Microporous Zirconium Silicate for the Treatment of Hyperkalemia

Abstract

The present invention relates to novel microporous zirconium silicate compositions that are formulated to remove toxins, e.g. potassium ions, from the gastrointestinal tract at an elevated rate without causing undesirable side effects. The preferred formulations are designed avoid increase in pH of urine in patients and/or avoid potential entry of particles into the bloodstream of the patient. Also disclosed is a method for preparing high purity crystals of UZSi-9 exhibiting an enhanced level of potassium exchange capacity. These compositions are particularly useful in the therapeutic treatment of hyperkalemia.

1 - 46 . (canceled) 
     
     
         47 . A method for removing potassium from a patient in need thereof comprising administering a potassium-binding particle in an oral dosage form to the patient, the potassium binding particle comprising a microporous material, the particle having an average in vitro binding capacity of at least about 1.8 mmol per gram for binding potassium, and the patient being administered a dose from about 0.005 grams per day to about 33 grams per day. 
     
     
         48 . The method of  claim 47 , wherein the dose is from about 0.5 grams per day to about 15 grams per day. 
     
     
         49 . The method of  claim 47 , wherein the dose is from about 5 grams per day to about 20 grams per day. 
     
     
         50 . The method of  claim 47 , wherein the dose is from about 5 grams per day to about 15 grams per day. 
     
     
         51 . The method of  claim 47 , wherein the dose is from about 10 grams per day to about 20 grams per day. 
     
     
         52 . The method of  claim 47 , wherein the dose is from about 10 grams per day to about 15 grams per day. 
     
     
         53 . The method of  claim 47 , wherein the potassium-binding particle has an average in vitro binding capacity of at least about 2.3 mmol per gram. 
     
     
         54 . The method of  claim 47 , wherein the potassium-binding particle has an average in vitro binding capacity of at least about 2.5 mmol per gram. 
     
     
         55 . The method of  claim 47 , wherein the potassium-binding particle has an average in vitro binding capacity of at least about 3.5 mmol per gram. 
     
     
         56 . The method of  claim 47 , wherein the microporous material having a capacity for binding potassium comprises a zirconium silicate. 
     
     
         57 . A method of treating hyperkalemia in a patient in need thereof comprising administering a potassium-binding particle in an oral dosage form to the patient, the potassium-binding particle comprising a microporous material, the particle having an average in vitro binding capacity of at least about 1.8 mmol per gram for binding potassium, and the patient being administered a daily dose from about 0.005 grams per day to about 33 grams per day. 
     
     
         58 . The method of  claim 57 , wherein the dose is from about 0.5 grams per day to about 15 grams per day. 
     
     
         59 . The method of  claim 57 , wherein the dose is from about 5 grams per day to about 20 grams per day. 
     
     
         60 . The method of  claim 57 , wherein the dose is from about 5 grams per day to about 15 grams per day. 
     
     
         61 . The method of  claim 57 , wherein the dose is from about 10 grams per day to about 20 grams per day. 
     
     
         62 . The method of  claim 57 , wherein the dose is from about 10 grams per day to about 15 grams per day. 
     
     
         63 . The method of  claim 57 , wherein the potassium-binding particle has an average in vitro binding capacity of at least about 2.3 mmol per gram. 
     
     
         64 . The method of  claim 57 , wherein the potassium-binding particle has an average in vitro binding capacity of at least about 2.5 mmol per gram. 
     
     
         65 . The method of  claim 57 , wherein the potassium-binding particle has an average in vitro binding capacity of at least about 3.5 mmol per gram. 
     
     
         66 . The method of  claim 57 , wherein the microporous material having a capacity for binding potassium comprises a zirconium silicate.