Pharmaceutical-grade ferric organic compounds, uses thereof and method of making same
View Patent ↗The present invention discloses a pharmaceutical-grade ferric organic compounds, including ferric citrate, which are soluble over a wider range of pH, and which have a large active surface area. A manufacturing and quality control process for making a pharmaceutical-grade ferric citrate that consistently complies with the established Manufacture Release Specification is also disclosed. The pharmaceutical-grade ferric organic compounds are suitable for treating disorders characterized by elevated serum phosphate levels.
1. A method of decreasing mortality rate in a dialysis patient, comprising administering to the patient an effective amount of ferric citrate having an intrinsic dissolution rate between 1.88 and 4.0 mg/cm 2 /min to decrease mortality rate of the dialysis patient.
2. A method of inhibiting calcium phosphate deposition in a subject, the method comprising administering to the subject an effective amount of ferric citrate having an intrinsic dissolution rate between 1.88 and 4.0 mg/cm 2 /min to inhibit calcium phosphate deposition in the subject.
3. A method of decreasing calcium-phosphorus product ([Ca]×[P]) in a subject, the method comprising administering to the subject an effective amount of ferric citrate having an intrinsic dissolution rate between 1.88 and 4.0 mg/cm 2 /min to decrease calcium-phosphorus product ([Ca]×[P]) in the subject.
4. A method of decreasing serum calcium levels in a subject, the method comprising administering to the subject an effective amount of ferric citrate having an intrinsic dissolution rate between 1.88 and 4.0 mg/cm 2 /min to decrease serum calcium levels in the subject.
5. A method of reversing calcification of soft tissue in a subject, the method comprising administering to the subject an effective amount of ferric citrate having an intrinsic dissolution rate between 1.88 and 4.0 mg/cm 2 /min to reverse calcification of soft tissue in the subject.
6. A method of aiding in dissolving a kidney stone in a subject, the method comprising administering to the subject an effective amount of ferric citrate having an intrinsic dissolution rate between 1.88 and 4.0 mg/cm 2 /min to aid in dissolving a kidney stone in the subject.
7. A method of reducing serum levels of phosphate in a subject, the method comprising administering to the subject an effective amount of ferric citrate having an intrinsic dissolution rate between 1.88 and 4.0 mg/cm 2 /min to reduce serum levels of phosphate.
8. The method of claim 7 wherein the ferric citrate is administered orally.
9. The method of claim 7 wherein the ferric citrate is administered with a meal.
10. The method of claim 9 wherein the ferric citrate is administered in the form of 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.
11. The method of claim 7 wherein the effective amount is from about 2 grams per day to about 30 grams per day.
12. The method of claim 7 wherein the effective amount is selected from about 2, 4 and 6 grams per day.
13. The method of claim 7 wherein said ferric citrate causes fewer side effects than chemical-grade ferric citrate.
14. The method of claim 13 wherein the side effects are selected from diarrhea, loose stool, constipation, bloating and nausea.
15. The method of claim 7 , wherein the subject has end stage renal disease.
16. The method of claim 15 , wherein the subject is on dialysis.
17. The method of claim 16 , wherein the dialysis is selected from hemodialysis and peritoneal dialysis.
18. The method of claim 7 , wherein the ferric citrate is administered in the form of a tablet.
19. The method of claim 18 , wherein the tablet comprises 1 gram of the ferric citrate.
20. The method of claim 7 , wherein the effective amount is 1 gram per day.
21. The method of claim 7 , wherein the effective amount is 6 grams per day.
22. The method of claim 7 , wherein the effective amount is 8 grams per day.
23. The method of claim 2 , wherein the ferric citrate is administered orally.
24. The method of claim 2 , wherein the ferric citrate is administered with a meal.
25. The method of claim 24 , wherein the ferric citrate is selected from a tablet, a powder, a suspension, an emulsion, a capsule, a lozenge, a granule, a troche, a pill, a liquid, a spirit, and a syrup.
26. The method of claim 2 , wherein the effective amount is from about 2 grams per day to about 30 grams per day.
27. The method of claim 2 , wherein the effective amount is selected from about 2, 4 and 6 grams per day.
28. The method of claim 2 , wherein ferric citrate causes fewer side effects than chemical-grade ferric citrate.
29. The method of claim 28 , wherein the side effects are selected from diarrhea, loose stool, constipation, bloating and nausea.
