Claims for Patent: 10,398,730

Summary for Patent: 10,398,730

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:	14/826,011
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for patent 10,398,730
Patent Claims:	1. A method of treating hyperkalemia comprising administering to a patient in need thereof a zirconium silicate composition having a median particle size of greater than 3 microns, where less than 1.44% of the zirconium silicate particles in the composition have a diameter less than 2 microns, wherein the zirconium silicate exhibits a selective potassium exchange capacity of greater than 1.7 mEq/g and wherein the zirconium silicate particles exhibit a uniform microporous structure. 2. The method of claim 1, wherein less than 7% of the particles in the composition have a diameter less than 3 microns. 3. The method of claim 1, wherein less than 3% of the particles in the composition have a diameter less than 3 microns. 4. The method of claim 1, wherein the zirconium silicate exhibits a sodium content below 12% by weight. 5. The method of claim 1, wherein the zirconium silicate exhibits a sodium content below 9% by weight. 6. The method of claim 1, wherein the zirconium silicate is a particle represented by 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 from 0 to less than 1, "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. 7. The method of claim 1, wherein the zirconium silicate is ZS-9. 8. The method of claim 1, wherein the selective potassium exchange capacity is at least 2.3 meq/g. 9. The method of claim 1, wherein the selective potassium exchange capacity is at greater than 2.5 meq/g. 10. A method of treating hyperkalemia comprising administering to a patient in need thereof a zirconium silicate composition having a median particle size of greater than 3 microns and less than 1.44% of the zirconium silicate particles in the composition have a diameter less than 2 microns, and wherein the zirconium silicate particles exhibit a uniform microporous structure, wherein the zirconium silicate is ZS-9. 11. The method of claim 10, wherein less than 7% of the particles in the composition have a diameter less than 3 microns. 12. The method of claim 10, wherein less than 3% of the particles in the composition have a diameter less than 3 microns. 13. The method of claim 10, wherein the composition is essentially free of particles having a diameter below 1 micron. 14. The method of claim 10, wherein the zirconium silicate exhibits a sodium content below 12% by weight. 15. The method of claim 10, wherein the zirconium silicate exhibits a sodium content below 9% by weight. 16. The method of claim 10, wherein the zirconium silicate is a particle represented by 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 from 0 to less than 1, "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. 17. The method of claim 10, wherein the zirconium silicate exhibits a selective potassium exchange capacity of at least 1.7 meq/g. 18. The method of claim 10, wherein the zirconium silicate exhibits a selective potassium exchange capacity of at least 2.3 meq/g. 19. The method of claim 10, wherein the zirconium silicate exhibits a selective potassium exchange capacity of at greater than 2.5 meq/g.