Patent ID: 8557861

Claim:
A sterile injectable oil-in-water emulsion comprising: (a) paclitaxel at a concentration selected from the group consisting of 0.03%, 0.04%, and 0.05% by weight, (b) an oil component at a concentration from 1% to 4% by weight, wherein the oil component comprises a vegetable oil or a medium chain triglyceride, or a mixture thereof, (c) a phospholipid component at a concentration from 1% to 4% by weight, wherein the weight ratio of the oil component to the phospholipid component is about 1:1, (d) sodium hydroxide and/or hydrochloric acid to adjust the pH to between about 6 and 7, and (e) water, wherein said injectable oil-in-water emulsion has an average oil droplet diameter in a range of 75 nm to 150 nm, is sterilized by filtration using a 0.2 μm filter, does not include a cryoprotectant or protein, and is stable for at least 18 months.