{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,10,6]],"date-time":"2026-10-06T08:28:47Z","timestamp":1791275327461,"version":"4.1.0"},"reference-count":18,"publisher":"Wiley","issue":"4","license":[{"start":{"date-parts":[[2004,7,27]],"date-time":"2004-07-27T00:00:00Z","timestamp":1090886400000},"content-version":"vor","delay-in-days":0,"URL":"http:\/\/onlinelibrary.wiley.com\/termsAndConditions#vor"}],"content-domain":{"domain":[],"crossmark-restriction":false},"short-container-title":["Brit J Clinical Pharma"],"published-print":{"date-parts":[[2004,10]]},"abstract":"<jats:sec><jats:title>Aims<\/jats:title><jats:p>The aim of this study was to compare salivary miconazole pharmacokinetics following once daily application of bioadhesive tablets (50 or 100\u2003mg), <jats:italic>vs<\/jats:italic> the current treatment with a gel (3 times a day, 375\u2003mg\u2003day<jats:sup>\u22121<\/jats:sup>).<\/jats:p><\/jats:sec><jats:sec><jats:title>Methods<\/jats:title><jats:p>A three way cross over study was carried out in 18 healthy subjects (nine males, nine females) with a 1\u2003week washout period between each treatment. Plasma and salivary pharmacokinetics of miconazole were assessed over a 24\u2010h period.<\/jats:p><\/jats:sec><jats:sec><jats:title>Results<\/jats:title><jats:p>In all subjects the tablets gave higher and more prolonged salivary miconazole concentrations than the gel. Thus salivary miconazole AUC(0,24\u2003h) was 37.2 times greater for the 100\u2003mg tablet (90% confidence interval [CI] 22.9, 60.5) and 18.9 times greater for the 50\u2003mg tablet (CI 11.7, 30.6) compared with the gel. Similarly, <jats:italic>C<\/jats:italic><jats:sub>max<\/jats:sub> was 17.2 times greater (CI 11.8, 25.2) and 7.8 times greater (CI 5.3, 11.4) for the 100\u2003mg tablet and 50\u2003mg tablet, respectively. Comparison of the 100\u2003mg and 50\u2003mg tablets gave ratios of 2.2 and 2.0 for <jats:italic>C<\/jats:italic><jats:sub>max<\/jats:sub> and AUC(0,24\u2003h), respectively (CI 1.5, 3.2 and 1.2, 3.2). The mean time that salivary miconazole concentrations were above 0.4\u2003\u00b5g\u2003ml<jats:sup>\u22121<\/jats:sup> (the concentration reached 3\u2003h after application of the oral gel according to published data) or above 1.0\u2003\u00b5g\u2003ml<jats:sup>\u22121<\/jats:sup> (the MIC of some <jats:italic>Candida<\/jats:italic> species) was greater for both bioadhesive tablets than for the oral gel (10\u201314\u2003h <jats:italic>vs<\/jats:italic> 1.5\u2003h and 7\u2003h <jats:italic>vs<\/jats:italic> 0.6\u2003h). Only 19 plasma samples from eight subjects had concentrations of miconazole above 0.4\u2003\u00b5g\u2003ml<jats:sup>\u22121<\/jats:sup>. Ten of these were taken from five subjects after administration of the gel and nine from three subjects after administration of the tablets.<\/jats:p><\/jats:sec><jats:sec><jats:title>Conclusions<\/jats:title><jats:p>These data strongly support the further development of miconazole bioadhesive tablets as a sustained release formulation leading to improved antifungal exposure in the buccal cavity. A single daily application should improve compliance, whereas the low systemic absorption of miconazole will alleviate concerns regarding drug interactions and adverse effects.<\/jats:p><\/jats:sec>","DOI":"10.1111\/j.1365-2125.2004.02154.x","type":"journal-article","created":{"date-parts":[[2004,9,17]],"date-time":"2004-09-17T08:20:51Z","timestamp":1095409251000},"page":"345-351","source":"Crossref","is-referenced-by-count":31,"title":["Comparison of the pharmacokinetics of miconazole after administration via a bioadhesive slow release tablet and an oral gel to healthy male and female subjects"],"prefix":"10.1111","volume":"58","author":[{"given":"J.\u2010M.","family":"Cardot","sequence":"first","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"C.","family":"Chaumont","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"C.","family":"Dubray","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"D.","family":"Costantini","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"J.\u2010M.","family":"Aiache","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"311","published-online":{"date-parts":[[2004,7,27]]},"reference":[{"key":"e_1_2_6_2_2","doi-asserted-by":"crossref","first-page":"942","DOI":"10.1080\/19424396.2000.12223143","article-title":"Candidiasis: pathogenesis, clinical characteristics and treatment","volume":"28","author":"Appleton SS.","year":"2000","journal-title":"J Calif Dent Assoc"},{"key":"e_1_2_6_3_2","doi-asserted-by":"publisher","DOI":"10.1016\/S1368-8375(01)00025-2"},{"key":"e_1_2_6_4_2","doi-asserted-by":"publisher","DOI":"10.1089\/088922299309658"},{"key":"e_1_2_6_5_2","first-page":"554","article-title":"Options for management of muccosal candidiasis in patients with AIDS and HIV infection","volume":"18","author":"Vaszquez JA.","year":"1999","journal-title":"Pharmacotherapy"},{"key":"e_1_2_6_6_2","doi-asserted-by":"publisher","DOI":"10.1086\/313749"},{"key":"e_1_2_6_7_2","doi-asserted-by":"crossref","first-page":"165","DOI":"10.12968\/denu.2000.27.4.165","article-title":"Miconazole agent in oral candidosis: an overview","volume":"27","author":"Ellopola AN","year":"2000","journal-title":"Dent Update"},{"key":"e_1_2_6_8_2","first-page":"404","volume-title":"Essentials of Pharmacology","author":"Lesse AJ.","year":"1995"},{"key":"e_1_2_6_9_2","doi-asserted-by":"publisher","DOI":"10.1055\/s-2008-1070999"},{"key":"e_1_2_6_10_2","doi-asserted-by":"publisher","DOI":"10.2165\/00003495-200161001-00002"},{"key":"e_1_2_6_11_2","doi-asserted-by":"publisher","DOI":"10.1111\/j.1600-0714.1989.tb01552.x"},{"key":"e_1_2_6_12_2","doi-asserted-by":"publisher","DOI":"10.2165\/00003495-197509060-00002"},{"key":"e_1_2_6_13_2","unstructured":"A\u00efacheJ\u2010M CostantiniD ChaumontC.2003Patent WO 03\/009800 Sustained release therapeutic bioadhesive system."},{"key":"e_1_2_6_14_2","unstructured":"Compendium Suisse(Swiss Medicinal Compendium). 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