Claims for Patent: 12,083,087
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Summary for Patent: 12,083,087
| 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: | US17/867,370 |
| Patent Claims: |
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 (t0) 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. |
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