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 - 29 . (canceled) 
     
     
         30 . A non-sterile stable liquid formulation formulated for oral administration, consisting of:
 (a) buffering agent,   (b) water,   (c) a sweetener,   (d) preservative,   (e) vancomycin hydrochloride, and   (f) at least one excipient selected from the group consisting of buffering agents, preservatives, sweeteners, flavoring agents, coloring agents, tonicity agents, chelating agents, ethyl alcohol, glycerin, syrup and oils,   wherein the non-sterile stable liquid formulation is homogenous and stable for at least 1 week at ambient and refrigerated temperature and has a pH of 2.5-4.5.   
     
     
         31 . The liquid formulation of  claim 30 , wherein the buffering agent is 0.1-0.4% w/v citric acid. 
     
     
         32 . The liquid formulation of  claim 30 , wherein the preservative is selected from the group consisting of ascorbic acid, ascorbyl palmitate, benzyl alcohol, BHA, BHT, erythorbic acid, fumaric acid, malic acid, propyl gallate, sodium ascorbate, sodium benzoate, sodium bisulfate, sodium metabisulfite, sodium sulfite, parabens, benzoic acid, potassium sorbate, and vanillin. 
     
     
         33 . The liquid formulation of  claim 30 , wherein the buffering agents is selected from the group consisting of citric acid, sodium citrate, sodium tartarate, sodium acetate, sodium carbonate, sodium polyphosphate, potassium polyphosphate, sodium pyrophosphate, potassium pyrophosphate, disodium hydrogenphosphate, trisodium phosphate, tripotassium phosphate, sodium acetate, potassium metaphosphate, magnesium oxide, magnesium carbonate, magnesium silicate, calcium acetate, calcium glycerophosphate, calcium chloride, calcium hydroxide, calcium lactate, calcium carbonate, and calcium bicarbonate. 
     
     
         34 . A non-sterile stable liquid formulation formulated for oral administration, comprising:
 (a) citric acid,   (b) water,   (c) a sweetener,   (d) a preservative, wherein the preservative is selected from the group consisting of benzyl alcohol, sodium benzoate, parabens, benzoic acid, and potassium sorbate, and   (e) vancomycin hydrochloride, and   wherein the non-sterile stable liquid formulation is homogenous and stable for at least 1 week at ambient and refrigerated temperature and has a pH of 2.5-4.5.   
     
     
         35 . The liquid formulation of  claim 34 , wherein the liquid formulation has 0.1-0.4% w/v anhydrous citric acid. 
     
     
         36 . The liquid formulation of  claim 34 , wherein the liquid formulation has 0.2% w/v sucralose. 
     
     
         37 . The liquid formulation of  claim 34 , wherein the liquid formulation has a flavoring agent. 
     
     
         38 . The liquid formulation of  claim 37 , wherein the flavoring agent is 0.05% w/v artificial grape flavor. 
     
     
         39 . The liquid formulation of  claim 34 , wherein the preservative is sodium benzoate.