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The Needle Shield Size and Applied Force of Subcutaneous Autoinjectors Significantly Influence the Injection Depth.

Anne-Sofie Madsen Staples^1,2, Mette Poulsen², Kezia Ann Friis Præstmark³

¹Department of Biomedical Sciences, University of Copenhagen, Copenhagen, Denmark.

Journal of Diabetes Science and Technology

|February 22, 2024

Summary

Shield size significantly impacts autoinjector (AI) injection depth, potentially causing inadvertent intramuscular delivery. Smaller shields increase depth more than applied force, necessitating further human studies.

Keywords:

applied force autoinjectors injection depth injection technology intramuscular risk subcutaneous tissue behavior

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Area of Science:

Biomedical Engineering
Drug Delivery Systems
Pharmacokinetics

Background:

Autoinjectors (AIs) are crucial for subcutaneous drug delivery.
Shield size and applied force are key parameters in AI function.
These parameters may influence injection depth, risking inadvertent intramuscular (IM) delivery.

Purpose of the Study:

To investigate the effect of autoinjector shield size and applied force on injection depth.
To determine the relative impact of shield size versus applied force on subcutaneous injection depth.
To assess the potential for inadvertent intramuscular injections due to tissue compression.

Main Methods:

A blinded ex-vivo study using porcine tissue (Landrace, Yorkshire, Duroc pigs) was conducted.
Investigated shield diameters of 15, 20, and 30 mm and applied forces from 2 to 10 N.
Injection depths were measured using computed tomography (CT) and confirmed with in-vivo fluoroscopy (FS).

Main Results:

Smaller shield sizes (15 mm) significantly increased injection depth.
Injection depth increased with applied force up to approximately 8 N.
Both shield size and applied force were statistically significant factors influencing injection depth (ANOVA, P < .05).

Conclusions:

Autoinjector shield size is a more critical factor for injection depth than applied force.
Findings from porcine models suggest potential risks for subcutaneous injection depth in humans.
Further in-vivo human studies are required to validate these findings for clinical AI use.