Claims for Patent: 9,913,860

Summary for Patent: 9,913,860

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 ZS-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:	14/628,017
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for patent 9,913,860
Patent Claims:	1. A zirconium silicate composition comprising zirconium silicate, wherein the composition comprises ZS-9 and ZS-7 and lacks detectable amounts of ZS-8. 2. The composition of claim 1, wherein the ZS-9 has an X-ray diffraction pattern of TABLE-US-00018 d(.ANG.) I 6.8-7.6 vs 5.6-6.4 m 3.7-4.5 m 3.6-4.4 m 2.6-3.4 s-vs 2.5-3.3 m 2.4-3.2 vs 3. The composition of claim 1, wherein the ZS-7 has an X-ray diffraction pattern of TABLE-US-00019 d(.ANG.) I 12.0-13.2 vs 3.9-4.7 m 2.8-3.6 m 2.3-3.1 m 2.2-3.0 w 2.1-2.9 w 4. The composition of claim 1, wherein the ZS-8 has an X-ray diffraction pattern of TABLE-US-00020 d(.ANG.) I 5.9-6.7 m 5.3-6.1 m-s 2.7-3.5 vs 2.0-2.8 w-m 1.6-2.4 w 5. The composition of claim 1, wherein the composition comprises ZS-9 at a weight percent ranging from about 50% to about 75%. 6. The composition of claim 1, wherein the composition comprises ZS-7 at a weight percent ranging from about 25% to about 50%. 7. The composition of claim 1, wherein the ZS-9 exhibits 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, and the composition exhibits a sodium content below 12% by weight. 8. The composition of claim 1, wherein the ZS-9 is partially protonated. 9. The composition of claim 1, wherein the ZS-9 has a potassium exchange rate of greater than 3.1 meq/g. 10. The composition of claim 1, wherein the ZS-9 has a potassium exchange rate in the range of 3.2 to 3.5 meq/g. 11. The composition of claim 1, wherein the ZS-9 has a potassium exchange rate of greater than 2.46 meq/g. 12. The composition of claim 1, wherein the ZS-9 has a sodium content of less than 12%. 13. A method of treating hyperkalemia in a patient comprising administering a zirconium silicate composition according to claim 1. 14. The method of claim 13, wherein the ZS-9 exhibits 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, and the composition exhibits a sodium content below 12% by weight. 15. The method of claim 13, wherein the patient is suffering from chronic hyperkalemia. 16. The method of claim 13, wherein the patient is suffering from acute hyperkalemia. 17. A zirconium silicate composition comprising zirconium silicate, wherein the composition comprises ZS-9 at a weight percent ranging from about 50% to about 75%, and ZS-7 at a weight percent ranging from about 25% to about 50%, and lacking detectable amounts of ZS-8. 18. The composition of claim 17, wherein the ZS-9 has an X-ray diffraction pattern of TABLE-US-00021 d(.ANG.) I 6.8-7.6 vs 5.6-6.4 m 3.7-4.5 m 3.6-4.4 m 2.6-3.4 s-vs 2.5-3.3 m 2.4-3.2 vs 19. The composition of claim 17, wherein the ZS-7 has an X-ray diffraction pattern of TABLE-US-00022 d(.ANG.) I 12.0-13.2 vs 3.9-4.7 m 2.8-3.6 m 2.3-3.1 m 2.2-3.0 w 2.1-2.9 w 20. The composition of claim 17, wherein the ZS-8 has an X-ray diffraction pattern of TABLE-US-00023 d(.ANG.) I 5.9-6.7 m 5.3-6.1 m-s 2.7-3.5 vs 2.0-2.8 w-m 1.6-2.4 w 21. The composition of claim 17, wherein the ZS-9 exhibits 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, and the composition exhibits a sodium content below 12% by weight. 22. The composition of claim 17, wherein the ZS-9 is partially protonated. 23. The composition of claim 17, wherein the ZS-9 has a potassium exchange rate of greater than 3.1 meq/g. 24. The composition of claim 17, wherein the ZS-9 has a potassium exchange rate in the range of 3.2 to 3.5 meq/g. 25. The composition of claim 17, wherein the ZS-9 has a potassium exchange rate of greater than 2.46 meq/g. 26. The composition of claim 17, wherein the ZS-9 has a sodium content of less than 12%. 27. A composition comprising ZS-9 and ZS-7 and lacking detectable amounts of ZS-8 , wherein the ZS-9 has a potassium exchange rate in the range of 2.5-4.7 meq/g. 28. The composition of claim 27, wherein the ZS-9 is partially protonated. 29. The composition of claim 27, wherein the ZS-9 has a potassium exchange rate in the range of 3.2 to 3.5 meq/g. 30. The composition of claim 27, wherein the ZS-9 has a sodium content of less than 12%. 31. The composition of claim 27, wherein the ZS-9 exhibits 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, and the composition exhibits a sodium content below 12% by weight. 32. A method of treating hyperkalemia in a patient comprising administering a zirconium silicate composition according to claim 27. 33. The method of claim 32, wherein the ZS-9 exhibits 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, and the composition exhibits a sodium content below 12% by weight. 34. The method of claim 32, wherein the patient is suffering from chronic hyperkalemia. 35. The method of claim 32, wherein the patient is suffering from acute hyperkalemia. 36. A powered pharmaceutical cation exchange composition comprising ZS-9 and ZS-7 , wherein the ZS-9 has an X-ray diffraction pattern of: TABLE-US-00024 d(.ANG.) 5.9-6.7 5.3-6.1 2.7-3.5 2.0-2.8 1.6-2.4 and ZS-7 has an X-ray diffraction pattern of: TABLE-US-00025 d(.ANG.) 6.8-7.6 5.6-6.4 3.7-4.5 3.6-4.4 2.6-3.4 2.5-3.3 2.4-3.2 wherein the X-ray diffraction is generated using a copper K-alpha radiation source; and wherein the composition lacks detectable amounts of ZS-8. 37. The composition of claim 36, wherein the ZS-9 is partially protonated. 38. The composition of claim 36, wherein the ZS-9 has a potassium exchange rate of greater than 2.46 meq/g. 39. The composition of claim 36, wherein the ZS-9 has a sodium content of less than 12%. 40. The composition of claim 36, wherein the ZS-9 exhibits 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, and the composition exhibits a sodium content below 12% by weight.