Background: Auto-injectors (automatic injection devices) for the self-administration of medication must function reliably, even under military conditions. The key factors are the volume actually delivered and the bioavailability of the injected substance.
Challenge: Current testing of auto-injectors is complex and costly, as it requires animal or human trials.
Goal: INERT aims to develop a standardised test method that uses tissue samples, microCT imaging and AI-based analysis to enable the reliable evaluation of auto-injectors for military use in the future.
Approach: Tissue samples are used to collect pharmacokinetic data on volume and bioavailability, which are essential for the functional evaluation of different auto-injector systems. Based on these data, a standardised test method is developed in which a substance can be injected subcutaneously or intramuscularly and the injection is captured at high resolution using microCT imaging. The resulting image data are then segmented, analysed and simulated using AI to precisely determine the volume, surface area and spatial distribution of the injected fluid.
Expected Results: The test method thus enables an objective assessment of the functionality of different auto-injectors in terms of reproducibility, delivered volume, bioavailability and absorption time. For the first time, this creates an alternative to existing testing methods that requires no animal testing and is both cost-effective and meaningful.
The HEALTH institute leads the INERT project and coordinates the collaboration between the partners FiveSquare, Zatloukal Innovations and the Austrian Federal Ministry of Defence. The project builds on a method developed at the institute that uses microCT to visualise injected fluid depots in tissue and calculate their volume. This method has already been used successfully to compare insulin catheters in subcutaneous adipose tissue. In INERT, HEALTH extends the method to muscle and skin tissue and applies it to auto-injectors for the first time. To do so, the team selects suitable contrast agents and dyes and introduces them into the auto-injectors without altering their function. It also develops a holder for the tissue samples, an optimised microCT scanning sequence and a standard operating procedure covering every step from triggering the auto-injector to the scan. The injections are performed in freshly explanted porcine tissue left over from other procedures, so no additional animal experiments are required. Finally, HEALTH validates the test method with two auto-injectors currently in military use and contributes its pharmacokinetic expertise to the AI-based analysis, drawing conclusions about absorption and bioavailability from the volume, surface area and location of the depots.
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