Composition and method of use of colchicine oral liquid

Abstract

Oral liquid colchicine formulations are described herein. Methods of using the oral liquid colchicine formulations are also provided.

What is claimed is: 
     
         1 . A liquid solution suitable for oral administration comprising colchicine, wherein the concentration of colchicine in the solution is 0.01-1.0 mg/mL, and a pharmaceutically acceptable solvent system, and wherein the liquid solution has a stable pH and is stable for 30 days to 24 months at ambient and refrigerated temperature conditions. 
     
     
         2 . The liquid solution of  claim 1 , wherein the liquid solution comprises a glycol, buffering agent, preservative, sweetener, and thickening agent. 
     
     
         3 . The liquid solution of  claim 2 , wherein the liquid solution is comprised of the following components:
 benzyl alcohol   citric acid   colchicine   dibasic sodium phosphate heptahydrate   propylene glycol   glycerin   xanthan gum, and   water.   
     
     
         4 . The liquid solution of  claim 1 , wherein the liquid solution has a bioavailability in vivo similar to single ingredient colchicine tablets and capsules. 
     
     
         5 . The liquid solution of  claim 1 , wherein the liquid solution has a viscosity in the range of 40-800 cps and is stable for 30 days to 24 months at ambient and refrigerated temperature conditions. 
     
     
         6 . A liquid solution suitable for oral administration comprising colchicine and a pharmaceutically acceptable solvent system, wherein the liquid solution is stable for 30 days to 24 months at ambient and refrigerated temperature conditions, and wherein the liquid solution comprises a glycol, buffering agent, preservative, sweetener, and thickening agent. 
     
     
         7 . The liquid solution of  claim 6 , wherein the liquid solution is comprised of the following components:
 benzyl alcohol   citric acid   colchicine   propylene glycol   glycerin, and   water.   
     
     
         8 . The liquid solution of  claim 6 , wherein the solution is stored in a light-resistant container. 
     
     
         9 . The liquid solution of  claim 6 , wherein the liquid solution has a viscosity in the range of 40-800 cps and a stable pH and is stable for 30 days to 24 months at ambient and refrigerated temperature conditions. 
     
     
         10 . A liquid solution suitable for oral administration comprising colchicine, wherein the concentration of colchicine in the solution is 0.01-1.0 mg/mL, and a pharmaceutically acceptable solvent system, wherein the liquid solution is stable for 30 days to 24 months at ambient and refrigerated temperature conditions, and wherein the liquid solution has a bioavailability in vivo similar to single ingredient colchicine tablets and capsules. 
     
     
         11 . The liquid solution of  claim 10 , wherein the liquid solution comprises water, 0.1-0.3% w/v of buffering agents, 2-18% glycols, 0.2-0.4% w/v of preservatives, and 0.1-0.2% w/v of thickening agents. 
     
     
         12 . The liquid solution of  claim 11 , wherein the solution has less than 0.5% of degradants and wherein the degradants comprise β-lumicolchicine, γ-lumicolchicine, and/or colchiceine. 
     
     
         13 . The liquid solution of  claim 10 , wherein the liquid solution has a bioavailability in vivo similar to single ingredient colchicine tablets and capsules. 
     
     
         14 . The liquid solution of  claim 10 , wherein the liquid solution has a stable pH. 
     
     
         15 . A liquid solution suitable for oral administration comprising colchicine, wherein the concentration of colchicine in the solution is 0.01-1.0 mg/mL, and a pharmaceutically acceptable solvent system, and wherein the liquid solution is stable for 30 days to 24 months at ambient and refrigerated temperature conditions and wherein the solution has less than 0.5% of degradants, optionally wherein the degradants comprise β-lumicolchicine, γ-lumicolchicine, and/or colchiceine. 
     
     
         16 . The liquid solution of  claim 15 , wherein the liquid solution comprises a glycerin. 
     
     
         17 . The liquid solution of  claim 15 , wherein the liquid solution comprises water, 0.1-0.3% w/v of buffering agents, 2-18% glycols, 0.2-0.4% w/v of preservatives, and 0.1-0.2% w/v of thickening agents. 
     
     
         18 . The liquid solution of  claim 16 , wherein the liquid solution has a viscosity in the range of 40-800 cps. 
     
     
         19 . The liquid solution of  claim 16 , wherein the liquid solution prevents photodegradation of colchicine. 
     
     
         20 . The liquid solution of  claim 16 , wherein the solution is stored in a light-resistant container.