An Assessment of the Ability of Submicron- and Micron-Size Silicone Oil Droplets in Dropped Prefillable Syringes to Invoke Early- and Late-Stage Immune Responses

Journal of Pharmaceutical Sciences
Elena KrayukhinaSusumu Uchiyama

Abstract

A number of biopharmaceuticals are available as lyophilized formulations along with a prefilled syringe (PFS) containing water for injection (WFI). Submicron- and micron-size droplets of lubricating silicone oil (SO) applied to the inner surface of the PFS barrel might migrate into the WFI, to which protein pharmaceuticals can adsorb, potentially inducing an immune response. In the present study, we subjected siliconized cyclo-olefin polymer PFSs filled with WFI to dropping stress to simulate actual shipping conditions as well as evaluated the risk associated with the released SO droplets. The results confirmed the undesirable effects of SO on therapeutic proteins, including adsorption to SO droplets and increased secretion of several innate cytokines from human peripheral blood mononuclear cells of a small donor panel. Assessment of immunogenicity in vivo using BALB/c mice revealed a slight increase in the plasma concentrations of antidrug antibodies over 21 days in response to SO-containing antibody samples compared to the absence of SO. These results indicate that SO droplets form complexes with pharmaceutical proteins that can potentially invoke early- and late-stage immune responses. Therefore, the use of SO-free cyclo-ole...Continue Reading

Citations

Mar 5, 2020·Eye·Celso de Souza Dias JúniorGustavo Barreto Melo
Nov 21, 2020·Expert Opinion on Drug Delivery·Saki YonedaSusumu Uchiyama
Apr 21, 2020·Progress in Retinal and Eye Research·Gustavo Barreto MeloEduardo Büchele Rodrigues
Nov 2, 2019·Journal of Pharmaceutical Sciences·Arni Gambe-GilbuenaSusumu Uchiyama
May 9, 2021·International Journal of Retina and Vitreous·William J AndersonGustavo Barreto Melo
Jul 9, 2021·European Journal of Pharmaceutics and Biopharmaceutics : Official Journal of Arbeitsgemeinschaft Für Pharmazeutische Verfahrenstechnik E.V·Nam Ah KimSeong Hoon Jeong
Jan 31, 2022·Journal of Pharmaceutical Sciences·Tapan K DasPaolo Arosio

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