title: Contribution of glucose to crystallization of phenytoin in injectable dosage form by dilution with infusion fluids.
abstract: The crystallization of phenytoin occurring after its dilution with infusion fluid is a major concern in the clinical use of injectable phenytoin. To gain further understanding of the crystallization, this study assessed details of the involvement of glucose in this action. For sample preparation, phenytoin crystals were created by diluting the injectable phenytoin with infusion fluids with different glucose concentrations at different temperature, and then the characteristics of the crystallization (e.g., crystal size in the long direction, accumulated amount over 24 h, and crystallization rate constant) were measured. Results of the analysis of variance indicated that the glucose concentration and temperature had significant impacts on the crystallization. The mode of action of the glucose concentration was suggested to be different from that of the incubation temperature. This study also examined the molecular mobility of components (i.e., glucose, propylene glycol, phenytoin) in the admixtures using diffusion NMR techniques. The findings will provide valuable information for the clinical use of injectable phenytoin.
authors.affiliation: Department of Pharmaceutics, Hoshi University.
authors.forename: Yoshinori
authors.initials: Y
authors.lastname: Onuki
authors.forename: Naoki
authors.initials: N
authors.lastname: Hasegawa
authors.forename: Mayumi
authors.initials: M
authors.lastname: Ikegami-Kawai
authors.forename: Takako
authors.initials: T
authors.lastname: Suematsu
authors.forename: Satoshi
authors.initials: S
authors.lastname: Sakurai
authors.forename: Shunsuke
authors.initials: S
authors.lastname: Shirozu
authors.forename: Masayoshi
authors.initials: M
authors.lastname: Tsubuki
authors.forename: Yasuko
authors.initials: Y
authors.lastname: Obata
authors.forename: Kozo
authors.initials: K
authors.lastname: Takayama
mesh_terms: D003460:Crystallization; D005947:Glucose / Q000737:chemistry*; D007700:Kinetics; D009682:Magnetic Resonance Spectroscopy; D010672:Phenytoin / Q000737:chemistry*; D019946:Propylene Glycol / Q000737:chemistry; D012995:Solubility; D013696:Temperature
chemical_list: D010672:Phenytoin; D019946:Propylene Glycol; D005947:Glucose