Marcus Niemeyer, Novo Nordisk A/S , Vandtårnsvej 114, DK-2860 Søborg , Denmark +45 4443 7853 ;
Expert Opin Drug Deliv. 2013 Dec;10(12):1613-9. doi: 10.1517/17425247.2013.863276.
The aim of the paper is to determine the dose accuracy and injection force of FlexTouch (FT) filled with insulin degludec 100 U/ml, insulin degludec 200 U/ml and insulin degludec/insulin aspart 100 U/ml, SoloStar (SS) filled with insulin glargine 100 U/ml and KwikPen (KP) filled with insulin lispro mix 75/25 100 U/ml.
Dose accuracy was measured at minimum, midpoint and maximum doses (FT 1, 2, 40, 80 and 160 U; SS 1, 40 and 80 U; KP 1, 30 and 60 U). Injection force was measured during the injection of the maximum dose.
All doses delivered from FT were within ISO limits (ISO 11608-1:2012) for degludec 100 U/ml, degludec 200 U/ml and degludec/aspart 100 U/ml, and the pens delivered insulin accurately and consistently at all doses tested. Similarly, all tested doses from KP filled with insulin lispro mix 75/25 100 U/ml were within ISO limits, while some doses from SS filled with insulin glargine 100 U/ml were outside ISO limits. FT had a significantly lower injection force than SS and KP (p < 0.05).
FT filled with insulin degludec and insulin degludec/insulin aspart, delivered insulin accurately and consistently within ISO limitations at all doses tested; similarly, KP delivered insulin within ISO limitations at all doses tested and SS delivered most doses within ISO limitations. The significantly lower injection force of FT compared to SS and KP is an important feature that has the potential to make the injection process easier for people with diabetes.
本文旨在确定 FlexTouch(FT)中填充的胰岛素德古鲁德 100U/ml、胰岛素德古鲁德 200U/ml 和胰岛素德古鲁德/门冬胰岛素 100U/ml、SoloStar(SS)中填充的甘精胰岛素 100U/ml 和 KwikPen(KP)中填充的赖脯胰岛素混合 75/25 100U/ml 的剂量准确性和注射力。
在最小、中点和最大剂量(FT 1、2、40、80 和 160U;SS 1、40 和 80U;KP 1、30 和 60U)下测量剂量准确性。在注射最大剂量时测量注射力。
FT 中输送的所有剂量均符合德古鲁德 100U/ml、德古鲁德 200U/ml 和德古鲁德/门冬胰岛素 100U/ml 的 ISO 限制(ISO 11608-1:2012),并且所有测试剂量的笔都能准确一致地输送胰岛素。同样,KP 中填充的胰岛素赖脯胰岛素混合 75/25 100U/ml 的所有测试剂量均符合 ISO 限制,而 SS 中填充的胰岛素甘精胰岛素 100U/ml 的一些剂量不符合 ISO 限制。FT 的注射力明显低于 SS 和 KP(p<0.05)。
FT 中填充的胰岛素德古鲁德和胰岛素德古鲁德/门冬胰岛素,在所有测试剂量下均能准确一致地输送胰岛素,符合 ISO 限制;同样,KP 在所有测试剂量下均能输送胰岛素符合 ISO 限制,而 SS 在 ISO 限制内输送大多数剂量。FT 的注射力明显低于 SS 和 KP,这是一个重要的特点,有可能使糖尿病患者的注射过程更加容易。