US2020215019A1PendingUtilityA1

Ferric citrate dosage forms

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Assignee: KERYX BIOPHARMACEUTICALS INCPriority: Jul 21, 2009Filed: Apr 5, 2019Published: Jul 9, 2020
Est. expiryJul 21, 2029(~3 yrs left)· nominal 20-yr term from priority
Inventors:Henry Trong Le
A61K 9/20A61K 31/295A61K 47/06A61K 47/36A61P 3/12A61K 9/2013A61K 9/2054A61K 9/2059A61K 9/2077A61K 9/2095A61P 3/00
58
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Claims

Abstract

The disclosure relates to ferric citrate tablets and dosage forms.

Claims

exact text as granted — not AI-modified
What is claimed is: 
     
         1 . A tablet comprising granule particles, said granule particles comprising 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. 
     
     
         2 . The tablet of  claim 1 , wherein the mean surface area to mass ratio of said granule particles is equal to or greater than 5 m 2  per gram. 
     
     
         3 . The tablet of  claim 1  wherein the mean surface area to mass ratio of said granule particles is equal to or greater than 10 m 2  per gram. 
     
     
         4 . The tablet of  claim 1  wherein the tablet comprises at least 70 weight percent ferric citrate. 
     
     
         5 . The tablet of  claim 1  wherein the tablet comprises at least 80 weight percent ferric citrate. 
     
     
         6 . The tablet of  claim 1  wherein the tablet comprises at least 90 weight percent ferric citrate. 
     
     
         7 . The tablet of  claim 1  wherein the binder comprises one or more of hydroxypropyl cellulose (HPC), hydroxypropylmethyl cellulose (HPMC), sodium alginate, alginic acid, guar gum, acacia gum, xanthan gum, carbolpol, cellulose gum (carboxymethyl cellulose), ethyl cellulose, maltodextrin, PVP/VA, povidone, microcrystalline cellulose, starch (partially or fully pregelatinized starch) and methyl cellulose. 
     
     
         8 . The tablet of  claim 1 , wherein the LOD % water of the tablet is less than 20% water w/w. 
     
     
         9 . The tablet of  claim 1 , wherein the LOD % water of the tablet is less than 15% water w/w. 
     
     
         10 . The tablet of  claim 1 , wherein the LOD % water of the tablet is less than 10% water w/w. 
     
     
         11 . The tablet of  claim 1  further comprising a disintegrant selected from one or more of microcrystalline cellulose, croscarmellose sodium, crospovidone, sodium starch glycolate, and starch. 
     
     
         12 . The tablet of  claim 1  further comprising a lubricant selected from one or more of magnesium stearate, calcium stearate, and sodium stearyl fumarate. 
     
     
         13 . The tablet of  claim 1  wherein the tablet comprises:
 between approximately 65% and 92% ferric citrate; 
 between approximately 4.5% and 30% binder; and 
 between 0.5% and 3% lubricant. 
 
     
     
         14 . The tablet of  claim 1  wherein the binder comprises pregelatinized starch. 
     
     
         15 . The tablet of  claim 12 , wherein the lubricant comprises calcium stearate, and sodium stearyl fumarate. 
     
     
         16 . The tablet of  claim 1  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>. 
     
     
         17 . The tablet of  claim 1  wherein the tablet comprises approximately 1000 mg of ferric citrate. 
     
     
         18 . The tablet of  claim 1  wherein the tablet comprises approximately 667 mg of ferric citrate. 
     
     
         19 . The tablet of  claim 1  wherein the tablet comprises approximately 500 mg of ferric citrate. 
     
     
         20 . A method of preparing a tablet according to  claim 1 , the method comprising:
 mixing the ferric citrate with one or more binders under conditions in which the LOD % water does not exceed 25% to form ferric citrate granules;   tableting the ferric citrate granules to form a tablet.   
     
     
         21 . The method according to  claim 20 , wherein said granule particles have a mean surface area to mass ratio greater than 1 m 2  per gram. 
     
     
         22 . The method according to  claim 21 , wherein the mean surface area to mass ratio of said granule particles is equal to or greater than 10 m 2  per gram. 
     
     
         23 . The process of  claim 18 , wherein the mixing step comprises fluid bed granulation. 
     
     
         24 . The process of  claim 18 , wherein the mixing step comprises high shear granulation. 
     
     
         25 . The method according to  claim 20 , further comprising heating said tablet above 50° C. 
     
     
         26 . A method for the prophylaxis or treatment of hyperphosphatemia comprising administering the tablet of  claim 1 .

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