Excipient and Packaging Material Impact on Glass and Polymer-Based Prefilled Syringe Functionality.

Abstract

Compared to glass prefilled syringes (PFSs), cyclic olefin polymer (COP) PFS showed more consistent and predictable extrusion forces when exposed to a variety of excipient combinations (buffers, tonicity agents, and surfactants) at various accelerated storage conditions. Furthermore, COP PFSs also showed significantly less variance in extrusion forces within each individual stroke, which is critical for precision applications. Observed performance differences can be explained by fundamental differences in the stability and homogeneity of the primary packaging materials (i.e., COP vs siliconized glass) and their physicochemical interactions with excipients.