a pharmaceutical formulation comprising a taxane, a solid taxane composition, a process for preparing said solid taxane composition, a solubulizing composition of said taxane composition, and an injectable taxane formulation kit

摘要

A pharmaceutical formulation comprising a taxane, a solid taxane composition, a process for preparing said solid taxane composition, a solubulizing composition of said texane composition, and a injectable texane formulation kit. A pharmaceutical formulation of taxane for administration to mammals, preferably humans, comprising two compositions which pre-combine on administration to form a clear precipitate-free solution, wherein said compositions comprise a solid and lyophilized taxane composition free of surfactants, oils, solubility enhancing polymers, preservatives and excipients and a solubilizing composition of said solid taxane composition comprising at least one surfactant. Said formulation is free of polysorbate 80 and polyoxyethylated castor oil. A procedure for the preparation of said solid composition by lyophilizing taxane in organic lyophilization solvent. A kit for said injectable taxane formulation comprising a pre-labeled syringe and an organic solvent free taxane infusion pharmaceutical solution.