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Physicochemical and toxicological characterization of a new generic iron sucrose preparation
- Source :
- Arzneimittelforschung. 61:112-119
- Publication Year :
- 2011
- Publisher :
- Georg Thieme Verlag KG, 2011.
-
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.
- Subjects :
- 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
Subjects
Details
- ISSN :
- 16167066 and 00044172
- Volume :
- 61
- Database :
- OpenAIRE
- Journal :
- Arzneimittelforschung
- Accession number :
- edsair.doi.dedup.....edf157641787508acd9742d6a857d3b9