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

Remarkably stability of main component, Suitable administration, Easiness of Formulation, Simple portable tablet

l  Technology Platform

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.

TABLE 1. Composition of dispersible tablet of this invention

Classification	Components
Disintegrant	A and B
Filler	Microcrystalline cellulose and silicon dioxide
Glydent	Magnesium stearate
Sweetner	Acesulfame potassium
Pertume	Strawberry flavor cotton

 

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.

TABLE 2. Specification

Item	Standard	Reference
Appearance	White or pale yellow circular tablet
Identification	Positive
Disintegration Time	Within 3 min	15-25°C in pure water
Water content	> 9.0%	Karl Fisher method
Assay	90-120%

 

TABLE 3. Stability Test under Long-term Storage Conditions and Accelerated Conditions

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

Early Stage

The GLPT has been already filed for a patent application in Korea. In addition, it will be filed for a PCT application in the near future.

development collaboration, or non-exclusive or exclusive licensing agreement