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KMID : 0370219980420010025
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Yakhak Hoeji
1998 Volume.42 No. 1 p.25 ~ p.30
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The Topical Absorption of Ketoprofen from Gels and Plaster in Human Volunteers
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강원구/Kang WK
이창현/우종수/권광일/Lee CH/Woo JS/Kwon KI
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Abstract
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This study was designed to compare the absorption fraction and extent of ketoprofen gels and a matrix typed ketoprofen plaster patch. 3g (90mg as ketoprofen) of the two gels whi ch has oleohydrogel or hydrogel as a base, respectively, and 3 pieces of plaster patches (90mg as ketoprofen) were, applied in the area of 210cm2 on forearm in 12 volunteers by cross over design. Blood samples were collected serially up to 24 hours and the plasma concentrations of ketoprofen were analyzed by HPLC using flurbiprofen as an internal standard. The detection limit of the assay was 1ng/ml of ketoprofen in plasma. The pharmacokinetic parameters (e.g. AUC24hr, AUMC24hr, MRT, Fraction Absorbed) were calculated from the plasma concentrations time data of each volunteer. The oleo-hydrogel showed significantly higher absorption fraction and extent of ketoprofen than the current hydrogel. The mean plasma concentrations of the oleo-hydrogel were increased to 98.46+/-23.15ng/ml by 6 hour after application, and increased futher to 100.61+/-18.65ng/ml at 24 hour. On the other hand, those of the hydrogel were increased 17.61+/-18.65ng/ml at 5 hour to 34.68+/-9.65ng/ml at 24 hour gradually. Therefore the plasma concentrations of oleo-hydrogel at each measured time were 3~7 times greater than those of the hydrogel with statistical significance. The AUC24hr (1797.26+/-52.09ng.h/ml) of the oleo-hydrogel was 3.5 times greater (P<0.05) than that (516.17+/-104.52ng.h/ml) of the hydrogel. The plaster patches showed higher bioavailability (AUC24hr 2877.37+/-578.27ng.h/ml) than the olea-hydrogel (AUC24hr 1797.26+/-52.09ng.h/ml) without statistical significance. But the absorption fraction of the oleo-hydrogel was rather higher than that of the plaster patches during the first 6 hours after administration. These results suggest that newly developed ketoprofen gel which is used oleo-hydrogel as a base would show excellent skin permeation on topical application for the corresponding clinical indications and could be absorbed as well as plaster patches.
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