Abstract ID: 8
Abstract Title: Adherence of and Fentanyl Absorption from the BioErodible MucoAdhesive (BEMA™) Drug Delivery System under Various Administration Conditions
Authors:
Vasisht N PhD 1, Stark J PhD 2, Finn A PharmD 3, Gever L PharmD 4
BioDelivery Sciences International, Inc Raleigh NC 1, CEDRA Corporation Austin TX 2, BioDelivery Sciences International, Inc. Raleigh NC 3, Meda Pharmaceuticals, Inc. Somerset NJ 4
Poster Type: Either
ABSTRACT BODY
Introduction: The BEMA™ (BioErodible MucoAdhesive) drug delivery system is a small, bilayered, water erodible, buccal soluble film designed to provide oral transmucosal dosing reliability, tolerability, and patient acceptance. BEMA™ Fentanyl is formulated with the opioid fentanyl for buccal administration.
Materials and Methods: Six healthy volunteers participated in an open-label, 5-period, Latin-square crossover Phase 1 clinical study. The effect of heat on transmucosal fentanyl absorption of BEMA™ Fentanyl 400 μg was assessed following consumption of hot tea or application of a warm heating pad to the external cheek before and during buccal administration. Fentanyl absorption following transdermal application of BEMA™ Fentanyl 1200 μg was assessed by application of the film to the skin of the forearm under a moist occlusive dressing for 8 hours. The extent of re-adherence to the buccal membranes following removal of BEMA™ Fentanyl was assessed using a placebo film.
Results: Consumption of hot liquid or application of an external heating pad did not meaningfully increase the speed (median Tfirst 10.2 minutes and Tmax 2 hours, for all three conditions) or extent (mean AUClast 3.7, 4.0, and 4.4 hr.ng/mL for hot liquid, heating pad, and no heat, respectively) of fentanyl absorption from the BEMA™ Fentanyl unit. The median dose-corrected AUClast following transdermal application was 10% of that following buccal application and the earliest Tfirst for transdermal application was 4 hours. Five of the six subjects were able to remove the placebo film within 2 minutes of initial application to the buccal mucosa; however, only 3 (60%) of these subjects could reapply the film. Removal was not possible beyond 5 minutes from buccal application in any subject.
Discussion: These results demonstrate that BEMA™ Fentanyl absorption is not meaningfully altered when subjects drink hot liquids or apply external heat during buccal administration. Transdermal absorption of fentanyl from the BEMA™ dose unit is substantially lower and slower than transmucosal absorption. In addition, BEMA™ dose units cannot readily be removed from or reapplied to the buccal mucosa.
ATTACHED FILES
Reg Anesth Pain Med 2008; 32:8