Once-weekly transdermal buprenorphine application results in sustained and consistent steady-state plasma levels.

摘要: Abstract Context Transdermal formulations of buprenorphine offer controlled delivery for sustained analgesic efficacy with reduced adverse events (AEs) compared the other modes administration. A transdermal system (BTDS) delivering 5, 10, or 20 mcg/hour seven days is now marketed in U.S. as Butrans ® (Lohmann Therapie-System AG, Andernach Germany), a Schedule III single-entity opioid indicated management moderate and chronic pain patients requiring continuous around-the-clock analgesia an extended period. Objectives This was randomized open-label study healthy subjects to characterize steady-state pharmacokinetics after three consecutive seven-day BTDS applications. Methods Thirty-seven were receive 10 (BTDS 10) patches applied deltoid upper back each. Blood samples concentration measurements taken. Safety assessed using recorded AEs, clinical laboratory test results, vital signs, pulse oximetry, physical examinations, electrocardiograms. Patch adhesion assessments Results Analysis C min demonstrated that steady state reached during first application. No significant difference observed across Total peak plasma exposures similar each administrations BTDS. Conclusion Three once-weekly applications provided consistent buprenorphine. Steady-state concentrations within 48 hours application 10. analysis confirmed appropriateness Overall, safe well tolerated.