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

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• 作者：Youssef Bennis^a ; ^b ; ^{bennis.youssef@chu-amiens.fr" class="auth_mail" title="E-mail the corresponding author} ; Amandine Savry^a ; ^{amandine.savry@ap-hm.fr" class="auth_mail" title="E-mail the corresponding author} ; Florian Correard^a ; ^{florian.correard@ap-hm.fr" class="auth_mail" title="E-mail the corresponding author} ; Marc Montana^a ; ^{marc.montana@ap-hm.fr" class="auth_mail" title="E-mail the corresponding author} ; Christophe Sauzet^c ; ^{christophe.sauzet@univ-amu.fr" class="auth_mail" title="E-mail the corresponding author} ; Laurence Gauthier-Villano^a ; ^{laurence.Gauthier-villano@ap-hm.fr" class="auth_mail" title="E-mail the corresponding author} ; Pascale Pisano^a ; ^{pascale.pisano@ap-hm.fr" class="auth_mail" title="E-mail the corresponding author} ; Bertrand Pourroy^a ; ^{bertrand.pourroy@ap-hm.fr" class="auth_mail" title="E-mail the corresponding author}
• 关键词：Anthracycline ; Transcatheter arterial chemoembolization ; Hepatocellular-carcinoma ; Cytotoxic drugs reconstitution ; Interventional radiology
• 刊名：International Journal of Pharmaceutics
• 出版年：2015
• 出版时间：30 November 2015
• 年：2015
• 卷：495
• 期：2
• 页码：956-962
• 全文大小：1147 K

文摘

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.