Ready-to-administer solution of fentanyl citrate

Abstract

A method of treating a patient in need of therapy with fentanyl or a salt thereof, the method comprising providing a ready-to-administer solution consisting essentially of fentanyl or a salt thereof as the sole active ingredient, a sugar or sugar alcohol and water for injection, the solution having a pH in the range of 3.5 to 7.5, and parenterally administering the solution to the patient.

We claim: 
     
         1 . A method of treating a patient in need of therapy with fentanyl or a salt thereof, said method comprising:
 a. providing a ready-to-administer solution consisting essentially of fentanyl or a salt thereof as the sole active ingredient, a sugar or sugar alcohol, and water for injection, said solution having a pH in the range of 3.5 to 7.5, and   b. parenterally administering said solution to the patient.   
     
     
         2 . The method as claimed in  claim 1 , wherein the sugar is selected from the group consisting of dextrose, glucose, fructose or mixtures thereof. 
     
     
         3 . The method as claimed in  claim 1 , wherein the sugar alcohol is selected from the group consisting of mannitol or sorbitol or mixtures thereof. 
     
     
         4 . The method as claimed in  claim 1 , wherein the solution is present in one or more containers, and fentanyl or a salt thereof is present in amount ranging from 0.001 mg/ml to 0.1 mg/ml. 
     
     
         5 . The method as claimed in  claim 4 , wherein fentanyl or a salt thereof is present in an amount ranging from 0.005 mg/ml to 0.075 mg/ml and the volume of the solution in containers is from 50 ml to 500 ml. 
     
     
         6 . The method as claimed in  claim 5 , wherein the patient in need of therapy with fentanyl or a salt thereof is a patient undergoing surgical procedure. 
     
     
         7 . The method as claimed in  claim 4 , wherein the container comprises a polymer of a cyclic olefin. 
     
     
         8 . The method as claimed in  claim 4 , wherein the solution has been sterilized by autoclaving. 
     
     
         9 . The method as claimed in  claim 1 , wherein the method does not include the administration of sodium other than sodium hydroxide and/or a buffer component present in an amount sufficient to adjust a pH of the solution. 
     
     
         10 . The method as claimed in  claim 1 , wherein the solution is present in a plurality of containers comprising larger and smaller containers, wherein a concentration of fentanyl or a salt thereof is greater in the smaller containers than in the larger containers, and wherein said administration occurs simultaneously or sequentially from the plurality of containers.