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Stable compound famotidine chewable tablet and preparation method thereof

A technique for famotidine and chewable tablets, which is applied in the field of preparation of compound famotidine chewable tablets and compound famotidine chewable tablets, which can solve the problems of sustained release of famotidine and ease of chewing and taking. , to achieve good chewability, easy industrial production, and low friability

Pending Publication Date: 2021-07-23
河南合智医药科技有限公司
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

The above solutions all solved the stability problem of famotidine and partially solved the problem of taste masking, but did not solve the problem of sustained release of famotidine and ease of chewing and taking at the same time

Method used

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  • Stable compound famotidine chewable tablet and preparation method thereof
  • Stable compound famotidine chewable tablet and preparation method thereof
  • Stable compound famotidine chewable tablet and preparation method thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1-5

[0038] Table 1 embodiment 1-5 prescription composition (mg / tablet, 500 tablets / batch)

[0039]

[0040]

[0041] Example 1-5 Preparation process: Weigh the material of granule A according to the prescription, mix, heat to 70°C, stir evenly, let cool to room temperature, crush and pass through a 20-mesh sieve to obtain granule A. Weigh PVP K30 according to the prescription, add water to dissolve and make 10% PVPK30 solution as the binder solution, weigh other materials of granule B according to the prescription, mix evenly, add the binder solution to make soft material, pass through a 20-mesh sieve to granulate, 60 ℃ drying, passing through 18-mesh sieve and sizing to obtain granule B. Mix granules A, granules B and excipients C evenly, control the tablet hardness to 60N, and press into tablets to obtain chewable tablets of this product.

Embodiment 6-11

[0043] Table 2 embodiment 6-11 prescription composition (mg / tablet, 500 tablets / batch)

[0044]

[0045]Example 6-11 Preparation process: Weigh the material of granule A according to the prescription, mix, heat to 70°C, stir evenly, let cool to room temperature, crush and pass through a 20-mesh sieve to obtain granule A. Weigh PVP K30 according to the prescription, add water to dissolve and make 10% PVPK30 solution as the binder solution, weigh other materials of granule B according to the prescription, mix evenly, add binder solution to make soft material, pass through a 20-mesh sieve to granulate, 60 ℃ drying, passing through 18-mesh sieve and sizing to obtain granule B. Mix granules A, granules B and excipients C evenly, control the tablet hardness to 60N, and press into tablets to obtain chewable tablets of this product.

Embodiment 12-15

[0047] Table 3 embodiment 12-15 prescription composition (mg / tablet, 500 tablets / batch)

[0048]

[0049] Examples 12-15 Preparation process: Weigh the material of granule A according to the prescription, mix, heat to 70°C, stir evenly, let cool to room temperature, crush and pass through a 20-mesh sieve to obtain granule A. Weigh PVP K30 according to the prescription, add water to dissolve and make 10% PVPK30 solution as the binder solution, weigh other materials of granule B according to the prescription, mix evenly, add binder solution to make soft material, pass through a 20-mesh sieve to granulate, 60 ℃ drying, passing through 18-mesh sieve and sizing to obtain granule B. Mix granules A, granules B and excipients C evenly, control the tablet hardness to 60N, and press into tablets to obtain chewable tablets of this product.

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PUM

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Abstract

The invention discloses a stable compound famotidine chewable tablet and a preparation method thereof. The preparation method comprises the following steps: preparing granules A from famotidine, polyethylene glycol and hydroxypropyl methylcellulose, preparing granules B from calcium carbonate and magnesium hydroxide, uniformly mixing the granules A and the granules B, adding an additional auxiliary material C, and tabletting to obtain the stable compound famotidine chewable tablet. The famotidine chewable tablet is good in stability, famotidine can be continuously released, the famotidine chewable tablet has a taste masking effect, the friability smaller than or equal to 1.0% can be obtained under the hardness of 30-120 N, good easy-chewing performance and low friability are provided, and the preparation process is a conventional process, is simple and convenient and is easy for industrial production.

Description

technical field [0001] The invention relates to a pharmaceutical composition for treating stomach diseases, in particular to a stable compound famotidine chewable tablet. [0002] The invention also relates to a preparation method of the stable compound famotidine chewable tablet. Background technique [0003] In 2000, Johnson & Johnson-Merck launched the FDA-approved Pepcid Complete chewable tablet for the treatment of heartburn and acid indigestion, consisting of 10mg famotidine, 800mg calcium carbonate and 165mg magnesium hydroxide , is a complete gastric acid inhibitor that combines long-acting and short-acting gastric acid-action drugs, thus fundamentally overcoming the problem that antacids alone can only neutralize gastric acid temporarily, and antacids need a certain period of time to start to work contradictory situation. The chewable tablet has the following characteristics: 1. Rapid action, quickly neutralize gastric acid after taking it, and relieve symptoms; 2...

Claims

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Application Information

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IPC IPC(8): A61K9/22A61K31/426A61K33/10A61K33/08A61K47/10A61K47/38A61P1/04
CPCA61K9/2054A61K9/2031A61K9/2095A61K9/0056A61K31/426A61K33/10A61K33/08A61P1/04A61K2300/00
Inventor 郑会勤吴淑飞李心雨
Owner 河南合智医药科技有限公司
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