This Article Full Text (PDF) References Alert me when this article is cited Alert me if a correction is posted Services Email this article to a friend Similar articles in this journal Alert me to new issues of the journal Add to Saved Citations Download to citation manager Request Permissions Request Reprints Add to My Marked Citations Citing Articles Citing Articles via Google Scholar Citing Articles via Scopus Google Scholar Articles by Xu, Q. A. Articles by Martinez, J. F. Search for Related Content PubMed Articles by Xu, Q. A. Articles by Martinez, J. F. Social Bookmarking                         What's this?

Stability of busulfan injection admixtures in 5 % dextrose injection and 0.9% sodium chloride injection

Pharmaceutical Analysis Laboratory, Division of Pharmacy, The University of Texas, M.D. Anderson Cancer Center, Houston, Texas

Yan-ping Zhang

University of Texas, M.D. Anderson Cancer Center, Houston, Texas

Lawrence A. Trissel

University of Texas, M.D. Anderson Cancer Center, Houston, Texas

Juan F. Martinez

University of Texas, M.D. Anderson Cancer Center, Houston, Texas

Objective. The purpose of this study was to deter mine the stability of busulfan injection at 0.5 and 0.1 mg/mL admixed in 5% dextrose injection and 0.9% sodium chloride injection in PVC and polyolefm bags over 24 hours at 23°C.

Methods. The busulfan injection was prepared by dissolving the bulk powder in a 1:2 mixture of N,N-dimethylacetamide and polyethylene glycol 400 to form a 6 mg/mL solution. The injection was filtered and admixed in the infusion solutions to yield busulfan concentrations of 0.5 and 0.1 mg/mL. Evaluations were performed initially and after 4, 8, and 24 hours of storage for physical and chemical stability. The admix tures were evaluated for physical stability using visual observation in normal light and using a high-intensity monodirectional light beam as well as measuring turbidity. The chemical stability was evaluated by using a stability-indicating HPLC analytical technique.

Results. No physical instabilities were observed. However, busulfan is chemically unstable. At 0.5 mg/mL, potency of at least 95% was retained through 4 hours and at least 90% was retained through 8 hours. After 24 hours, losses of 20% to 30% occurred. At 0.1 mg/mL, drug loss was more rapid. Potency of at least 90% was retained through 4 hours. Losses after 24 hours were about 30% to 40%.

Conclusions. Busulfan injection admixed in 5% dextrose injection or 0.9% sodium chloride injection is unstable. At a concentration of 0.5 mg/mL, ade quate drug delivery is provided within 8 hours of admixture. At the lower concentration of 0.1 mg/mL, adequate drug delivery is only provided for 4 hours.

Key Words: Busulfan • stability • compatibility • injection • HPLC analysis.

Journal of Oncology Pharmacy Practice, Vol. 2, No. 2, 101-105 (1996)
DOI: 10.1177/107815529600200202


CiteULike    Complore    Connotea    Del.icio.us    Digg    Reddit    Technorati    Twitter    What's this?