Comparison of the pharmacokinetics of miconazole after administration via a bioadhesive slow release tablet and an oral gel to healthy male and female subjects

British Journal of Clinical Pharmacology
J-M CardotJ M Aiache

Abstract

The aim of this study was to compare salivary miconazole pharmacokinetics following once daily application of bioadhesive tablets (50 or 100 mg), vs the current treatment with a gel (3 times a day, 375 mg day(-1)). A three way cross over study was carried out in 18 healthy subjects (nine males, nine females) with a 1 week washout period between each treatment. Plasma and salivary pharmacokinetics of miconazole were assessed over a 24-h period. In all subjects the tablets gave higher and more prolonged salivary miconazole concentrations than the gel. Thus salivary miconazole AUC(0,24 h) was 37.2 times greater for the 100 mg tablet (90% confidence interval [CI] 22.9, 60.5) and 18.9 times greater for the 50 mg tablet (CI 11.7, 30.6) compared with the gel. Similarly, Cmax was 17.2 times greater (CI 11.8, 25.2) and 7.8 times greater (CI 5.3, 11.4) for the 100 mg tablet and 50 mg tablet, respectively. Comparison of the 100 mg and 50 mg tablets gave ratios of 2.2 and 2.0 for Cmax and AUC(0,24 h), respectively (CI 1.5, 3.2 and 1.2, 3.2). The mean time that salivary miconazole concentrations were above 0.4 micro g ml(-1) (the concentration reached 3 h after application of the oral gel according to published data) or above 1.0 microg ml(...Continue Reading

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Citations

Apr 13, 2012·Clinical Infectious Diseases : an Official Publication of the Infectious Diseases Society of America·José A Vazquez, Jack D Sobel
May 29, 2008·Future Microbiology·Andrei Barasch, Andreea Voinea Griffin
Jan 12, 2010·European Journal of Pharmaceutical Sciences : Official Journal of the European Federation for Pharmaceutical Sciences·Yanfeng WangMoses S S Chow
Sep 7, 2007·Journal of Veterinary Pharmacology and Therapeutics·F GasthuysJ P Remon
Aug 3, 2014·Supportive Care in Cancer : Official Journal of the Multinational Association of Supportive Care in Cancer·C OrvainA Tanguy-Schmidt
Oct 18, 2016·Dental Materials : Official Publication of the Academy of Dental Materials·Andrés Felipe CartagenaNara Hellen Campanha
Jun 10, 2008·Revue de stomatologie et de chirurgie maxillo-faciale·L Ben Slama, W Hasni
Dec 3, 2016·Chemistry : a European Journal·Stephan SinnLuisa De Cola

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