caa a22 4500 445312122 CHVBK 20180317142633.0 cr unu---uuuuu 170323e20110901xx s 000 0 eng 10.1007/s11095-011-0444-3 doi (NATIONALLICENCE)springer-10.1007/s11095-011-0444-3 Assessment of Topical Bioequivalence Using Dermal Microdialysis and Tape Stripping Methods [Elektronische Daten] [Tuba Incecayir, Ilbeyi Agabeyoglu, Ulver Derici, Sukru Sindel] ABSTRACT: Purpose: To assess the bioequivalence of two commercial topical formulations of oxytetracycline HCl by tape stripping and microdialysis in healthy volunteers. Methods: Tape stripping study was conducted on 12 healthy volunteers. After a 30-minute application of the formulations, adhesive tapes were used to sample stratum corneum at 0.25, 0.5, 1, 1.5, 2, 3, 4hr. Ten of these volunteers were included in the microdialysis study with a period of 4weeks between the experiments. Microdialysis probes were inserted into the dermis of the forearm. Following the application of the test and reference simultaneously, dialysates were collected in 30-minute sampling intervals up to 4hr. Results: Pharmacokinetic evaluation by microdialysis yielded that the test could not be said to be bioequivalent to the reference at 90% CI. The intersubject variability of oxytetracycline content in stratum corneum was moderate when it was compared to the dermal levels. The test was found to be bioequivalent to reference according to the dermatopharmacokinetic evaluation by tape stripping. Conclusions: No significant correlations were found between microdialysis and tape stripping methods as regarding the topical bioequivalence of oxytetracycline HCl formulations. Springer Science+Business Media, LLC, 2011 bioequivalence nationallicence microdialysis nationallicence oxytetracycline nationallicence tape stripping nationallicence topical nationallicence AUC : area under the OTC content-time profile or area under the OTC concentration-time profile nationallicence BA : bioavailability nationallicence BE : bioequivalence nationallicence C : amount of OTC at SC nationallicence CI : confidence intervals nationallicence CL : clearance nationallicence Cmax : maximum observed OTC content of the DPK profile or maximum observed OTC concentration in dermis nationallicence CV : coefficient of variation nationallicence D : dose nationallicence DMD : dermal microdialysis nationallicence DPK : dermatopharmacokinetics nationallicence HPLC : high performance liquid chromatography nationallicence ka : absorption rate constant nationallicence kd : elimination rate constant nationallicence LOD : limit of detection nationallicence LOQ : limit of quantification nationallicence MD : microdialysis nationallicence OTC : oxytetracycline HCl nationallicence PK : pharmacokinetics nationallicence RR : relative recovery nationallicence SC : stratum corneum nationallicence SD : standard deviation nationallicence t1/2 : half life nationallicence tmax : time point at which Cmax was observed nationallicence to : lag time nationallicence TS : tape stripping nationallicence UPLC-MS-MS : ultra performance liquid chromatography tandem mass spectroscopy nationallicence V : area of distribution nationallicence Vd : volume of distribution nationallicence Incecayir Tuba Department of Pharmaceutical Technology, Faculty of Pharmacy, Gazi University, Etiler, 06330, Ankara, Turkey aut Agabeyoglu Ilbeyi Department of Pharmaceutical Technology, Faculty of Pharmacy, Gazi University, Etiler, 06330, Ankara, Turkey aut Derici Ulver Department of Nephrology, Faculty of Medicine, Gazi University, Ankara, Turkey aut Sindel Sukru Department of Nephrology, Faculty of Medicine, Gazi University, Ankara, Turkey aut Pharmaceutical Research Springer US; http://www.springer-ny.com 28/9(2011-09-01), 2165-2175 0724-8741 28:9<2165 2011 28 11095 https://doi.org/10.1007/s11095-011-0444-3 text/html Onlinezugriff via DOI 1 research-article jats NATIONALLICENCE 856 40 https://doi.org/10.1007/s11095-011-0444-3 text/html Onlinezugriff via DOI NATIONALLICENCE 700 1- Incecayir Tuba Department of Pharmaceutical Technology, Faculty of Pharmacy, Gazi University, Etiler, 06330, Ankara, Turkey aut NATIONALLICENCE 700 1- Agabeyoglu Ilbeyi Department of Pharmaceutical Technology, Faculty of Pharmacy, Gazi University, Etiler, 06330, Ankara, Turkey aut NATIONALLICENCE 700 1- Derici Ulver Department of Nephrology, Faculty of Medicine, Gazi University, Ankara, Turkey aut NATIONALLICENCE 700 1- Sindel Sukru Department of Nephrology, Faculty of Medicine, Gazi University, Ankara, Turkey aut NATIONALLICENCE 773 0- Pharmaceutical Research Springer US; http://www.springer-ny.com 28/9(2011-09-01), 2165-2175 0724-8741 28:9<2165 2011 28 11095 Metadata rights reserved Springer special CC-BY-NC licence nationallicence BK010053 XK010053 XK010000 NATIONALLICENCE NATIONALLICENCE NL-springer