Stability of new, iron-replete total nutrient admixtures

DESCRIPTION (provided by applicant): There has been little progress in the treatment of iron deficiency anemia using a parenteral nutrient (PN) admixture with lipids as a suitable drug delivery vehicle. Currently approved parenteral iron colloids (e.g., iron dextrans) destabilize total nutrient admixtures with lipids and also present safety risks to the patient. This project will assess the safety and efficacy of a new approach for treatment of iron-deficiency anemia in which iron is delivered in clinically relevant total nutrient admixtures prepared using a monomeric iron complex that has unique binding characteristics that limit the amount of free iron. In Phase I the physicochemical stability of the new iron-replete PN admixtures will be evaluated using a multifactorial research design that has been validated for this application. The results will be compared with those obtained in identical assessments of PN admixtures containing iron dextrans. If iron-replete PN admixture stability is found, the Phase II clinical study will evaluate (1) the efficacy of iron-replete TPN admixtures in treating or preventing the development of iron deficiency, compared with conventional TPN admixtures; and (2) the safety of iron-replete TPN admixtures, compared with conventional TPN admixtures, by monitoring adverse reactions manifesting clinically or on laboratory testing. Furthermore, this Phase II study will provide information regarding generation of free iron and oxidant stress following intravenous administration of the iron complex in this drug delivery vehicle.