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Physiochemical Stability of Diluted Trastuzumab Infusion Solutions in Polypropylene Infusion Bags

Author(s):  Kaiser Jeanette, Kramer Irene

Issue:  Nov/Dec 2011 - Volume 15, Number 6
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Abstract:  The purpose of this study was to determine the physicochemical stability of ready-to administer trastuzumab infusion solutions in 0.9% sodium chloride solution as the vehicle over a prolonged period of 28 days. Trastuzumab lyophilized powder was reconstituted with water for injection to a nominal concentration of 21 mg/mL. The reconstituted trastuzumab concentrate was further diluted with 0.9 % sodium chloride solution in polypropylene infusion bags. The physicochemical stability of the infusion solutions was assessed over a four-week storage period. Test solutions were stored under refrigeration (2°C to 8°C) or at room temperature under light protection and exposed to light. Samples of test solutions were withdrawn on day 0 (initial), 1, 3, 7, 14, 21, and 28. Preparation of the test solutions and sampling were conducted under aseptic conditions. Stability of trastuzumab infusion solutions was determined by size-exclusion high-performance liquid chromatography, ultraviolet-visible spectrometry, and sodium dodecyl sulphate polyacrylamide gel electrophoresis. In addition, pH values were measured weekly over the storage period, and test solutions were visually examined for potential color changes, turbidity, or particulate matter. The stability tests used revealed that in ready-to administer trastuzumab infusion solutions (0.4 mg/mL, 4 mg/mL) trastuzumab concentrations remained above 90% of the initial concentrations, independent of the storage conditions. No degradation products were observed. Exposure to daylight did not affect the stability of the trastuzumab test solutions. Readyto-administer trastuzumab infusion solutions prepared with 0.9% sodium chloride solution in polypropylene bags are storable over a four-week period, even when stored at room temperature without light protection. For microbiological reasons, storage under refrigeration is recommended.

Related Keywords: Jeanette Kaiser, PhD, Irene Kramer, PhD, trastuzumab, stability, monoclonal antibody, infusion solutions, microbial contamination, storage conditions


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