PT  - JOURNAL ARTICLE
AU  - E. Lynne Kelley
AU  - Andrea Fernandes
AU  - Marc Pelletier
AU  - Eri Ashley Takami
AU  - Christine Emery
AU  - Bobby Dyer
AU  - Mary V. Jacoski
AU  - Valery Lozko
AU  - Bart Burgess
AU  - Richard H. Smith
TI  - Advances in Large Volume Subcutaneous Injections: A Pilot Tolerability Study of an Innovative Needle-Free Injection Platform
AID  - 10.5731/pdajpst.2021.012670
DP  - 2022 Jan 01
TA  - PDA Journal of Pharmaceutical Science and Technology
PG  - pdajpst.2021.012670
4099  - http://journal.pda.org/content/early/2022/03/16/pdajpst.2021.012670.short
4100  - http://journal.pda.org/content/early/2022/03/16/pdajpst.2021.012670.full
AB  - Many medical conditions require chronic treatment with subcutaneous injectable biologics often exceeding 1.0 mL. However, subcutaneous administration of volumes of 1.5-2.0 mL using a standard needle and syringe or auto-injector proves challenging, and patients often must administer two separate injections of up to 1.0 mL to achieve their full dose or endure injection times in excess of 10 seconds, if using a mechanical autoinjector. In addition, needle-based injections often cause patient anxiety and discomfort. In this letter we describe an approach to meet these needs with a needle-free medication delivery device capable of rapidly delivering up to 2.0 mL with minimal discomfort. A pilot study was conducted with this needle-free injection system to evaluate the delivery of a 2.0 mL volume in human subjects. The results demonstrated that injections of up to 2.0 mL were well tolerated, and often preferred over two separate 1.0 mL injections using the needle-free injection system.