title: Comparisons of Aluminum and Silica Elution from Various Glass Vials.
abstract: To understand the risk of particle formation in glass vials, we investigated the correlation between vial surface condition and alminum (Al) or silicon (Si) elution using various suppliers' vials with or without surface treatment. The elution of Si, which can also be an indicator of Al elution, consists of two phases; the first phase is influenced by roughness of the glass surface at the time of filling, and the second phase is dependent on the fundamental elution rate from the glass tube. When vials were filled with citrate buffer at pH 7, vials with varied surface conditions showed the most obvious differences in Al and Si elution. Sulfur-treated vials showed slightly lower Al and Si elution than the non-treated vials. It is considered that this effect of the sulfur treatment on elution is due to the surface being smoothed during heat treatment after the washing process. Different from the sulfur treatment, silicon dioxide (SiO2)-coated vials hardly showed any Al elution as long as the surface was fully coated with the SiO2 layer. It was found that the protective effect of the SiO2 layer against Al elution is more effective in a vial filled with a solution having a lower pH, due to the lower Si dissolving rate occurring at a lower pH. As shown above, pre-measuring the Si and Al present in a citrate buffer at pH 7 placed within a glass container can be a useful tool for selecting the appropriate container for liquid drugs.
authors.affiliation: Formulation Technology Research Laboratories, Daiichi Sankyo Co., Ltd.
authors.forename: Toru
authors.initials: T
authors.lastname: Ogawa
authors.forename: Makoto
authors.initials: M
authors.lastname: Miyajima
authors.forename: Norihiro
authors.initials: N
authors.lastname: Nishimoto
authors.forename: Hidemi
authors.initials: H
authors.lastname: Minami
authors.forename: Katsuhide
authors.initials: K
authors.lastname: Terada
mesh_terms: D000535:Aluminum / Q000737:chemistry*; D005898:Glass / Q000737:chemistry*; D006358:Hot Temperature; D006863:Hydrogen-Ion Concentration; D010316:Particle Size; D012822:Silicon Dioxide / Q000737:chemistry*; D013499:Surface Properties
chemical_list: D012822:Silicon Dioxide; D000535:Aluminum