Stability of micafungin sodium solutions at different concentrations in glass bottles and syringes
| Autor: | Thomas Briot, Frédéric Lagarce, Sandy Vrignaud |
|---|---|
| Přispěvatelé: | Micro et Nanomédecines Biomimétiques (MINT), Université d'Angers (UA)-Institut National de la Santé et de la Recherche Médicale (INSERM)-Centre National de la Recherche Scientifique (CNRS)-Université Bretagne Loire (UBL), Centre Hospitalier Universitaire d'Angers (CHU Angers), PRES Université Nantes Angers Le Mans (UNAM) |
| Jazyk: | angličtina |
| Rok vydání: | 2015 |
| Předmět: |
Antifungal Agents
Sodium [SDV]Life Sciences [q-bio] Pharmaceutical Science chemistry.chemical_element Sodium Chloride Polypropylenes Micafungin Sodium 030226 pharmacology & pharmacy High-performance liquid chromatography Drug formulations Echinocandins Lipopeptides 03 medical and health sciences chemistry.chemical_compound 0302 clinical medicine Polypropylene syringe Drug Stability 030225 pediatrics medicine Relative humidity Chromatography High Pressure Liquid Polypropylene Chromatography Syringes Micafungin Hydrogen-Ion Concentration Pharmaceutical Solutions chemistry Sodium hydroxide CIVAS Glass HPLC Stability medicine.drug |
| Zdroj: | International Journal of Pharmaceutics International Journal of Pharmaceutics, Elsevier, 2015, 492, pp.137-40. ⟨10.1016/j.ijpharm.2015.07.019⟩ |
| ISSN: | 0378-5173 |
| DOI: | 10.1016/j.ijpharm.2015.07.019⟩ |
| Popis: | International audience; 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. |
| Databáze: | OpenAIRE |
| Externí odkaz: |
|
Full Text from ScienceDirect