Injectable ibuprofen formulation

Abstract

The present invention provides a pharmaceutical composition comprising an aqueous solution of an ibuprofen solubilizing agent and ibuprofen, the ibuprofen solubilizing agent being in an effective amount such that the ibuprofen in the solution remains soluble at concentrations from 100 mg/mL to 5 mg/mL without undergoing a phase transition. The invention further provides a method of treating a condition chosen from pain, inflammation, fever, and/or patent ductus arteriosis, comprising administering to a patient in need thereof an effective amount of an aqueous solution a ibuprofen solubilizing agent and ibuprofen, the ibuprofen solubilizing agent being in an effective amount such that the ibuprofen in the solution remains soluble at concentrations from 100 mg/mL to 5 mg/mL without undergoing a phase transition, as well as a method for manufacturing the composition.

1 .- 44 . (canceled) 
     
     
         45 . A pre-filled container for intravenous injection containing a stable pharmaceutical composition comprising water for injection, from 1 mg/mL to 10 mg/mL ibuprofen, and sodium hydroxide, wherein the sodium hydroxide to ibuprofen molar ratio is at least 1.05:1, and wherein the pharmaceutical composition is clear. 
     
     
         46 . The pre-filled container according to  claim 45 , wherein the pharmaceutical composition is sterile filtered or terminally sterilized. 
     
     
         47 . The pre-filled container according to  claim 45 , wherein the pharmaceutical composition remains clear when exposed to at least one freeze-thaw cycle. 
     
     
         48 . The pre-filled container according to  claim 45 , wherein the pharmaceutical composition is clear when stored for at least 12 weeks at ambient temperature. 
     
     
         49 . The pre-filled container according to  claim 45 , wherein the pharmaceutical composition shows no detectable chemical degradation after incubation for one month at 40° C. 
     
     
         50 . The pre-filled container according to  claim 45 , wherein the container is a bag. 
     
     
         51 . The pre-filled container according to  claim 50 , wherein the bag is made of a material selected from the group consisting of polypropylene, polyolefin, and polyvinylchloride. 
     
     
         52 . The pre-filled container according to  claim 51 , wherein the material is polypropylene. 
     
     
         53 . The pre-filled container according to  claim 45 , wherein the container is a vial. 
     
     
         54 . The pre-filled container according to  claim 53 , wherein the vial is made of plastic or glass. 
     
     
         55 . The pre-filled container according to  claim 45 , wherein the container is a bottle. 
     
     
         56 . The pre-filled container according to  claim 45 , wherein the stable pharmaceutical composition comprises about 4 mg/mL ibuprofen. 
     
     
         57 . The pre-filled container according to  claim 45 , wherein the stable pharmaceutical composition comprises 3.2 mg/mL ibuprofen. 
     
     
         58 . The pre-filled container according to  claim 45 , wherein the stable pharmaceutical composition is contained in the container at a volume of 100 mL. 
     
     
         59 . A pre-filled bag for intravenous injection containing a stable pharmaceutical composition comprising water for injection, 4 mg/mL ibuprofen, and sodium hydroxide, wherein the sodium hydroxide to ibuprofen molar ratio is at least 1.05:1, and wherein the pharmaceutical composition is clear. 
     
     
         60 . The pre-filled bag according to  claim 59 , wherein the bag is made of polypropylene. 
     
     
         61 . A method of treating pain in a patient, comprising administering the pharmaceutical composition from the container according to  claim 53  intravenously to the patient. 
     
     
         62 . A method of treating fever in a patient, comprising administering the pharmaceutical composition from the container according to  claim 53  intravenously to the patient. 
     
     
         63 . A method of treating pain in a patient, comprising administering the pharmaceutical composition from the pre-filled bag according to  claim 59  intravenously to the patient. 
     
     
         64 . A method of treating fever in a patient, comprising administering the pharmaceutical composition from the pre-filled bag according to  claim 59  intravenously to the patient.