PT  - JOURNAL ARTICLE
AU  - Lindner, Robert
AU  - Zuccato, Daniele
AU  - Rupertus, Volker
TI  - Ensuring Robust Drug Delivery: A Comprehensive Study on the Mechanical and Chemical Performance of 3 ml RTU Cartridges
AID  - 10.5731/pdajpst.2025-000016.1
DP  - 2025 Jan 01
TA  - PDA Journal of Pharmaceutical Science and Technology
PG  - pdajpst.2025-000016.1
4099  - http://journal.pda.org/content/early/2025/06/16/pdajpst.2025-000016.1.short
4100  - http://journal.pda.org/content/early/2025/06/16/pdajpst.2025-000016.1.full
AB  - Driven by more patient-centric at-home treatments, the pharmaceutical industry is shifting toward subcutaneous drug formulations, particularly for biologics. This aids in simplifying patient self-administration, improving adherence, and reducing healthcare costs. Hence, there is an increasing need for optimized drug containment systems, as these will frequently be used by non-professionals in home settings. This study evaluates the break-loose and gliding forces (BLGF) as well as the inorganic and organic leachable profiles of cartriQ® 3 mL ready-to-use (RTU) cartridges to ensure safe and effective drug delivery. The cartridges, made from FIOLAX® clear Type I borosilicate glass, underwent hot forming into tubular cartridges, ensuring a hydrolytic resistance of not more than 80% of the ISO 4802-1 limit, followed by washing, siliconization, and steam sterilization. Testing was conducted after accelerated aging over up to 24 weeks at 40°C using ultrapure water, histidine buffer, and phosphate buffer as model solutions. Key performance metrics, including BLGF, siliconization performance, and levels of inorganic leachables, e.g., boron, sodium, silicon, and select organic leachables, were assessed following ISO 21881 and ICH Q3D guidelines.