IP Library Patent Application 12162543
Patent Application
App. No. 12/162,543

Method of Treating Chronic Kidney Disease

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Quick Facts
Patent No.
US None
App. No.
12/162,543
Abstract

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.

Claims (30)

1 - 45 . (canceled)

46 . A method of treating a subject having chronic kidney disease, comprising administering to said subject a therapeutically effective amount of a ferric organic compound.

47 . The method of claim 46 , wherein the ferric organic compound has a dissolution rate of at least 2 mg/cm 2 /min.

48 . The method of claim 46 , wherein the ferric organic compound has a dissolution rate from about 2 mg/cm 2 /min to about 4 mg/cm 2 /min.

49 . The method of claim 46 , wherein the ferric organic compound is manufactured by a method comprising the steps of:

a) adding an alkaline metal hydroxide to a ferric iron salt under conditions suitable to produce a mixture comprising polyiron oxide;

b) precipitating and isolating a precipitate comprising the polyiron oxide from the mixture;

c) adding an organic acid to the precipitate;

d) heating the organic acid and the precipitate to form a ferric organic acid solution; and

e) adding an organic solvent to the ferric organic acid solution to precipitate a ferric organic compound.

50 . The method of claim 49 , wherein the alkaline metal hydroxide is added to the ferric iron salt at a rate of less than 20 ml/min., while maintaining a temperature of less than 40° C.

51 . The method of claim 49 , wherein the organic acid and the precipitate are heated to a temperature of between about 80° C. to about 90° C.

52 . The method of claim 49 , wherein the step of precipitating the ferric organic compound comprises cooling the ferric organic acid solution to less than 30° C. before adding the organic solvent.

53 . The method of claim 49 , wherein the organic acid is in crystalline form.

54 . The method of claim 49 , wherein the organic acid is selected from the group consisting of citric acid, acetic acid, isocitric acid, succinic acid, fumaric acid, and tartaric acid.

55 . The method of claim 49 , wherein the organic solvent is selected from the group consisting of ethanol, methanol, butanol, isopropyl alcohol, acetone, and tetrahydrofuran.

56 . The method of claim 49 , wherein the ferric iron salt is ferric chloride hexahydrate, the alkaline metal hydroxide is sodium hydroxide, and the organic acid is crystalline citric acid.

57 . The method of claim 46 , wherein the subject is a mammal.

58 . The method of claim 46 , wherein the chronic kidney disease includes any stage of chronic kidney disease and end stage renal disease

59 . The method of claim 46 , wherein the subject is undergoing renal dialysis.

60 . The method of claim 46 , wherein the ferric organic compound is administered at a dose of from about 2 to about 20 gm/day

61 . The method of claim 46 , wherein the ferric organic compound is administered orally.

62 . The method of claim 46 , wherein the ferric organic compound is formulated as a tablet, a powder, a suspension, an emulsion, a capsule, a lozenge, a granule, a troche, a pill, a liquid, a spirit, or a syrup.

63 . The method of claim 46 , wherein administration of the ferric organic compound decreases the serum level of any one or more substances in the subject, said substances comprising creatinine, BUN, phosphorus, and calcium and phosphorus product (CaxP).

64 . The method of claim 46 , wherein the administration of the ferric organic compound prevents, reverses, maintains or delays one or more conditions in the subject, said conditions comprising progression of chronic kidney disease, development of hyperparathyroidism, development of bone disorder, development of cardiovascular disease, calcium phosphate precipitation in renal tissue, kidney stone formation, and development of metabolic acidosis.

65 . The method of claim 46 wherein the ferric organic compound is ferric citrate.

66 . A pharmaceutical composition for treating a subject having chronic kidney disease, the composition comprising an effective amount of a ferric organic compound having a dissolution rate from about 2 mg/cm 2 /min to about 4 mg/cm 2 /min.

67 . The pharmaceutical composition of claim 66 , wherein the ferric organic compound is ferric citrate.

68 . The pharmaceutical composition of claim 66 , wherein the composition is in a form suitable for oral administration.

69 . The pharmaceutical composition of claim 68 , wherein the form suitable for oral administration is a tablet, a powder, a suspension, an emulsion, a capsule, a lozenge, a granule, a troche, a pill, a liquid, a spirit, or a syrup.

Assignments (4)
CORRECTION BY DECLARATION OF ERRONEOUSLY ASSIGNED FILED ASSIGNMENT - REEL/FRAME: 021447/0912 Recorded Aug 2, 2017
From: PANION & BF BIOTECH INC.
To: PANION & BF BIOTECH INC.
Reel/Frame 043409/0020 →
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded Apr 13, 2011
From: CHAN, KEITH; TOWN, WINSTON; GLOBOASIA, LLC
To: PANION & BF BIOTECH INC.
Reel/Frame 026123/0116 →
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded Apr 16, 2009
From: CHAN, KEITH; TOWN, WINSTON
To: GLOBOASIA, LLC
Reel/Frame 022554/0110 →
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded Aug 27, 2008
From: HERSELMAN, PAUL LE ROUX
To: CSIR
Reel/Frame 021447/0912 →