An innovative Phase I population pharmacokinetic approach to investigate the pharmacokinetics of an intranasal fentanyl spray in healthy subjects

Abstract

The implementation of a PopPK approach in the planning and analysis of this trial yielded an innovative, cost- and time-saving trial design that successfully delivered the required information about the PK of the 400 μg dose strength within this small clinical study.

Pictorial prescribing reduces fentanyl drug administration errors: a simulated controlled study

“…Self-adhesive preprinted drug chart labels were manufactured that included pictures of the four immediate-release fentanyl citrate preparations in the formulary at our university hospital in 2010 (Actiq,5 Effentora,8 Instanyl10 and Abstral9 manufactured at the time by Teva, Nycomed (Zürich, Switzerland), Cephalon (Frazer, Pennsylvania, USA) and ProStrakan (Galashiels, UK), respectively; figure 1). These were applied to five specimen drug charts written about five fictitious patients.…”

“…In the past 5 years, there has been a proliferation of alternative transmucosal fentanyl citrate products7 exploiting the buccal,8 sublingual,9 nasal10 and even respiratory11 routes for the same licensed indication. Each has certain advantages and disadvantages that lie outside the scope of this study; however, each aims to increase bioavailability by increasing exposure to the mucosa while avoiding swallowing.…”