Patent ID: 7871632
Filing Date: 2011-01-18
Classification: A61K,A61P

Abstract:
1. A composition comprising vinorelbine bitartrate in an oil-in-water emulsion having an oil phase and an aqueous phase, wherein the oil phase comprises a triglyceride oil having medium chain fatty acids, soy lecithin, and oleic acid, and the aqueous phase comprises water, sucrose, and disodium edetate (EDTA) dihydrate, wherein in excess of 80% of the vinorelbine bitartrate is dissolved and remains in the oil phase, and wherein: (a) vinorelbine bitartrate is at a concentration of 1.4% (w/w); (b) triglyceride oil having medium chain fatty acids is at a concentration of 15% (w/w); (c) soy lecithin is at a concentration of 7.5% (w/w); (d) oleic acid is at a concentration of 1.5% (w/w); (e) sucrose is at a concentration of 15% (w/w); (f) disodium edetate (EDTA) dihydrate is at a concentration of 0.005% (w/w); (g) vinorelbine bitartrate to oleic acid is in a 1:4 molar ratio; (h) the composition is at a pH of 3.7; and (i) water is to QS.