Extractables profile of inner-coated containers for pharmaceutical use

Rubrik: Originale

(Treffer aus pharmind, Nr. 04, Seite 382 (2023))

Zuccato D | Rudigier-Voigt E | Löber D

Extractables profile of inner-coated containers for pharmaceutical use / Zuccato et al. • Inner-coated containers · Zuccato D¹, Rudigier-Voigt E², Löber D¹ · ¹SCHOTT Pharma AG & Co. KGaA, Mainz (Germany) und SCHOTT AG, Mainz (Germany)
Borosilicate glass Cyclic Olefin Polymers Coated vial Alkaline solution Extractables Advanced characterization Oxygen transmission rate The interaction between drug solution and primary packaging containers should be reduced to a minimum extent [ 4 ] during the entire drug product’s shelf life. Leaching of glass elements can trigger adverse effects such as protein aggregation or drug inactivation that may compromise the treatment efficacy and, therefore, become a significant source of risk especially for highly sensitive biologics [ 5 ]. For this reason, the chemical resistance of the primary packaging represents one of its most relevant properties. Thanks to its high chemical ...