprazan fumarate pharmaceutical composition
  • Vonoprazan fumarate pharmaceutical composition
  • Vonoprazan fumarate pharmaceutical composition

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0085] Embodiment 1 (sample 3) [table 5] tablet core composition

[0086]

[0087] ▲When necessary, use microcrystalline cellulose as an adjustment component to change the content.

[0088] [Table 6] Composition of film coating aqueous solution

[0089]

[0090] ▲Purified water accounts for 90% (w / w) of the film coating aqueous solution.

[0091] A plain tablet (core tablet) containing voronoprazan fumarate was prepared according to the composition ratio shown in the above table [5].

[0092] 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 into a plain table...

Embodiment 2

[0094] Embodiment 2 (sample 4)

[0095] [Table 7] Chip composition

[0096]

[0097] ▲When necessary, use microcrystalline cellulose as an adjustment component to change the content.

[0098] [Table 8] Composition of film coating aqueous solution

[0099]

[0100] ▲Purified water accounts for 90% (w / w) of the film coating aqueous solution.

[0101] A plain tablet (core tablet) containing vonoprazan fumarate was prepared according to the composition ratio shown in the above table [7].

[0102] 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 obtained granules a...

Embodiment 3

[0104] Embodiment 3 (sample 5)

[0105] [Table 9] Chip composition

[0106]

[0107] ▲When necessary, use microcrystalline cellulose as an adjustment component to change the content.

[0108] [Table 10] Composition of film coating aqueous solution

[0109]

[0110] ▲Purified water accounts for 90% (w / w) of the film coating aqueous solution.

[0111] A plain tablet (core tablet) containing voronoprazan fumarate was prepared according to the composition ratio shown in the above table [9].

[0112] Dissolve 3.1 g of hydroxypropyl cellulose in 87.9 g of purified water to obtain a binder solution. The prepared binder solution was added to the excipients consisting of vonoprazan fumarate (26.72g), mannitol (125.98g) and microcrystalline cellulose (51g) 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 into a pla...

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Abstract

The invention relates to a vonoprazan fumarate pharmaceutical composition; and the invention provides the pharmaceutical composition which contains vonoprazan fumarate as an active ingredient and a method for stabilizing the pharmaceutical composition. Specifically, the pharmaceutical composition containing the vonoprazan fumarate is free from a plasticizer; the pharmaceutical composition is excellent in preparation stability; and the pharmaceutical composition shows excellent stability in a high-temperature environment and during an illuminating phase.

Description

technical field [0001] The invention relates to the field of pharmaceutical preparations, specifically, a stable pharmaceutical composition containing vonoprazan fumarate and excipients, and a stabilization 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 I), 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 ion competitive acid blockers (Potassium-competitive acid blockers, P-CAB), through competitive inhibition of hydrogen ion / potassium ion-ATPase 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 ...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K31/4439A61K47/32A61K47/26A61K47/38A61P1/04
CPCA61K31/4439A61K47/26A61K47/32A61K47/38
Inventor 董礼常毅敏王小雷孙运栋
Owner JIANGSU HANSOH PHARMA CO LTD
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