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Claims for Patent: 9,387,191

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Claims for Patent: 9,387,191

Title: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).
Inventor(s): Le; Henry Trong (Englewood Cliffs, NJ)
Assignee: Keryx Biopharmaceuticals, Inc. (New York, NY)
Application Number:13/255,326
Patent Claims: 1. A ferric citrate tablet comprising: (a) a core comprising approximately 90% to approximately 92% by weight of ferric citrate, approximately 4.5% to approximately 30% by weight of pregelatinized starch, and approximately 0.5% to approximately 3% by weight of a lubricant; and (b) a coating, wherein the tablet has a friability equal or less than 1% w/w, and wherein at least 80% of the ferric citrate in the tablet is dissolved in 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).

2. The tablet of claim 1, wherein the lubricant is magnesium stearate.

3. The tablet of claim 1, wherein the lubricant is calcium stearate.

4. The tablet of claim 1, wherein the tablet comprises approximately 1000 mg of ferric citrate.

5. The tablet of claim 1, wherein the tablet has a disintegration time equal to or less than 30 minutes.

6. A ferric citrate tablet comprising: (a) a core comprising approximately 90% to approximately 92% by weight of ferric citrate, approximately 4.5% to approximately 30% by weight of pregelatinized starch, and approximately 0.5% to approximately 3% by weight of a lubricant; and (b) a coating, wherein the tablet has a friability equal or less than 1% w/w, and wherein at least 80% of the ferric citrate is dissolved in less than or equal to 60 minutes as measured by test method USP <711>, and the moisture content of the tablet is between 5% to 10% by LOD.

7. The tablet of claim 6, wherein the lubricant is magnesium stearate.

8. The tablet of claim 6, wherein the lubricant is calcium stearate.

9. The tablet of claim 6, wherein the tablet comprises approximately 1000 mg of ferric citrate.

10. The tablet of claim 6, wherein the tablet has a disintegration time equal to or less than 30 minutes.

11. A ferric citrate tablet comprising: (a) a core comprising approximately 90% to approximately 92% by weight of ferric citrate, approximately 1.5% to approximately 15% by weight of pregelatinized starch, and approximately 0.5% to approximately 3% by weight of a lubricant; and (b) a coating, wherein the tablet has a friability equal or less than 1%, and wherein at least 80% of the ferric citrate in the tablet is dissolved in less than or equal to 60 minutes as measured by test method USP <711>, and the moisture content of the tablet is between 5% to 10% by LOD.

12. The tablet of claim 11, wherein the lubricant is magnesium stearate.

13. The tablet of claim 11, wherein the lubricant is calcium stearate.

14. The tablet of claim 11, wherein the tablet comprises approximately 1000 mg of ferric citrate.

15. The tablet of claim 11, wherein the tablet has a disintegration time equal to or less than 30 minutes.

16. A ferric citrate tablet containing approximately 210 mg of ferric iron, wherein the tablet comprises: (a) a core comprising approximately 87.6% by weight of ferric citrate, approximately 10% by weight of pregelatinized starch, and approximately 2.4% by weight of calcium stearate; and (b) a coating, wherein the tablet has a friability equal or less than 1% w/w and a disintegration time less than 15 minutes, and wherein at least 80% of the ferric citrate in the tablet is dissolved in less than or equal to 60 minutes as measured by test method USP <711>, and the moisture content of the tablet is 8.84% (LOD).
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