Stability of unused reconstituted bortezomib in original manufacturer vials

Joshua P Vanderloo; Marcia L Pomplun; Lee C Vermeulen; Jill M Kolesar

doi:10.1177/1078155210386268

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Stability of unused reconstituted bortezomib in original manufacturer vials

Journal article

Peer reviewed

Stability of unused reconstituted bortezomib in original manufacturer vials

Joshua P Vanderloo, Marcia L Pomplun, Lee C Vermeulen and Jill M Kolesar

Journal of oncology pharmacy practice, Vol.17(4), pp.400-402

12/2011

DOI: 10.1177/1078155210386268

PMID: 20926455

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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. 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. 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. 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.

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

Details

Title: Subtitle: Stability of unused reconstituted bortezomib in original manufacturer vials
Creators: Joshua P Vanderloo - University of Wisconsin–Madison
Marcia L Pomplun - University of Wisconsin Carbone Cancer Center
Lee C Vermeulen - UW Health University Hospital
Jill M Kolesar - University of Wisconsin Carbone Cancer Center
Resource Type: Journal article
Publication Details: Journal of oncology pharmacy practice, Vol.17(4), pp.400-402
DOI: 10.1177/1078155210386268
PMID: 20926455
ISSN: 1078-1552
eISSN: 1477-092X
Grant note: P30 CA014520 / NCI NIH HHS
Language: English
Date published: 12/2011
Academic Unit: Pharmacy; Pharmaceutical Sciences and Experimental Therapeutics
Record Identifier: 9984695798402771

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