Ibuprofen intravenous infusion

摘要

A novel pharmaceutical formulation includes a four mg per ml (4 mg/mL) Ibuprofen in an aqueous solution of Arginine and Ibuprofen, wherein the molar ratio of Arginine to ibuprofen is more than or equal to 1.000625:1, Tris buffered, isotonic, and adjusted to pH between 7.2-8.5 by addition of 1.0 N HCL, none of the excipients used contains material of animal or human origin. There were no novel excipients used. A method of treating through anti-inflammatory, analgesic, and antipyretic activity: fever, pain, dysmenorrhea and inflammatory diseases are also described. It is also used for pericarditis and patent ductus arteriosus (Patent ductus arteriosus (PDA)), relieve moderate to severe pain, dental pain and pain after an operation, mild to moderate pain including migraine headache, and for short term treatment of pyrexia in children over one year of age. The formulation is meant to be used as ready to use intravenous infusion.

主权项

1. A pharmaceutical composition, in a form ready-to-use for intravenous administration to a subject, comprising 4 mg/ml of Ibuprofen in an aqueous solution, tris-buffer and Arginine, the molar ratio of Arginine to Ibuprofen being in a range of from 1.000625:1 to 1.10:1, the composition being isotonic with body fluid of the subject and buffered at a physiological pH of 7.2 to 8.5.