A NOVEL STABLE SUSTAINED RELEASE COMPOSITION WITH 7-ALPHA-9-(4,4,5,5,5-PENTA FLUOROPENTYLSULPHINYL) NONYLESTRA-1,3,5-(10)- TRIENE-3,17-BETA-DIOL FOR INTRAMUSCULAR ADMINISTRATION

摘要

A stable intramuscular formulation comprising 7-x-[9-(4,4,5,5,5-penta fluoropentyl sulphinyl) nonyl]estra-l,3,5-(10)-triene-3,17-P- diol (Fulvestrant) as active pharmaceutical ingredient is disclosed. The formulation contains ethanol and/ benzyl alcohol/ propylene glycol/ polyethylene glycol as co-solvents, castor oil to prevent injection site precipitation of the active, made up to 100% w/v with medium chain triglycerides as a release rate modifier and vehicle. The disclosed formulation exhibits superior chromatographic profile, release characteristics and greater patient compliance to that of currently marketed injection.