Relative biodistribution of FDA-approved innovator and generic sodium ferric gluconate\n(SFG) drug products was investigated to identify differences in tissue distribution of iron after\nintravenous dosing to rats. Three equal cohorts of 42 male Sprague-Dawley rats were created with\neach cohort receiving one of three treatments: (1) the innovator SFG product dosed intravenously\nat a concentration of 40 mg/kg; (2) the generic SFG product dosed intravenously at a concentration\nof 40 mg/kg; (3) saline dosed intravenously at equivalent volume to SFG products. Sampling\ntime points were 15 min, 1 h, 8 h, 1 week, two weeks, four weeks, and six weeks post-treatment.\nSix rats from each group were sacrificed at each time point. Serum, femoral bone marrow, lungs,\nbrain, heart, kidneys, liver, and spleen were harvested and evaluated for total iron concentration by\nICP-MS. The ICP-MS analytical method was validated with linearity, range, accuracy, and precision.\nResults were determined for mean iron concentrations (�¼g/g) and mean total iron (whole tissue)\ncontent (�¼g/tissue) for each tissue of all groups at each time point. A percent of total distribution\nto each tissue was calculated for both products. At any given time point, the overall percent iron\nconcentration distribution did not vary between the two SFG drugs by more than 7% in any tissue.\nOverall, this study demonstrated similar tissue biodistribution for the two SFG products in the\nexamined tissues.
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