Single-dose pharmacokinetics of fentanyl buccal soluble film

Pain Medicine

Volumn 11, Issue 7, 2010, Pages 1017-1023

  Vasisht, Niraj ^a   Gever, Larry N ^b   Tagarro, Ignacio ^c   Finn, Andrew L ^a  

^a BioDelivery Sciences International Inc   (United States)

^b Meda Pharmaceuticals Inc   (United States)

^c Meda Pharma SAU   (Spain)

Author keywords

Breakthrough Pain; Buccal Absorption; Buccal Soluble Film; Drug Absorption; Fentanyl; Pharmacokinetics

Indexed keywords

EFFENTORA; FENTANYL; FENTANYL CITRATE; ONSOLIS; UNCLASSIFIED DRUG; NARCOTIC ANALGESIC AGENT;

ADULT; ARTICLE; BIOEQUIVALENCE; CHEEK MUCOSA; CLINICAL TRIAL; CONSTIPATION; CONTACT DERMATITIS; CONTROLLED CLINICAL TRIAL; CONTROLLED STUDY; CROSSOVER PROCEDURE; DIZZINESS; DRUG ABSORPTION; DRUG BIOAVAILABILITY; DRUG BLOOD LEVEL; DRUG DELIVERY SYSTEM; DRUG DOSE COMPARISON; DRUG FORMULATION; DYSMENORRHEA; FEMALE; HEADACHE; HUMAN; HUMAN EXPERIMENT; LOOSE FECES; MALE; MULTIPLE DRUG DOSE; NAUSEA; NORMAL HUMAN; OUTCOME ASSESSMENT; PAIN; RANDOMIZED CONTROLLED TRIAL; RASH; SINGLE DRUG DOSE; AREA UNDER THE CURVE; BIOAVAILABILITY; BUCCAL DRUG ADMINISTRATION; DOSE RESPONSE; METABOLISM; MOUTH MUCOSA; TIME; TREATMENT OUTCOME; YOUNG ADULT;

ADMINISTRATION, BUCCAL; ADULT; ANALGESICS, OPIOID; AREA UNDER CURVE; BIOLOGICAL AVAILABILITY; CROSS-OVER STUDIES; DOSE-RESPONSE RELATIONSHIP, DRUG; FEMALE; FENTANYL; HUMANS; MALE; MOUTH MUCOSA; PAIN; TIME FACTORS; TREATMENT OUTCOME; YOUNG ADULT;

EID: 77955129007     PISSN: 15262375     EISSN: 15264637     Source Type: Journal    
DOI: 10.1111/j.1526-4637.2010.00875.x     Document Type: Article

References (11)

1. Caraceni A, Martini C, Zecca E. Breakthrough pain characteristics and syndromes in patients with cancer pain. An international survey. Palliat Med 2004, 18:177-83.
2. William L, Macleod R. Management of breakthrough pain in patients with cancer. Drugs 2008, 68:913-24.
3. Portenoy RK, Payne D, Jacobsen P. Breakthrough pain: Characteristics and impact in patients with cancer pain. Pain 1999, 81:129-34.
4. Zeppetella G, O'Doherty CA, Collins S. Prevalence and characteristics of breakthrough pain in cancer patients admitted to a hospice. J Pain Symptom Manage 2000, 20:87-92.
5. Zhang H, Zhang J, Streisand JB. Oral mucosal drug delivery: Clinical pharmacokinetics and therapeutic applications. Clin Pharmacokinet 2002, 41:661-80.
6. Streisand JB, Varvel JR, Stanski DR. Absorption and bioavailability of oral transmucosal fentanyl citrate. Anesthesiology 1991, 75:223-9.
7. Lee M, Kern SE, Kisicki JC, Egan TD. A pharmacokinetic study to compare two simultaneous 400 microg doses with a single 800 microg dose of oral transmucosal fentanyl citrate. J Pain Symptom Manage 2003, 26:743-7.
8. Darwish M, Tempero K, Kirby M, Thompson J. Pharmacokinetics and dose proportionality of fentanyl effervescent buccal tablets in healthy volunteers. Clin Pharmacokinet 2005, 44:1279-86.
9. Darwish M, Kirby M, Robertson P, Hellriegel E, Jiang JG. Comparison of equivalent doses of fentanyl buccal tablets and arteriovenous differences in fentanyl pharmacokinetics. Clin Pharmacokinet 2006, 45:843-50.
10. Guidance for Industry: Statistical Approaches to Establishing Bioequivalence 2001, Food and Drug Administration, Rockville, MD, Center for Drug Evaluation and Research
11. Darwish M, Kirby M, Robertson P, Tracewell W, Jiang JG. Absolute and relative bioavailability of fentanyl buccal tablet and oral transmucosal fentanyl citrate. J Clin Pharmacol 2007, 47:343-50.