Sustained-release formulations of colchicine and methods of using same

Abstract

Pharmaceutical compositions of colchicine for once-a-day oral administration are provided. The formulations comprise a sustained-release component and an optional immediate-release component, the compositions of which can be selectively adjusted, respectively, to release the active ingredient along a pre-determined or desired release profile. Methods of treating or preventing cardiovascular disease and/or inflammatory disease in mammalian subjects comprising the administration of the novel formulations disclosed herein are also provided.

What is claimed is: 
     
         1 . A method of treating cardiovascular disease in a subject, which comprises:
 orally administering, once daily to the subject, a sustained release means for delivering colchicine.   
     
     
         2 . The method of  claim 1 , wherein the cardiovascular disease is at least one chosen from acute pericarditis, recurrent pericarditis, post-pericardiotomy syndrome (PPS), and cardiovascular events in subjects with stable coronary disease. 
     
     
         3 . The method of  claim 1 , wherein the subject has acute cardiovascular disease and is concurrently administered an agent that treats acute cardiovascular events, and wherein the acute cardiovascular event is at least one chosen from acute coronary syndrome, out-of-hospital cardiac arrest, and noncardioembolic ischemic stroke. 
     
     
         4 . The method of  claim 3 , wherein the agent that treats acute cardiovascular events is chosen from at least one of atorvastatin, rosuvastatin, simvastatin and pravastatin, and a pharmaceutically acceptable salt thereof. 
     
     
         5 . The method of  claim 1 , wherein the sustained release means results in less than about 70% of colchicine being released in vitro within about 2 hours at 37.degree. C. 
     
     
         6 . A method of treating cardiovascular disease in a subject, which comprises:
 administering to the subject a sustained release means for delivering colchicine, wherein the colchicine sustained release means results in less than about 70% of colchicine being released in vitro within about 2 hours at 37.degree. C.   
     
     
         7 . The method of  claim 6 , wherein the cardiovascular disease is chosen from at least one of acute pericarditis, recurrent pericarditis, post-pericardiotomy syndrome (PPS), and cardiovascular events in subjects with stable coronary disease. 
     
     
         8 . The method of  claim 6 , wherein the subject has acute cardiovascular disease and is concurrently administered an agent that treats acute cardiovascular events, and wherein the acute cardiovascular event is chosen from acute coronary syndrome, out-of-hospital cardiac arrest, and noncardioembolic ischemic stroke. 
     
     
         9 . The method of  claim 8 , wherein the agent that treats acute cardiovascular events is chosen from at least one of atorvastatin, rosuvastatin, simvastatin and pravastatin, and a pharmaceutically acceptable salt thereof. 
     
     
         10 . The method of  claim 6 , wherein the colchicine sustained release means is administered once daily.