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. An aqueous composition comprising 2.8-3.2 mg/ml ibuprofen and 9.8-10.2 mg/ml paracetamol and having a pH at the time of preparation (t 0 ) that is between 6.3 and 6.8, inclusive, 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 aqueous composition of claim 1 , wherein after one year of storage at 25±2° C. and 40±5% relative humidity, the level of 4-aminophenol in the composition is below 0.05% and the level of 4-nitrophenol in the composition is below 0.05%.
3. The aqueous composition of claim 1 , wherein the pH six months after the time of preparation is no higher than 7.3.
4. The aqueous composition of claim 1 , comprising 3 mg/ml ibuprofen and 10 mg/ml paracetamol.
5. The aqueous composition of claim 1 , further comprising an isotonic agent.
6. The aqueous composition of claim 1 , wherein the isotonic agent is mannitol.
7. The aqueous composition of claim 1 , further comprising cysteine.
8. The composition of claim 1 , having a dissolved oxygen content below 2 ppm.