title: Randomized 5-treatment crossover study to assess the effects of external heat on serum fentanyl concentrations during treatment with transdermal fentanyl systems.
abstract: This randomized, open-label, 5-treatment, 5-sequence crossover study was designed to evaluate the effects of a heating pad on serum fentanyl concentrations with reservoir and matrix transdermal fentanyl systems. Subjects were randomized to 1 of 5 treatment sequences, receiving 5 fentanyl treatments (1 per period) for 36 hours: 25 µg/h reservoir without heat, 25 µg/h reservoir with heat, 25 µg/h matrix without heat, 25 µg/h matrix with heat, and a 50 µg/h reservoir without heat. The 25 µg/h systems with heat had a heating pad applied from 0 to 10 and 26 to 36 hours post application. Washout periods between treatments were 5 to 14 days. Naltrexone was given to block the opioid effects of fentanyl. Study results indicate that external heat had a similar effect on both matrix and reservoir systems, with heat applied during the first 10 hours of treatment increasing fentanyl exposure by approximately 61% to 81% at 10 hours (observed serum concentration at 10 hours) and overall exposure (area under the curve from 0 to 10 hours) by approximately 120% to 184%, but had minimal effect from 26 to 36 hours. The increased exposure observed with heat in both 25 µg/h systems, between 0 and 10 hours, was higher than that obtained with the 50 µg/h reservoir system applied without heat.
authors: Clinical Pharmacology, Johnson & Johnson Pharmaceutical Researchand Development, Titusville, NJ, USA.
authors: Kenneth T
authors: KT
authors: Moore
authors: Gayatri
authors: G
authors: Sathyan
authors: Ute
authors: U
authors: Richarz
authors: Jaya
authors: J
authors: Natarajan
authors: Joris
authors: J
authors: Vandenbossche
mesh_terms: D000279:Administration, Cutaneous; D000293:Adolescent; D000328:Adult; D000701:Analgesics, Opioid / Q000097:blood* / Q000493:pharmacokinetics / Q000627:therapeutic use*; D019540:Area Under Curve; D003131:Combined Modality Therapy; D018592:Cross-Over Studies; D005260:Female; D005283:Fentanyl / Q000097:blood* / Q000493:pharmacokinetics / Q000627:therapeutic use*; D006801:Humans; D006979:Hyperthermia, Induced / Q000379:methods*; D008297:Male; D008875:Middle Aged; D009271:Naltrexone / Q000627:therapeutic use; D009292:Narcotic Antagonists / Q000627:therapeutic use; D055815:Young Adult
chemical_list: D000701:Analgesics, Opioid; D009292:Narcotic Antagonists; D009271:Naltrexone; D005283:Fentanyl