Using First Principles to Link Silicone Oil/Formulation Interfacial Tension With Syringe Functionality in Pre-Filled Syringes Systems

Numerous interactions can arise at the interface between the glass barrel/silicone oil coating/aqueous formulation in pre-filled syringes that can affect the functionality of the medical device. In this study, the Young-Dupré equation was applied at these interfaces to correlate the interfacial tension between the silicone oil coating and aqueous formulation to the functionality of the syringe. It was shown that lower silicone oil/drug product formulation interfacial tension led to an increase in the glide force of the syringe. The relationship between glide force profiles and silicone oil thickness after injection was also investigated and the data revealed that the silicone oil was removed at the end of the syringe barrel when the formulation contains polysorbate 80.