Paracetamol for parenteral administration

Abstract

The invention relates to an aqueous pharmaceutical composition, preferably an infusion solution, for parenteral administration which contains paracetamol and has an electrical conductivity of not more than 200 μS cm −1 . The invention relates to an aqueous pharmaceutical composition, preferably an infusion solution, for parenteral administration which contains paracetamol and has an electrical conductivity of not more than 200 μS cm −1 .v

1 .- 15 . (canceled) 
     
     
         16 . An aqueous pharmaceutical composition comprising paracetamol and a non-ionic isotonicity agent, wherein the composition is in the form of an infusion solution that is free of organic solvents; exhibits an electrical conductivity of, at most, 50 μS/cm; and has a pH in the range from 5.0 to 7.0. 
     
     
         17 . The aqueous pharmaceutical composition of  claim 16 , wherein the composition has a buffer capacity 0 of at most 0.8 mmol l −1  pH −1 . 
     
     
         18 . The aqueous pharmaceutical composition of  claim 16 , wherein the composition, after storage at 60° C. for 4 weeks, contains at least 99.0% of the paracetamol originally contained in the composition. 
     
     
         19 . The aqueous pharmaceutical composition of  claim 16 , wherein the non-ionic isotonicity agent comprises a sugar alcohol or cysteine. 
     
     
         20 . The aqueous pharmaceutical composition of  claim 16 , wherein the non-ionic isotonicity agent is a sugar alcohol. 
     
     
         21 . The aqueous pharmaceutical composition of  claim 16 , wherein the non-ionic isotonicity agent is mannitol. 
     
     
         22 . The aqueous pharmaceutical composition of  claim 16 , wherein the non-ionic isotonicity agent is cysteine. 
     
     
         23 . The aqueous pharmaceutical composition of  claim 16 , wherein the composition comprises mannitol and cysteine. 
     
     
         24 . The aqueous pharmaceutical composition of  claim 16 , wherein the proportion by weight of the nonionic isotonicity agent is greater than the proportion by weight of paracetamol in the composition. 
     
     
         25 . The aqueous pharmaceutical composition of  claim 16 , wherein the composition has an osmolarity of at least 0.25 osmol/l. 
     
     
         26 . The aqueous pharmaceutical composition of  claim 16 , wherein the composition has an osmolarity of at most 0.36 osmol/l. 
     
     
         27 . The aqueous pharmaceutical composition of  claim 16 , wherein the paracetamol is present at a concentration of 10.0±5.0 g/l. 
     
     
         28 . The aqueous pharmaceutical composition of  claim 16 , wherein the composition contains 10 g/liter of paracetamol and no more than 36.7 g/l of mannitol. 
     
     
         29 . The aqueous pharmaceutical composition of  claim 16 , wherein the composition is in ready-to-use form. 
     
     
         30 . An aqueous pharmaceutical composition consisting of water, paracetamol, mannitol, cysteine, and a buffering agent, wherein the composition has an electrical conductivity of at most 50 μS/cm and is formulated as an infusion solution. 
     
     
         31 . The aqueous pharmaceutical composition of  claim 30 , wherein the composition comprises 10 g/l of paracetamol and no more than 36.7 g/l of mannitol. 
     
     
         32 . A method of treating a patient who is suffering from pain, the method comprising administering to the patient the composition of  claim 16 . 
     
     
         33 . The method of  claim 32 , wherein the composition is administered as an intravenous infusion over a period of 2 minutes to 24 hours. 
     
     
         34 . A method of treating a patient who is suffering from pain, the method comprising administering to the patient the composition of  claim 30 . 
     
     
         35 . The method of  claim 34 , wherein the composition is administered as an intravenous infusion over a period of 2 minutes to 24 hours.