Stability of Intravesical Epirubicin Infusion: A Sequential Temperature Study

J Clin Pharm Ther. 2003 Oct;28(5):349-53. doi: 10.1046/j.0269-4727.2003.00501.x.

Abstract

Objective: To investigate the stability of epirubicin bladder instillation, prepared from two different epirubicin formulations, under refrigerated storage, transportation and clinical use conditions.

Method: A sequential study design was used. Epirubicin instillation (1 mg/mL) in polypropylene syringes was sequential incubated for periods of 84 days at 8 degrees C followed by 2 h at 25 degrees C and 1 h at 37 degrees C, the latter two temperatures replicating transport and intravesical conditions, respectively.

Results: The instillation was both chemically and physically stable under those incubation conditions. The formulation of epirubicin used to prepare the instillation infusions did not affect stability.

MeSH terms

  • Administration, Intravesical
  • Antibiotics, Antineoplastic / administration & dosage*
  • Chemistry, Pharmaceutical
  • Chromatography, Liquid
  • Drug Stability*
  • Drug Storage
  • Epirubicin / administration & dosage*

Substances

  • Antibiotics, Antineoplastic
  • Epirubicin