US2022143044A1PendingUtilityA1

Fulvestrant formulations

73
Assignee: FRESENIUS KABI USA LLCPriority: Feb 14, 2014Filed: Dec 14, 2021Published: May 12, 2022
Est. expiryFeb 14, 2034(~7.5 yrs left)· nominal 20-yr term from priority
Inventors:Jabar A. Faraj
A61K 31/565A61K 47/44A61K 9/0019A61K 47/22A61K 47/26
73
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Claims

Abstract

The invention provides a fulvestrant composition comprising a pharmaceutically acceptable vehicle and not more than 2% total impurities 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.

Claims

exact text as granted — not AI-modified
What is claimed is: 
     
         1 . A composition comprising fulvestrant and a pharmaceutically acceptable vehicle, wherein the composition is substantially free of a non-aqueous ester solvent and comprises not more than 2% total impurities. 
     
     
         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 1 , wherein the vehicle is an oleaginous vehicle. 
     
     
         7 . The composition of  claim 1 , wherein the total impurities are determined following storage of the composition at room temperature for a period of 12 months. 
     
     
         8 . The composition of  claim 1 , comprising not more than 1% total impurities. 
     
     
         9 . The composition of  claim 8 , wherein the total impurities are determined following storage of the composition at 2-40° C. for a period of 3 months. 
     
     
         10 . The composition of  claim 9 , wherein the total impurities are determined following storage of the composition at 25° C. 
     
     
         11 . A container comprising 2.5 mL-5 mL of the composition of  claim 1 . 
     
     
         12 . The container of  claim 11 , wherein the container is a vial, an ampoule, a cartridge, or a syringe. 
     
     
         13 . 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. 
     
     
         14 . A composition comprising 4% w/v or more fulvestrant, a nonionic surfactant, and not more than 2% total impurities. 
     
     
         15 . The composition of  claim 14 , wherein the composition is substantially free of a non-aqueous ester solvent. 
     
     
         16 . The composition of  claim 14 , wherein the composition comprises an oleaginous vehicle. 
     
     
         17 . The composition of  claim 14 , wherein the nonionic surfactant is polysorbate 80. 
     
     
         18 . The composition of  claim 14 , wherein the composition comprises a pharmaceutically acceptable alcohol and/or an antioxidant. 
     
     
         19 . The composition of  claim 14 , wherein the total impurities are determined following storage of the composition at room temperature for a period of 12 months. 
     
     
         20 . A container comprising 2.5 mL-5 mL of the composition of  claim 14 .

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