Ion binding polymers and uses thereof

Abstract

The present invention provides methods and compositions for the treatment of ion imbalances. In particular, the invention provides compositions comprising potassium binding polymers and pharmaceutical compositions thereof. Methods of use of the polymeric and pharmaceutical compositions for therapeutic and/or prophylactic benefits are disclosed herein. Examples of these methods include the treatment of hyperkalemia, such as hyperkalemia caused by renal failure and/or the use of hyperkalemia causing drugs.

What is claimed is: 
     
         1 . A pharmaceutical composition comprising a potassium-binding polymer and a pharmaceutically acceptable excipient, wherein said potassium-binding polymer comprises a α-fluoroacrylate polymer crosslinked with divinyl benzene. 
     
     
         2 . A method of treating a disease comprising administering to an animal subject in need thereof an effective amount of a pharmaceutical composition of  claim 1 . 
     
     
         3 . A core-shell composition comprising a core and a shell, said core comprising a potassium binding polymer selected from polystyrene sulfonate or α-fluoroacrylate polymer crosslinked with divinyl benzene and said shell comprising Eudragit RL 100, Eudragit RS 100, a combination thereof, benzylated polyethyleneimine, or N-dodecyl polyethyleneimine. 
     
     
         4 . The composition of  claim 3  wherein said shell comprises a mixture of Eudragit RL 100 and Eudragit RS 100 in a ratio of about 50: about 50. 
     
     
         5 . The composition of  claim 3  wherein said shell comprises benzylated polyethyleneimine with a degree of benzylation being about 20% to about 99% of nitrogen mole content. 
     
     
         6 . The composition of  claim 3  wherein said shell comprises N-dodecyl polyethyleneimine with a degree of dodecyl alkylation being about 20% to about 99% of nitrogen mole content. 
     
     
         7 . The composition of  claim 3  wherein said core-shell composition is synthesized by a Wurster fluid bed coating process or a controlled coating precipitation process. 
     
     
         8 . The composition of  claim 7  wherein said controlled coating precipitation process is a solvent coacervation process, a pH triggered precipitation process, or temperature triggered precipitation process. 
     
     
         9 . A method of treating a disease comprising administering to an animal subject in need thereof an effective amount of a core-shell composition of  claim 3 . 
     
     
         10 . A method of removing potassium from an animal subject comprising administering to said animal subject in need thereof an effective amount of a pharmaceutical composition comprising a potassium-binding polymer and a pharmaceutically acceptable excipient, wherein said potassium-binding polymer comprises a α-fluoroacrylate polymer crosslinked with divinyl benzene. 
     
     
         11 . A method of removing potassium from an animal subject in need thereof comprising administering to said animal subject an effective amount of a core-shell composition comprising a core and a shell, said core comprising a potassium binding polymer selected from polystyrene sulfonate or α-fluoroacrylate polymer crosslinked with divinyl benzene and said shell comprising Eudragit RL 100, Eudragit RS 100, a combination thereof, or benzylated polyethyleneimine. 
     
     
         12 . The method of  claim 10  or  11  wherein said animal subject is suffering from hyperkalemia. 
     
     
         13 . The method of  claim 10  or  11  wherein said composition is co-administered with a drug that promotes potassium retention. 
     
     
         14 . The method of  claim 10  or  11  wherein said composition is co-administered with an ACE inhibitor, an ARB, a potassium sparing diuretic, or any combination thereof 
     
     
         15 . A method of synthesis of α-fluoroacrylate polymer comprising suspension polymerization of a α-fluoroacrylate monomerin the presence of a low water soluble free radical initiator and a water soluble salt. 
     
     
         16 . The method of  claim 15  wherein said low water soluble free radical initiator is lauryl peroxide and said water soluble salt is sodium chloride.