By Jessica Baseggio, Chiara Callegari, and Enrico Barichello, Stevanato Group
Most parenteral packaging components require surface treatment or lubrication to ensure they work smoothly. Silicone oil has traditionally been used for this purpose – and is still regarded as an industry-standard solution. But it is not without its problems, as it can interact with some highly sensitive drug formulations.
Silicone migration can lead to an accumulation of sub-visible particles in certain drug products. High-molecular-weight drugs containing protein are particularly susceptible to this, as they have a propensity to generate and aggregate hazardous particles. This may cause non-compliance with pharmacopeias and registration failure if product safety and efficacy are compromised.
Another potential issue is that protein can adsorb at the silicone oil interface, which can eventually lead to protein denaturation. This makes protein-protein interactions more likely – resulting in aggregation and an increased risk of triggering an immune reaction in a patient.