Ready-to-administer fentanyl formulations
The stable liquid formulations for parenteral administration include fentanyl or a pharmaceutically acceptable salt thereof. The formulations include a diluent and buffer, either containing sodium, in an aqueous solution that has a pH of about 3 to about 4.5. The parenteral liquid formulations are stable formulations that are supplied as a ready-to-administer product in an infusion container or bag. The stable formulations are terminally sterilized in the infusion container. The stable formulations are suitable for administration to a patient in need of therapy with fentanyl or a pharmaceutically acceptable salt thereof.
1. A ready-to-administer parenteral liquid formulation comprising:
a. 5 mcg/mL to about 25 mcg/mL of fentanyl citrate;
b. a sodium-containing diluent; and
c. about 0.5 mg/mL to about 5 mg/mL of a buffer;
wherein the ready-to-administer parenteral liquid formulation has a pH of about 3 to about 4.5 and has been terminally sterilized in a polymeric infusion container, wherein the ready-to-administer parenteral liquid formulation is stable for at least 6 months at about 40° C.
2. The ready-to-administer parenteral liquid formulation of claim 1 , wherein the buffer comprises at least one of citric acid, sodium citrate, acetic acid, sodium acetate or a combination thereof.
3. The ready-to-administer parenteral liquid formulation of claim 1 , wherein the formulation has a volume of from about 50 mL to about 500 mL and the polymeric infusion container is a bag terminally sterilized by autoclaving.
4. The ready-to-administer parenteral liquid formulation of claim 1 , wherein the formulation is free of a sugar-alcohol.
5. The ready-to-administer parenteral liquid formulation of claim 1 , wherein the sodium-containing diluent is aqueous sodium chloride solution and the pH is about 3.5 to about 4.5.
6. The ready-to-administer parenteral liquid formulation of claim 1 , wherein the formulation contains about 1.0% or less of an individual impurity after storage for 6 months at about 40° C. or for 12 months at about 25° C.
7. The ready-to-administer parenteral liquid formulation of claim 1 , wherein the formulation contains about 1.0% or less of total impurities after storage for 6 months at about 40° C. or for 12 months at about 25° C.
8. The ready-to-administer parenteral liquid formulation of claim 1 , wherein the formulation retains about 98% or more of the initial concentration of fentanyl or a pharmaceutically acceptable salt thereof after storage for 6 months at about 40° C. or for 12 months at about 25° C.
9. A method of treating a patient in need of anesthesia by administering to the patient a ready-to-administer parenteral liquid formulation of claim 1 .