FORMULATION PHARMACEUTIQUE DE TAXANE, COMPOSITION SOLIDE DE TAXANE, PROCÉDÉ DE PRÉPARATION DE LA COMPOSITION SOLIDE DE TAXANE, COMPOSITION SOLUBILISANT DE LA COMPOSITION SOLIDE DE TAXANE ET ENSEMBLE D'ÉLÉMENTS (KIT) POUR CETTE FORMULATION
BOUZADA, ANTONIO OSVALDO,NUNEZ, JOSE LUCIO,ITURRASPE, JOSE BERNARDO,MOYANO DE ITURRASPE, NORA ADRIANA
申请号：
EP07712569
公开号：
EP1994925A4
申请日:
2007.01.18
申请国别(地区):
EP
年份:
2013
代理人:
摘要：
A pharmaceutical formulation of taxane intended to be administered to mammals, preferably humans, comprising two compositions combined prior to being administered, forming a transparent solution free from precipitates, in which said compositions comprise a solid composition of lyophilised taxane, free from tensoactives, oils, polymers, solubility enhancers, preservatives and excipients and a solubilising composition of said lyophilised taxane solid composition that comprises at least one tensoactive. Said formulation is free from polysorbate 80 and polyoxyethylated castor oil. A procedure for the preparation of said solid composition by means of the lyophilisation of taxane in a lyophilising organic solvent. A kit for said injectable formulation of taxane comprising a prefilled syringe. Also a pharmaceutical taxane solution for perfusion, free from organic solvent.
