Claims for Patent: 10,300,087

Summary for Patent: 10,300,087

Title:	Extended use zirconium silicate compositions and methods of use thereof
Abstract:	The present invention relates to zirconium silicate compositions having a lead content that is below 0.6 ppm and methods of manufacturing zirconium silicate at reactor volumes exceeding 200-L with a lead content below 1.1 ppm. The lead content of the zirconium silicate of this invention are within the levels that are considered acceptable for extended use given the dose requirements for zirconium silicate.
Inventor(s):	Keyser; Donald Jeffrey (Southlake, TX), Guillem; Alvaro F. (Lantana, TX)
Assignee:	ZS PHARMA, INC. (Coppell, TX)
Application Number:	15/421,132
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for patent 10,300,087
Patent Claims:	1. A cation exchange composition comprising a zirconium silicate of formula (I): A.sub.pM.sub.xZr.sub.1-xSi.sub.nGe.sub.yO.sup.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 about 0 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 exhibits a lead content below 0.6 ppm. 2. The composition of claim 1, wherein the lead content ranges from 0.1 to 0.5 ppm. 3. The composition of claim 1, wherein the lead content ranges from 0.3 to 0.5 ppm. 4. The composition of claim 1, wherein the lead content ranges from 0.3 to 0.45 ppm. 5. The composition of claim 1, wherein the composition comprises less than 7% particles having a diameter less than 3 microns. 6. The composition of claim 5, wherein less than 0.5% of the particles in the composition have a diameter less than 1 microns. 7. The composition of claim 1, wherein the composition comprises less than 7% particles having a diameter less than 3 microns, and the sodium content is below 12%. 8. The composition of claim 1, wherein the composition comprises less than 7% particles having a diameter less than 3 microns, and the sodium content is 9% or less. 9. The composition of claim 1, wherein the pH of the composition ranges from 7 to 9. 10. The composition of claim 1, wherein the potassium loading capacity is between 2.7 and 3.7 mEq/g. 11. The composition of claim 1, wherein the potassium loading capacity is approximately 3.5 mEq/g. 12. A method for treatment of hyperkalemia comprising administering the composition of claim 1 to a patient in need thereof. 13. The composition of claim 1, wherein the composition comprises less than 3% particles having a diameter less than 3 microns. 14. The composition of claim 1, wherein the zirconium silicate is predominately ZS-9. 15. The composition of claim 1, wherein the zirconium silicate is predominately ZS-9 and the potassium loading capacity is between 2.7 and 3.7 mEq/g. 16. A cation exchange composition comprising a zirconium silicate of formula (I): A.sub.pM.sub.xZr.sub.1-xSi.sub.nGe.sub.yO.sup.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 about 0 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 is predominately ZS-9 and exhibits a lead content that ranges from ranges from 0.1 to below 0.6 ppm, and has a potassium loading capacity between 2.7 and 3.7 mEq/g. 17. The composition of claim 16, wherein the lead content ranges from 0.3 to 0.45 ppm. 18. The composition of claim 16, wherein the composition comprises less than 7% particles having a diameter less than 3 microns. 19. The composition of claim 18, wherein less than 0.5% of the particles in the composition have a diameter less than 1 microns. 20. The composition of claim 16, wherein the composition comprises less than 7% particles having a diameter less than 3 microns, and the sodium content is below 12%. 21. The composition of claim 16, wherein the composition comprises less than 7% particles having a diameter less than 3 microns, and the sodium content is 9% or less. 22. The composition of claim 16, wherein the pH of the composition ranges from 7 to 9.