Ferric citrate dosage forms

Abstract

The disclosure relates to ferric citrate tablets and dosage forms.

1 .- 26 . (canceled) 
     
     
         27 . A ferric citrate tablet comprising
 (a) a core comprising
 80.0-90.0% by weight of ferric citrate; 
 8.0-15.0% by weight of pregelatinized starch; 
 1.0-3.0% by weight of calcium stearate; 
 and 
   (b) a coating.   
     
     
         28 . The ferric citrate tablet of  claim 27 , wherein the core comprises 85-90% by weight of ferric citrate. 
     
     
         29 . The ferric citrate table of  claim 27 , comprising 210 mg of ferric iron. 
     
     
         30 . The ferric citrate tablet of  claim 27 , wherein the moisture content of the tablet is less than 10% by loss on drying (LOD). 
     
     
         31 . The ferric citrate tablet of  claim 27 , wherein at least 80% of the ferric citrate in the tablet is dissolved in a time less than or equal to 60 minutes as measured by test method USP <711>. 
     
     
         32 . The ferric citrate tablet of  claim 27 , wherein the tablet has a friability equal or less than 1% w/w. 
     
     
         33 . The ferric citrate tablet of  claim 27 , wherein the tablet comprises 1000 mg ferric citrate. 
     
     
         34 . The ferric citrate tablet of  claim 27 , having a disintegration time of less than 30 minutes. 
     
     
         35 . A ferric citrate tablet comprising
 (a) a core comprising
 80.0-90.0% w/w ferric citrate; 
 8.0-15.0% w/w pregelatinized starch; 
 1.0-3.0% w/w of calcium stearate; 
 and 
   (b) a coating,   
       wherein
 the tablet has a friability equal or less than 1% w/w, 
 at least 80% of the ferric citrate in the tablet is dissolved in a time less than or equal to 60 minutes as measured by test method USP <711>, and 
 the moisture content of the tablet is less than 10% by loss on drying (LOD). 
 
     
     
         36 . The ferric citrate tablet of  claim 35 , wherein the tablet comprises 1000 mg ferric citrate. 
     
     
         37 . The ferric citrate tablet of  claim 35 , having a disintegration time of less than 30 minutes. 
     
     
         38 . A ferric citrate tablet comprising
 (a) a core comprising
 85.0-90.0% w/w ferric citrate; 
 8.0-15.0% w/w pregelatinized starch; 
 0.5-3.0% w/w of a lubricant; 
 and 
   (b) a coating.   
     
     
         39 . The ferric citrate table of  claim 38 , comprising 210 mg of ferric iron. 
     
     
         40 . The ferric citrate table of  claim 38 , wherein the lubricant is calcium stearate. 
     
     
         41 . The ferric citrate tablet of  claim 38 , wherein the moisture content of the tablet is less than 10% by loss on drying (LOD). 
     
     
         42 . The ferric citrate tablet of  claim 38 , wherein at least 80% of the ferric citrate in the tablet is dissolved in a time less than or equal to 60 minutes as measured by test method USP <711>. 
     
     
         43 . The ferric citrate tablet of  claim 38 , wherein the tablet has a friability equal or less than 1% w/w. 
     
     
         44 . The ferric citrate tablet of  claim 38 , wherein the tablet comprises 1000 mg ferric citrate. 
     
     
         45 . The ferric citrate tablet of  claim 38 , having a disintegration time of less than 30 minutes. 
     
     
         46 . A ferric citrate tablet comprising
 (a) a core comprising
 85.0-90.0% w/w ferric citrate; 
 8.0-15.0% w/w pregelatinized starch; 
 0.5-3.0% w/w calcium stearate; 
 and 
   (b) a coating,   
       wherein
 the tablet has a friability equal or less than 1% w/w, 
 at least 80% of the ferric citrate in the tablet is dissolved in a time less than or equal to 60 minutes as measured by test method USP <711>, and 
 the moisture content of the tablet is less than 10% by loss on drying (LOD). 
 
     
     
         47 . The ferric citrate tablet of  claim 46 , wherein the tablet comprises 1000 mg ferric citrate. 
     
     
         48 . The ferric citrate tablet of  claim 46 , having a disintegration time of less than 30 minutes. 
     
     
         49 . A method for the prophylaxis or treatment of hyperphosphatemia comprising administering to a patient in need thereof the ferric citrate tablet of  claim 27 . 
     
     
         50 . A method for the prophylaxis or treatment of hyperphosphatemia comprising administering to a patient in need thereof the ferric citrate tablet of  claim 35 . 
     
     
         51 . A method for the prophylaxis or treatment of hyperphosphatemia comprising administering to a patient in need thereof the ferric citrate tablet of  claim 38 . 
     
     
         52 . A method for the prophylaxis or treatment of hyperphosphatemia comprising administering to a patient in need thereof the ferric citrate tablet of  claim 46 . 
     
     
         53 . A method for controlling serum phosphorus levels in an end-stage renal disease patient on hemodialysis comprising administering to the patient the ferric citrate tablet of  claim 27 . 
     
     
         54 . A method for controlling serum phosphorus levels in an end-stage renal disease patient on hemodialysis comprising administering to the patient the ferric citrate tablet of  claim 35 . 
     
     
         55 . A method for controlling serum phosphorus levels in an end-stage renal disease patient on hemodialysis comprising administering to the patient the ferric citrate tablet of  claim 38 . 
     
     
         56 . A method for controlling serum phosphorus levels in an end-stage renal disease patient on hemodialysis comprising administering to the patient the ferric citrate tablet of  claim 46 .