One-month physicochemical stability study of idarubicin prepared in polyolefin-type bags for the treatment of hematological diseases.

Abstract

Idarubicine is a mainstay of the treatment strategy for hematological cancer. The literature lacks stability data that comply with current preparation practices and recommendations for conducting stability studies. The aim of the present work is to establish the stability of idarubicin preparations diluted in polyolefin-type bags (Freeflex + ®) for intravenous administration in hematological clinical settings. Preparations were produced by diluting Zavedos® idarubicin in Freeflex + ® bags containing 0.9% sodium chloride (NaCl) or 5% dextrose (Dex) at concentrations of 0.04 mg/mL and 0.2 mg/mL. These preparations were stored at 5 ± 3 °C or 22 ± 3 °C. Three bags were prepared to evaluate each condition, for a total of 24 bags. To assess chemical stability, a stability-indicating high pressure liquid chromatography-ultraviolet/visible diode array detector assay was used. Samples were assayed on days D0, D1, D2, D7, D15, D22 and D30. A physical stability study was carried out on days D0, D15 and D30, looking for visible and sub-visible particles, measuring pH and osmolality. During the study, sample concentrations remained above 95% of the initial concentration, and no degradation products were detected. No color change or precipitation were observed with the naked eye. Sub-visible particles count remained below recommended limits. The pH and osmolality values remained unchanged from D0. This study demonstrates the stability of idarubicin, diluted to concentrations between 0.04 and 0.2 mg/mL in solutions of 0.9% NaCl and 5% Dex, stored at 5 ± 3 °C or 22 ± 3 °C for 30 days.