Dose accuracy of a durable insulin pen with memory function, before and after simulated lifetime use and under stress conditions

作者：Xue Ligang^*; Mikkelsen Kristian Handberg

来源：Expert Opinion on Drug Delivery, 2013, 10(3): 301-306.

DOI：10.1517/17425247.2013.761970

• accuracy
• durability
• insulin pen
• memory function
• NovoPen (R) 5

Objectives: The objective of this study was to assess the dose accuracy of NovoPen (R) 5 in delivering low, medium and high doses of insulin before and after simulated lifetime use. A secondary objective was to evaluate the durability of the pen and its memory function under various stress conditions designed to simulate conditions that may be encountered in everyday use of an insulin pen.
Research design and methods: All testing was conducted according to International Organization for Standardization guideline 11608-1, 2000 for pen injectors. Dose accuracy was measured for the delivery of 1 unit (U) (10 mg), 30 U (300 mg) and 60 U (600 mg) test medium in standard, cool and hot conditions and before and after simulated lifetime use. Dose accuracy was also tested after preconditioning in dry heat storage; cold storage; damp cyclical heat; shock, bump and vibration; free fall and after electrostatic charge and radiated field test. Memory function was tested under all temperature and physical conditions.
Results: NovoPen 5 maintained dosing accuracy and memory function at minimum, medium and maximum doses in standard, cool and hot conditions, stress tests and simulated lifetime use. The pens remained intact and retained dosing accuracy and a working memory function at all doses after exposure to variations in temperature and after physical challenge.
Conclusions: NovoPen 5 was accurate at all doses tested and under various functionality tests. Its durable design ensured that the dose accuracy and memory function were retained under conditions of stress likely to be encountered in everyday use.

• 出版日期2013-3