Solubilized sterile injectable formulation of docetaxel without Tween 80

摘要

A sterile pharmaceutical formulation for use in treatment of a patient in need thereof is disclosed, which comprises:(a) docetaxel, or a pharmaceutically acceptable salt thereof, wherein the docetaxel or pharmaceutically acceptable salt thereof is in an amount of about mg/mL to about 20 mg/mL;(b) glycofurol or ethanol;(c) one or more hydrotropes comprising d-alpha-tocopheryl polyethylene glycol succinate (TPGS), polyethylene glycol (PEG), propylene glycol (PG), or a mixture thereof; and(d) water;wherein the formulation is substantially free of polysorbate surfactants and polyethoxylated castor oil; and wherein the formulation is precipitate-free at about six hours; andwherein the formulation may further comprise: (e) a buffer and (f) one or more antioxidants comprising alpha-lipoic acid.