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 analgesic composition comprising ibuprofen and paracetamol 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 analgesic 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 analgesic composition of claim 1 , wherein the pH six months after the time of preparation is no higher than 7.3.
4. The aqueous analgesic composition of claim 1 , further comprising an isotonic agent.
5. The aqueous analgesic composition of claim 4 , wherein the isotonic agent is mannitol.
6. The aqueous analgesic composition of claim 1 , further comprising cysteine.
7. The aqueous analgesic composition of claim 1 , having a dissolved oxygen content below 2 ppm.
8. The aqueous analgesic composition of claim 2 , wherein the pH six months after the time of preparation is no higher than 7.3.
9. The aqueous analgesic composition of claim 2 , further comprising an isotonic agent.
10. The aqueous analgesic composition of claim 9 , wherein the isotonic agent is mannitol.
11. The aqueous analgesic composition of claim 2 , further comprising cysteine.
12. The aqueous analgesic composition of claim 2 , having a dissolved oxygen content below 2 ppm.
13. The aqueous analgesic composition of claim 8 , further comprising an isotonic agent.
14. The aqueous analgesic composition of claim 13 , wherein the isotonic agent is mannitol.
15. The aqueous analgesic composition of claim 8 , further comprising cysteine.
16. The aqueous analgesic composition of claim 8 , having a dissolved oxygen content below 2 ppm.
17. The aqueous analgesic composition of claim 10 , wherein the mass ratio (w/w) of mannitol:
paracetamol is between 2:1 and 6:1.
18. The aqueous analgesic composition of claim 17 , wherein the mass ratio (w/w) of mannitol:
paracetamol is between 3:1 and 5:1.
19. The aqueous analgesic composition of claim 18 , wherein the mass ratio (w/w) of mannitol:
paracetamol is 4:1.
20. The aqueous analgesic composition of claim 2 further comprising cysteine hydrochloride.
21. The aqueous analgesic composition of claim 20 , wherein the mass ratio (w/w) of cysteine hydrochloride to paracetamol is between 0.010:1 and 0.040:1.
22. The aqueous analgesic composition of claim 20 , wherein the mass ratio (w/w) of cysteine hydrochloride to paracetamol is between 0.020:1 and 0.030:1.
23. The aqueous analgesic composition of claim 20 , wherein the mass ratio (w/w) of cysteine hydrochloride to paracetamol is 0.025:1.
24. The aqueous analgesic composition of claim 20 , wherein the mass ratio (w/w) of cysteine hydrochloride to ibuprofen is between 0.20:1 and 0.40:1.
25. The aqueous analgesic composition of claim 20 , wherein the mass ratio (w/w) of cysteine hydrochloride to ibuprofen is between 0.10:1 and 0.20:1.
26. The aqueous analgesic composition of claim 20 , wherein the mass ratio (w/w) of cysteine hydrochloride to ibuprofen is 0.08:1.
27. The aqueous analgesic composition of claim 1 , wherein the ratio of ibuprofen to paracetamol is 3 to 10 wt/wt.
28. The aqueous analgesic composition of claim 2 , wherein the ratio of ibuprofen to paracetamol is 3 to 10 wt/wt.