Ypsomed Pulse

​​Learn how hand-held devices break barriers and inject innovation into large-volume subcutaneous drug delivery.

In the evolving landscape of pharmaceutical innovation, large-volume subcutaneous delivery of biologics is taking center stage as an attractive and often preferred alternative to intravenous infusion. Recent innovations in hand-held autoinjectors with dose volume capacities greater than 2.0 mL have generated both intrigue and skepticism. Therefore, we conducted a comprehensive literature review to synthesize evidence of their feasibility from 31 studies. Research shows that large-volume subcutaneous drug delivery is not only tolerable and suitable for home use, but also maintains pharmacokinetic equivalence with low-volume dosing options. Despite packaging and formulation challenges, large-volume autoinjectors have transformative potential, paving the way for new approaches to drug delivery and accelerating the shift from hospital-based infusion to home self-injection of high-value biologics.

Understanding the potential of large-volume autoinjectors
Breaking barriers: Understanding the potential of large-volume autoinjectors

Exploring the potential and concerns of large-volume autoinjectors: A comprehensive review

The spotlight of pharmaceutical innovation has turned to the vibrant field of subcutaneous drug delivery. Subcutaneous delivery of biologics has emerged as a viable and often preferred alternative to intravenous infusion, enabling new treatment options at home, reducing the cost of therapy, and decreasing the use of healthcare resources. Scientists have made significant progress in breaking the barriers of the upper volume limits of feasibility for subcutaneous drug delivery. The catalyst? Innovative drug delivery devices designed to break the barrier of what was thought to be the upper feasible limit of single large volume drug delivery.

Injection volume-rate ranges

More recently, the advancement of handheld autoinjectors with dose volume capacities greater than 2.0 mL has garnered significant attention. Despite the promise, large-volume autoinjectors are not immune to skepticism. Industry, healthcare providers, patients and regulators remain cautious about their potential. Questions linger about the suitability of hand-held autoinjectors for self-administration of single large-volume doses between 2.0 and 5.0 mL, or even beyond. Therefore, we conducted a comprehensive literature review that synthesized evidence from 31 studies to examine the feasibility of single large-volume dose delivery using autoinjectors. As we embark on this endeavor, the critical issues of injection tolerability, self-administration suitability, and pharmacokinetic equivalence with low-volume dosing options emerge as the key themes shaping the discourse.

Characterized by the ability to break the 2.0 mL single dose volume barrier, handheld autoinjector devices may represent the next frontier in drug delivery. Leveraging proven push-on-skin handling principles, large-volume autoinjectors aim to provide a seamless transition for healthcare professionals and patients alike, requiring minimal training requirements – in contrast to large-volume wearable devices, which differ fundamentally from the standard handling principle of handheld autoinjectors. In addition, high-volume autoinjectors leverage the potential of established technologies, manufacturing processes and regulatory pathways. These benefits enable pharmaceutical companies to strengthen existing capabilities, mitigate device development risks, and accelerate time to market.

Challenges and promise of large-volume autoinjectors in drug delivery

However, the road to large-volume autoinjectors is not without its challenges. The introduction of new primary packaging and the development of innovative drug formulations, possibly including permeation enhancers, loom as obstacles to widespread adoption. Yet, the potential benefits of these devices are too compelling to ignore. The emerging device category not only helps reduce the frequency of injections, but also minimizes the duration of injections - both attributes that have been cited as having a strong impact on treatment preference and market acceptance of subcutaneous drug delivery. Large-volume autoinjectors therefore hold the promise of revolutionizing drug delivery in critical areas such as immuno-oncology, neurology and autoimmune diseases, enabling a shift from hospital-based care to self-administration of biologics at home. As the industry navigates these new territories, the parallel marketing of multiple dosing options seems inevitable, creating a landscape rich with different device technologies that provide more flexibility to personalize treatment decisions to individual patient needs. Personally, I am absolutely convinced that large-volume autoinjectors will be one of them.

Best regards,

Andreas Schneider

Andreas Schneider is Head of Innovation at Ypsomed Delivery Systems. He leads business development, strategy, and engineering teams to drive new drug delivery device platforms and service offerings such as next generation autoinjectors and pens, smart connected systems and digital solutions. Andreas has published various articles and given presentations in the areas of innovation management and drug delivery. He holds a PhD in Innovation Management from ETH Zurich, Switzerland.

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