Aqueous formulation comprising paracetamol and ibuprofen
The present invention relates to an aqueous ibuprofen and paracetamol composition of pH 6.3-7.3 and to its use. The present invention relates to a method for preparing a combination product of ibuprofen and paracetamol. It also relates to the compositions for use as a medicament, especially for the treatment of pain and/or inflammation; especially for administration of the composition by intravenous injection.
1. A process for manufacturing an aqueous composition comprising 2.8-3.2 mg/ml ibuprofen and 9.8-10.2 mg/ml paracetamol in combination, comprising the steps of:
a) providing an aqueous solvent of pH 6.0-8.0,
b) dissolving in said aqueous solvent ibuprofen and paracetamol,
c) if required adjusting the pH to 6.3-6.8,
d) thereby obtaining said aqueous composition comprising 2.8-3.2 mg/ml ibuprofen and 9.8-10.2 mg/ml paracetamol in combination at 6.3-6.8,
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 process according to claim 1 , wherein said aqueous solvent has a dissolved oxygen content below 2 ppm obtainable using an aqueous solvent having a temperature between 85° C. and 99° C. and/or by bubbling an inert gas through said solvent.
3. The process according to claim 1 , wherein the composition comprises an anti-oxidant.
4. The process according to claim 1 , wherein the aqueous solvent comprises an isotonic agent.
5. The process according to claim 3 , wherein the anti-oxidant is cysteine or acetyl cysteine.
6. The process according to claim 4 , wherein the isotonic agent is mannitol.
7. The process according to claim 2 , wherein the inert gas is selected from the group consisting of nitrogen, and argon.