Year: 2025
Type: conference-paper
Abstract: Background and Importance Leachables are chemical compounds that migrate from packaging materials into pharmaceutical formulations during regular use and can cause potential health risks alone or in interaction with other compounds of the pharmaceutical formulation. We expect a higher risk in solvents such as complex emulsions. Especially in new formulations such as mRNA vaccines, leachables may cause unknown interactions and are present in higher amounts. Identifying and quantifying these compounds is crucial to ensure product safety. As the stability of the vaccine in syringes is 12 hours after filling into the syringes, knowledge about the leachable situation in syringes is of interest. Aim and Objectives Our aim is to quantify the concentration of leachables during the official shelf life of Comirnaty Vaccine (12 hours, room temperature 15–25). Material and Methods Emulsions of Comirnaty, Propofol and ethanol were stored at room temperature in plastic syringes for 2 weeks. Leachables were quantified at 3, 5, 12 hours and 14 days after filling. The samples were analysed by HPLC (Ultimate 3000, ThermoScientific) coupled with massspectrometry (4000 qTrap, Sciex), GC-MS (8890GC System, Agilent) and UV-Spectrometry (DrugLog, Pharmacolog). Results Using GC-MS, Vulkanox BKF could be identified, which was also confirmed and quantified by HPLC-MS on a Raptor Biphenyl column. UV-Vis (Druglog) provided more general confirmation of leachables but lacked the specificity required for precise quantification. The concentration of leachables increased over time in all three solvents. The concentration of Vulkanox BKF in the Comirnaty vaccine and Propofol was similar increased. In Ethanol was the concentration ca. 10 times higher compared with the emulsions. Conclusion and Relevance Vulkanox was detected in measurable quantities, but it is not possible to evaluate whether this substance is harmful at these levels due to the lack of available toxicological data. Regulatory guidelines should ensure that the migration of such leachables remains below hazardous levels and possible influence on the stability of the mRNA vaccine is excluded. However, prolonged exposure or higher concentrations of these compounds could increase health risks. References and/or Acknowledgements Conflict of Interest No conflict of interest
Authors: T Kostadinova, R Trittler, R Hoppe, MJ Hug
Institution: University Medical Center Freiburg
Language: English
Subfield: Analytical Chemistry
Field: Chemistry
Domain: Physical Sciences
Open Access status: gold
OpenAlex ID: W4408376611