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Vonoprazan fumarate enteric coated tablet and preparation method thereof

A technology for vonoprazan fumarate and enteric-coated tablets, which is applied in pharmaceutical formulations, medical preparations with inactive ingredients, and medical preparations containing active ingredients, etc., can solve problems such as unstable release of ordinary tablets, and achieve Good release effect

Active Publication Date: 2015-11-11
DISHA PHARMA GRP
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0005] Purpose of the invention: to provide a enteric-coated tablet of Vonorazan fumarate to solve the problem of unstable release of ordinary tablets

Method used

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  • Vonoprazan fumarate enteric coated tablet and preparation method thereof
  • Vonoprazan fumarate enteric coated tablet and preparation method thereof
  • Vonoprazan fumarate enteric coated tablet and preparation method thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0030] Embodiment 1, a kind of vonorazansu fumarate tablet (chip tablet), the composition of every 1000 tablets is as follows:

[0031] Chip:

[0032] Vonoprazan Fumarate 13.36g Mannitol 22g microcrystalline cellulose 58.14g Hydroxypropyl Cellulose 5.5g fumaric acid 3.3g Croscarmellose Sodium 6.6g Magnesium stearate 1.1g production 1000 pieces

[0033] The preparation process is as follows:

[0034] (1) Weigh the prescribed amount of mannitol, vonoprazan fumarate, microcrystalline cellulose, fumaric acid, and croscarmellose sodium and mix them in a wet granulator;

[0035] (2) Add hydroxypropyl cellulose aqueous solution to the wet granulator for wet mixing to make soft materials, and granulate with a 20-mesh screen;

[0036] (3) Dry the wet granules in an oven at 40°C, and granulate with a 20-mesh sieve;

[0037] (4) Add the prescribed amount of magnesium stearate to the dry granules, and mix them in a mixer;

[003...

Embodiment 2

[0039] Embodiment 2, a kind of vonorazansu fumarate tablet (tablet core tablet), the composition of every 1000 tablets is as follows:

[0040] Chip:

[0041] Vonoprazan Fumarate 13.36g Mannitol 44g microcrystalline cellulose 36.14g Hydroxypropyl Cellulose 5.5g fumaric acid 3.3g Croscarmellose Sodium 6.6g Magnesium stearate 1.1g production 1000 pieces

[0042] The preparation process is the same as in Example 1.

Embodiment 3

[0043] Embodiment 3, a kind of vonorazansu fumarate tablet (tablet core tablet), the composition of every 1000 tablets is as follows:

[0044] Chip:

[0045] Vonoprazan Fumarate 13.36g Mannitol 66g microcrystalline cellulose 14.14g Hydroxypropyl Cellulose 5.5g fumaric acid 3.3g Croscarmellose Sodium 6.6g Magnesium stearate 1.1g production 1000 pieces

[0046] The preparation process is the same as in Example 1.

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Abstract

The invention belongs to the field of pharmaceutical preparations and particularly relates to a vonoprazan fumarate enteric coated tablet and a preparation method thereof. The invention adopts the following technical scheme: vonoprazan fumarate and pharmaceutical auxiliary materials are prepared into tablet cores, and then an enteric layer is coated; every 1000 tablet cores comprise 13.36g of vonoprazan fumarate, 40-50g of mannitol, 10-20g of microcrystalline cellulose, 3-8g of hydroxypropyl vonoprazan fumarate enteric coated tablet cellulose, 1-5g of fumaric acid, 8-30g of croscarmellose sodium and 1-3g of magnesium stearate; every 1000 enteric film-coated layers comprise 7.0g of acrylic resin, 0.1g of triethyl citrate and 3.9g of talcum powder. The technical scheme provided by the invention solves the problem that the release of common tablets in the stomach is unstable.

Description

technical field [0001] The invention belongs to the field of pharmaceutical preparations, and in particular relates to a vonoprazan fumarate enteric-coated tablet and a preparation method thereof. Background technique [0002] Vonoprazan fumarate, chemical name (1-(5-(2-fluorophenyl)-1-(pyridin-3-ylsulfonyl)-1H-pyrrol-3-yl)-N -Methylmethylamine fumarate, molecular formula: C 21 h 20 FN 3 o 6 S, molecular weight: 461.46, melting point: 201~203°C, white or off-white crystalline powder. The chemical structural formula is as follows: [0003] [0004] Vonorazan Fumarate Tablets are a new class of gastric acid secretion inhibitors developed by Takeda Pharmaceuticals. They were launched in Japan in 2014 and are used for the eradication of erosive esophagitis, gastric ulcer, duodenal ulcer and Helicobacter pylori. treat. The commercially available vonoprazan fumarate is an ordinary tablet released in the stomach. The in vitro dissolution test found that vonoprazan fumarat...

Claims

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Application Information

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IPC IPC(8): A61K9/36A61K31/4439A61K47/38A61K47/10A61P1/04
Inventor 祁伟力高飞白莉田军超
Owner DISHA PHARMA GRP
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