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

PDA J Pharm Sci Technol. 2024 Feb 20;78(1):70-89. doi: 10.5731/pdajpst.2022.012760.

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.

Keywords: Contact angle; Cyclic olefin polymer; Excipients; Extrusion force; Prefilled syringe; Silicone oil.

MeSH terms

  • Drug Packaging
  • Excipients*
  • Glass
  • Polymers*
  • Silicone Oils
  • Syringes

Substances

  • Polymers
  • Excipients
  • Silicone Oils