Vonoprazan fumarate-containing tablet and determination method for dissolution rate thereof

A technology of vornorazan fumarate and fumaric acid, which is applied in the field of medicine, can solve the problems of high requirements on material fluidity, unfavorable product preparation process, poor powder fluidity, etc. Excellent stability and stable tablet weight

Inactive Publication Date: 2020-11-24
NANJING HEALTHNICE MEDICAL TECH +2
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

The co-grinding powder proposed in this patent has a low yield in actual operation, and the material has obvious static electricity, and the powder fluidity is not good, which is unfavorable to the product preparation process, and the powder direct pressure process has high requirements on the fluidity of the material, which is not conducive to large-scale production. Production

Method used

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  • Vonoprazan fumarate-containing tablet and determination method for dissolution rate thereof
  • Vonoprazan fumarate-containing tablet and determination method for dissolution rate thereof
  • Vonoprazan fumarate-containing tablet and determination method for dissolution rate thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0049] Tablet formulation (1000 formulation units):

[0050]

[0051]

[0052] ＊ The particle size of the active component after crushing is d90=83.38μm

[0053] The preparation method of the present invention comprises the following steps:

[0054] (1) Pretreatment: the active ingredient is pulverized through a 60-mesh sieve by a universal pulverizer for subsequent use, and other auxiliary materials are sieved for subsequent use;

[0055] (2) Pre-mixing: put the active ingredient, mannitol, fumaric acid, microcrystalline cellulose 102, hydroxypropyl cellulose LXF, and cross-linked carmellose sodium into a hopper mixer (HLS-10, Zhejiang Small Lun) in mixing (20rpm, 10min);

[0056] (3) Dry granulation: put the mixed powder in a dry granulator (GL1-25, created by Zhangjiagang), adjust the roller pressure to 2.0-4.0MPa, the roller speed to 10-15rpm, the cutter speed to 10-15rpm, collect For particles between 30 mesh and 100 mesh (the particles exceeding the upper and l...

Embodiment 2

[0062] Tablet formulation (1000 formulation units):

[0063]

[0064]

[0065] ＊ The particle size of the active component after crushing is d90=63.31μm

[0066] The preparation method of the present invention comprises the following steps:

[0067] (1) Pretreatment: use a universal pulverizer to pulverize the active ingredient through an 80-mesh sieve for subsequent use, and sieve other auxiliary materials for subsequent use;

[0068] (2) Pre-mixing: put the active ingredient, mannitol, fumaric acid, microcrystalline cellulose 102, hydroxypropyl cellulose LXF, and cross-linked carmellose sodium into a hopper mixer (HLS-10, Zhejiang Small Lun) in mixing (20rpm, 10min);

[0069] (3) Dry granulation: put the mixed powder in the dry granulator, adjust the roller pressure to 2.0-4.0MPa, the roller speed to 10-15rpm, the cutter speed to 10-15rpm, and collect the particles between 30 mesh and 100 mesh (the particles exceeding the upper and lower limits are collected by gra...

Embodiment 3

[0075] Tablet formulation (1000 formulation units):

[0076]

[0077]

[0078] ＊ The particle size of the active component after crushing is d90=20.12μm

[0079] The preparation method of the present invention comprises the following steps:

[0080] (1) Pretreatment: the active ingredient is pulverized through a 100-mesh sieve by a universal pulverizer for subsequent use, and other auxiliary materials are sieved for subsequent use;

[0081] (2) Pre-mixing: put the active ingredient, mannitol, fumaric acid, microcrystalline cellulose 102, hydroxypropyl cellulose LXF, and cross-linked carmellose sodium into a hopper mixer (HLS-10, Zhejiang Small Lun) in mixing (20rpm, 10min);

[0082] (3) Dry granulation: put the mixed powder in the dry granulator, adjust the roller pressure to 2.0-4.0MPa, the roller speed to 10-15rpm, the cutter speed to 10-15rpm, and collect the particles between 30 mesh and 100 mesh (the particles exceeding the upper and lower limits are collected b...

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Abstract

The invention relates to a vonoprazan fumarate-containing tablet and a determination method for a dissolution rate thereof. The vonoprazan fumarate-containing tablet provided by the invention is composed of the following components in parts by weight: 10-15 parts of vonoprazan fumarate, 65-75 parts of mannitol, 2-5 parts of organic acid, 2-4 parts of hydroxy propyl cellulose, 8-12 parts of microcrystalline cellulose, 2-6 parts of croscarmellose sodium, 0.5-2 parts of magnesium stearate, 3-4 parts of coating powder and 0.2-1.0 part of polyethylene glycol. According to the tablet prepared by using the method, a damp-heat process is avoided; the granules of the tablet are good in flowability and compressibility, and the tablet is free of sticking, smooth in surface, qualified in friability and stable in tablet weight; after coating is completed, an aqueous polyethylene glycol solution is used for polishing treatment, so the appearance of the tablet is more glossy, a better moisture insulation effect is achieved on the tablet, and the dissolution behavior of the tablet is not influenced.

Description

technical field [0001] The invention belongs to the technical field of medicine, and in particular relates to a tablet containing vonoprazan fumarate and a method for measuring its dissolution rate. Background technique [0002] Reflux esophagitis is a common disease of the digestive system. Its characteristic symptoms include heartburn and acid reflux caused by gastric content reflux, which may be accompanied by extraesophageal symptoms and erosion of the esophageal mucosa, which seriously affects the quality of life and sleep of patients. . Epidemiological data show that the incidence of reflux esophagitis in the general population in China is as high as 6.4%. Vonolata Fumarate Tablets is the first Potassium Competitive Acid Blocker (P-CAB) approved to enter the Chinese market. Clinical data show that it has full effect of the first dose, long-lasting acid suppression and convenient administration. Vonoprazan Fumarate Tablets has been approved for marketing in China, whi...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K9/20A61K47/10A61K31/4439A61P1/04G01N30/02G01N30/06
CPCA61K9/2095A61K9/2031A61K31/4439A61P1/04G01N30/02G01N30/06
Inventor 石文晶辛妮王华娟
Owner NANJING HEALTHNICE MEDICAL TECH
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