Sublingual fentanyl spray
View Patent ↗The present invention is directed to sublingual formulations containing fentanyl, a pharmaceutically acceptable sale thereof, or derivative thereof, suitable for administration to a patient, and methods for treatment with the formulations.
1. A sublingual spray formulation comprising a dose of fentanyl which provides one or more mean pharmacokinetic values selected from the group consisting of: AUClast 4.863+/−1.70821 hr*ng/mL, AUCinf 5.761+/−1.916 hr*ng/milliliter, and AUCextrap 10.26+/−5.66%, when administered to humans.
2. A sublingual spray formulation comprising a dose of fentanyl, a free base or a pharmaceutically acceptable salt thereof, which provides a substantially dose proportional mean AUClast based on a mean AUClast of about 4.863+/−1.70821 hr*ng/milliliter when administered to humans.
3. A sublingual spray formulation comprising a dose of fentanyl, a free base or a pharmaceutically acceptable salt thereof, which provides a mean F(AUClast) of about 0.721+/−0.199 ng/milliliter when administered to humans.