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Compositions and Methods of Preperation Comprising Amoxicillin and Potassium Clavulanate, or Salts Thereof
Korea Health Industry Development Institute (KHIDI) South Korea flag South Korea
Abstract ID:
We have developed the tablet for suspension containing Amoxicillin and Potassium Clavulanate, equivalent to GSK\'s Augmentin® Suspension, This product is much superior to the reference product in terms of stability during storage and don\'t require stor...
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MECHANISM OF ACTION
Remarkably stability of main component, Suitable administration, Easiness of Formulation, Simple portable tablet

The core technology of GLPT is to provide promising dispersible tablet.  The dispersible tablet of this invention has some advantages: easy formulation procedures and high solubility in water.


Background and unmet needs: Amoxicillin is a representative of β-lactam antibiotic substances and has efficacies on bacterial infection. Potassium clavulanate has a role of expanding anti-bacterial spectrum of amoxicillin as a function to inhibit β-lactamase. Mixture of amoxicillin/potassium clavulanate has been already developed and commercially utilized as a representative product, Augmentin®.


Discovery and Achievements: Mixture of amoxicillin/potassium clavulanate could be commercially purchased, which contains forms of tablet, dry syrup and injection. Among them, dry syrup was used in a form of suspension solution dissolved in a constant amount of water. However, dry syrup is prone to deterioration according to resuspended or storage conditions.


To overcome this problem, the GLPT has made intensive studies to develop an dispersible tablet for improving administration, formulation and solubility. As results, the GLPT has discovered the simple portable dispersible tablet of this invention with great stability, exact administration, easy formulation and high solubility in water.

The dispersible tablet of this invention was composed of disintegrant, filler, glydent, sweetner and pertume. The dispersible tablet of this invention was fabricated to be resuspended by disintegration in small amount of water within 1 min.


Karl Fisher method


Assay


90-120%


Period


Storage


Conditions


Appearance


Confirm Test


Disintegration Time (sec)


Water content


Content (%)




Amoxicillin






Potassium clavulanate






Standard






White~pale yellow






Positive






Within 3 min






> 9.0%






90-120%






90-120%






Initial






-






fit






positive






39






6.88






103.16






105.57






1 month






25°C/RH60%






fit






positive






36






7.02

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Type of Business Relationship Sought
Patent Pending
FEATURED
Last Updated Jun 2016
Technology Type MEDICAL DEVICE
Phase of Development EARLY STAGE
GOVERNMENT INSTITUTE