Preclinical Development – Chemical
2019 PharmSci 360
Naloxone, an opioid antagonist, was primarily available as injectable and recently introduced as intranasal (IN) formulations to facilitate easy and quick treatment of opioid overdose victims. Due to the change of administration route, excipients used to formulate the intranasal formulations could affect permeation and systemic absorption of naloxone. While there are many naloxone IN formulations under development, there is little literature on the effect of formulation variables including preservatives and stabilizes on the nasal absorption. To evaluate the effect of these excipients and other formulation variables such as solution pH could affect the performance and stability of IN naloxone, the nasal permeation and stability of various naloxone IN formulations prepared in-house were investigated in the present work using an in vitro nasal permeation model and a systematic stability study.
DISCLAIMER: this work reflects the views of the authors and should not be construed to represent FDA’s views or policies