Abstract

Iron deficiency is a significant health problem across the world. While many patients benefit from oral iron supplements, some, including those on hemodialysis require intravenous iron therapy to maintain adequate iron levels. Until recently, all iron compounds suitable for parenteral administration were colloidal iron–carbohydrate conjugates that require uptake and processing by macrophages. These compounds are associated with variable risk of anaphylaxis, oxidative stress, and inflammation, depending on their physicochemical characteristics. Ferric pyrophosphate citrate (FPC) is a novel iron compound that was approved for parenteral administration by US Food and Drug Administration in 2015. Here we report the physicochemical characteristics of FPC. FPC is a noncolloidal, highly water soluble, complex iron salt that does not contain a carbohydrate moiety. X-ray absorption spectroscopy data indicate that FPC consists of iron (III) complexed with one pyrophosphate and two citrate molecules in the solid state. This structure is preserved in solution and stable for several months, rendering it suitable for pharmaceutical applications in solid or solution state.

Highlights

  • Iron deficiency with or without associated anemia represents a significant health problem worldwide

  • The results presented here describe the physicochemical characterization of ferric pyrophosphate citrate (FPC) in the solid state and in solution and characterize the unique iron (III)-citratepyrophosphate ternary complex oligomeric structure, which is stable for extended periods in aqueous solution

  • IR and high-performance liquid chromatography (HPLC) analyses of FPC confirm the presence of the expected anions, citrate and pyrophosphate, as well as phosphate and sulfate

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Summary

Introduction

Iron deficiency with or without associated anemia represents a significant health problem worldwide. Multiple IV iron formulations are available, including iron dextran, iron sucrose, sodium ferric gluconate, iron carboxymaltose, ferrumoxytol, and iron isomaltoside (Macdougall et al 1996). Intravenous iron products have been used extensively for over 30 years for the treatment of irondeficiency anemia and to maintain iron balance in hemodialysis patients since these patients have obligatory excessive losses. While these agents are generally well tolerated, they have been associated with risk of anaphylaxis (Wang et al 2015). Higher mortality rates have been reported with use of high-dose IV iron in hemodialysis patients (Bailie et al 2015)

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