Abstract
Insulin lispro was subjected to a simulated in-use study in the Medtronic MiniMed Paradigm(®) pump system (Medtronic, Northridge, CA) under stressed conditions over 14 days. Basal and bolus insulin doses were delivered under conditions of elevated temperature (37°C) and continuous shaking over 14 days. The simulation included a study arm with infusion set changes every 3 days and an arm with no infusion set changes over the entire study period. Analyses were performed on samples pumped through the infusion system and on samples retained in the pump reservoir. Results met U.S. Pharmacopeia criteria for insulin lispro potency through the entire testing period. No precipitation was observed on visual inspection, and no occlusion alarms were noted. Insulin lispro demonstrated appropriate physicochemical stability for up to 14 days in the MiniMed Paradigm pump system.
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