Ferric citrate dosage forms

Abstract

Disclosed herein are ferric citrate-containing tablets. In various embodiments, the tablets include ferric citrate formulations that meet certain dissolution, tableting and disintegration standards. In various aspects, the tablet formulations can include ferric citrate as the active ingredient and a binder. The formulations also can include a lubricant and/or a disintegrant (which, in some embodiments, can be the same as the binder).

1 - 26 . (canceled) 
     
     
         27 . A tablet produced by the process of compressing granule particles, said granule particles comprising 65% by weight-92% by weight of ferric citrate and a binder, wherein the mean surface area to mass ratio of said granule particles is equal to or greater than 1 m 2  per gram. 
     
     
         28 . The tablet of  claim 27 , wherein the mean surface area to mass ratio of said granule particles is equal to or greater than 5 m 2  per gram. 
     
     
         29 . The tablet of  claim 27 , wherein the mean surface area to mass ratio of said granule particles is equal to or greater than 10 m 2  per gram. 
     
     
         30 . The tablet of  claim 27 , wherein the tablet comprises at least 70 weight percent ferric citrate. 
     
     
         31 . The tablet of  claim 27 , wherein the tablet comprises at least 80 weight percent ferric citrate. 
     
     
         32 . The tablet of  claim 27 , wherein the tablet comprises at least 90 weight percent ferric citrate. 
     
     
         33 . The tablet of  claim 27 , wherein the binder comprises one or more of hydroxypropyl cellulose (HPC), hydroxypropylmethyl cellulose (HPMC), sodium alginate, alginic acid, guar gum, acacia gum, xanthan gum, carboxymethyl cellulose, ethyl cellulose, maltodextrin, PVP/VA, povidone, microcrystalline cellulose, starch (partially or fully pregelatinized starch) and methyl cellulose. 
     
     
         34 . The tablet of  claim 27 , wherein the LOD % water of the tablet is less than 20% water w/w. 
     
     
         35 . The tablet of  claim 27 , wherein the LOD % water of the tablet is less than 15% water w/w. 
     
     
         36 . The tablet of  claim 27 , wherein the LOD % water of the tablet is less than 10% water w/w. 
     
     
         37 . The tablet of  claim 27 , further comprising a disintegrant. 
     
     
         38 . The tablet of  claim 37 , wherein the disintegrant is selected from one or more of microcrystalline cellulose, croscarmellose sodium, crospovidone, sodium starch glycolate, and starch. 
     
     
         39 . The tablet of  claim 27 , further comprising a lubricant. 
     
     
         40 . The tablet of  claim 39 , wherein the lubricant is selected from one or more of magnesium stearate, calcium stearate, and sodium stearyl fumarate. 
     
     
         41 . The tablet of  claim 39 , wherein the lubricant comprises calcium stearate and sodium stearyl fumarate. 
     
     
         42 . The tablet of  claim 27 , wherein the tablet comprises:
 between approximately 4.5% and 30% binder; and   between 0.5% and 3% lubricant.   
     
     
         43 . The tablet of  claim 27 , wherein the binder comprises pregelatinized starch. 
     
     
         44 . The 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>. 
     
     
         45 . The tablet of  claim 27 , wherein the tablet has a disintegration time of less than 30 minutes as measured by test method USP <701>. 
     
     
         46 . The tablet of  claim 27 , wherein the tablet has a disintegration time equal to or less than 19.8 minutes. 
     
     
         47 . The tablet of  claim 27 , wherein the tablet has a disintegration time equal to or less than 11.7 minutes. 
     
     
         48 . The tablet of  claim 27 , wherein the tablet comprises approximately 1000 mg of ferric citrate. 
     
     
         49 . The tablet of  claim 27 , wherein the tablet comprises approximately 667 mg of ferric citrate. 
     
     
         50 . The tablet of  claim 27 , wherein the tablet comprises approximately 500 mg of ferric citrate. 
     
     
         51 . The tablet of  claim 27 , wherein the tablet comprises approximately 250 mg of ferric citrate. 
     
     
         52 . A method for the prophylaxis or treatment of hyperphosphatemia comprising administering the tablet of  claim 27 . 
     
     
         53 . A granule particle comprising 65% by weight-92% by weight of ferric citrate and a binder, wherein the surface area to mass ratio of said granule particle is equal to or greater than 1 m 2  per gram. 
     
     
         54 . The granule particle of  claim 53 , wherein the surface area to mass ratio of said granule particle is equal to or greater than 5 m 2  per gram. 
     
     
         55 . The granule particle of  claim 53 , wherein the surface area to mass ratio of said granule particles is equal to or greater than 10 m 2  per gram. 
     
     
         56 . The granule particle of  claim 53 , wherein the binder comprises one or more of hydroxypropyl cellulose (HPC), hydroxypropylmethyl cellulose (HPMC), sodium alginate, alginic acid, guar gum, acacia gum, xanthan gum, carboxymethyl cellulose, ethyl cellulose, maltodextrin, PVP/VA, povidone, microcrystalline cellulose, starch (partially or fully pregelatinized starch) and methyl cellulose. 
     
     
         57 . The granule particle of  claim 53 , wherein the LOD % water of the granule particle is less than 20% water w/w. 
     
     
         58 . The granule particle of  claim 53 , wherein the LOD % water of the granule particle is less than 15% water w/w. 
     
     
         59 . The granule particle of  claim 53 , wherein the LOD % water of the granule particle is less than 10% water w/w. 
     
     
         60 . The granule particle of  claim 53 , further comprising a lubricant. 
     
     
         61 . The granule particle of  claim 60 , wherein the lubricant is selected from one or more of magnesium stearate, calcium stearate, and sodium stearyl fumarate. 
     
     
         62 . The granule particle of  claim 60 , wherein the lubricant comprises calcium stearate, and sodium stearyl fumarate. 
     
     
         63 . The granule particle of  claim 60 , further comprising a disintegrant. 
     
     
         64 . The granule particle of  claim 63 , wherein the disintegrant is selected from one or more of microcrystalline cellulose, croscarmellose sodium, crospovidone, sodium starch glycolate, and starch. 
     
     
         65 . The granule particle of  claim 53 , wherein the binder comprises pregelatinized starch. 
     
     
         66 . A method for the prophylaxis or treatment of hyperphosphatemia comprising administering one or more granule particles according to  claim 53 .