title: Elimination of ketoprofen from the stratum corneum after topical administration with ketoprofen formulations in human subjects.
abstract: OBJECTIVE
  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.
authors: Medical Corporation Shinanokai Shinanozaka Clinic, 20 Samon-cho, Shinjuku-ku, Tokyo 160-0017, Japan. Electronic address: m-takeshi@shinanokai.com.
authors: Masahiko
authors: M
authors: Takeshi
authors: Department of Dermatology, Keio University School of Medicine, 25 Shinano-machi, Shinjuku-ku, Tokyo 160-8582, Japan. Electronic address: ebitamo@z6.keio.jp.
authors: Tamotsu
authors: T
authors: Ebihara
authors: Research and Development Division, Hisamitsu Pharmaceutical Co., Inc., 1-25-11 Kannondai, Tsukuba, Ibaraki 305-0856, Japan. Electronic address: Koutarou_Maekawa@hisamitsu.co.jp.
authors: Kotaro
authors: K
authors: Maekawa
authors: Research and Development Division, Hisamitsu Pharmaceutical Co., Inc., 2-4-1 Marunouchi, Chiyoda-ku, Tokyo 100-6330, Japan. Electronic address: Kaori_Yamamoto@hisamitsu.co.jp.
authors: Kaori
authors: K
authors: Yamamoto
authors: Research and Development Division, Hisamitsu Pharmaceutical Co., Inc., 2-4-1 Marunouchi, Chiyoda-ku, Tokyo 100-6330, Japan. Electronic address: Naruhito_Higo@hisamitsu.co.jp.
authors: Naruhito
authors: N
authors: Higo
mesh_terms: D000279:Administration, Cutaneous; D000328:Adult; D000894:Anti-Inflammatory Agents, Non-Steroidal / Q000008:administration & dosage* / Q000009:adverse effects / Q000493:pharmacokinetics*; D002626:Chemistry, Pharmaceutical; D002853:Chromatography, Liquid; D018592:Cross-Over Studies; D017454:Dermatitis, Photoallergic / Q000209:etiology / Q000517:prevention & control; D004350:Drug Residues; D004817:Epidermis / Q000378:metabolism*; D005782:Gels; D006207:Half-Life; D006801:Humans; D007564:Japan; D007660:Ketoprofen / Q000008:administration & dosage* / Q000009:adverse effects / Q000493:pharmacokinetics*; D008297:Male; D008657:Metabolic Clearance Rate; D018570:Risk Assessment; D012307:Risk Factors; D012869:Skin Absorption; D053719:Tandem Mass Spectrometry; D057968:Transdermal Patch; D055815:Young Adult
chemical_list: D000894:Anti-Inflammatory Agents, Non-Steroidal; D005782:Gels; D007660:Ketoprofen
keywords: Elimination half-life; Gel formulation; Ketoprofen; Photocontact dermatitis; Tape formulation