Pharmaceutical formulations comprising amoxicillin and clavulanante

A technology of clavulanate and amoxicillin, which is applied in the field of pharmaceutical preparations containing amoxicillin and clavulanate, and can solve problems such as no beneficial effects observed

Inactive Publication Date: 2006-07-26
GLAXO GRP LTD
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

However, which apparently already includes conventional suspending or thickening agents, no discernible beneficial effect has yet been observed due to the relatively low levels of amoxicillin used

Method used

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  • Pharmaceutical formulations comprising amoxicillin and clavulanante

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Embodiment 5

[0071] The effect of adding carboxymethylcellulose sodium to a series of typical formulations containing amoxicillin and clavulanate on the loss of clavulanate from the reconstituted suspension was determined over a period of 10 days. The prototype formulations evaluated corresponded to those in Examples 1A and 2 to 4, with 600 to 1200 mg / 5 ml amoxicillin and 43 mg / 5 ml constant levels of clavulanate. In addition, another formulation with a similar amount of excipient and containing 400 mg / 5 ml, and a reference formulation containing 200 mg / 5 ml were also included for comparison.

[0072] The formulations are made up of defined concentrations with water. Samples were taken initially and after 10 days of storage (at 4°C). Samples were analyzed for clavulanate concentration using HPLC and UV detection. In addition, the pH of the suspension was measured at the same time point.

[0073] The results of the pH change and loss of clavulanate after 10 days are shown in the table be...

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Abstract

The present invention provides formulations comprising amoxicillin and clavulanate for reconstitution into an aqueous suspension incorporate low levels of carboxymethylcellulose sodium to stabilise the pH thereof.

Description

technical field [0001] The present invention relates to a pharmaceutical formulation suitable for pediatric use containing amoxicillin and clavulanate. Background technique [0002] The combination of amoxicillin and clavulanate (co-amoxiclav) is an effective empiric treatment for bacterial infections and can be given by oral administration e.g. Usually a flavored aqueous solution or suspension. Various formulations of co-amoxiclav are marketed by GlaxoSmithKline under the brand name Amistene. [0003] Pediatric formulations containing amoxicillin and clavulanate are typically provided as dry powder or granules in containers such as bottles. It is reconstituted with a defined amount of water before first use to provide a suspension of defined concentration, generally a multi-dose suspension covering the entire course of treatment. [0004] Clavulanate is known to be readily degradable in dry powder or reconstituted state. Stability in the dry state is critical as it can ...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K31/43A61K31/424A61P31/04
CPCA61K31/424A61K31/43A61P31/04A61K2300/00
Inventor M·G·拉姆西J·T·里克曼
Owner GLAXO GRP LTD
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