Development and optimization of the drug release determination of iron from iron prolonged release tablets.
The aim of this research was to develop and optimize the drug release determination of iron from iron prolonged release tablets. First, solubility characteristics of ferrous sulfate in different aqueous media with a pH in the range of 1 to 8 were studied. According to the results obtained different physicochemical conditions that influence drug release of iron from iron prolonged release tablets were checked. Various aqueous media with a pH in the range of 1 to 7.4, different volumes of dissolution media, various rotation speeds of stirring elements, different dissolution apparatus (apparatus 1/basket apparatus and apparatus 2/paddle apparatus according to USP/Ph. Eur.) were verified. For evaluation of dissolved iron two different methods were checked: atomic absorption spectrometry and redox titration. Redox titration was proved to be a reproducible, discriminatory, selective and cost effective method for evaluation of dissolved iron from iron prolonged release tablets and can be applied in the quality control of solid dosage forms containing iron compounds.
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Physicochemical Development Department, R & D, Krka, d.d., Novo mesto, Slovenia. maja.kincl@krka.si
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D003692:Delayed-Action Preparations; D005296:Ferrous Compounds / Q000032:analysis / Q000737:chemistry; D006863:Hydrogen-Ion Concentration; D019266:Iron, Dietary / Q000008:administration & dosage* / Q000032:analysis / Q000493:pharmacokinetics; D010084:Oxidation-Reduction; D011786:Quality Control; D015203:Reproducibility of Results; D012995:Solubility; D013054:Spectrophotometry, Atomic; D013696:Temperature
D003692:Delayed-Action Preparations; D005296:Ferrous Compounds; D019266:Iron, Dietary; C020748:ferrous sulfate