The degradation of poloxamer 188 in buffered formulation conditions

Abstract Poloxamer 188 (P188) as a non-ionic surfactant is used in proteinaceous formulations to prevent protein adsorption hydrophobic surfaces and unfolding at interfaces, preventing the formation of aggregates particles. Its chemical intactness crucial stability drug products due its protecting effects interfaces. In order identify mitigate potential risks that might cause degradation P188 during manufacturing process storage, current work, was investigated by forced buffered formulation conditions via oxidation thermal stress conditions. The monitored through dedicated liquid chromatography (LAC) with high sensitivity, degradants were characterized high-resolution mass spectrometry. Results suggest vulnerability largely related buffer Histidine promotes presence hydroxyl radicals but inhibits H 2 O alkyl radicals. conditions, histidine protects from 40 °C, activates decay only higher temperature, like 60 °C.