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Last Updated: November 22, 2024

Claims for Patent: 8,299,298

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Summary for Patent: 8,299,298

Title:	Pharmaceutical-grade ferric organic compounds, uses thereof and method of making same
Abstract:	The present invention discloses 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:	Globoasia, LLC (Rockville, MD)
Application Number:	13/289,048
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for patent 8,299,298
Patent Claims:	1. A pharmaceutical composition comprising ferric citrate having a BET active surface area of at least 16 sq. m/g 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 ferric citrate has an intrinsic dissolution rate of 1.88-4.0 mg/cm.sup.2/min. 3. The pharmaceutical composition of claim 1, wherein the effective amount of ferric citrate is from 2 grams per day-30 grams per day. 4. The pharmaceutical composition of claim 1, wherein the effective amount of ferric citrate is from 4 grams per day-15 grams per day. 5. The pharmaceutical composition of claim 1, wherein the effective amount of ferric citrate is from 2 grams per day-12 grams per day. 6. 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. 7. The pharmaceutical composition of claim 1, wherein the effective amount of ferric citrate is 1 gram per day. 8. The pharmaceutical composition of claim 1, wherein the effective amount of ferric citrate is 500 mg per unit dosage form. 9. A pharmaceutical composition comprising 500 mg of ferric citrate having a BET active surface area of at least 16 sq. m/g, and a pharmaceutically suitable carrier, wherein the pharmaceutical composition is in a capsule dosage form.

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