Pharmaceutical-grade ferric organic compounds, uses thereof...

A - Human Necessities – 61 – K

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A61K 33/26 (2006.01) A61P 3/00 (2006.01) A61P 7/00 (2006.01)

Patent

CA 2619591

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.

L'invention concerne des composés organiques ferriques de qualité pharmaceutique comprenant du citrate ferrique, lesquels sont solubles dans une large gamme de pH et qui possèdent une grande surface active. L'invention concerne également un procédé de fabrication et de contrôle de qualité permettant de fabriquer un citrate ferrique de qualité pharmaceutique qui est conforme, de façon consistante, avec les prescriptions de lancement de fabrication. Ces composés organiques ferriques de qualité pharmaceutique sont adaptés à une utilisation pour le traitement de troubles caractérisés par des niveaux élevés de phosphate de sérum.

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