“Formulation Dependent Silicone Depletion From Sprayed-On Siliconized Pre-Filled Syringes”

Monoclonal antibodies are ones of the most common classes of biologic, used in the treatment of chronic and acute diseases, for which parenteral formulations are generally prepared. The key purpose of the study was to investigate the stability of sprayed-on pre-filled syringes employed as DDCP, drug device combination product, dependent on different formulations filled in the container. However, these formulations encountered other challenges to overcome, such as the compatibility between the drug formulation and the container, the stability inside the same and the influence of the properties of the formulation on the functionality of the container system. The project involved the investigation of the stability behaviour of the different formulations in the drug device combination product in use, during the shelf life. To investigate the compatibility of the combination product, interactions between protein and silicone oil that can provide some mechanistic understanding were studied. The protein aggregation trend in silicone oil lubricated syringes could be prevented by formulation additives such as Polysorbate 20 and Poloxamer 188.The results discussed clearly show that the formulation filled into a primary container can influence the stability of a DDCP. In particular, Poloxamer 188 compared to Polysorbate 20 showed the best device stability over time. Poloxamer 188 seems then to be a valuable alternative to the commonly used surfactants for parenteral products PS20 and PS80.