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Stability of alemtuzumab solutions at room temperature.
MedLine Citation:
PMID:  23413168     Owner:  NLM     Status:  In-Data-Review    
Abstract/OtherAbstract:
PURPOSE: The 24-hour stability of alemtuzumab solutions prepared at concentrations not included in the product label and stored in glass or polyolefin containers at room temperature was evaluated.
METHODS: Triplicate solutions of alemtuzumab (6.67, 40, and 120 μg/mL) in 0.9% sodium chloride were prepared in either glass bottles or polyolefin containers and stored at room temperature under normal fluorescent lighting conditions. The solutions were analyzed by a validated stability-indicating high-performance liquid chromatography (HPLC) assay at time zero and 8, 14, and 24 hours after preparation; solution pH values were measured and the containers visually inspected at all time points. Stability was defined as the retention of ≥90% of the initial alemtuzumab concentration.
RESULTS: HPLC analysis indicated that the percentage of the initial alemtuzumab concentration retained was >90% for all solutions evaluated, with no significant changes over the study period. The most dilute alemtuzumab solution (6.67 μg/mL) showed some degradation (91% of the initial concentration retained at hour 24), whereas the retained concentration was >99% for all other preparations throughout the study period. Solution pH values varied by drug concentration but did not change significantly over 24 hours. No evidence of particle formation was detected in any solution by visual inspection at any time during the study.
CONCLUSION: Solutions of alemtuzumab 6.67 μg/mL stored in glass bottles and solutions of 40 and 120 μg/mL stored in polyolefin containers were stable for at least 24 hours at room temperature.
Authors:
Justin T Goldspiel; Barry R Goldspiel; George J Grimes; Peng Yuan; Gopal Potti
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Publication Detail:
Type:  Journal Article    
Journal Detail:
Title:  American journal of health-system pharmacy : AJHP : official journal of the American Society of Health-System Pharmacists     Volume:  70     ISSN:  1535-2900     ISO Abbreviation:  Am J Health Syst Pharm     Publication Date:  2013 Mar 
Date Detail:
Created Date:  2013-02-15     Completed Date:  -     Revised Date:  -    
Medline Journal Info:
Nlm Unique ID:  9503023     Medline TA:  Am J Health Syst Pharm     Country:  United States    
Other Details:
Languages:  eng     Pagination:  439-42     Citation Subset:  IM    
Affiliation:
Justin T. Goldspiel is a 2012 graduate of the Science, Math, and Computer Science Program at Poolesville High School, Poolesville, MD. At the time of this study, he was a summer intern in the Pharmaceutical Development Service, Pharmacy Department, National Institutes of Health (NIH) Clinical Center, Bethesda, MD.
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