title: The effect of Tween(®) 20 on silicone oil-fusion protein interactions.
abstract: There is evidence in the literature that silicone oil, a lubricant, can induce aggregation in protein formulations delivered through prefilled syringes. Surfactants are commonly used to minimize protein-silicone oil and protein-container interactions; however, these interactions are not well characterized and understood. The purpose of this manuscript was to understand the competitive interactions of a fusion protein with the silicone oil in the presence of Tween(®) 20. An adsorption isotherm for Tween(®) 20 at the silicone oil/water interface, using silicone oil coated quartz crystals, was generated at 25°C to identify surface saturation concentrations. A concentration of Tween(®) 20 providing interfacial saturation was selected for protein adsorption studies at the silicone oil/water interface. The surfactant molecules adsorbed at the interface in a monolayer with a reduced viscoelastic character in comparison to the bound protein layer. A significant reduction in protein adsorption was observed when the surfactant was present at the interface. No desorption of the pre-adsorbed protein molecules was observed when Tween(®) 20 was introduced, suggesting that the protein has strong interactions with the interface. However, both, Tween(®) 20 and protein, adsorbed to the silicone oil/water interface when adsorption was carried out from a mixture of protein and Tween(®) 20.
authors.affiliation: Department of Pharmaceutical Sciences, School of Pharmacy, University of Connecticut, 69 North Eagleville Road, Unit 3092, Storrs, CT 06269, USA.
authors.forename: Nitin
authors.initials: N
authors.lastname: Dixit
authors.forename: Kevin M
authors.initials: KM
authors.lastname: Maloney
authors.forename: Devendra S
authors.initials: DS
authors.lastname: Kalonia
mesh_terms: D000327:Adsorption; D004548:Elasticity; D054327:Lubricants / Q000737:chemistry; D011136:Polysorbates / Q000737:chemistry*; D011506:Proteins / Q000737:chemistry*; D012827:Silicone Oils / Q000737:chemistry*; D013501:Surface-Active Agents / Q000737:chemistry*; D014783:Viscosity; D014867:Water / Q000737:chemistry
chemical_list: D054327:Lubricants; D011136:Polysorbates; D011506:Proteins; D012827:Silicone Oils; D013501:Surface-Active Agents; D014867:Water