RT Journal Article
SR Electronic
T1 Advances in Large Volume Subcutaneous Injections: A Pilot Tolerability Study of an Innovative Needle-Free Injection Platform
JF PDA Journal of Pharmaceutical Science and Technology
JO PDA J Pharm Sci Technol
FD Parenteral Drug Association (PDA)
SP pdajpst.2021.012670
DO 10.5731/pdajpst.2021.012670
A1 Kelley, E. Lynne
A1 Fernandes, Andrea
A1 Pelletier, Marc
A1 Takami, Eri Ashley
A1 Emery, Christine
A1 Dyer, Bobby
A1 Jacoski, Mary V.
A1 Lozko, Valery
A1 Burgess, Bart
A1 Smith, Richard H.
YR 2022
UL http://journal.pda.org/content/early/2022/03/16/pdajpst.2021.012670.abstract
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.