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Pig Ear Skin ex Vivo as a Model for in Vivo Dermatopharmacokinetic Studies in Man

Herkenne, Christophe ; Naik, Aarti ; Kalia, Yogeshvar ; Hadgraft, Jonathan ; Guy, Richard

In: Pharmaceutical Research, 2006, vol. 23, no. 8, p. 1850-1856

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    Titre
    • Pig Ear Skin ex Vivo as a Model for in Vivo Dermatopharmacokinetic Studies in Man
    Auteur
    • Herkenne, Christophe. School of Pharmaceutical Sciences, University of Geneva, 30 quai E. Ansermet, CH-1211, Geneva 4, Switzerland
    • Naik, Aarti. School of Pharmaceutical Sciences, University of Geneva, 30 quai E. Ansermet, CH-1211, Geneva 4, Switzerland
    • Kalia, Yogeshvar. School of Pharmaceutical Sciences, University of Geneva, 30 quai E. Ansermet, CH-1211, Geneva 4, Switzerland
    • Hadgraft, Jonathan. The School of Pharmacy, University of London, 29/39 Brunswick Square, WC1N 1AX, London, UK
    • Guy, Richard. School of Pharmaceutical Sciences, University of Geneva, 30 quai E. Ansermet, CH-1211, Geneva 4, Switzerland
    Type de document
    • Postprint
    Langue
    • Anglais
    Publié dans
    • Pharmaceutical Research, 2006, vol. 23, no. 8, p. 1850-1856. Kluwer Academic Publishers-Plenum Publishers; http://www.springer-ny.com
    Autre version électronique
    Identifiant OAI-PMH
    • oai:doc.rero.ch:317131
    Summary
    Objective: The objective was to investigate pig ear skin as a surrogate for human skin in the assessment of topical drug bioavailability by sequential tape-stripping of the stratum corneum (SC). The potential benefits of ex vivo investigations are manifold: ethical approval is not required, multiple replicate experiments are more easily performed, and toxic compounds can be evaluated. Materials and Methods: Ex vivo experiments on isolated pig ears were compared with in vivo studies in human volunteers. Four formulations, comprising the model drug, ibuprofen, in different propylene glycol (PG)-water mixtures (25:75, 50:50, 75:25 and 100:0), were compared. Results: Derived dermatopharmacokinetic parameters characterizing the diffusion and partitioning of the drug in the SC ex vivo were consistent with those in vivo following a 30-minute application period. Further, the non-steady-state ex vivo results could be used to predict the in vivo concentration profile of the drug across the SC when a formulation was administered for 3h (i.e., close to steady-state). Conclusions: Taken together, the results obtained suggest that pig ear skin ex vivo has promise as a tool for topical formulation evaluation and optimization