Claims for Patent: 10,300,039

Summary for Patent: 10,300,039

Title:	Ferric citrate dosage forms
Abstract:	Disclosed herein are ferric citrate-containing tablets. In various embodiments, the tablets include ferric citrate formulations that meet certain dissolution, tableting and disintegration standards. In various aspects, the tablet formulations can include ferric citrate as the active ingredient and a binder. The formulations also can include a lubricant and/or a disintegrant (which, in some embodiments, can be the same as the binder).
Inventor(s):	Le; Henry Trong (Englewood Cliffs, NJ)
Assignee:	KERYX BIOPHARMACEUTICALS, INC. (Boston, MA)
Application Number:	15/159,008
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for patent 10,300,039
Patent Claims:	1. A method for the prophylaxis or treatment of hyperphosphatemia comprising administering to a patient in need thereof a ferric citrate tablet, wherein the ferric citrate tablet comprises: (a) a core comprising approximately 90% to approximately 92% by weight of ferric citrate, approximately 4.5% to approximately 30% by weight of pregelatinized starch, and approximately 0.5% to approximately 3% by weight of a lubricant; and (b) a coating, wherein the tablet has a friability equal or less than 1% w/w, and wherein at least 80% of the ferric citrate in the tablet is dissolved in less than or equal to 60 minutes as measured by test method USP <711>, and the moisture content of the tablet is less than 10% by loss on drying (LOD). 2. The method of claim 1, wherein the lubricant is calcium stearate. 3. The method of claim 1, wherein the tablet comprises approximately 1000 mg of ferric citrate. 4. A method for the prophylaxis or treatment of hyperphosphatemia comprising administering to a patient in need thereof a ferric citrate tablet containing approximately 210 mg of ferric iron, wherein the ferric citrate tablet comprises: (a) a core comprising approximately 87.6% by weight of ferric citrate, approximately 10% by weight of pregelatinized starch, and approximately 2.4% by weight of calcium stearate; and (b) a coating, wherein the tablet has a friability equal or less than 1% w/w and a disintegration time less than 15 minutes, and wherein at least 80% of the ferric citrate in the tablet is dissolved in less than or equal to 60 minutes as measured by test method USP <711>, and the moisture content of the tablet is 8.84% (LOD). 5. A method for the prophylaxis or treatment of hyperphosphatemia comprising administering to a patient in need thereof a ferric citrate tablet, wherein the ferric citrate tablet comprises: (a) a core comprising approximately 90% to approximately 92% by weight of ferric citrate, approximately 4.5% to approximately 30% by weight of pregelatinized starch, and approximately 0.5% to approximately 3% by weight of a lubricant; and (b) a coating, wherein the tablet has a friability equal or less than 1% w/w, and wherein at least 80% of the ferric citrate is dissolved in less than or equal to 60 minutes as measured by test method USP <711>, and the moisture content of the tablet is between 5% to 10% by LOD. 6. The method of claim 5, wherein the lubricant is calcium stearate. 7. The method of claim 5, wherein the tablet comprises approximately 1000 mg of ferric citrate. 8. A method for the prophylaxis or treatment of hyperphosphatemia comprising administering to a patient in need thereof a ferric citrate tablet, wherein the ferric citrate tablet comprises: (a) a core comprising approximately 90% to approximately 92% by weight of ferric citrate, approximately 1.5% to approximately 15% by weight of pregelatinized starch, and approximately 0.5% to approximately 3% by weight of a lubricant; and (b) a coating, wherein the tablet has a friability equal or less than 1%, and wherein at least 80% of the ferric citrate in the tablet is dissolved in less than or equal to 60 minutes as measured by test method USP<711>, and the moisture content of the tablet is between 5% to 10% by LOD. 9. The method of claim 8, wherein the lubricant is calcium stearate. 10. The method of claim 8, wherein the tablet comprises approximately 1000 mg of ferric citrate. 11. A method for controlling serum phosphorus levels in an end-stage renal disease patient on hemodialysis comprising administering to the patent a ferric citrate tablet, wherein the ferric citrate tablet comprises: (a) a core comprising approximately 90% to approximately 92% by weight of ferric citrate, approximately 4.5% to approximately 30% by weight of pregelatinized starch, and approximately 0.5% to approximately 3% by weight of a lubricant; and (b) a coating, wherein the tablet has a friability equal or less than 1% w/w, and wherein at least 80% of the ferric citrate in the tablet is dissolved in less than or equal to 60 minutes as measured by test method USP <711>, and the moisture content of the tablet is less than 10% by loss on drying (LOD). 12. The method of claim 11, wherein the lubricant is calcium stearate. 13. The method of claim 11, wherein the tablet comprises approximately 1000 mg of ferric citrate. 14. A method for controlling serum phosphorus levels in an end-stage renal disease patient on hemodialysis comprising administering to the patent a ferric citrate tablet containing approximately 210 mg of ferric iron, wherein the ferric citrate tablet comprises: (a) a core comprising approximately 87.6% by weight of ferric citrate, approximately 10% by weight of pregelatinized starch, and approximately 2.4% by weight of calcium stearate; and (b) a coating, wherein the tablet has a friability equal or less than 1% w/w and a disintegration time less than 15 minutes, and wherein at least 80% of the ferric citrate in the tablet is dissolved in less than or equal to 60 minutes as measured by test method USP <711>, and the moisture content of the tablet is 8.84% (LOD). 15. A method for controlling serum phosphorus levels in an end-stage renal disease patient on hemodialysis comprising administering to the patent a ferric citrate tablet, wherein the ferric citrate tablet comprises: (a) a core comprising approximately 90% to approximately 92% by weight of ferric citrate, approximately 4.5% to approximately 30% by weight of pregelatinized starch, and approximately 0.5% to approximately 3% by weight of a lubricant; and (b) a coating, wherein the tablet has a friability equal or less than 1% w/w, and wherein at least 80% of the ferric citrate is dissolved in less than or equal to 60 minutes as measured by test method USP <711>, and the moisture content of the tablet is between 5% to 10% by LOD. 16. The method of claim 15, wherein the lubricant is calcium stearate. 17. The method of claim 15, wherein the tablet comprises approximately 1000 mg of ferric citrate.