Pharmaceutical-grade ferric organic compounds, uses thereof and methods of making same

Abstract

The present invention discloses 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 - 57 . (canceled) 
     
     
         58 . A method of treating hyperphosphatemia, comprising administering one or more tablets comprising ferric citrate and a pharmaceutically acceptable carrier to an adult subject, wherein:
 (a) the subject has chronic kidney disease and is undergoing dialysis,   (b) the tablets are prepared from a form of ferric citrate having a BET active surface area of at least about 16 m 2 /g, and   (c) the tablets are administered to provide a dose between 4 and 15 grams of ferric citrate to the subject per day.   
     
     
         59 . The method of  claim 58 , wherein the chronic kidney disease is selected from mid-stage kidney disease and late-stage kidney disease. 
     
     
         60 . The method of  claim 58 , wherein the dialysis is selected from hemodialysis and peritoneal dialysis. 
     
     
         61 . The method of  claim 58 , wherein the tablets are administered to provide a dose of 6 to 12 grams of the ferric citrate to the subject per day. 
     
     
         62 . The method of  claim 58 , wherein the tablets are administered to provide a dose of 6 grams of the ferric citrate to the subject per day. 
     
     
         63 . The method of  claim 58 , wherein the tablets are administered twice, or three times per day. 
     
     
         64 . The method of  claim 58 , wherein the dose of the ferric citrate is adjusted based on serum phosphorus levels of the subject.