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Dispersible tablet containing amoxicillin and potassium clavulanate

A technology of potassium clavulanate and amoxicillin, which is applied in the field of dispersible tablets containing amoxicillin and potassium clavulanate, can solve the problems of heavy economic burden for patients, low dissolution rate and dissolution rate, and inconvenient administration, and achieve Excellent dispersion uniformity and dissolution rate, reduced medication burden, and shortened time to peak

Active Publication Date: 2012-07-25
NANJING CHENGONG PHARM CO LTD
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

However, ordinary tablets and capsules have their own disadvantages. They cannot disintegrate quickly when exposed to water, their dissolution rate and dissolution rate are low, their absorption is poor, and the proportion of excipients is large. Children, the elderly, bedridden patients and patients with dysphagia cannot take them. Convenience, poor compliance, etc., affect the therapeutic effect of amoxicillin / clavulanate potassium compound preparation
[0004] Although the dispersible tablets of amoxicillin / potassium clavulanate have been listed at home and abroad at present, and these three materials of croscarmellose sodium, carboxymethyl starch sodium and crospovidone are used to apply in amoxicillin / In the prescription of potassium clavulanate dispersible tablets, however, because the two disintegrants crospovidone and croscarmellose sodium are relatively expensive, the joint use of disintegrants increases the production cost of this variety , bringing a heavy economic burden to patients
In addition, the hardness of this dispersible tablet is not enough (the hardness is generally lower than 50N), and the tablet is easily broken during transportation after ordinary packaging

Method used

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  • Dispersible tablet containing amoxicillin and potassium clavulanate
  • Dispersible tablet containing amoxicillin and potassium clavulanate
  • Dispersible tablet containing amoxicillin and potassium clavulanate

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0052] Example 1 Screening study of disintegrants

[0053]The dispersible tablets of the prior art that contain amoxicillin and potassium clavulanate mostly adopt the mixed disintegrant of croscarmellose sodium and crospovidone, but because crospovidone, croscarmellose Plain sodium is more expensive, and the use of disintegrants increases production costs. On the premise of ensuring the quality of the finished product, in order to reduce the production cost, the inventors further screened many disintegrants. Specifically, in terms of the selection of disintegrants, the inventors have found through a large number of experiments: the use of sodium carboxymethylcellulose, precrossified starch, and calcium sodium carboxymethylcellulose as a single disintegrant cannot meet the technical requirements of the present invention. Therefore, cross-linked sodium carboxymethyl cellulose, sodium carboxymethyl starch, low-substituted hydroxypropyl cellulose and cross-linked povidone were ...

Embodiment 2

[0057] Example 2 Preparation of Amoxicillin / Potassium Clavulanate Dispersible Tablets

[0058] Prescription composition:

[0059] Amoxicillin 420 g;

[0060] Potassium clavulanate 60 g;

[0061] 210 g powdered sugar;

[0062] Microcrystalline cellulose 180 g;

[0063] Low-substituted hydroxypropyl cellulose 85 g;

[0064] Colloidal silicon dioxide 18 g;

[0065] Magnesium stearate 5 g.

[0066] Preparation Process:

[0067] Under the conditions of temperature ≤ 20°C and relative humidity ≤ 20%, follow the steps below:

[0068] (1) Weigh the raw and auxiliary materials of the above prescription quantity, and the prescription quantity of amoxicillin-clavulanate potassium mixed powder is calculated as clavulanic acid.

[0069] (2) Dry the raw and auxiliary materials except amoxicillin-clavulanate potassium mixed powder and colloidal silicon dioxide, in which the temperature of amoxicillin and magnesium stearate is set at 40±5°C for 5 hours. The rest of the accesso...

Embodiment 3

[0074] Example 3 Preparation of Amoxicillin / Potassium Clavulanate Dispersible Tablets

[0075] Prescription composition:

[0076] Amoxicillin 420 g;

[0077] Potassium clavulanate 60 g;

[0078] 160 g powdered sugar;

[0079] Starch 190 g;

[0080] Low-substituted hydroxypropyl cellulose 100 g;

[0081] Colloidal silicon dioxide 20 g;

[0082] Magnesium stearate 5 g.

[0083] Preparation process: with embodiment 2.

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Abstract

The invention belongs to the technical field of western medicine preparations, and particularly relates to a dispersible tablet containing amoxicillin and potassium clavulanate. The dispersible tablet comprises the following components in parts by weight: 420 parts of amoxicillin, 60 parts of potassium clavulanate, 350-400 parts of filler, 80-100 parts of low-substituted hydroxypropyl cellulose, 1-20 parts of colloidal silicon dioxide and 5-8 parts of magnesium stearate. For the dispersible tablet, both the dispersing uniformity and dissolution achieve the technological effects of the existing product, simultaneously, and the hardness of the pressed tablet is within 50-70N, so that the problems of insufficient hardness and difficulty in common packaging existing in products on the market are solved.

Description

technical field [0001] The invention belongs to the technical field of western medicine preparations, in particular to a dispersible tablet containing amoxicillin and potassium clavulanate. Background technique [0002] Compound preparations consisting of amoxicillin and potassium clavulanate, a β-lactamase inhibitor, are increasingly popular in clinical practice. Clavulanic acid, also known as clavulanic acid, is a metabolite of streptococcus, which itself has only a small antibacterial activity, but it can interact with various strains of gram-negative and positive bacteria, aerobic bacteria, anaerobic bacteria, etc. β-lactamase binds firmly to form an irreversible conjugate, thereby protecting amoxicillin from being hydrolyzed by β-lactamase. Since the pharmacokinetic properties of the two drugs are similar, and they are also compatible in terms of physical and chemical properties, the compound preparation has an expanded antibacterial spectrum and more indications than ...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K31/43A61K31/424A61K9/20A61K47/38A61P31/04
Inventor 郭昭
Owner NANJING CHENGONG PHARM CO LTD
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