Injectable ibuprofen formulation

摘要

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.

主权项

1. A pharmaceutical composition comprising an aqueous solution of ibuprofen, water for injection, and an ibuprofen solubilizing agent consisting of tribasic sodium phosphate, the aqueous solution being at a pH from 6.8 to 7.8, the molar ratio of tribasic sodium phosphate to ibuprofen being greater than 0.65:1to about 0.9:1, such that the ibuprofen in the solution remains soluble at concentrations from 100 mg/mL to 4 mg/mL without undergoing a phase transition, and the pharmaceutical composition is clear, colorless and suitable for intravenous administration.