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

• Published in: PDA journal of pharmaceutical science and technology Vol. 76; no. 6; p. 474
• Main Authors: Kelley, E Lynne, Fernandes, Andrea, Pelletier, Marc, Takami, Eri A, Emery, Christine, Dyer, Bobby, Jacoski, Mary V, Lozko, Valery, Burgess, Bart, Smith, Richard H
• Format: Journal Article
• Language: English
• Published: United States 01-11-2022
• Subjects: Drug Delivery Systems; Humans; Injections, Subcutaneous; Pharmaceutical Preparations; Pilot Projects; Syringes; Needle-free injector; Drug delivery; Pain; Subcutaneous injection; Preference
• ISSN: 1948-2124
• DOI: 10.5731/pdajpst.2021.012670

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.