Stability of unused reconstituted bortezomib in original manufacturer vials

J Oncol Pharm Pract. 2011 Dec;17(4):400-2. doi: 10.1177/1078155210386268. Epub 2010 Oct 6.

Abstract

BACKGROUND. Bortezomib is a modified dipeptidyl boronic acid analogue used to treat multiple myeloma, mantle cell lymphoma, and, more recently, renal transplantation graft rejection. As per manufacturer recommendations, bortezomib is to be administered within 8 h of preparation or may be stored for up to 8 h in the vial or a syringe following reconstitution. Preserving unused reconstituted bortezomib beyond these 8 h may allow for cost savings. This study aims to examine the stability of unused reconstituted bortezomib when stored at 4°C for up to 15 days.

Methods: Using an LC-MS/MS assay, the concentration of reconstituted bortezomib was measured at predetermined time points following storage at 4°C in the manufacturer vial. Percent bortezomib remaining at a time point was calculated versus initial bortezomib concentration.

Results: The concentrations of bortezomib were found to be 51.93 ng/mL±4.60 after 1 day of storage, 57.40 ng/mL±4.77 after 8 days of storage, and 49.43 ng/mL±2.85 after 15 days of storage. The percent of bortezomib remaining was 110.53% and 95.19% after 8 days and 15 days, respectively.

Conclusion: Unused reconstituted bortezomib is stable for up to 15 days stored at 4°C in the original manufacturer vial. Such use of bortezomib may improve cost efficiency by reducing bortezomib waste.

Publication types

  • Comparative Study
  • Research Support, N.I.H., Extramural

MeSH terms

  • Boronic Acids / analysis*
  • Boronic Acids / chemistry
  • Boronic Acids / standards*
  • Bortezomib
  • Chromatography, Liquid / methods
  • Drug Packaging / methods
  • Drug Packaging / standards*
  • Drug Stability
  • Drug Storage / methods
  • Drug Storage / standards
  • Mass Spectrometry / methods
  • Pyrazines / analysis*
  • Pyrazines / chemistry
  • Pyrazines / standards*
  • Tandem Mass Spectrometry / methods
  • Time Factors

Substances

  • Boronic Acids
  • Pyrazines
  • Bortezomib