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Papers of the Week

2022 Mar 16

PDA J Pharm Sci Technol

Advances in Large Volume Subcutaneous Injections: A Pilot Tolerability Study of an Innovative Needle-Free Injection Platform.


Kelley LE, Fernandes A, Pelletier M, Takami E A, Emery C, Dyer B, Jacoski MV, Lozko V, Burgess B, Smith RH
PDA J Pharm Sci Technol. 2022 Mar 16.
PMID: 35296562.


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.