Abstract

Stable isotopes represent a useful tool for the assessment of biokinetic parameters in in vivo studies on humans. A procedure is described to evaluate the bioavailability of iron in pharmaceutical preparations by means of 54Fe as a tracer and mass spectrometry for the determination of time dependent changes in the isotope ratio of 54Fe/56Fe in red blood cells. Iron tablets with an increased portion of 54Fe were administered to iron deficient subjects and red cell iron utilization was used as a measure of iron bioavailability. Iron utilization was derived from changes in the 54Fe/56Fe ratio as evaluated by means of fast atom bombardment-mass spectrometry (FAB-MS) on processed blood samples. A good intraindividual reproducibility was observed for blood samples drawn at various times after application of the trial drug. Figures for bioavailability and its interindividual variations were in the range expected from comparable studies on similar iron preparations using radioiron as tracers. The results obtained show that quantitative data of bioavailability from pharmaceutical iron preparations may be obtained without radiation exposure of the subjects investigated.

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