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Dosing Accuracy of Two Disposable Insulin Pens According to New ISO 11608-1: 2012 Requirements
Mona Abdel-Tawab1, Mario Schmitz2, Stefan Kamlot2
1Central Laboratory of German Pharmacists, Eschborn, Germany M.Tawab@zentrallabor.com.
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).
Conclusion:
Both insulin pens fulfilled the dosing accuracy requirements defined by ISO 11608-1:2012 at all 3 dosage levels.
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