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Method for preparing cefixime dispersible tablets

A technology of cefixime and dispersible tablets, which is applied in the field of preparation of anti-infective cefixime dispersible tablets and cefixime dispersible tablets, can solve the problem of slow dissolution rate, insufficient bioavailability and failure to achieve complete Dissolution and other problems, to achieve the effect of complete dissolution and fast dissolution

Active Publication Date: 2012-09-19
SHANGHAI NEW ASIATIC PHARMA MINHANG
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

However, it is precisely because of the large particle size that the dissolution rate of the prepared cefixime dispersible tablet is relatively slow. Although the dissolution rate of this product can basically meet the requirements of the national standard (>75%), in the actual test, its 30-minute cumulative Generally, the dissolution rate can only reach about 90%, and the complete dissolution cannot be achieved, resulting in insufficient bioavailability in the body, and the best therapeutic effect cannot be achieved.

Method used

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  • Method for preparing cefixime dispersible tablets
  • Method for preparing cefixime dispersible tablets
  • Method for preparing cefixime dispersible tablets

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0040] Example 1 Cefixime Dispersible Tablet Prescription Ⅰ:

[0041] Cefixime 500g (18.7%)

[0042] Microcrystalline Cellulose 850g (31.8%)

[0043] Pregelatinized starch 190g (7.1%)

[0044] Sodium starch glycolate 300g (11.2%)

[0045] 2% hypromellose aqueous solution 800g (29.9%)

[0046] Magnesium Stearate 15g (0.56%)

[0047] Sodium Lauryl Sulfate 20g (0.75%)

[0048] Made into 10000 pieces

[0049] The preparation process is as follows:

[0050]500g of cefixime bulk drug was micronized into a powder with a particle size between 20 μm and 120 μm, mixed evenly with 200 g of microcrystalline cellulose, and dried into dry granules by a dry granulator to obtain material 1. 16 g of hydroxypropyl methylcellulose (another name called hypromellose) and 20 g of sodium lauryl sulfate were dissolved in 764 g of water to obtain a binder solution. The...

Embodiment 2

[0051] Example 2 Cefixime Dispersible Tablets Prescription Ⅱ:

[0052] Cefixime 500g (17.6%)

[0053] Microcrystalline Cellulose 200g (7.1%)

[0054] Lactose 1000g (35.3%)

[0055] Crospovidone 300g (10.6%)

[0056] 2% hypromellose aqueous solution 800g (28.2%)

[0057] Magnesium Stearate 15g (0.5%)

[0058] Tween 80 20g (0.7%)

[0059] Made into 10000 pieces

[0060] The preparation process is as follows:

[0061] 500g of cefixime bulk drug was micronized into a powder with a particle size between 20 μm and 120 μm, mixed evenly with 200 g of lactose, and dried into dry granules by a dry granulator to obtain material 1. 16 g of hypromellose and 20 g of Tween 80 were dissolved in 764 g of water to obtain a binder solution. Mix the remaining 1000g of lactose with 200g of microcrystalline cellulose and 200g of crospovidone evenly, use t...

Embodiment 3

[0062] Example 3 Cefixime Dispersible Tablets Prescription Ⅲ:

[0063] Cefixime 500g

[0064] Starch 800g

[0065] Lactose 500g

[0066] Croscarmellose Sodium 200g

[0067] 5% povidone K30 aqueous solution 800g

[0068] Magnesium Stearate 15g

[0069] Tween 80 20g

[0070] Made into 10000 pieces

[0071] The preparation process is as follows:

[0072] 500g of cefixime bulk drug was micronized into a powder with a particle size between 20 μm and 120 μm, mixed evenly with 300 g of starch, and dried into dry granules by a dry granulator to obtain material 1. 40 g of povidone K30 and 20 g of Tween 80 were dissolved in 740 g of water to obtain a binder solution. Mix the remaining 500g of lactose with 500g of starch and 100g of croscarmellose sodium evenly, use the above-mentioned adhesive to make wet granules, dry and granulate the wet granules to obtain ...

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Abstract

The invention discloses a method for preparing cefixime dispersible tablets, relates to the field of pharmaceutical preparation and particularly relates to cefixime dispersible tablets which are anti-infective agents and the method for preparing the cefixime dispersible tablets. Cefixime serves as an active pharmaceutical ingredient of the cefixime dispersible tablets and auxiliary materials are added in the cefixime dispersible tablets. The auxiliary materials include solubilizing agents, filling agents, lubricating agents, bonding agents and disintegrating agents. The cefixime dispersible tablets include, by weight, 15%-60% of the micronized cefixime, 10%-70% of the filling agents or diluents, 1%-20% of the disintegrating agents, 0.3%-5% of the lubricating agents, 0.5%-10% of the bonding agents and 0.5%-5% of the solubilizing agents, wherein grain diameters of the micronized cefixime range from 20 mu m to 120 mu m. The method has the advantages that the dissolving speed of the cefixime dispersible tablets is rapid and the dissolving is complete.

Description

technical field [0001] The invention relates to a preparation method of a cefixime dispersible tablet, which relates to the field of pharmaceutical preparations, in particular to an anti-infective drug cefixime dispersible tablet, and a preparation method of the dispersible tablet. Background technique [0002] Cefixime, chemical name: (6R,7R)-7-[(Z)-2-(2-amino-4-thiazolyl)-2-(carboxymethoxyimino)acetamido]-8-oxo Substituent-3-vinyl-5-thia-1-azabicyclo[4.2.0]-oct-2-ene-2-carboxylic acid trihydrate, the structural formula is as follows: [0003] [0004] Cefixime is the third-generation cephalosporin product developed by Japan's Fujisawa Pharmaceutical Co., Ltd. It was launched in Japan in 1987. In 1999, more than 80 countries in the world had used cefixime clinically. [0005] Cefixime is an oral broad-spectrum cephalosporin, especially against Streptococcus in Gram-positive bacteria, Pneumococcus in Gram-negative bacteria, Neisseria gonorrhoeae in Gram-negative bacter...

Claims

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Application Information

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IPC IPC(8): A61K9/20A61K31/546A61P31/04
Inventor 曾垂宇王佩芳商鼎
Owner SHANGHAI NEW ASIATIC PHARMA MINHANG
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