Stability of micafungin sodium solutions at different concentrations in glass bottles and syringes

Abstract

Micafungin is a costly treatment and packaging of 50mg or 100mg bottles only are available, while doses lower than 5mg and 20mg are often necessary in neonates and paediatrics patients, respectively. The stability of micafungin sodium in polypropylene syringes and glass bottles was studied at different concentrations. Solutions of micafungin diluted with NaCl 0.9% were prepared in glass bottles (20 and 10mg/mL) or syringes (1 and 0.5mg/mL) and stored at 25°C, 60% humidity (RH), in the dark (ICH conditions). Solutions were also exposed to heat (70°C) or alkaline solution (NaOH) in order to force degradation. Samples were analysed at days 1, 5, 8 (for bottles) and also 15 (for syringes) after the preparation and assayed in triplicate. Stability was studied using a stability-indicating high-performance liquid chromatographic method. Syringes stored at 25°C retained over 90% of their initial concentration over the study period. Temperature and alkaline conditions had significant effect on the stability of micafungin, leading to apparition of degradation products. Moreover, sub visible particles were in the specification of the European Pharmacopeia along 15 days. To conclude, micafungin diluted in NaCl 0.9% and stored in polypropylene syringes was chemically stable for at least 15 days at 25°C in the dark.