Ferric citrate dosage forms
AssigneeKeryx Biopharmaceuticals, Inc.
InventorHenry Trong Le
Life of this patent
Estimating the term…
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).
Claims17
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).
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).
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.
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.
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).
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).
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.
Dependencies are inferred from the claim text.