An Evaluation of Total Disintegration Time for Three Different Doses of Sublingual Fentanyl Tablets in Patients with Breakthrough Pain

摘要

Introduction Breakthrough pain is common among patients with cancer and presents challenges to effective pain management. Breakthrough pain is characterized by rapid onset, severe intensity, and duration typically lasting Methods This was a single-center, non-randomized, open-label study. Opioid-tolerant adult patients ( N =?30) with chronic pain were assigned to one of three dose groups and self-administered a single 100, 200, or 300?μg sublingual fentanyl tablet (Abstral?, Galena Biopharma, Portland, OR, USA). Time to complete disintegration was measured by each patient with a stopwatch and independently verified by study personnel. Results Disintegration time (mean?±?SD) for sublingual fentanyl tablets (all doses) was 88.2?±?55.1?s. Mean disintegration times tended to be slightly longer for the 200?μg (96.7?±?57.9?s) and 300?μg doses (98.6?±?64.8?s) compared to the 100?μg dose (69.5?±?40.5?s). Differences were not statistically significant. Disintegration time was not significantly different between men and women and was not affected by age. Conclusion Sublingual fentanyl tablets dissolved rapidly (average time