title: Functional evaluation and characterization of a newly developed silicone oil-free prefillable syringe system.
abstract: The functionality of a newly developed silicone oil-free (SOF) syringe system, of which the plunger stopper is coated by a novel coating technology (i-coating™), was assessed. By scanning electron microscopy observations and other analysis, it was confirmed that the plunger stopper surface was uniformly covered with the designed chemical composition. A microflow imaging analysis showed that the SOF system drastically reduced both silicone oil (SO) doplets and oil-induced aggregations in a model protein formulation, whereas a large number of subvisible particles and protein aggregations were formed when a SO system was used. Satisfactory container closure integrity (CCI) was confirmed by means of dye and microorganism penetration studies. Furthermore, no significant difference between the break loose and gliding forces was observed in the former, and stability studies revealed that the SOF system could perfectly show the aging independence in break loose force observed in the SO system. The results suggest that the introduced novel SOF system has a great potential and represents an alternative that can achieve very low subvisible particles, secure CCI, and the absence of a break loose force. In particular, no risk of SO-induced aggregation can bring additional value in the highly sensitive biotech drug market.
authors.affiliation: Terumo Corporation, R&D Center, Nakai-machi, Ashigarakami-gun, Kanagawa, 259-0151, Japan.
authors.forename: Keisuke
authors.initials: K
authors.lastname: Yoshino
authors.forename: Koji
authors.initials: K
authors.lastname: Nakamura
authors.forename: Arisa
authors.initials: A
authors.lastname: Yamashita
authors.forename: Yoshihiko
authors.initials: Y
authors.lastname: Abe
authors.forename: Kazuhiro
authors.initials: K
authors.lastname: Iwasaki
authors.forename: Yukie
authors.initials: Y
authors.lastname: Kanazawa
authors.forename: Kaori
authors.initials: K
authors.lastname: Funatsu
authors.forename: Tsuyoshi
authors.initials: T
authors.lastname: Yoshimoto
authors.forename: Shigeru
authors.initials: S
authors.lastname: Suzuki
mesh_terms: D002626:Chemistry, Pharmaceutical / Q000379:methods; D004355:Drug Stability; D011506:Proteins / Q000737:chemistry; D012827:Silicone Oils / Q000737:chemistry*; D013594:Syringes
chemical_list: D011506:Proteins; D012827:Silicone Oils
keywords: container closure integrity; gliding force; imaging analysis; particle size; physical stability; prefilled syringe; protein aggregation; silicone oil; stability; surface chemistry