分析および生物分析技術ジャーナル

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Physico-Chemical Stability of Mixtures of Fosaprepitant used in Clinical Practice

Maria Amparo Martínez- Gómez, Ana Moya Gil, Begoña Porta Oltra and Mónica Climente Martí

Fosaprepitant dimeglumine is a new drug indicated to prevent nausea and vomiting associated with highly emetogenic cisplatin-based and moderately emetogenic cancer chemotherapy in adults. Due to its complexity in managing, since it requires reconstitution and dilution before intraveonous administration, it is necessary to evaluate physico-chemical stability of fosaprepitant at concentrations used in our routine clinical practice and at different conditions of storage to expand the information datasheet (fosaprepitant 150 mg in 150 mL of 0.9 g/dl sodium chloride (NaCl) at ambient conditions and light for 24 hours) and simplify preparation technique conforming to the fluid marketed branches. These studies should be carried out following the recommendations International Conference on Harmonisation (ICH) guidelines for evaluate stability and the criteria of the United States Pharmacopeia to maintain quality and safety of the preparation. So, stability study of fosaprepitant 150 mg in 50, 100 and 250 mL of 0.9 g/dl NaCl at room temperature/refrigerated and protective from/exposed to ambient light has been carried out. An HPLC method has been developed and validated according to ICH guidelines to evaluate chemical stability of fosaprepitant. Physical stability study has been carried out by visual inspection, measure of pH and gravimetry to control evaporation. The results shown in this paper represent the first evidence of the physico-chemical stability of the mixtures of fosaprepitant 150 mg in 50, 100 and 250 mL of 0.9 g/dl NaCl are physico-chemically stable for 7 days at room temperature (27.0 ± 0.9°C) and refrigerated (4.9 ± 1.5°C); and exposed to ambient light, 15 days at room temperature and refrigerated and protected from light and 12 days fosaprepitant reconstituted and stored refrigerated and exposed to light.