Claims for Patent: 9,861,658

Summary for Patent: 9,861,658

Title:	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.
Inventor(s):	Keyser; Donald Jeffrey (Southlake, TX), Guillem; Alvaro F. (Lantana, TX)
Assignee:	ZS PHARMA, INC. (Coppell, TX)
Application Number:	14/826,038
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for patent 9,861,658
Patent Claims:	1. A method of treating hyperkalemia comprising administering to a patient in need thereof a particulate zirconium silicate composition having a uniform microporosity with a pore diameter of about 3 angstroms and exhibiting a selective potassium exchange capacity of greater than 1.7 mEq/g and a sodium content below 12% by weight, wherein the zirconium silicate is formula (I): A.sub.pM.sub.xZr.sub.1-xSi.sub.nGe.sub.yO.sub.m (I) where A is a potassium ion, sodium ion, rubidium ion, cesium ion, calcium ion, magnesium ion, hydronium ion or mixtures thereof, M is at least one framework metal, wherein the framework metal is hafnium (4+), tin (4+), niobium (5+), titanium (4+), cerium (4+), germanium (4+), praseodymium (4+), terbium (4+) or mixtures thereof, "p" has a value from about 1 to about 20, "x" has a value of 0 or approaching 0, "n" has a value from 1 to about 12, "y" has a value from 0 to about 12, "m" has a value from about 3 to about 36 and 1.ltoreq.n+y.ltoreq.12. 2. The method of claim 1, wherein the selective potassium exchange capacity is between 1.7-4.7 mEq/g. 3. The method of claim 2, wherein the selective potassium exchange capacity is between 2.7-3.7 mEq/g. 4. The method of claim 1, wherein the zirconium silicate exhibits a sodium content below 9% by weight. 5. The method of claim 1, wherein the zirconium silicate is ZS-9. 6. The method of claim 1, wherein the selective potassium exchange capacity is greater than 3.5 mEq/g. 7. The method of claim 1, wherein the selective potassium exchange capacity is greater than 4.0 mEq/g. 8. A method of treating hyperkalemia comprising administering to a patient in need thereof a particulate zirconium silicate composition having a uniform microporosity with a pore diameter of about 3 angstroms and exhibiting a selective potassium exchange capacity of greater than 1.7 mEq/g and a sodium content below 12% by weight, wherein the zirconium silicate is formula (I): A.sub.pM.sub.xZr.sub.1-xSi.sub.nGe.sub.yO.sub.m (I) where A is a potassium ion, sodium ion, rubidium ion, cesium ion, calcium ion, magnesium ion, hydronium ion or mixtures thereof, M is at least one framework metal, wherein the framework metal is hafnium (4+), tin (4+), niobium (5+), titanium (4+), cerium (4+), germanium (4+), praseodymium (4+), terbium (4+) or mixtures thereof, "p" has a value from about 1 to about 20, "x" has a value of 0 or approaching 0, "n" has a value from 1 to about 12, "y" has a value from 0 to about 12, "m" has a value from about 3 to about 36 and 1.ltoreq.n+y.ltoreq.12, wherein the zirconium silicate in the composition comprises particles having a median particle size of greater than 3 microns and less than 7% of the particles in the composition have a diameter less than 3 microns. 9. The method of claim 8, wherein the zirconium silicate in the composition exhibits a median particle size of greater than 3 microns and less than 3% of the particles in the composition have a diameter less than 3 microns. 10. A method of treating hyperkalemia comprising administering to a patient in need thereof a particulate zirconium silicate composition having a uniform microporosity and exhibiting a selective potassium exchange capacity in the range of 1.7 mEq/g to 3.7 mEq/g and a sodium content below 12% by weight, wherein the zirconium silicate is formula (I): A.sub.pM.sub.xZr.sub.1-xSi.sub.nGe.sub.yO.sub.m (I) where A is a potassium ion, sodium ion, rubidium ion, cesium ion, calcium ion, magnesium ion, hydronium ion or mixtures thereof, M is at least one framework metal, wherein the framework metal is hafnium (4+), tin (4+), niobium (5+), titanium (4+), cerium (4+), germanium (4+), praseodymium (4+), terbium (4+) or mixtures thereof, "p" has a value from about 1 to about 20, "x" has a value of 0 or approaching 0, "n" has a value from 1 to about 12, "y" has a value from 0 to about 12, "m" has a value from about 3 to about 36 and 1.ltoreq.n+y.ltoreq.12. 11. The method of claim 10, wherein the zirconium silicate in the composition comprises particles having a median particle size of greater than 3 microns and less than 7% of the particles in the composition have a diameter less than 3 microns. 12. The method of claim 11, wherein the zirconium silicate in the composition exhibits a median particle size of greater than 3 microns and less than 3% of the particles in the composition have a diameter less than 3 microns. 13. The method of claim 10, wherein the zirconium silicate is ZS-9. 14. The method of claim 10, wherein the sodium content is below 9% by weight.