ABSTRACT:
Multidose parenteral products administered using reusable injection devices require a scientifically justified in-use period due to repeated breaches of container closure integrity during use. Innovative Semaglutide injection 15 mg/3 mL (5 mg/mL) is a preserved multidose formulation supplied in a reusable pen system. An in-use stability study was conducted to understand the in-use storage stability. Prefilled cartridges were assembled into the reusable pen device were subjected to worst-case simulated use involving up to 32 needle punctures and stored for up to 8 months at 2–8 °C and 56 days at 15–30 °C. Samples were evaluated at predefined intervals for physicochemical quality attributes, preservative content, particulate matter, and antimicrobial effectiveness in accordance with applicable compendial requirements and predefined acceptance criteria. All tested parameters remained within specifications throughout the study, with no clinically relevant trends observed. The generated data confirmed the in-use storage stability of semaglutide multidose formulation.