Abstract
A new type of rubber plug reduces leakage in the Lantus® OptiClick® 300 insulin pen (Sanofi Aventis K.K. ; n-OPC).In order to evaluate this improvement, using a questionnaire, we asked patients whether they had experienced leakage with the pen having the previous rubber plug (o-OPC) as well as concerning the effect of such leakage. Twenty-seven outpatients with diabetes provided responses.
In Japan, the pre-filled insulin pen product NovoRapid FlexPen® (Novo Nordisk Pharma K.K. ; FLX) is widely used. As basic testing, we examined the material and structure of its rubber plug, and conducted an insulin injection accuracy test and a puncture resistance test. We also assessed the n-OPC to see how much it prevented the leakage that frequently occurred with the o-OPC. We compared the elasticity of plugs, conducted a puncture resistance test and an accuracy test, and compared how well they fit in the pens.
The responses to the questionnaire indicated that leakage increases patient anxiety and required preventive measures to be taken as early as possible. The results of the basic testing showed that there were no problems with the FLX but the o-OPC had problems with regard to all test parameters. For the n-OPC, while the new plug material helped prevent leakage, there were still various points of the product that required improvement.
