PT  - JOURNAL ARTICLE
AU  - Kelley, E. Lynne
AU  - Fernandes, Andrea
AU  - Pelletier, Marc
AU  - Takami, Eri A.
AU  - Emery, Christine
AU  - Dyer, Bobby
AU  - Jacoski, Mary V.
AU  - Lozko, Valery
AU  - Burgess, Bart
AU  - Smith, Richard H.
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 Nov 01
TA  - PDA Journal of Pharmaceutical Science and Technology
PG  - 474--484
VI  - 76
IP  - 6
4099  - http://journal.pda.org/content/76/6/474.short
4100  - http://journal.pda.org/content/76/6/474.full
SO  - PDA J Pharm Sci Technol2022 Nov 01; 76
AB  - Many medical conditions require chronic treatment with subcutaneous injectable biologics often exceeding 1.0 mL. However, subcutaneous administration of volumes of 2.0 mL or greater using a standard needle and syringe or auto-injector proves challenging, and patients often must administer two separate injections to achieve their full dose or endure injection times in excess of 10 s if using a mechanical autoinjector. In addition, needle-based injections often cause patient anxiety and discomfort. In this article, 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.