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Taste-masking compound famotidine chewable tablet and preparation method thereof

A technology of famotidine and chewable tablets, which is applied in the field of compound pharmaceutical compositions, can solve problems such as difficult to chew, bitter taste of famotidine, instability, etc., achieve moderate tablet hardness, solve taste masking, and improve stability Effect

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

[0006] In order to solve the problem of famotidine's bitter taste, instability and difficult chewing, the present invention provides a taste-masked compound famotidine chewable tablet

Method used

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  • Taste-masking compound famotidine chewable tablet and preparation method thereof
  • Taste-masking compound famotidine chewable tablet and preparation method thereof
  • Taste-masking compound famotidine chewable tablet and preparation method thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1-5

[0036] Table 1 embodiment 1-5 prescription composition (mg / tablet, 500 tablets / batch)

[0037]

[0038] Example 1-5 Preparation process: Weigh the famotidine granules according to the prescription, mix them, add an appropriate amount of 50% ethanol to granulate, dry at 40° C., and pass through a 20-mesh sieve to obtain famotidine granules. Weigh PVP K30 according to the prescription, add water to dissolve and make 10% PVPK30 solution as the binder solution, weigh calcium carbonate magnesium hydroxide particles and other materials according to the prescription, mix evenly, add binder solution to make soft material, and pass through a 20-mesh sieve Granulate, dry at 60°C, and pass through a 18-mesh sieve for granulation to obtain calcium carbonate magnesium hydroxide granules. Mix the two kinds of granules and the excipient A evenly, control the tablet hardness to 60N, and press the tablet to obtain the chewable tablet of this product.

[0039] Friability Test

[0040] Det...

Embodiment 6

[0055] Table 5 Embodiment 6 prescription composition (mg / tablet, 1000 tablets / batch)

[0056]

[0057]Example 6 Preparation process: Weigh the famotidine granules according to the prescription, mix them, add an appropriate amount of 50% ethanol to granulate, dry at 40° C., and pass through a 20-mesh sieve to obtain famotidine granules. Weigh PVP K30 according to the prescription, add water to dissolve and make 10% PVPK30 solution as the binder solution, weigh calcium carbonate magnesium hydroxide particles and other materials according to the prescription, mix evenly, add binder solution to make soft material, and pass through a 20-mesh sieve Granulate, dry at 60°C, and pass through a 18-mesh sieve for granulation to obtain calcium carbonate magnesium hydroxide granules. The two kinds of granules and excipient A are mixed evenly, and tablets are compressed with different compression pressures to obtain chewable tablets with different hardness tablets. Test tablet friabili...

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Abstract

The invention discloses a taste-masking compound famotidine chewable tablet. The compound famotidine chewable tablet is prepared by the following steps: preparing famotidine granules from famotidine and polyoxyethylene water-soluble resin (PEO), preparing calcium carbonate and magnesium hydroxide granules from calcium carbonate and magnesium hydroxide, uniformly mixing the two granules, adding an additional auxiliary material A, and tabletting to obtain the compound famotidine chewable tablet. The chewable tablet can obtain the friability smaller than or equal to 1.0% under the hardness of 40-100 N, is good in stability and has a taste masking effect.

Description

technical field [0001] The invention relates to a compound pharmaceutical composition of famotidine, calcium carbonate and magnesium hydroxide for treating gastric diseases, in particular to a taste-masked compound famotidine chewable tablet. [0002] The invention also relates to a preparation method of the taste-masked compound famotidine chewable tablet. Background technique [0003] Johnson & Johnson-Merck launched Pepcid Complete chewable tablets in 2000 for the treatment of heartburn and acid indigestion, consisting of 10mg famotidine, 800mg calcium carbonate and 165mg magnesium hydroxide. According to Johnson & Johnson patents US5075114 and US6814978, the preparation process of this product is as follows: coat famotidine with a mixture of cellulose acetate and hydroxypropyl cellulose, the solvent is a mixed solution of acetone and methanol, and then coat the famotidine coating powder with carbonic acid Excipients in the form of calcium, magnesium hydroxide and hydrat...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K9/22A61K31/426A61K33/10A61K33/08A61K47/10A61P1/04
CPCA61K9/0056A61K9/2095A61K9/2031A61K9/2077A61K31/426A61K33/10A61K33/08A61P1/04A61K2300/00
Inventor 王宇丰万山青轩豪月
Owner 河南合智医药科技有限公司
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