Method of managing or treating pain

摘要

A composition for the intranasal delivery of fentanyl or a pharmaceutically acceptable salt thereof to an animal includes an aqueous solution of fentanyl or a pharmaceutically acceptable salt thereof and a pharmaceutically acceptable additive selected from (i) a pectin and (ii) a poloxamer and chitosan or a salt or derivative thereof; provided that when the composition comprises a pectin it is substantially free of divalent metal ions; and which, in comparison to a simple aqueous solution of fentanyl administered intranasally at the same dose, provides a peak plasma concentration of fentanyl (Cmax) that is from 10 to 80% of that achieved using a simple aqueous solution of fentanyl administered intranasally at an identical fentanyl dose. A method for treating or managing pain by intranasally administering the composition is also disclosed.

主权项

1. A method of treating or managing pain comprising intranasally administering to an animal in need thereof in a single dosage regimen in an amount to effectively treat or manage pain, a pharmaceutical composition comprising an aqueous solution of
fentanyl or a pharmaceutically acceptable salt thereof in an amount to effectively treat or manage pain and a pectin having a degree of esterification (DE value) of less than 30%, provided that the composition is substantially free of divalent metal ions; wherein the animal administered the composition is provided with a peak plasma concentration of fentanyl (Cmax) that is from 10 to 80% of that achieved using a simple aqueous solution of fentanyl administered intranasally at an identical fentanyl dose; and wherein the intranasal administration of the composition provides a time to achieve peak plasma concentration (Tmax) of fentanyl in the animal's plasma of 5 to 30 minutes.