title: 14-day in vitro chemical stability of insulin lispro in the MiniMed Paradigm pump.
abstract: BACKGROUND
  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.
  
  
  METHODS
  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
  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.
  
  
  CONCLUSIONS
  Insulin lispro demonstrated appropriate physicochemical stability for up to 14 days in the MiniMed Paradigm pump system.
authors: Eli Lilly and Company, Indianapolis, Indiana 46285, USA. Sharrow_Scott_D@Lilly.com
authors: Scott D
authors: SD
authors: Sharrow
authors: Leonard C
authors: LC
authors: Glass
authors: Michael A
authors: MA
authors: Dobbins
mesh_terms: D004355:Drug Stability; D006358:Hot Temperature; D006801:Humans; D007004:Hypoglycemic Agents / Q000737:chemistry*; D007332:Insulin Infusion Systems; D061268:Insulin Lispro / Q000737:chemistry*; D013997:Time Factors; D014481:United States; D014732:Vibration
chemical_list: D007004:Hypoglycemic Agents; D061268:Insulin Lispro