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

Autor: Bertrand Pourroy, Youssef Bennis, Florian Correard, Amandine Savry, Christophe Sauzet, Pascale Pisano, Laurence Gauthier-Villano, Marc Montana
Přispěvatelé: Vascular research center of Marseille (VRCM), Aix Marseille Université (AMU)-Institut National de la Santé et de la Recherche Médicale (INSERM), Centre de Recherches en Oncologie biologique et Oncopharmacologie (CRO2), Institut National de la Santé et de la Recherche Médicale (INSERM)- Hôpital de la Timone [CHU - APHM] (TIMONE)-Aix Marseille Université (AMU), Service Pharmacie [Hôpital de la Timone - APHM], Aix Marseille Université (AMU)-Assistance Publique - Hôpitaux de Marseille (APHM)- Hôpital de la Timone [CHU - APHM] (TIMONE), Institut de neurophysiopathologie (INP), Centre National de la Recherche Scientifique (CNRS)-Aix Marseille Université (AMU), Institut de Chimie Radicalaire (ICR), Aix Marseille Université (AMU)-Institut de Chimie du CNRS (INC)-Centre National de la Recherche Scientifique (CNRS), Laboratoire de Galénique, Université de la Méditerranée - Aix-Marseille 2, Mécanismes physiopathologiques et conséquences des calcifications vasculaires - UR UPJV 7517 (MP3CV), Université de Picardie Jules Verne (UPJV)-CHU Amiens-Picardie, Aix Marseille Université (AMU)- Hôpital de la Timone [CHU - APHM] (TIMONE)-Institut National de la Santé et de la Recherche Médicale (INSERM), Aix Marseille Université (AMU)-Centre National de la Recherche Scientifique (CNRS)
Rok vydání: 2015
Předmět:
Zdroj: International Journal of Pharmaceutics
International Journal of Pharmaceutics, Elsevier, 2015, 495 (2), pp.956-962. ⟨10.1016/j.ijpharm.2015.10.012⟩
International Journal of Pharmaceutics, 2015, 495 (2), pp.956-962. ⟨10.1016/j.ijpharm.2015.10.012⟩
ISSN: 1873-3476
0378-5173
DOI: 10.1016/j.ijpharm.2015.10.012⟩
Popis: Introduction Epirubicin 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 methods Fifty 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. Results Neither 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. Conclusion Epirubicin 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.
Databáze: OpenAIRE
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