Effect of filling volume and head space on the release of silicone oil from glass prefilled syringe with formulations containing polysorbate

Abstract

Prefilled syringe usually uses silicone oil as lubricant to coat and lubricate the inner surface of barrels and rubber stoppers. The release of coated silicone oil was found to affect the product quality and patient safety. Surfactants are added in many formulations to prevent protein aggregation and adhesion to surfaces of primary packaging. However, surfactants are also found to induce the release of silicone oil from glass prefilled syringe. This study aimed to examine the effect of filled volume and head space on the release of silicone oil from prefilled syringe containers containing polysorbate solution. Samples are prepared at different filling volume, level head space and agitated by orbital shaker at predefined speed and time. Amount of silicone oil released from containers was detected by Micro-flow Imaging (MFI™) technology. Results showed that the higher head space to filled volume ratio, more release of silicone oil was released from prefilled syringe was observed. In addition, when head space was held constant, the lower filling volume released more silicone oil than higher filling volume due to air bubble were allowed to move freely along the interior of the barrel of prefilled syringe. In conclusion, to minimize the risk of silicone oil leaching, setting appropriate parameters of the filling line and transferring machines must be monitored and controlled to the proper filling volume and head space of the product.