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

Authors: Xue, Ligang1; Mikkelsen, Kristian Handberg2

Source: Expert Opinion on Drug Delivery, Volume 10, Number 3, March 2013 , pp. 301-306(6)

Publisher: Informa Healthcare

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Abstract:

Objectives: The objective of this study was to assess the dose accuracy of NovoPenĀ® 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.

Keywords: NovoPenĀ® 5; accuracy; durability; insulin pen; memory function

Document Type: Research Article

DOI: http://dx.doi.org/10.1517/17425247.2013.761970

Affiliations: 1: 1Novo Nordisk A/S, Brennum Park, DK-3400, Hilleroed, Denmark +45 30792580;, Email: LGGX@novonordisk.com 2: 2Novo Nordisk A/S, Vandtaarnsvej 108-110, DK-2860, Soeborg, Denmark

Publication date: March 1, 2013

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