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ADVERSE EVENT REPORTING FOR A DERMATOPHARMACOKINETIC STUDY OF DICLOFENAC SODIUM TOPICAL FORMULATIONS

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Author(s): Mayee Rahul | Rawat Swati | Thosar Ambrish | Atre Kavita | Mane Prafulla

Journal: International Research Journal of Pharmacy
ISSN 2230-8407

Volume: 2;
Issue: 9;
Start page: 185;
Date: 2011;
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Keywords: Dermatopharmacokinetic | Diclofenac | Tape stripping technique | Adverse events.

ABSTRACT
In this single-dose-one arm, open label three way parallel design, pharmacokinetic study of three marketed formulations of Diclofenac Sodium using 12 healthy Indian male subjects, the pharmacokinetic parameters of three marketed Diclofenac Sodium topical formulations were compared. Marketed Diclofenac Sodium topical formulations (A, B & C) were applied on the pre-marked forearms of the subjects as per the dosing schedule. Treatment sample C was used as a reference sample. Subjects received treatment A, treatment B & treatment C on both the arms simultaneously, following open label three way parallel design. Skin Stratum Corneum samples were collected in sterile glass test tubes during the study period. The samples were collected pre-dose and at 0.5, 1.0, 1.5, 2.0, 3.0, 4.0, & 6.0 hours post-dose application. Diclofenac Sodium was estimated in Stratum Corneum using a validated Spectroscopic method and the treatments were claimed to be bio-equivalent.The aim of this article was to report the occurrence of adverse events during this study. It was observed that only a single incidence of mild adverse event was reported in two volunteers, and it involved mild laceration on the right forearm. But, the event was found to be self resolving & with the relationship of the adverse event to study medication was “unlikely” but it could be due to the ‘tape stripping method’ employed for DPK analysis.
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