Drug Container Interactions: Why Packaging Must Be Treated as a Critical Quality Attribute Across the Product Lifecycle
Introduction Pharmaceutical packaging has traditionally been viewed as a downstream activity selected after formulation and process development are finalized. However, increasing scientific evidence and regulatory expectations have demonstrated that packaging is not a passive component. Instead, it is an integral part of the drug product system that can significantly influence quality, safety, and efficacy. Drug container interactions can lead to chemical, physical, or biological changes in the product, making packaging a Critical Quality Attribute (CQA) that must be addressed throughout the product lifecycle. Key Drug–Container Interaction Mechanisms 1. Silicone Oil Interactions Silicone oil is widely used as a lubricant in prefilled syringes and cartridges. Nonuniform silicone distribution and silicone droplet formation can contribute to protein aggregation, subvisible particles, and dose variability. Interaction between silicone and biologics is a growing concern fo...