Claims for Patent: 10,842,770

Summary for Patent: 10,842,770

Title:	Non-aqueous taxane pro-emulsion formulations and methods of making and using the same
Abstract:	Non-aqueous taxane pro-emulsion formulations are provided. Pro-emulsion formulations of embodiments of the invention include a taxane, an oil component, a surfactant component and, optionally, a non-aqueous solvent component. Also provided are methods of making and using the pro-emulsion formulations, as well as kits that include the pro-emulsion formulations.
Inventor(s):	Nabeta; Kiichiro (Setagaya-ku, JP)
Assignee:	Teikoku Pharma USA, Inc. (San Jose, CA)
Application Number:	13/098,031
Patent Claims:	1. A non-aqueous docetaxel liquid pro-emulsion formulation comprising: anhydrous docetaxel or a hydrate thereof; an organic acid component in an amount ranging from 0.3 to 3% w/w, selected from the group consisting of acetic acid, lactic acid, and citric acid; an oil component in an amount ranging from 0.5 to 5% w/w, selected from the group consisting of soybean oil, olive oil, sesame oil, corn oil, a medium chain triglyceride, and combinations thereof; a polysorbate component in an amount of 30 to 70% w/w; and a non-aqueous solvent component selected from the group consisting of polyethylene glycols in an amount ranging from 35 to 55% w/w, wherein the anhydrous docetaxel or a hydrate thereof is present in an amount ranging from 0.1 to 5% w/w, wherein the formulation does not include ethanol, and wherein the amount of the docetaxel and the amount of the oil component differ by 50% w/w or less. 2. The pro-emulsion formulation according to claim 1, wherein the docetaxel is docetaxel trihydrate. 3. The pro-emulsion formulation according to claim 1, wherein the oil is soybean oil. 4. The pro-emulsion formulation according to claim 1, wherein the amounts of the docetaxel and oil components differ by 10% w/w or less. 5. The pro-emulsion formulation according to claim 1, wherein the polysorbate is polysorbate 80. 6. A method of administering docetaxel to a subject, the method comprising: (a) combing the docetaxel pro-emulsion formulation according to claim 1 with an aqueous medium to produce docetaxel emulsion; and (b) intravenously administering the docetaxel emulsion to the subject. 7. A kit comprising: (a) the docetaxel pro-emulsion formulation according to claim 1; and (b) an aqueous medium suitable for intravenous injection. 8. The pro-emulsion formulation according to claim 1, wherein the non-aqueous solvent component comprises polyethylene glycol 300. 9. The pro-emulsion formulation according to claim 1, wherein the oil is soybean oil or a medium chain triglyceride. 10. The pro-emulsion formulation according to claim 9, wherein the oil is soybean oil; the polysorbate surfactant is polysorbate 80; and the non-aqueous solvent component comprises polyethylene glycol 300. 11. The pro-emulsion formulation according to claim 10, wherein the particle size of the formulation upon the addition to an aqueous medium, ranges from 3 to 70 nm. 12. The pro-emulsion formulation according to claim 1, wherein the polyethylene glycol has an average molecular weight of 1000 or less. 13. The non-aqueous docetaxel liquid pro-emulsion formulation of claim 1, wherein the non-aqueous docetaxel liquid pro-emulsion formulation is suitable for the preparation of an intravenously injectable composition.