Elimination of ketoprofen from the stratum corneum after topical administration with ketoprofen formulations in human subjects.

Masahiko Takeshi, Tamotsu Ebihara, Kotaro Maekawa, Kaori Yamamoto, Naruhito Higo

Journal: International journal of pharmaceutics 2014;465(1-2):197-201

PMID: 24530385

Full Text on Elsevier Science View on PubMed

Abstract

PURPOSE

To assess the drug concentrations and elimination rate of ketoprofen in the stratum corneum following topical administration of two different formulations in human subjects for reference in the risk management of photocontact dermatitis caused by topical ketoprofen.

METHODS

Ketoprofen tape and gel were used as test formulations. The stratum corneum at the application sites was removed by tape-stripping at scheduled times after removal of the formulations. The ketoprofen concentration in the stratum corneum was determined by liquid chromatography with tandem mass spectrometry.

RESULTS

The ketoprofen concentration in the stratum corneum decreased and the elimination half-life in the stratum corneum was comparable between tape and gel after removal of the test formulations. The ketoprofen concentration in the stratum corneum decreased more rapidly after the subjects took a shower. Ketoprofen was not detected in the stratum corneum adjacent to the tape application sites.

CONCLUSIONS

Ketoprofen in the stratum corneum appears to reach the lower limit of quantitation (0.005 μg) 12-16 days after removal of tape or gel. This period is similar to that recommended for avoiding ultraviolet light after removal of topical ketoprofen formulations in the Summary of Product Characteristics for topical ketoprofen in the European Union.

Address: Medical Corporation Shinanokai Shinanozaka Clinic, 20 Samon-cho, Shinjuku-ku, Tokyo 160-0017, Japan. Electronic address: [email protected].; Department of Dermatology, Keio University School of Medicine, 25 Shinano-machi, Shinjuku-ku, Tokyo 160-8582, Japan. Electronic address: [email protected].; Research and Development Division, Hisamitsu Pharmaceutical Co., Inc., 1-25-11 Kannondai, Tsukuba, Ibaraki 305-0856, Japan. Electronic address: [email protected].; Research and Development Division, Hisamitsu Pharmaceutical Co., Inc., 2-4-1 Marunouchi, Chiyoda-ku, Tokyo 100-6330, Japan. Electronic address: [email protected].; Research and Development Division, Hisamitsu Pharmaceutical Co., Inc., 2-4-1 Marunouchi, Chiyoda-ku, Tokyo 100-6330, Japan. Electronic address: [email protected].

DOI: 10.1016/j.ijpharm.2014.02.015

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MeSH Terms: Administration, Cutaneous, Adult, Anti-Inflammatory Agents, Non-Steroidal, Chemistry, Pharmaceutical, Chromatography, Liquid, Cross-Over Studies, Dermatitis, Photoallergic, Drug Residues, Epidermis, Gels, Half-Life, Humans, Japan, Ketoprofen, Male, Metabolic Clearance Rate, Risk Assessment, Risk Factors, Skin Absorption, Tandem Mass Spectrometry, Transdermal Patch, Young Adult