JPWO2021005129A5 - - Google Patents

Claims (15)

1. A pharmaceutical composition for treating pain in humans, said pharmaceutical composition comprising a combination of ibuprofen in the form of a pharmaceutically acceptable salt and tramadol or a pharmaceutically acceptable salt thereof. wherein the dosage of ibuprofen in said combination is from 350 mg to 450 mg and the dosage of tramadol or a pharmaceutically acceptable salt thereof in said combination is from 35 mg to Said pharmaceutical composition , characterized in that it is 40 mg. Pharmaceutical composition according to claim 1, characterized in that the pharmaceutically acceptable salt of ibuprofen is selected from ibuprofen alginate, ibuprofen lysinate and ibuprofen sodium. 3. The pharmaceutical composition according to Claim 2 , wherein the pharmaceutically acceptable salt of ibuprofen is ibuprofen alginate. Pharmaceutical composition according to any one of claims 1 to 3, characterized in that the dose of ibuprofen is between 390 mg and 410 mg . 5. The method according to any one of claims 1 to 4, characterized in that the dosage of tramadol or a pharmaceutically acceptable salt thereof, expressed as the equivalent of tramadol hydrochloride, is 36 mg to 39 mg. Pharmaceutical composition as described. Pharmaceutical composition according to any one of claims 1 to 5, characterized in that the tramadol is in the form of tramadol hydrochloride. Pharmaceutical composition according to any one of claims 1 to 6, characterized in that said pharmaceutical composition is administered by the oral route. Pharmaceutical composition according to any one of claims 1 to 6, characterized in that said pharmaceutical composition is administered intravenously. The pharmaceutical composition according to any one of claims 1 to 8, characterized in that it is used for the treatment of acute pain or chronic pain . The pharmaceutical composition comprises a fixed dose combination of ibuprofen in the form of a pharmaceutically acceptable salt and tramadol or a pharmaceutically acceptable salt thereof, and at least one pharmaceutically acceptable excipient. The pharmaceutical composition according to any one of claims 1 to 9, characterized in that it comprises 11. Pharmaceutical composition according to claim 10, characterized in that said pharmaceutical composition is for oral administration and is selected from the group consisting of granules, powders, tablets and capsules. 11. Pharmaceutical composition according to claim 10, characterized in that said pharmaceutical composition is an aqueous solution for intravenous injection. about 37.5 mg of tramadol hydrochloride, about 400 mg of ibuprofen, arginine in an amount to provide an ibuprofen:arginine molar ratio of 1.2:1 to 1:1.2, and at least one pharmaceutically acceptable excipients, said pharmaceutical composition being selected from granules, tablets and capsules , wherein a numerical value preceded by the term "about" is a stated amount said pharmaceutical composition, which is meant to contain a variation of ±2% of about 37.5 mg of tramadol hydrochloride, about 400 mg of ibuprofen, arginine in an amount to provide an ibuprofen:arginine molar ratio of 1.2:1 to 1:1.2, and at least one pharmaceutically acceptable excipients, wherein numbers preceded by the term "about" are meant to include a variation of ±2% of the stated amount aqueous solution . A pharmaceutical composition according to claim 13 or an intravenous aqueous solution according to claim 14 for treating pain .