Claims for Patent: 11,389,416

Summary for Patent: 11,389,416

Title:	Aqueous formulation comprising paracetamol and ibuprofen
Abstract:	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.
Inventor(s):	Thomas Jacobsen
Assignee:	Hyloris Pharmaceuticals SA
Application Number:	US17/502,899
Patent Claims:	1. An aqueous analgesic composition comprising ibuprofen and paracetamol having a pH at the time of preparation (t0) 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.