title: Physicochemical and toxicological characterization of a new generic iron sucrose preparation.
abstract: Intravenous iron preparations are key components in the management of anaemia of various etiologies. These iron-carbohydrate complexes permit safe systemic delivery of iron, whilst protecting from the potential toxic effects of over-saturation. This in turn permits efficient haematopoiesis following erythropoietin administration. Since the rate of release of iron is dependent upon the structure of this iron-carbohydrate complex, it is essential to ensure that an intravenous iron preparation is well characterized and its properties documented. This report describes physicochemical and toxicological studies into a new iron sucrose generic preparation, "Iron Sucrose Azad (ISA)", using the original iron sucrose product as reference. It could be demonstrated that the specifications and physicochemical characteristics of ISA reflect those of the reference product. Furthermore, in a rat model previously shown to identify possible toxicological effects of "unsimilar" iron sucrose preparations, ISA was found to have the same properties as the reference product, with both being well tolerated.
authors.affiliation: Cilag AG, Schaffhausen, Switzerland. tmeier@its.jnj.com
authors.forename: Thomas
authors.initials: T
authors.lastname: Meier
authors.forename: Patricia
authors.initials: P
authors.lastname: Schropp
authors.forename: Christian
authors.initials: C
authors.lastname: Pater
authors.forename: Anne-Laure
authors.initials: AL
authors.lastname: Leoni
authors.forename: Van Van
authors.initials: VV
authors.lastname: Khov-Tran
authors.forename: Peter
authors.initials: P
authors.lastname: Elford
mesh_terms: D000465:Algorithms; D000818:Animals; D002850:Chromatography, Gel; D002851:Chromatography, High Pressure Liquid; D003404:Creatinine / Q000378:metabolism; D016568:Drugs, Generic; D005260:Female; D005290:Ferric Compounds / Q000737:chemistry* / Q000493:pharmacokinetics / Q000633:toxicity*; D000077605:Ferric Oxide, Saccharated; D005937:Glucaric Acid; D006397:Hematinics / Q000737:chemistry* / Q000493:pharmacokinetics / Q000633:toxicity*; D007501:Iron / Q000097:blood; D007700:Kinetics; D008111:Liver Function Tests; D018625:Microscopy, Atomic Force; D008970:Molecular Weight; D009391:Nephelometry and Turbidimetry; D010316:Particle Size; D011048:Polarography; D011507:Proteinuria / Q000139:chemically induced; D051381:Rats; D017207:Rats, Sprague-Dawley; D012015:Reference Standards; D013482:Superoxide Dismutase / Q000378:metabolism
chemical_list: D016568:Drugs, Generic; D005290:Ferric Compounds; D006397:Hematinics; D003404:Creatinine; D007501:Iron; D013482:Superoxide Dismutase; D000077605:Ferric Oxide, Saccharated; D005937:Glucaric Acid