Pharmaceutical-grade ferric organic compounds, uses thereof and methods of making same

摘要

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.

主权项

1. A pharmaceutical composition comprising a form of ferric citrate having an intrinsic dissolution rate of 1.88-4.0 mg/cm2/min and a pharmaceutically suitable carrier, wherein the ferric citrate is present in an amount effective to reduce serum phosphate levels.