title: Dosing Accuracy of Two Disposable Insulin Pens According to New ISO 11608-1: 2012 Requirements.
abstract: OBJECTIVE
  The aim was to compare 2 disposable insulin pens, FlexTouch® (Novo Nordisk, insulin aspart) and SoloSTAR® (Sanofi, insulin glulisine), according to new ISO 11608-1:2012 requirements for dosing accuracy.
  
  
  METHODS
  Sixty pens of each type were tested at 1, 40, and 80 U doses. Following the new ISO requirements, each dose was delivered from the front, middle, and rear one-third of the pen. Statistical analysis was performed using Student's t test.
  
  
  RESULTS
  Both pens delivered all doses within ISO limits. The difference between the average measured dose and the target dose was significantly smaller for SoloSTAR than FlexTouch at 40 U (P = .009) and 80 U (P = .008), but not at 1 U (P = .417).
  
  
  CONCLUSIONS
  Both insulin pens fulfilled the dosing accuracy requirements defined by ISO 11608-1:2012 at all 3 dosage levels.
authors.affiliation: Central Laboratory of German Pharmacists, Eschborn, Germany M.Tawab@zentrallabor.com.
authors.forename: Mona
authors.initials: M
authors.lastname: Abdel-Tawab
authors.affiliation: sanofi-aventis Deutschland GmbH, Site Frankfurt Devices, Frankfurt, Germany.
authors.forename: Mario
authors.initials: M
authors.lastname: Schmitz
authors.affiliation: sanofi-aventis Deutschland GmbH, Site Frankfurt Devices, Frankfurt, Germany.
authors.forename: Stefan
authors.initials: S
authors.lastname: Kamlot
authors.affiliation: Institute of Pharmaceutical Chemistry, J.W. Goethe-University, Frankfurt, Germany.
authors.forename: Manfred
authors.initials: M
authors.lastname: Schubert-Zsilavecz
mesh_terms: D004209:Disposable Equipment / Q000592:standards*; D006801:Humans; D007004:Hypoglycemic Agents / Q000008:administration & dosage*; D007279:Injections, Subcutaneous / Q000379:methods / Q000592:standards; D007328:Insulin / Q000008:administration & dosage*
chemical_list: D007004:Hypoglycemic Agents; D007328:Insulin
keywords: FlexTouch; SoloSTAR; disposable insulin pens; dosing accuracy