Claims for Patent: 10,188,663

Summary for Patent: 10,188,663

Title:	Fulvestrant formulations
Abstract:	The invention provides a fulvestrant composition comprising not more than 2% total impurities that comprises a nonionic surfactant and/or a ricinoleate vehicle and which, optionally, is free of a non-aqueous ester solvent. The composition may be used to treat hormone receptor positive metastatic breast cancer in a subject.
Inventor(s):	Faraj; Jabar A. (Birmingham, AL)
Assignee:	Fresenius Kabi USA, LLC (Lake Zurich, IL)
Application Number:	15/799,281
Patent Claims:	1. A composition comprising fulvestrant, a ricinoleate vehicle, and not more than 2% total impurities, wherein the composition is substantially free of a non-aqueous ester solvent following storage of the composition at room temperature for a period of 12 months. 2. The composition of claim 1, wherein the composition is completely free of a non-aqueous ester solvent. 3. The composition of claim 1, wherein the composition comprises at least one of a pharmaceutically acceptable alcohol, a nonionic surfactant, and an antioxidant. 4. The composition of claim 3, wherein the composition comprises at least two of a pharmaceutically acceptable alcohol, a nonionic surfactant, and an antioxidant. 5. The composition of claim 2, wherein the composition comprises a pharmaceutically acceptable alcohol, a nonionic surfactant, and an antioxidant. 6. The composition of claim 5, wherein the nonionic surfactant is polysorbate 80. 7. The composition of claim 1, wherein the ricinoleate vehicle is castor oil. 8. The composition of claim 7, wherein the castor oil is characterized by a carbonyl value of 0.5 micromole/gram or less, a peroxide value of 5.0 meq O.sub.2/kg or less, an iodine value of 85 g iodine/100 g castor oil or less, and/or a Gardner 1933 value of 1.5 or less. 9. The composition of claim 1, comprising not more than 1% total impurities. 10. The composition of claim 9, wherein the total impurities are determined following storage of the composition at 2-40.degree. C. for a period of 3 months. 11. The composition of claim 10, wherein the total impurities are determined following storage of the composition at 25.degree. C. 12. A syringe comprising 2.5 mL-5 mL of the composition of claim 1. 13. A vial comprising 2.5 mL-5 mL of the composition of claim 1. 14. A method of treating hormone receptor positive metastatic breast cancer in a subject in need thereof, the method comprising administering a therapeutically effective amount of the composition of claim 1 to the subject, thereby treating the hormone receptor positive metastatic breast cancer in the subject.