Physicochemical and toxicological characterization of a new generic iron sucrose preparation
| العنوان: | Physicochemical and toxicological characterization of a new generic iron sucrose preparation |
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| المؤلفون: | Thomas Meier, Anne-Laure Leoni, Van Van Khov-Tran, Christian Pater, Patricia Schropp, Peter Elford |
| المصدر: | Arzneimittelforschung. 61:112-119 |
| بيانات النشر: | Georg Thieme Verlag KG, 2011. |
| سنة النشر: | 2011 |
| مصطلحات موضوعية: | Iron, Rat model, Intravenous iron, Microscopy, Atomic Force, Iron sucrose, Ferric Compounds, Rats, Sprague-Dawley, Glucaric Acid, Liver Function Tests, Nephelometry and Turbidimetry, Drug Discovery, medicine, Animals, Drugs, Generic, Particle Size, Reference standards, Chromatography, High Pressure Liquid, Ferric Oxide, Saccharated, Superoxide Dismutase, Chemistry, Reference Standards, Rats, Molecular Weight, Sprague dawley, Kinetics, Proteinuria, Reference product, Biochemistry, Creatinine, Chromatography, Gel, Hematinics, Female, Delivery system, Creatinine metabolism, Algorithms, Polarography, medicine.drug |
| الوصف: | 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. |
| تدمد: | 1616-7066 0004-4172 |
| URL الوصول: | https://explore.openaire.eu/search/publication?articleId=doi_dedup___::edf157641787508acd9742d6a857d3b9 https://doi.org/10.1055/s-0031-1296176 |
| رقم الأكسشن: | edsair.doi.dedup.....edf157641787508acd9742d6a857d3b9 |
| قاعدة البيانات: | OpenAIRE |
| تدمد: | 16167066 00044172 |
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