Performance characterization of spring actuated autoinjector devices for Emgality and Aimovig

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

Abstract

Objective: 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.Methods: 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.Results: 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.Conclusions: 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.

Keywords: Galcanezumab; autoinjector; bolus injection; drug delivery; erenumab; high-speed imaging; subcutaneous injection.

Publication types

  • Research Support, Non-U.S. Gov't

MeSH terms

  • Antibodies, Monoclonal, Humanized / administration & dosage*
  • Calcitonin Gene-Related Peptide Receptor Antagonists / administration & dosage*
  • Humans
  • Injections, Subcutaneous / instrumentation*
  • Self Administration

Substances

  • Antibodies, Monoclonal, Humanized
  • Calcitonin Gene-Related Peptide Receptor Antagonists
  • erenumab