CYTOSTATIC DRUGS PREDILUTED IN NORMAL SALINE IN POLYPROPYLENE INFUSION BAGS FLEBOFLEX®. STABILITY AT SEVERAL STORAGE CONDITIONS.
S. Jané, J. Menéndez, J. Girbau, A. Clopés*, C. Muñoz*, S. Narváez*
Pharmaceutical Technology Department, Laboratorios Grifols & *Servei de Farmàcia del Institut Català d’Oncologia-Hospital Duran i Reynals, Barcelona, Spain
Background: Many cytostatic drugs must be prediluted, before intravenous administration, in an isotonic solution. Normal saline in polypropylene bags is a good option because of its weight when compared to glass and inertness in relation to PVC
Methods: Three Cytostatic drugs, Docetaxel, Doxorubicin•HCl and Cyclophosphamide were prediluted in normal saline solutions at concentrations usually prepared in hospital pharmacy. Glass bottles, polypropylene and pvc bags all of 100ml were used. Docetaxel was not prepared in pvc. They were stored at 5°C and 25°C and controlled up to 7 days for docetaxel, 10 days for Cyclophosphamide and 30 days for doxorubicin•HCl. According to USP monographs when available, colour, turbidity, assay, related compounds and pH were controlled at several intervals for all the drugs. Assay was assessed with HPLC-UV. For PVC bags DEHP content was controlled at the
end of stability.
Results: Docetaxel solutions were stable along the study, Doxorubicin•HCl 30 days at 5°C and 15 days at 25°C, and Cyclophosphamide 6 days at 5°C and 5 days at 25°C.
No DEHP was found in solutions in PVC bags.
Conclusions: Normal saline in polypropylene bags is suitable to prepare stable solutions of Docetaxel, Cyclophosphamide and Doxorubicin•HCl. The physicochemical stability depends on the storage temperature.
Reference: 13th EAHP Congress, Maastricht, the Netherlands, 27-29 February 2008
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