Peroxide removal from non-ionic surfactants

A Quantitative Kinetic Study of Polysorbate Autoxidation: The Role of Unsaturated Fatty Acid Ester Substituents

“…These results indicate that additional care should be taken when using PS-80 in formulations, and suggests possible strategies to avoid oxidation of formulated APIs. Successful options for minimizing oxidative degradation of pharmaceuticals exposed to autoxidative environment presented by polysorbates include protection from heat and light, which can initiate the chain reaction; the use of radical chain terminating antioxidants; scavenging peroxides; and protection from oxygen using sealed containers or nitrogen filled head space (2,13,17,29). The results presented here suggest that substituting with polysorbates that do not have unsaturated fatty acid esters as a primary component could also help to control oxidation.…”

“…Whenever polysorbates are used in formulations, the chemical stability of the active pharmaceutical ingredient (API) must be addressed due to their ability to promote oxidation (12)(13)(14)(15)(16)(17). Polysorbates are susceptible to autoxidation, resulting in the formation of high concentrations of reactive oxygen species (ROS), which can oxidize APIs.…”

Polysorbates 20 and 80 Used in the Formulation of Protein Biotherapeutics: Structure and Degradation Pathways

“…Chemical stability of the polysorbates is another important consideration for their use. The polysorbates are notorious for undergoing autooxidation34, 73–79 and cleavage at the ethylene oxide subunits34, 74 as well as hydrolysis of the fatty acid ester bond 34, 80. A generalized reaction scheme depicting these processes is shown in Figure 6.…”

Degradation of Polysorbates 20 and 80: Studies on Thermal Autoxidation and Hydrolysis

“…The above‐mentioned studies and work by others26–31,33–37 throw light on the cause and nature of initiation30 of autoxidation and rates of hydrolysis31—mechanisms that cause degradation of PSs. To understand the mechanism of PS degradation in parenteral protein formulations, we applied current knowledge to pharmaceutically relevant conditions and monitored the course of degradation of PSs in aqueous formulations typically used for proteins.…”