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Claims for Patent: 8,754,257

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Claims for Patent: 8,754,257

Title:Pharmaceutical-grade ferric organic compounds, uses thereof and methods of making same
Abstract: The present invention discloses a pharmaceutical-grade ferric organic compounds, including ferric citrate, which are soluble over a wider range of pH, and which have a large active surface area. A manufacturing and quality control process for making a pharmaceutical-grade ferric citrate that consistently complies with the established Manufacture Release Specification is also disclosed. The pharmaceutical-grade ferric organic compounds are suitable for treating disorders characterized by elevated serum phosphate levels.
Inventor(s): Chan; Keith (Rockville, MD), Town; Winston (Hong Kong, CN)
Assignee: Panion & BF Biotech Inc. (TW)
Application Number:13/661,558
Patent Claims: 1. A pharmaceutical composition comprising a form of ferric citrate having an intrinsic dissolution rate of 1.88-4.0 mg/cm.sup.2/min and a pharmaceutically suitable carrier, wherein the ferric citrate is present in an amount effective to reduce serum phosphate levels.

2. The pharmaceutical composition of claim 1, wherein the effective amount of ferric citrate is from 2 grams per day to 30 grams per day.

3. The pharmaceutical composition of claim 1, wherein the effective amount of ferric citrate is from 4 grams per day to 15 grams per day.

4. The pharmaceutical composition of claim 1, wherein the effective amount of ferric citrate is from 2 grams per day to 12 grams per day.

5. The pharmaceutical composition of claim 1, wherein the effective amount of ferric citrate is selected from 2 grams per day, 4 grams per day and 6 grams per day.

6. The pharmaceutical composition of claim 1, wherein the effective amount of ferric citrate is 1 gram per day.

7. The pharmaceutical composition of claim 1, wherein the effective amount of ferric citrate is 500 mg per unit dosage form.

8. A pharmaceutical composition comprising 500 mg of a form of ferric citrate having an intrinsic dissolution rate of 1.88-4.0 mg/cm.sup.2/min, and a pharmaceutically suitable carrier, wherein the pharmaceutical composition is in a capsule dosage form.
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