Injectable ibuprofen formulation
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. A pre-filled bag for intravenous injection containing a stable pharmaceutical composition comprising water for injection, 4 mg/mL ibuprofen, sodium chloride, and sodium hydroxide, wherein the sodium hydroxide to ibuprofen molar ratio is at least 1.05:1, and wherein the pharmaceutical composition is clear and has a pH of 7.4.
2. The pre-filled bag according to claim 1 , wherein the bag is made of a material selected from the group consisting of polypropylene, polyolefin, and polyvinylchloride.
3. The pre-filled bag according to claim 2 , wherein the material is polypropylene.
4. The pre-filled bag according to claim 1 , wherein the pharmaceutical composition is sterile filtered or terminally sterilized.
5. The pre-filled bag according to claim 1 , wherein the pharmaceutical composition remains clear when exposed to at least one freeze-thaw cycle.
6. The pre-filled bag according to claim 1 , wherein the pharmaceutical composition is clear when stored for at least 12 weeks at ambient temperature.
7. The pre-filled bag according to claim 1 , wherein the pharmaceutical composition shows no detectable chemical degradation after incubation for one month at 40° C.
8. A pre-filled bag for intravenous injection containing a stable pharmaceutical composition comprising water for injection, 800 mg ibuprofen, sodium chloride, and sodium hydroxide, wherein the sodium hydroxide to ibuprofen molar ratio is at least 1.05:1, and wherein the pharmaceutical composition is clear and has a pH of 7.4.
9. The pre-filled bag according to claim 8 , wherein the bag is made of a material selected from the group consisting of polypropylene, polyolefin, and polyvinylchloride.
10. The pre-filled bag according to claim 9 , wherein the material is polypropylene.
11. The pre-filled bag according to claim 8 , wherein the pharmaceutical composition is sterile filtered or terminally sterilized.
12. The pre-filled bag according to claim 8 , wherein the pharmaceutical composition remains clear when exposed to at least one freeze-thaw cycle.
13. The pre-filled bag according to claim 8 , wherein the pharmaceutical composition is clear when stored for at least 12 weeks at ambient temperature.
14. The pre-filled bag according to claim 8 , wherein the pharmaceutical composition shows no detectable chemical degradation after incubation for one month at 40° C.
15. A method of treating pain in a patient, comprising administering the pharmaceutical composition from the pre-filled bag according to claim 1 intravenously to the patient.
16. A method of treating fever in a patient, comprising administering the pharmaceutical composition from the pre-filled bag according to claim 1 intravenously to the patient.