Edouard Pagnoud

GLP-1 formulations are not standard injectables Liraglutide, semaglutide, tirzepatide and the molecules following them present chemical sensitivity profiles that materially affect their interaction with primary packaging. Compared with conventional small‑molecule injectables, the impact of: extractables from elastomeric components silicone oil particles from plunger coatings surface interactions at the stopper–drug interface may be amplified.

The regulatory position From a regulatory standpoint, elastomeric components are expected to be assessed for biosimilars using the same core principles applied to originator products - covering functional suitability, extractables and leachables (E&L), and container closure integrity (CCI). USP <382> outlines an approach to functional suitability assessment of elastomeric components for injectable drug products.

Citation: Guillemot L-H, Brocco B, Pagnoud E, Sircoulomb P, “Vial Stopper Compatibility: Criteria and Testing Methods for Pharmaceutical Packaging”. ONdrugDelivery, Issue 160 (May 2024), pp 74–80. Laure-Hélène Guillemot, Benjamin Brocco, Edouard Pagnoud and Pascal Sircoulomb, discuss some of the key parameters to consider when choosing a vial stopper and present evaluation methods that were developed to test and demonstrate the compatibility of various stoppers with commonly used vial designs.