{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,3,23]],"date-time":"2026-03-23T13:01:55Z","timestamp":1774270915005,"version":"3.50.1"},"reference-count":24,"publisher":"Wiley","issue":"11","license":[{"start":{"date-parts":[[2018,8,17]],"date-time":"2018-08-17T00:00:00Z","timestamp":1534464000000},"content-version":"vor","delay-in-days":0,"URL":"http:\/\/creativecommons.org\/licenses\/by-nc\/4.0\/"}],"content-domain":{"domain":[],"crossmark-restriction":false},"short-container-title":["Brit J Clinical Pharma"],"published-print":{"date-parts":[[2018,11]]},"abstract":"<jats:sec><jats:title>Aims<\/jats:title><jats:p>Doxycycline (DFD\u201009) oral capsules 40\u00a0mg are approved for the treatment of inflammatory lesions of rosacea. Unlike the food\u2010induced lowering of doxycycline's peak plasma concentration (C<jats:sub>max<\/jats:sub>), its exposure under fed conditions in the skin, the drug's target site for rosacea, is unknown. The present study explored the effect of food on the dermal pharmacokinetics of doxycycline.<\/jats:p><\/jats:sec><jats:sec><jats:title>Methods<\/jats:title><jats:p>The pharmacokinetics of doxycycline in the dermal interstitial fluid (d\u2010ISF) and plasma of healthy volunteers were assessed in parallel groups under fed (<jats:italic>n<\/jats:italic> = 6) and fasting (<jats:italic>n<\/jats:italic> = 6) conditions during a 14\u2010day once\u2010daily treatment course with doxycycline oral capsules 40\u00a0mg (DFD\u201009). Sampling of d\u2010ISF and plasma was performed on days 1, 10 (fasting group d\u2010ISF only) and 14.<\/jats:p><\/jats:sec><jats:sec><jats:title>Results<\/jats:title><jats:p>Twelve subjects were randomized, and 11 analysed. No causally drug\u2010related adverse events occurred. Dermal doxycycline exposures (C<jats:sub>max<\/jats:sub> and area under the curve) under the fed state were about 30% lower than under the fasting state at day 1 but were similar at steady state. In analogy to skin, plasma exposure showed no between\u2010group difference at steady state. Accumulation ratios were higher in the skin than in plasma. Correcting for plasma protein binding (~90%), dermal doxycycline exposure was approximately threefold higher than unbound plasma exposure.<\/jats:p><\/jats:sec><jats:sec><jats:title>Conclusions<\/jats:title><jats:p>At steady state, doxycycline concentrations in the skin of fed and fasting healthy volunteers were comparable. Doxycycline's efficacy in rosacea is possibly due to considerable dermal accumulation of unbound doxycycline and is independent of the effect of food.<\/jats:p><\/jats:sec>","DOI":"10.1111\/bcp.13721","type":"journal-article","created":{"date-parts":[[2018,7,23]],"date-time":"2018-07-23T00:43:35Z","timestamp":1532306615000},"page":"2625-2633","source":"Crossref","is-referenced-by-count":8,"title":["Target site pharmacokinetics of doxycycline for rosacea in healthy volunteers is independent of the food effect"],"prefix":"10.1111","volume":"84","author":[{"given":"Arindam","family":"Pal","sequence":"first","affiliation":[{"name":"Dr. Reddy's Laboratories Ltd  Hyderabad India"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"ORCID":"https:\/\/orcid.org\/0000-0001-8175-3028","authenticated-orcid":false,"given":"Peter","family":"Matzneller","sequence":"additional","affiliation":[{"name":"Department of Clinical Pharmacology Medical University of Vienna  Vienna Austria"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Anirudh","family":"Gautam","sequence":"additional","affiliation":[{"name":"Dr. Reddy's Laboratories S.A.  Basel Switzerland"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Zoe","family":"\u00d6sterreicher","sequence":"additional","affiliation":[{"name":"Department of Clinical Pharmacology Medical University of Vienna  Vienna Austria"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Beatrix","family":"Wulkersdorfer","sequence":"additional","affiliation":[{"name":"Department of Clinical Pharmacology Medical University of Vienna  Vienna Austria"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Birgit","family":"Reiter","sequence":"additional","affiliation":[{"name":"Department of Laboratory Medicine Medical University of Vienna  Vienna Austria"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Thomas","family":"Stimpfl","sequence":"additional","affiliation":[{"name":"Department of Laboratory Medicine Medical University of Vienna  Vienna Austria"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Markus","family":"Zeitlinger","sequence":"additional","affiliation":[{"name":"Department of Clinical Pharmacology Medical University of Vienna  Vienna Austria"}],"role":[{"role":"author","vocabulary":"crossref"}]}],"member":"311","published-online":{"date-parts":[[2018,8,17]]},"reference":[{"key":"e_1_2_9_2_1","unstructured":"ORACEA\u00ae.Oracea package insert.2017. 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