Claims for Patent: 11,738,044

Summary for Patent: 11,738,044

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):	Donald Jeffrey Keyser, Alvaro F. GUILLEM
Assignee:	ZS Pharma Inc
Application Number:	US16/415,550
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for patent 11,738,044
Patent Claims:	1. A method of treatment of hyperkalemia comprising administering over a period of more than 5 consecutive days to a patient in need thereof a cation exchange composition comprising a zirconium silicate of formula (I): ApMxZr1-xSinGeyOm (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≤n+y≤12, wherein the composition exhibits a lead content below 0.6 ppm. 2. The method of claim 1, wherein the lead content ranges from 0.1 to 0.5 ppm. 3. The method of claim 1, wherein the lead content ranges from 0.3 to 0.5 ppm. 4. The method of claim 1, wherein the lead content ranges from 0.3 to 0.45 ppm. 5. The method of claim 1, wherein less than 7% of the particles in the composition have a diameter less than 3 microns. 6. The method of claim 1, wherein less than 0.5% of the particles in the composition have a diameter less than 1 microns. 7. The method of claim 1, wherein less than 7% of the particles in the composition have a diameter less than 3 microns, and the sodium content is below 12%. 8. The method of claim 1, wherein less than 7% of the particles in the composition have a diameter less than 3 microns, and the sodium content is 9% or less. 9. The method of claim 1, wherein the composition exhibits an XRD diffractogram having the two highest peaks occur at approximately 15.5 and 28.9, with the highest peak occurring at 28.9. 10. The method of claim 1, wherein the cation exchange composition has a pH that ranges from 7 to 9. 11. The method of claim 1, wherein the potassium loading capacity is between 2.7 and 3.7 mEq/g. 12. The method of claim 1, wherein the potassium loading capacity is approximately 3.5 mEq/g. 13. The method of claim 1, wherein the lead content is determined using inductively coupled plasma-mass spectrometry (ICP-MS).