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Abstract
Background: The time fentanyl buccal tablet (FBT) takes to completely dissolve after placement on the buccal mucosa (i.e., ‘dwell time’) could exceed the time to onset of analgesia. Objective: To examine the relationship between FBT dwell time and fentanyl pharmacokinetic parameters. Research design and methods: This was a post hoc exploratory analysis of data from two randomized, open-label, crossover, pharmaco�kinetic studies that were designed to assess dose proportionality within the anticipated therapeutic dose range. Healthy adults received single FBT doses of 200 – 1080 μg in Study 1 (n = 28) and 270 – 1300 μg in Study 2 (n = 42). Main outcome measures: Assessments included buccal dwell time, defined as the duration of FBT presence in the oral cavity, and the following pharmacokinetic measures: maximum serum concentration (Cmax), time to Cmax (Tmax) and area under the concentration–time curve (AUC; exposure) from 0 minutes to median Tmax adjusted for the dose (Tmax′) (AUC0 – Tmax′). Spontaneously reported adverse events were recorded. Results: Mean buccal dwell time for FBT across the dose range varied from 14 to 25 minutes (range 3 – 62 minutes). There was no evidence of an association between FBT dwell time and values for Tmax (medians 45 – 60 minutes), dose-normalized Cmax (means 0.42 – 0.66 pg/ml/200 μg) or dose-normalized AUC0 – Tmax′ (means 0.24 – 0.38 pg·h/ml/200 μg) over the range of FBT doses delivered. All adverse events reported were mild to moderate; none were unexpected or serious. Conclusion: The pharmacokinetic parameters of FBT did not appear to be related to its buccal dwell time.
Disclosure
This study was supported by Cephalon, Inc., Frazer, PA and writing support was provided by Embryon.
