FERRIC CITRATE DOSAGE FORMS
The disclosure relates to ferric citrate tablets and dosage forms.
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 .