Impact of Filling Process Interruptions on m-Cresol Concentration in Parenteral Drug Formulations

Renata Sobieska-Żołądkiewicz; Małgorzata Ulanowicz; Radoslaw Gladysz; Marek Mularewicz

doi:10.56782/pps.391

Published : 2025-06-23

Vol. 23 No. 2 (2025)

Impact of Filling Process Interruptions on m-Cresol Concentration in Parenteral Drug Formulations

Renata Sobieska-Żołądkiewicz

Małgorzata Ulanowicz

Radoslaw Gladysz

Marek Mularewicz

DOI: https://doi.org/10.56782/pps.391

Abstract

Ensuring the appropriate concentration of antimicrobial preservatives in multi-dose sterile pharmaceutical formulations is critical for maintaining sterility, quality, and stability throughout the product’s shelf life. However, preservatives such as m-cresol and phenol are known to adsorb onto silicone components used during manufacturing, leading to potential preservative loss. This study investigates the impact of manufacturing process stops, particularly during the filling stage, on m-cresol concentration in dosed cartridges. Laboratory-scale experiments and full-scale manufacturing studies were conducted using solutions containing recombinant human insulin (RHI), insulin lispro, and a placebo solution to evaluate the effects of interruptions in the filling process—such as internal process control (IPC) checks—on the adsorption of m-cresol from pharmaceutical formulations.

Keywords:

preservative, insulin, filling process, parenteral formulation, m-cresol

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Sobieska-Żołądkiewicz, R., Ulanowicz, M., Gladysz, R., & Mularewicz, M. (2025). Impact of Filling Process Interruptions on m-Cresol Concentration in Parenteral Drug Formulations. Prospects in Pharmaceutical Sciences, 23(2), 96–100. https://doi.org/10.56782/pps.391

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