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Bioequivalence Determination of Topical Ketoprofen Using a Dermatopharmacokinetic Approach and Excised Skin Penetration by M LODEN; U AKERSTROM; K LINDAHL; B BERNE is a Pharmacology, Toxicology and Pharmaceutics article available to read on EtoBox.

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Ketoprofen is a photolabile drug. The aim of the present study was to compare the bioavailability of ketoprofen in a photostabilised formulation with a gel without photoprotection using a new dermatopharmacokinetic tape-stripping model and an established ex vivo penetration method using human skin. Analyses of the stratum corneum showed that during the first 45 min about 12 g/cm 2 ketoprofen was absorbed into the skin from the formulations. The area under the ketoprofen content-time curve (AUC 0-6 h ) for the ratio photo-stabilised gel/transparent gel was 73% with a 90% confidence interval (CI) 65-83. The rate of penetration of ketoprofen through isolated skin was approximately 0.2 g/cm 2 h for both formulations. AUC 0-36 h for the ratio was 84% with 90% CI 64-105. Thus, the two methods did not disagree in terms of relative efficacy of the two gels. However, the difference obtained in vivo was statistically significant, whereas no significant data arise from the ex vivo study. Comparing the amount of ketoprofen in the skin after 45 min with the amount penetrated through the excised skin during 36 h, suggests a change in the thermodynamic activity of ketoprofen during the exposure.

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Author

M LODEN; U AKERSTROM; K LINDAHL; B BERNE

Publisher

Elsevier Science; Elsevier ; Elsevier BV (ISSN 0378-5173)

Published

2004

Language

EN

Field

Pharmacology, Toxicology and Pharmaceutics (Life Sciences)