Stability of a highly concentrated solution of epirubicin for conventional transcatheter arterial chemoembolization

IntroductionEpirubicin is widely used for conventional transcatheter arterial chemoembolization (cTACE) in patients with hepatocellular-carcinoma. However, there is no data about its stability in solution at concentration higher than 2 mg/L, yet needed when mixing it with a standard volume of Lipiodol® to produce an efficient water-in-oil emulsion. The aim of this study was therefore to evaluate the stability of a highly concentrated solution of epirubicin for cTACE and verify whether epirubicin solution could be prepared in advance.Materials and methodsFifty milligrams of epirubicin were dissolved in 6 mL of 0.9% sodium chloride and conditioned in brown polypropylene syringe. Physical and chemical stability assays including particles and HPLC-DAD analysis were performed in triplicate, using series of 5 syringes stored over 72 h at 4 ± 2 °C followed by 4 h at 22 ± 4 °C.ResultsNeither weight loss nor pH or spectrum change occurred. No haze or turbidity was observed and the number of subvisible particles was below the recommended limits. Epirubicin concentration remained above 95% of the initial value over the 72 h of storage at +4 °C followed by 4 h at 22 ±4 °C and no degradation was observed.ConclusionEpirubicin at 50 mg/6 mL in 0.9% NaCl conditioned in brown propylene syringe is stable for at least 72 h at 4 ±2 °C with additional 4 h at 22 ±4 °C allowing its preparation in advance for programmed cTACE and the standardization of its use in clinical practice.

Fifty milligrams of epirubicin hydrochloride, reconstituted in 6 mL of NaC l0.9% and stored in brown polypropylene syringe, are stable at least 72 h at 4 ± 2 °C with additional 4 h at 22 ± 4 °C and can be prepared in advance for conventional transcatheter arterial chemoembolization of hepatocellular carcinoma.Figure optionsDownload high-quality image (127 K)Download as PowerPoint slide