Aqueous formulation comprising paracetamol and ibuprofen
An aqueous ibuprofen and paracetamol composition has a pH 6.3-7.3. The composition can be used as a medicament, especially for the treatment of pain and/or inflammation. The composition can be formulated for intravenous injection.
1. A method for treating pain comprising intravenously administering an aqueous analgesic composition comprising 2.8-3.2 mg/ml ibuprofen and 9.8-10.2 mg/ml paracetamol, wherein the aqueous analgesic composition has a pH at the time of preparation (t 0 ) that is between 6.3 and 6.8, inclusive and wherein the ibuprofen and the paracetamol remain in solution for at least 6 months at 25±2° C. and 40±5% relative humidity.
2. The method of claim 1 , wherein the pH of the aqueous analgesic composition six months after the time of preparation is no higher than 7.3.
3. The method of claim 1 , wherein the aqueous analgesic composition comprises an isotonic agent.
4. The method of claim 1 , wherein the isotonic agent is mannitol.
5. The method of claim 1 , wherein the aqueous analgesic composition comprises cysteine.
6. The method of claim 1 , wherein the aqueous analgesic composition has dissolved oxygen content below 2 ppm.
7. The method of claim 1 , wherein after one year of storage at 25±2° C. and 40±5% relative humidity, the aqueous analgesic composition comprises less than 0.05% wt/wt 4-aminophenol and less than 0.05% wt/wt 4-nitrophenol.
8. The method of claim 1 , wherein the aqueous analgesic composition comprises 3 mg/ml ibuprofen and 10 mg/ml paracetamol.