Single-Dose Pharmacokinetics of Fentanyl Buccal Soluble Film
作者： Niraj Vasisht , Larry N. Gever , Ignacio Tagarro , Andrew L. Finn
DOI: 10.1111/J.1526-4637.2010.00875.X
关键词: Dosing 、 Fentanyl Buccal Soluble Film 、 Bioequivalence 、 Buccal Absorption 、 Fentanyl 、 Bioavailability 、 Medicine 、 Pharmacokinetics 、 Anesthesia 、 Crossover study
摘要: Objective. The objectives of the study were to determine absolute bioavailability fentanyl from buccal soluble film, estimate percentage a dose absorbed through mucosa, and compare equivalent doses administered either as single or multiple units. Design. Open-label, randomized, four-period, Latin-square crossover pharmacokinetic study. Setting. Inpatient phase 1 unit. Patients. Twelve healthy volunteers. Interventions. Injectable citrate (200 µg) by intravenous infusion, injectable (800 µg/16 mL) orally, film (800 µg) four separate 200 µg films simultaneously. Outcome Measures. Plasma concentrations after dosing; parameters. Results. two treatments bioequivalent both had an 71%. mucosa was calculated be 51%. Conclusions. Fentanyl effectively delivers high nearly identical plasma profiles are obtained when delivered dosage units.
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Mona Darwish, Mary Kirby, Philmore Robertson, Edward Hellriegel, John G Jiang, Comparison of equivalent doses of fentanyl buccal tablets and arteriovenous differences in fentanyl pharmacokinetics. Clinical Pharmacokinectics. ,vol. 45, pp. 843- 850 ,(2006) , 10.2165/00003088-200645080-00006
Hao Zhang, Jie Zhang, James B. Streisand, Oral mucosal drug delivery: clinical pharmacokinetics and therapeutic applications. Clinical Pharmacokinectics. ,vol. 41, pp. 661- 680 ,(2002) , 10.2165/00003088-200241090-00003
Mona Darwish, Kenneth Tempero, Mary Kirby, Jeffrey Thompson, Pharmacokinetics and Dose Proportionality of Fentanyl Effervescent Buccal Tablets in Healthy Volunteers Clinical Pharmacokinectics. ,vol. 44, pp. 1279- 1286 ,(2005) , 10.2165/00003088-200544120-00006
James B. Streisand, John R. Varvel, Donald R. Stanski, Leon Le Maire, Michael A. Ashburn, Brian I. Hague, Stephen D. Tarver, Theodore H. Stanley, Absorption and Bioavailability of Oral Transmucosal Fentanyl Citrate Anesthesiology. ,vol. 75, pp. 223- 229 ,(1991) , 10.1097/00000542-199108000-00009
Leeroy William, Rod MacLeod, Management of breakthrough pain in patients with cancer. Drugs. ,vol. 68, pp. 913- 924 ,(2008) , 10.2165/00003495-200868070-00003
Maureen Lee, Steven E Kern, James C Kisicki, Talmage D Egan, A pharmacokinetic study to compare two simultaneous 400 μg doses with a single 800 μg dose of oral transmucosal fentanyl citrate Journal of Pain and Symptom Management. ,vol. 26, pp. 743- 747 ,(2003) , 10.1016/S0885-3924(03)00241-0
Giovambattista Zeppetella, Catherine A O'Doherty, Silke Collins, Prevalence and characteristics of breakthrough pain in cancer patients admitted to a hospice. Journal of Pain and Symptom Management. ,vol. 20, pp. 87- 92 ,(2000) , 10.1016/S0885-3924(00)00161-5
Mona Darwish, Mary Kirby, Philmore Robertson, William Tracewell, John G. Jiang, Absolute and Relative Bioavailability of Fentanyl Buccal Tablet and Oral Transmucosal Fentanyl Citrate The Journal of Clinical Pharmacology. ,vol. 47, pp. 343- 350 ,(2007) , 10.1177/0091270006297749
Russell K. Portenoy, David Payne, Paul Jacobsen, Breakthrough pain: characteristics and impact in patients with cancer pain Pain. ,vol. 81, pp. 129- 134 ,(1999) , 10.1016/S0304-3959(99)00006-8
Augusto Caraceni, Cinzia Martini, Ernesto Zecca, Russell K Portenoy, , Breakthrough pain characteristics and syndromes in patients with cancer pain. An international survey. Palliative Medicine. ,vol. 18, pp. 177- 183 ,(2004) , 10.1191/0269216304PM890OA