Guest Editors
Dr. Wenlei Jiang
Center for Drug Evaluation and Research, U.S. Food and Drug Administration
<p>Dr. Wenlei Jiang is a Senior Science Advisor at Office of Research and Standards, Office of Generic Drugs, Center for Drug Evaluation and Research, U.S. FDA. Her research interests focus on bioequivalence standard development for generic complex drug products, global harmonization of generic drug approval criteria, and post-market surveillance of generic drugs. She currently serves as Chair at Product Quality Research Institute (PQRI) Steering Committee and co-Chair of International Pharmaceutical Regulatory Program (IPRP) Nanotechnology Working Group. She is also a member of National Cancer Institute (NCI) Nanotechnology Characterization Laboratory (NCL) Scientific Oversight Committee.</p>
Dr. James E. Polli
University of Maryland Baltimore, Department of Pharmaceutical Sciences
<p>Dr. James E. Polli is Professor of Pharmaceutical Sciences and Ralph F. Shangraw/Noxell Endowed Professor in Industrial Pharmacy and Pharmaceutics at University of Maryland. His research interest is drug absorption and formulation, involving laboratory and clinical research. He has served as an advisor to 21 PhD graduates. He is the co-Director of a recently initiated Center for Research on Complex Generics, an FDA-funded collaborative agreement with the Agency.</p>
Dr. Sarah L. J. Michel
University of Maryland Baltimore, Department of Pharmaceutical Sciences
<p>Dr. Sarah L. J. Michel is a Professor of Pharmaceutical Sciences and Associate Dean for Graduate Studies. Her research interests span basic and translational research with a focus on metals in biology and bioinorganic chemistry. She recently completed an FDA sponsored clinical trial on iron nanoparticle drug products, in collaboration with Dr. Polli and Jiang, where her laboratory examined a range of physicochemical methods to characterize the iron products. These methods comprise some of the JOVE articles in this issue.</p>
Collection Overview
Iron complex products are administered intravenously to treat iron deficiency anemia and are one of the oldest and most frequently administered classes of nanomedicines. There are several iron complex products, such as iron dextran, iron sucrose, sodium ferric gluconate and others, where the ferric oxyhydroxide core is enveloped in a carbohydrate coating. Nano size iron complex products are more complex than conventional drug formulations, which presents significant challenges to characterize these products. Efforts were made to understand the iron core, the carbohydrate shell, and interactions of the iron core with the carbohydrate ligands with the advancement of analytical techniques. Orthogonal analytical methods were used to characterize pharmaceutical iron complex products including optical spectroscopy, inductively coupled plasma mass spectrometry, X-Ray powder diffraction, 57Fe Mössbauer spectroscopy, X-ray absorbance spectroscopy, dynamic light scattering, analytical ultracentrifugation, liquid chromatography-tandem mass spectrometry, gel permeation chromatography, and others. This comprehensive methods collection captures current approaches to investigate physicochemical properties of pharmaceutical iron complex products, which is a great resource for scientists and clinicians interested in understanding or developing any new or generic versions of pharmaceutical iron complex products.
