Methods and compositions for selectively removing potassium ion from the gastrointestinal tract of a mammal

Abstract

The present invention provides methods and compositions for the treatment of ion imbalances using core-shell composites and compositions comprising such core-shell composites. In particular, the invention provides core-shell particles and compositions comprising potassium binding polymers, and core-shell particles and compositions comprising sodium binding polymers, and in each case, pharmaceutical compositions thereof. Methods of use of the polymeric and pharmaceutical compositions for therapeutic and/or prophylactic benefits are also disclosed. The compositions and methods of the invention offer improved approaches for treatment of hyperkalemia and other indications related to potassium ion homeostasis, and for treatment of hypertension and other indicates related to sodium ion homeostasis.

1 . (canceled) 
     
     
         2 . A method for removing potassium from a patient in need thereof comprising administering a potassium-binding agent in an oral dosage form to the patient, the potassium-binding agent comprising a zeolite, and the patient being administered a dose of up to about 20 grams per day. 
     
     
         3 . The method of  claim 2  wherein the dose is up to about 15 gram per day. 
     
     
         4 . The method of  claim 2  wherein the dose is from about 5 gram per day to about 20 gram per day. 
     
     
         5 . The method of  claim 2  wherein the dose is from about 5 gram per day to about 15 gram per day. 
     
     
         6 . The method of  claim 2  wherein the dose is from about 10 gram per day to about 20 gram per day. 
     
     
         7 . The method of  claim 2  wherein the dose is from about 10 gram per day to about 15 gram per day. 
     
     
         8 . The method of  claim 2  wherein the potassium-binding agent has an average in vitro binding capacity of at least (about) 2.0 mmol per gram. 
     
     
         9 . The method of  claim 2  wherein the potassium-binding agent has an average in vitro binding capacity of at least (about) 2.5 mmol per gram. 
     
     
         10 . The method of  claim 2  wherein the potassium-binding agent has an average in vitro binding capacity of at least (about) 3.0 mmol per gram. 
     
     
         11 . The method of  claim 2  wherein the potassium-binding agent has an average in vitro binding capacity of at least (about) 3.5 mmol per gram. 
     
     
         12 . A method of treating hyperkalemia in a patient in need thereof comprising administering a potassium-binding agent in an oral dosage form to the patient, the potassium-binding agent comprising a zeolite, and the patient being administered a daily dose of up to about 20 grams per day. 
     
     
         13 . The method of  claim 12  wherein the dose is up to about 15 gram per day. 
     
     
         14 . The method of  claim 12  wherein the dose is from about 5 gram per day to about 20 gram per day. 
     
     
         15 . The method of  claim 12  wherein the dose is from about 5 gram per day to about 15 gram per day. 
     
     
         16 . The method of  claim 12  wherein the dose is from about 10 gram per day to about 20 gram per day. 
     
     
         17 . The method of  claim 12  wherein the dose is from about 10 gram per day to about 15 gram per day. 
     
     
         18 . The method of  claim 12  wherein the potassium-binding agent has an average in vitro binding capacity of at least (about) 2.0 mmol per gram. 
     
     
         19 . The method of  claim 12  wherein the potassium-binding agent has an average in vitro binding capacity of at least (about) 2.5 mmol per gram. 
     
     
         20 . The method of  claim 12  wherein the potassium-binding agent has an average in vitro binding capacity of at least (about) 3.0 mmol per gram. 
     
     
         21 . The method of  claim 12  wherein the potassium-binding agent has an average in vitro binding capacity of at least (about) 3.5 mmol per gram.