Composition and method for vancomycin oral liquid

Abstract

The invention relates to stable vancomycin hydrochloride powder for oral liquid formulations. Also provided herein are methods of using vancomycin oral liquid formulations for the treatment of certain diseases such as Clostridium difficile pseudomembranous colitis and Staphylococcal enterocolitis as well as kits and related products thereof.

What is claimed is: 
     
         1 . A non-sterile stable liquid formulation comprising a compounded solution of vancomycin hydrochloride that is homogenous and stable for at least 30 days at ambient and refrigerated temperature conditions, wherein the compounded solution is prepared from vancomycin hydrochloride and a liquid solution that is not Ora-Sweet. 
     
     
         2 . The liquid formulation of  claim 1 , wherein the liquid solution is stable for up to 3 months at accelerated conditions. 
     
     
         3 . The liquid formulation of  claim 1 , wherein the liquid solution is stable for up to 24 months at ambient conditions. 
     
     
         4 . The liquid formulation of  claim 1 , wherein the liquid solution comprises:
 (a) a buffering agent,   (b) water,   (c) a sweetener,   (d) a flavoring agent,   (e) a preservative, and   (f) a dye.   
     
     
         5 . The liquid formulation of  claim 4 , wherein the buffering agent is about 0.12% (w/v) citric acid (anhydrous). 
     
     
         6 . The liquid formulation of  claim 4 , wherein the sweetener is about 0.2% (w/v) sucralose. 
     
     
         7 . The liquid formulation of  claim 4 , wherein the flavoring agent is about 0.05% (w/v) artificial grape flavor. 
     
     
         8 . The liquid formulation of  claim 4 , wherein the preservative is about 0.1% (w/v) sodium benzoate. 
     
     
         9 . The liquid formulation of  claim 4 , wherein the dye comprises about 0.0002% (w/v) D&C Yellow No. 10 and about 0.000038% (w/v) FD&C Red No. 40. 
     
     
         10 . The liquid formulation of  claim 1 , wherein the compounded solution is formulated for use in the treatment of  C. difficile  pseudomembranous colitis and  Staphylococcal enterocolitis . 
     
     
         11 . The liquid formulation of  claim 1 , wherein the compounded solution is formulated to inhibit the growth of bacteria, mold and yeast for at least 30 days at ambient and refrigerated temperature conditions. 
     
     
         12 . The liquid formulation of  claim 1 , wherein the liquid solution is formulated to inhibit the growth of mold and yeast for greater than 30 days at room temperature conditions. 
     
     
         13 . The liquid formulation of  claim 1 , wherein the concentration of vancomycin in the compounded solution is 1-100 mg/ml. 
     
     
         14 . The liquid formulation of  claim 1 , wherein the concentration of vancomycin in the compounded solution is 20-60 mg/ml. 
     
     
         15 . The liquid formulation of  claim 1 , wherein the concentration of vancomycin in the compounded solution is 25-50 mg/ml. 
     
     
         16 - 19 . (canceled) 
     
     
         20 . A non-sterile stable liquid formulation comprising a compounded solution of vancomycin hydrochloride that is homogenous and stable for at least 30 days at ambient and refrigerated temperature conditions, wherein the compounded solution has a high solubility in water and a pH of about 2.5-4.5. 
     
     
         21 . The liquid formulation of  claim 20 , wherein the compounded solution is an amber color. 
     
     
         22 . The liquid formulation of  claim 20 , wherein the compounded solution includes a sweetener. 
     
     
         23 . A non-sterile stable liquid formulation comprising a compounded solution of vancomycin hydrochloride that has been dissolved in a liquid solution comprising a preservative, wherein the compounded solution is stable for at least 30 days at ambient and refrigerated temperature conditions and wherein the preservative is present in the liquid solution at a concentration range of 0.08- 0.2% (w/v). 
     
     
         24 . A liquid solution comprising:
 (a) 0.1-0.4% (w/v) citric acid (anhydrous),   (b) water,   (c) 0.1-0.3% (w/v) sucralose,   (d) 0.01-0.1 (w/v) of a flavoring agent,   (e) 0.08- 0.2% (w/v) sodium benzoate, and   (f) 0.0001-0.0003% (w/v) of a dye.   
     
     
         25 - 29 . (canceled)