Details for Patent: 8,093,423

Title:	Pharmaceutical-grade ferric organic compounds, uses thereof and method of making same
Abstract:	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.
Inventor(s):	Chan; Keith (Rockville, MD), Town; Winston (Hong Kong, HK)
Assignee:	GloboAsia, LLC (Rockville, MD)
Filing Date:	Aug 18, 2006
Application Number:	12/064,058
Claims:	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.sup.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.sup.2/min to inhibit calcium phosphate deposition in the subject. 3. A method of decreasing calcium-phosphorus product ([Ca].times.[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.sup.2/min to decrease calcium-phosphorus product ([Ca].times.[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.sup.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.sup.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.sup.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.sup.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.