Physical and chemical stability of high-dose ifosfamide and mesna for prolonged 14-day continuous infusion

J Oncol Pharm Pract. 2014 Feb;20(1):51-7. doi: 10.1177/1078155213478284. Epub 2013 Mar 19.

Abstract

Purpose: Ifosfamide plus mesna have been used recently in a high-dose regimen that allows this chemotherapy to be given to outpatients with less toxicity over 14 days using a portable pump. However, there is a need for published stability information. The aim of this study was to investigate the physicochemical stability of ifosfamide with mesna in normal saline at room temperature over a prolonged period of 14 days.

Methods: Infusion solutions of 1:1 ifosfamide and mesna at final concentrations of 10, 20 and 30 mg/mL were prepared with 0.9% sodium chloride in PVC bags. Solutions were stored at room temperature. Concentrations of ifosfamide and mesna were measured at 0 and 1, 3, 7 and 14 days using a stability-indicating reversed phase high-performance liquid chromatography (HPLC) assay with ultraviolet detection.

Results: Ifosfamide and mesna were both physicochemically stable (>94%) for 14 days in all tested infusion solutions (10, 20 and 30 mg/mL).

Conclusions: Our stability data indicate that ifosfamide and mesna (1:1) combination can be administered as a prolonged continuous infusion with portable pump in an outpatient setting without replacement of the infusion bag. We suggest 20 mg/mL as a reasonable concentration for infusion rates of about 2-4 cc/hr over prolonged periods of time.

Keywords: Ifosfamide; improved therapeutic index; infusion solutions; mesna; outpatient chemotherapy; physicochemical stability; prolonged stability.

Publication types

  • Research Support, Non-U.S. Gov't

MeSH terms

  • Chemical Phenomena
  • Drug Combinations
  • Drug Stability
  • Drug Storage
  • Humans
  • Ifosfamide / administration & dosage
  • Ifosfamide / chemistry*
  • Infusions, Intravenous
  • Mesna / administration & dosage
  • Mesna / chemistry*
  • Outpatients
  • Pharmaceutical Solutions / administration & dosage
  • Pharmaceutical Solutions / chemistry*

Substances

  • Drug Combinations
  • Pharmaceutical Solutions
  • Mesna
  • Ifosfamide