METHOD OF TREATING CHRONIC KIDNEY DISEASE
The present invention discloses pharmaceutical-grade ferric organic compounds having enhanced dissolution rate. These ferric organic compounds, including but are not limited to ferric citrate, are useful for treating chronic kidney disease.
1 . A method of treating a subject having chronic kidney disease, comprising administering to said subject an effective amount of a ferric organic compound having a dissolution rate of at least approximately 2 mg/cm 2 /min.
2 - 4 . (canceled)
5 . The method of claim 1 , wherein the ferric organic compound is prepared according a method comprising the steps of:
a) obtaining a ferric iron salt;
b) adding an alkaline metal hydroxide to the ferric iron salt under conditions suitable to produce a mixture comprising polyiron oxide;
c) isolating a precipitate from the mixture;
d) adding an organic acid to the precipitate;
e) heating the organic acid and the precipitate, thereby forming a ferric organic acid solution; and
f) precipitating a ferric organic compound from the ferric organic acid solution by an organic solvent.
6 . The method of claim 5 , wherein the alkaline metal hydroxide is sodium hydroxide or potassium hydroxide.
7 . The method of claim 5 , wherein the alkaline metal hydroxide is added at a rate of less than 20 ml/min., and the alkaline metal hydroxide is added to the ferric iron salt at a temperature of less than 40° C.
8 . The method of claim 5 , wherein the organic acid and the precipitate are heated to a temperature of between about 80° C. to about 90° C., and precipitating the ferric organic compound from the ferric organic acid solution by an organic solvent comprises cooling the ferric organic acid solution to less than 30° C. before adding the organic solvent.
9 . (canceled)
10 . The method of claim 5 , wherein the organic acid is selected from the group consisting of citric acid, acetic acid, isocitric acid, succinic acid, fumaric acid, and tartaric acid.
11 . The method of claim 5 , wherein the organic solvent is selected from the group consisting of ethanol, methanol, butanol, isopropyl alcohol, acetone, and tetrahydrofuran.
12 . The method of claim 5 , wherein the ferric iron salt is ferric chloride hexahydrate, the alkaline metal hydroxide is sodium hydroxide, and the organic acid is crystalline citric acid.
13 . (canceled)
14 . The method of claim 1 , wherein the chronic kidney disease includes any stage of chronic kidney disease and end stage renal disease.
15 . The method of claim 1 , wherein the subject is undergoing renal dialysis.
16 . The method of claim 1 , wherein the ferric organic compound is administered at a dose of about 2-20 gm/day.
17 - 20 . (canceled)
21 . A method of treating a subject having chronic kidney disease, comprising administering to said subject an effective amount of a ferric organic compound.
22 - 23 . (canceled)
24 . The method of claim 21 , wherein the subject is having any stage of chronic kidney disease, or is undergoing renal dialysis.
25 . (canceled)
26 . The method of claim 21 , wherein the ferric organic compound has a dissolution rate of at least approximately 2 mg/cm 2 /min.
27 - 28 . (canceled)
29 . The method according to claim 21 , wherein the ferric organic compound is ferric citrate.
30 . A therapeutic regimen for a subject having chronic kidney, the regiment comprising a pharmaceutical composition comprising an acceptable carrier and an effective amount of ferric organic compound having a dissolution rate of at least 2 mg/cm 2 /min., wherein the pharmaceutical composition is administered in single or multiple doses regimens.
31 - 33 . (canceled)
34 . The therapeutic regimen of claim 30 , wherein at least a portion of the pharmaceutical composition is administered orally.
35 . The therapeutic regimen of claim 30 , wherein the chronic kidney disease includes any stage of chronic kidney disease and end stage renal disease.
36 . The therapeutic regimen of claim 30 , further comprising renal dialysis or peritoneal dialysis.
37 . (canceled)
38 . The therapeutic regimen according to claim 30 , wherein the ferric organic compound is ferric citrate.
39 - 45 . (canceled)