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Last Updated: December 22, 2024

Claims for Patent: 11,213,498

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Summary for Patent: 11,213,498

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):	Jacobsen Thomas
Assignee:	Hyloris Pharmaceuticals S.A.
Application Number:	US16424274
Patent Claims:	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) 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 claim 1 , 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.

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