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.
| Original language | English |
|---|---|
| Pages (from-to) | 197-201 |
| Number of pages | 5 |
| Journal | International Journal of Pharmaceutics |
| Volume | 465 |
| Issue number | 1-2 |
| DOIs | |
| Publication status | Published - 2014 Apr 25 |
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Keywords
- Elimination half-life
- Gel formulation
- Ketoprofen
- Photocontact dermatitis
- Tape formulation
ASJC Scopus subject areas
- Pharmaceutical Science
- Medicine(all)
Cite this
Elimination of ketoprofen from the stratum corneum after topical administration with ketoprofen formulations in human subjects. / Takeshi, Masahiko; Ebihara, Tamotsu; Maekawa, Kotaro; Yamamoto, Kaori; Higo, Naruhito.
In: International Journal of Pharmaceutics, Vol. 465, No. 1-2, 25.04.2014, p. 197-201.Research output: Contribution to journal › Article
}
TY - JOUR
T1 - Elimination of ketoprofen from the stratum corneum after topical administration with ketoprofen formulations in human subjects
AU - Takeshi, Masahiko
AU - Ebihara, Tamotsu
AU - Maekawa, Kotaro
AU - Yamamoto, Kaori
AU - Higo, Naruhito
PY - 2014/4/25
Y1 - 2014/4/25
N2 - 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.
AB - 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.
KW - Elimination half-life
KW - Gel formulation
KW - Ketoprofen
KW - Photocontact dermatitis
KW - Tape formulation
UR - http://www.scopus.com/inward/record.url?scp=84898599748&partnerID=8YFLogxK
UR - http://www.scopus.com/inward/citedby.url?scp=84898599748&partnerID=8YFLogxK
U2 - 10.1016/j.ijpharm.2014.02.015
DO - 10.1016/j.ijpharm.2014.02.015
M3 - Article
C2 - 24530385
AN - SCOPUS:84898599748
VL - 465
SP - 197
EP - 201
JO - International Journal of Pharmaceutics
JF - International Journal of Pharmaceutics
SN - 0378-5173
IS - 1-2
ER -