FERRIC CITRATE DOSAGE FORMS
The disclosure relates to ferric citrate tablets and dosage forms.
1 .- 26 . (canceled)
27 . A ferric citrate tablet comprising
(a) a core comprising
80.0-90.0% by weight of ferric citrate;
8.0-15.0% by weight of pregelatinized starch;
1.0-3.0% by weight of calcium stearate;
and
(b) a coating.
28 . The ferric citrate tablet of claim 27 , wherein the core comprises 85-90% by weight of ferric citrate.
29 . The ferric citrate table of claim 27 , comprising 210 mg of ferric iron.
30 . The ferric citrate tablet of claim 27 , wherein the moisture content of the tablet is less than 10% by loss on drying (LOD).
31 . The ferric citrate tablet of claim 27 , wherein at least 80% of the ferric citrate in the tablet is dissolved in a time less than or equal to 60 minutes as measured by test method USP <711>.
32 . The ferric citrate tablet of claim 27 , wherein the tablet has a friability equal or less than 1% w/w.
33 . The ferric citrate tablet of claim 27 , wherein the tablet comprises 1000 mg ferric citrate.
34 . The ferric citrate tablet of claim 27 , having a disintegration time of less than 30 minutes.
35 . A ferric citrate tablet comprising
(a) a core comprising
80.0-90.0% w/w ferric citrate;
8.0-15.0% w/w pregelatinized starch;
1.0-3.0% w/w of calcium stearate;
and
(b) a coating,
wherein
the tablet has a friability equal or less than 1% w/w,
at least 80% of the ferric citrate in the tablet is dissolved in a time 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).
36 . The ferric citrate tablet of claim 35 , wherein the tablet comprises 1000 mg ferric citrate.
37 . The ferric citrate tablet of claim 35 , having a disintegration time of less than 30 minutes.
38 . A ferric citrate tablet comprising
(a) a core comprising
85.0-90.0% w/w ferric citrate;
8.0-15.0% w/w pregelatinized starch;
0.5-3.0% w/w of a lubricant;
and
(b) a coating.
39 . The ferric citrate table of claim 38 , comprising 210 mg of ferric iron.
40 . The ferric citrate table of claim 38 , wherein the lubricant is calcium stearate.
41 . The ferric citrate tablet of claim 38 , wherein the moisture content of the tablet is less than 10% by loss on drying (LOD).
42 . The ferric citrate tablet of claim 38 , wherein at least 80% of the ferric citrate in the tablet is dissolved in a time less than or equal to 60 minutes as measured by test method USP <711>.
43 . The ferric citrate tablet of claim 38 , wherein the tablet has a friability equal or less than 1% w/w.
44 . The ferric citrate tablet of claim 38 , wherein the tablet comprises 1000 mg ferric citrate.
45 . The ferric citrate tablet of claim 38 , having a disintegration time of less than 30 minutes.
46 . A ferric citrate tablet comprising
(a) a core comprising
85.0-90.0% w/w ferric citrate;
8.0-15.0% w/w pregelatinized starch;
0.5-3.0% w/w calcium stearate;
and
(b) a coating,
wherein
the tablet has a friability equal or less than 1% w/w,
at least 80% of the ferric citrate in the tablet is dissolved in a time 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).
47 . The ferric citrate tablet of claim 46 , wherein the tablet comprises 1000 mg ferric citrate.
48 . The ferric citrate tablet of claim 46 , having a disintegration time of less than 30 minutes.
49 . A method for the prophylaxis or treatment of hyperphosphatemia comprising administering to a patient in need thereof the ferric citrate tablet of claim 27 .
50 . A method for the prophylaxis or treatment of hyperphosphatemia comprising administering to a patient in need thereof the ferric citrate tablet of claim 35 .
51 . A method for the prophylaxis or treatment of hyperphosphatemia comprising administering to a patient in need thereof the ferric citrate tablet of claim 38 .
52 . A method for the prophylaxis or treatment of hyperphosphatemia comprising administering to a patient in need thereof the ferric citrate tablet of claim 46 .
53 . A method for controlling serum phosphorus levels in an end-stage renal disease patient on hemodialysis comprising administering to the patient the ferric citrate tablet of claim 27 .
54 . A method for controlling serum phosphorus levels in an end-stage renal disease patient on hemodialysis comprising administering to the patient the ferric citrate tablet of claim 35 .
55 . A method for controlling serum phosphorus levels in an end-stage renal disease patient on hemodialysis comprising administering to the patient the ferric citrate tablet of claim 38 .
56 . A method for controlling serum phosphorus levels in an end-stage renal disease patient on hemodialysis comprising administering to the patient the ferric citrate tablet of claim 46 .