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弹簧驱动自动注射器设备在 Emgality 和 Aimovig 中的性能特征分析。

Performance characterization of spring actuated autoinjector devices for Emgality and Aimovig.

机构信息

School of Mechanical Engineering, Purdue University, West Lafayette, IN, USA.

Delivery, Device and Connected Solutions, Eli Lilly and Company, Indianapolis, IN, USA.

出版信息

Curr Med Res Opin. 2020 Aug;36(8):1343-1354. doi: 10.1080/03007995.2020.1783219. Epub 2020 Jun 30.

DOI:10.1080/03007995.2020.1783219
PMID:32544355
Abstract

Autoinjectors are a convenient and efficient way to self-administer subcutaneous injections of biopharmaceuticals. Differences in device mechanical design can affect the autoinjector functionality and performance. This study investigates the performance differences of two single-spring-actuated autoinjectors. We compare the performance between Emgality (120 mg/mL) and Aimovig (140 mg/mL) autoinjector devices from an engineering point of view at two test conditions: room (25 C[Formula: see text]) and storage (5 C[Formula: see text]) temperatures. We employ a novel experimental procedure to simultaneously acquire the force and acoustic signals during operation, and high-speed imaging during the needle insertion and drug injection. We perform 18 quantitative comparisons between Emgality and Aimovig, and we observe that 14 of these have statistically significant differences. For both test conditions, Emgality requires an 8 N activation force while Aimovig requires 14 N activation force, and the needle of Emgality has an insertion depth of 5 mm while Aimovig has an insertion depth of 7 mm. The injection speeds are significantly affected by temperature. Emgality has an injection speed of 0.40 mL/s and 0.28 mL/s at room and storage temperature condition, respectively; while Aimovig has an injection speed of 0.24 mL/s and 0.16 mL/s at those conditions. Lastly, confirmation "click" sound of Emgality occurs 0.75-1.53 s after dose completion, while in Aimovig, the confirmation "click" sound occurs 0.26-0.46 s before dose completion. This study revealed performance differences between Emgality and Aimovig autoinjector devices, despite the fact that the delivery principle of these single-spring-actuated autoinjectors are the same. These differences may result in different risk of intramuscular injection and premature device removal, both of which need to be further verified in clinical trials.

摘要

自动注射器是一种方便、高效的方式,可以自行进行生物制药的皮下注射。设备机械设计的差异会影响自动注射器的功能和性能。本研究从工程学的角度比较了两种单弹簧驱动自动注射器的性能差异。我们比较了两种自动注射器在两种测试条件下的性能:室温(25°C)和储存温度(5°C)。我们采用一种新颖的实验程序,在操作过程中同时获取力和声学信号,并在针插入和药物注射过程中进行高速成像。我们对 Emgality(120mg/mL)和 Aimovig(140mg/mL)自动注射器设备进行了 18 项定量比较,观察到其中 14 项具有统计学意义上的差异。对于两种测试条件,Emgality 需要 8N 的激活力,而 Aimovig 需要 14N 的激活力,并且 Emgality 的针插入深度为 5mm,而 Aimovig 的针插入深度为 7mm。注射速度受温度的显著影响。Emgality 在室温下的注射速度为 0.40mL/s,在储存温度下的注射速度为 0.28mL/s;而 Aimovig 在室温下的注射速度为 0.24mL/s,在储存温度下的注射速度为 0.16mL/s。最后,Emgality 的确认“咔嗒”声在剂量完成后 0.75-1.53s 发生,而在 Aimovig 中,确认“咔嗒”声在剂量完成前 0.26-0.46s 发生。本研究揭示了 Emgality 和 Aimovig 自动注射器设备之间的性能差异,尽管这些单弹簧驱动自动注射器的输送原理相同。这些差异可能导致不同的肌肉内注射风险和设备过早移除,这两者都需要在临床试验中进一步验证。

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