PMID- 23026548
OWN - NLM
STAT- MEDLINE
DCOM- 20140124
LR  - 20220321
IS  - 1873-6513 (Electronic)
IS  - 0885-3924 (Linking)
VI  - 46
IP  - 1
DP  - 2013 Jul
TI  - Once-weekly transdermal buprenorphine application results in sustained and 
      consistent steady-state plasma levels.
PG  - 65-75
LID - S0885-3924(12)00371-5 [pii]
LID - 10.1016/j.jpainsymman.2012.06.014 [doi]
AB  - CONTEXT: Transdermal formulations of buprenorphine offer controlled delivery of 
      buprenorphine for sustained analgesic efficacy with reduced adverse events (AEs) 
      compared with the other modes of administration. A buprenorphine transdermal 
      system (BTDS) delivering 5, 10, or 20 mcg/hour for seven days is now marketed in 
      the U.S. as Butrans((R)) (Lohmann Therapie-System AG, Andernach Germany), a 
      Schedule III single-entity opioid analgesic indicated for the management of 
      moderate and chronic pain in patients requiring continuous around-the-clock 
      analgesia for an extended period. OBJECTIVES: This was a randomized open-label 
      study in healthy subjects to characterize the steady-state buprenorphine 
      pharmacokinetics after the delivery of three consecutive seven-day BTDS 
      applications. METHODS: Thirty-seven subjects were randomized to receive three 
      consecutive BTDS 10 mcg/hour (BTDS 10) patches applied to the deltoid or upper 
      back for seven days each. Blood samples for buprenorphine concentration 
      measurements were taken. Safety was assessed using recorded AEs, clinical 
      laboratory test results, vital signs, pulse oximetry, physical examinations, and 
      electrocardiograms. Patch adhesion assessments were taken. RESULTS: Analysis of 
      Cmin demonstrated that steady state was reached during the first BTDS 10 
      application. No significant difference in Cmin was observed across the three 
      applications. Total and peak plasma buprenorphine exposures were similar after 
      each of the seven-day administrations of BTDS. CONCLUSION: Three consecutive 
      once-weekly applications of BTDS 10 provided consistent and sustained delivery of 
      buprenorphine. Steady-state plasma concentrations were reached within 48 hours of 
      the first application of BTDS 10. Patch adhesion analysis confirmed the 
      appropriateness of the seven-day application period. Overall, BTDS 10 was safe 
      and well tolerated.
CI  - Copyright (c) 2013 U.S. Cancer Pain Relief Committee. Published by Elsevier Inc. 
      All rights reserved.
FAU - Kapil, Ram P
AU  - Kapil RP
AD  - Purdue Pharma L.P., Stamford, Connecticut 06901, USA. Ram.Kapil@pharma.com
FAU - Cipriano, Alessandra
AU  - Cipriano A
FAU - Friedman, Kristen
AU  - Friedman K
FAU - Michels, Gregory
AU  - Michels G
FAU - Shet, Manjunath S
AU  - Shet MS
FAU - Colucci, Salvatore V
AU  - Colucci SV
FAU - Apseloff, Glen
AU  - Apseloff G
FAU - Kitzmiller, Joseph
AU  - Kitzmiller J
FAU - Harris, Stephen C
AU  - Harris SC
LA  - eng
PT  - Journal Article
PT  - Randomized Controlled Trial
PT  - Research Support, Non-U.S. Gov't
DEP - 20120929
PL  - United States
TA  - J Pain Symptom Manage
JT  - Journal of pain and symptom management
JID - 8605836
RN  - 0 (Analgesics, Opioid)
RN  - 40D3SCR4GZ (Buprenorphine)
SB  - IM
MH  - Administration, Cutaneous
MH  - Adolescent
MH  - Adult
MH  - Analgesics, Opioid/*administration & dosage/blood/*pharmacokinetics
MH  - Buprenorphine/*administration & dosage/blood/*pharmacokinetics
MH  - Humans
MH  - Middle Aged
OTO - NOTNLM
OT  - Buprenorphine pharmacokinetics
OT  - analgesia
OT  - consistent and sustained delivery of buprenorphine
OT  - once-weekly
OT  - pain management
OT  - patch
OT  - randomized trials
OT  - seven-day transdermal delivery
EDAT- 2012/10/03 06:00
MHDA- 2014/01/25 06:00
CRDT- 2012/10/03 06:00
PHST- 2012/04/18 00:00 [received]
PHST- 2012/06/20 00:00 [revised]
PHST- 2012/07/01 00:00 [accepted]
PHST- 2012/10/03 06:00 [entrez]
PHST- 2012/10/03 06:00 [pubmed]
PHST- 2014/01/25 06:00 [medline]
AID - S0885-3924(12)00371-5 [pii]
AID - 10.1016/j.jpainsymman.2012.06.014 [doi]
PST - ppublish
SO  - J Pain Symptom Manage. 2013 Jul;46(1):65-75. doi: 
      10.1016/j.jpainsymman.2012.06.014. Epub 2012 Sep 29.