By Aurélie Pager, Anne Combedazou, Karen Guerrero, Tzvetelina Tzvetkova-
Chevolleau, Didier Morel, Cécile Frolet & Stanislav Glezer
Subcutaneous injection is one of the most common routes of administration used for administration of therapeutic proteins, peptides, and other biologics used in chronic diseases (growth hormone, insulin, heparin, interferons, monoclonal antibodies), mainly due to low oral bioavailability, gastric degradation of oral drugs, local toxicity at the site of absorption, suboptimal pharmacokinetics associated with gastrointestinal absorption or lack of efficient gastrointestinal transport mechanisms for these molecules. Moreover, the benefits of home administration by patients themselves or lay caregivers and the increasing interest in new biotherapeutics, such as monoclonal antibody-based therapies, has challenged the limits of volume and viscosity of drug formulations. Although subcutaneous administration improves patient compliance and quality of life by enabling at-home injections, as compared to intravenous or intramuscular route, the associated anxiety, pain, discomfort, and the frequency of injections can play a significant role in patient non-adherence with chronic subcutaneous treatments. In order to address these challenges, through reducing the required frequency of subcutaneous injections and increasing injection comfort for novel biotherapeutics, drug delivery systems should be designed to enable the administration of large-volume injections and/or high-viscosity drugs.
Therefore, to support the delivery of higher drug viscosities and volumes into the targeted subcutaneous tissue, we developed a pre-fillable glass syringe featuring a stacked 8 mm needle with an ultra-thin wall (UTW) cannula technology, BD Neopak™ XtraFlow™ 2.25 mL, hereafter referred to ‘8mmUTW’. In comparison to the currently marketed BD Neopak™ 2.25 mL pre-fillable glass syringe equipped with a 12.7 mm special thin wall (STW) needle, hereafter named as 12.7mmSTW, the 8mmUTW offers an optimized flow capacity due to shorter needle length and larger inner diameter of the cannula. The UTW technology makes the use of smaller gauge (larger outer diameter) needles unnecessary, which can positively impact the pain perception when enabling the injection of viscous solutions.