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.

1 . A method of treating a colchicine sensitive disorder, comprising orally administering a composition, comprising a liquid colchicine solution to a human subject having a colchicine sensitive disorder in an effective amount to treat the disorder. 
     
     
         2 . The method of  claim 1 , wherein the colchicine sensitive disorder is selected from gout, prophylactic treatment of gout, familial Mediterranean fever (FMF), prophylactic treatment of FMF, pericarditis, prophylactic treatment of pericarditis, Behçet's disease, atrial fibrillation, prophylactic treatment of atrial fibrillation, amyloidosis, calcium pyrophosphate deposition disease (pseudogout), cirrhosis of the liver, sarcoid arthritis, inflammatory diseases, and disk diseases and related spinal disorders. 
     
     
         3 - 20 . (canceled) 
     
     
         21 . The method of  claim 2 , wherein the gout is acute gout flares. 
     
     
         22 . The method of  claim 1 , wherein the colchicine is rapidly absorbed by the subject, producing peak concentrations in 0.5 to 2 hours. 
     
     
         23 . The method of  claim 1 , wherein the daily dosages administered to the human subject are from about 0.2 mg-1.5 mg/dose/day. 
     
     
         24 . The method of  claim 1 , wherein the daily dosages administered to the human subject are from about 0.5 mg-1.5 mg/dose/day. 
     
     
         25 . The method of  claim 1 , wherein the daily dosages administered to the human subject are from about 0.6-1.2 mg/dose/day. 
     
     
         26 . The method of  claim 1 , wherein the colchicine solution comprises water, buffering agent, glycol, preservative, sweetener, and thickening agent. 
     
     
         27 . The method of  claim 1 , wherein the liquid solution is stable for 30 days to at least 24 months at ambient and refrigerated temperature conditions. 
     
     
         28 . The method of  claim 1 , wherein the colchicine 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. 
     
     
         29 . The method of  claim 1 , wherein the liquid solution has a bioavailability in vivo similar to single ingredient colchicine tablets and capsules. 
     
     
         30 . The method of  claim 1 , wherein the liquid solution has a concentration of colchicine of 0.01-1.0 mg/mL. 
     
     
         31 . The method of  claim 1 , wherein the liquid solution has a concentration of colchicine of 0.01-1.0 mg/mL and is comprised of the following components:
 Benzyl Alcohol   Citric Acid, Anhydrous   Colchicine   Dibasic Sodium Phosphate Heptahydrate   Propylene Glycol   Glycerin   Xanthan Gum, and   Water.   
     
     
         32 . The method of  claim 1 , wherein the solution is stable for 3 months to 12 months at accelerated conditions. 
     
     
         33 . The method of  claim 1 , wherein the solution has a stable pH. 
     
     
         34 . The method of  claim 33 , wherein the pH is range is 6.2-7.2. 
     
     
         35 . The method of  claim 1 , wherein the solution has a viscosity in the range of 40-800 cps. 
     
     
         36 . The method of  claim 1 , wherein the solution is volume packaged 60 mL-473 mL. 
     
     
         37 . The method of  claim 1 , wherein the solution has less than 5% of total impurities. 
     
     
         38 . The method of  claim 1 , wherein the solution has less than 0.5% of degradants, optionally wherein the degradants comprise β-lumicolchicine, γ-lumicolchicine, and/or colchiceine. 
     
     
         39 . The method of  claim 1 , wherein the solution is stored in a light-resistant container.