30. The method of claim 2 , wherein the subject has end stage renal disease.
31. The method of claim 30 , wherein the subject is on dialysis.
32. The method of claim 31 , wherein the dialysis is selected from hemodialysis and peritoneal dialysis.
33. The method of claim 2 , wherein the ferric citrate is administered in the form of a tablet.
34. The method of claim 33 , wherein the tablet comprises 1 gram of the ferric citrate.
35. The method of claim 2 , wherein the effective amount is 1 gram per day.
36. The method of claim 2 , wherein the effective amount is 6 grams per day.
37. The method of claim 2 , wherein the effective amount is 8 grams per day.
38. The method of claim 3 , wherein the ferric citrate is administered orally.
39. The method of claim 3 , wherein the ferric citrate is administered with a meal.
40. The method of claim 39 , wherein the ferric citrate is selected from a tablet, a powder, a suspension, an emulsion, a capsule, a lozenge, a granule, a troche, a pill, a liquid, a spirit, and a syrup.
41. The method of claim 3 , wherein the effective amount is from about 2 grams per day to about 30 grams per day.
42. The method of claim 3 , wherein the effective amount is selected from about 2, 4 and 6 grams per day.
43. The method of claim 3 , wherein ferric citrate causes fewer side effects than chemical-grade ferric citrate.
44. The method of claim 43 , wherein the side effects are selected from diarrhea, loose stool, constipation, bloating and nausea.
45. The method of claim 3 , wherein the subject has end stage renal disease.
46. The method of claim 45 , wherein the subject is on dialysis.
47. The method of claim 46 , wherein the dialysis is selected from hemodialysis and peritoneal dialysis.
48. The method of claim 3 , wherein the ferric citrate is administered in the form of a tablet.
49. The method of claim 48 , wherein the tablet comprises 1 gram of the ferric citrate.
50. The method of claim 3 , wherein the effective amount is 1 gram per day.
51. The method of claim 3 , wherein the effective amount is 6 grams per day.
52. The method of claim 3 , wherein the effective amount is 8 grams per day.
53. The method of claim 4 , wherein the ferric citrate is administered orally.
54. The method of claim 4 , wherein the ferric citrate is administered with a meal.
55. The method of claim 54 , wherein the ferric citrate is selected from a tablet, a powder, a suspension, an emulsion, a capsule, a lozenge, a granule, a troche, a pill, a liquid, a spirit, and a syrup.
56. The method of claim 4 , wherein the effective amount is from about 2 grams per day to about 30 grams per day.
57. The method of claim 4 , wherein the effective amount is selected from about 2, 4 and 6 grams per day.
58. The method of claim 4 , wherein ferric citrate causes fewer side effects than chemical-grade ferric citrate.
59. The method of claim 58 , wherein the side effects are selected from diarrhea, loose stool, constipation, bloating and nausea.
60. The method of claim 4 , wherein the subject has end stage renal disease.
61. The method of claim 60 , wherein the subject is on dialysis.
62. The method of claim 61 , wherein the dialysis is selected from hemodialysis and peritoneal dialysis.
63. The method of claim 4 , wherein the ferric citrate is administered in the form of a tablet.
64. The method of claim 63 , wherein the tablet comprises 1 gram of the ferric citrate.
65. The method of claim 4 , wherein the effective amount is 1 gram per day.
66. The method of claim 4 , wherein the effective amount is 6 grams per day.
67. The method of claim 4 , wherein the effective amount is 8 grams per day.
68. The method of claim 5 , wherein the ferric citrate is administered orally.
69. The method of claim 5 , wherein the ferric citrate is administered with a meal.
70. The method of claim 69 , wherein the ferric citrate is selected from a tablet, a powder, a suspension, an emulsion, a capsule, a lozenge, a granule, a troche, a pill, a liquid, a spirit, and a syrup.
71. The method of claim 5 , wherein the effective amount is from about 2 grams per day to about 30 grams per day.
72. The method of claim 5 , wherein the effective amount is selected from about 2, 4 and 6 grams per day.
73. The method of claim 5 , wherein ferric citrate causes fewer side effects than chemical-grade ferric citrate.
74. The method of claim 73 , wherein the side effects are selected from diarrhea, loose stool, constipation, bloating and nausea.
75. The method of claim 5 , wherein the subject has end stage renal disease.
76. The method of claim 73 , wherein the subject is on dialysis.
77. The method of claim 76 , wherein the dialysis is selected from hemodialysis and peritoneal dialysis.
78. The method of claim 5 , wherein the ferric citrate is administered in the form of a tablet.
79. The method of claim 78 , wherein the tablet comprises 1 gram of the ferric citrate.
80. The method of claim 5 , wherein the effective amount is 1 gram per day.
81. The method of claim 5 , wherein the effective amount is 6 grams per day.
82. The method of claim 5 , wherein the effective amount is 8 grams per day.