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IN VIVO STUDIES FURTHER DETAILS

In Vivo Study No: 826

METHODS

Chemical	Membrane	Concentration mg/ml	Concentration mg/ml	loading (mg/cm2)	Species	Site	Area (cm2)	Occluded?	Exposure Time (h)	Analytical Method
Hydrocortisone	0.02	1.67	0.01333	acetone	Human	arm	2.5	2	24	Radiolabelled (14C)

RESULTS

Length of Study (h)	% Recovery	+/-	Dose remaining on surface (mg)	% remaining on Surface	Dose remaining in stratum corneum (mg)	% remaining in stratum corneum	Dose remaining in the viable skin	% remaining in the viable skin	Amount Absorbed (mg)	% Absorbed	+/-	% Absorbed
168	76.69	17.65	0.02534	76.03	0.0001	0.31			0.00012	0.35	0.34	0.35

Maximal Flux (mcrg/cm2/h)	Average Flux (mcrg/cm2/h)	+/-	Time Plasma/Blood Levels Peaked (h)	Peak Blood Concentration (mg/l)	n	kp (cm/h)	Lag Time (h)
					6

NOTES

The application site was covered with a non-occlusive modified hilltop chamber. The test material was washed off the treated areas five times using 2 cotton balls dipped in 50% soap-water alternated with 3 dipped in water. The chamber was then replaced with a new one. A finl wash chamber collection and skin tape stripping with cellophane tape were performed 7 days after the original application. Urine was collected and measured every 24h for the 7 days. The percentage of the dose exctreted was calculated from the amount recovered in the urine corrected for incomplete excretion by the comparison with iv data collected from the rhesus monkey.

REFERENCE

In Vivo Percutaneous Absorption of Hydrocortisone: Multiple-Application Dosing In Man (1992) Pharmaceut. Res., 9 :1164-1167