Dosing Accuracy of Two Disposable Insulin Pens According to New ISO 11608-1: 2012 Requirements |
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| Authors: | Mona Abdel-Tawab Mario Schmitz Stefan Kamlot Manfred Schubert-Zsilavecz |
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| Affiliation: | 1.Central Laboratory of German Pharmacists, Eschborn, Germany;2.sanofi-aventis Deutschland GmbH, Site Frankfurt Devices, Frankfurt, Germany;3.Institute of Pharmaceutical Chemistry, J.W. Goethe-University, Frankfurt, Germany |
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| 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).Conclusion:Both insulin pens fulfilled the dosing accuracy requirements defined by ISO 11608-1:2012 at all 3 dosage levels. |
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| Keywords: | disposable insulin pens dosing accuracy FlexTouch SoloSTAR |
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