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IN VIVO STUDIES FURTHER DETAILS

In Vivo Study No: 230

METHODS

Chemical	Membrane	Concentration mg/ml	Concentration mg/ml	loading (mg/cm2)	Species	Site	Area (cm2)	Occluded?	Exposure Time (h)	Analytical Method
Beta-Estradiol	0.02	0.5	0.004	Acetone	Human	Ventral Forearm	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	100.5		0.0097	97	1E-05	0.1			0.00034	3.4	1.2	3.4

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

100.5

0.0097

1E-05

0.1

0.00034

3.4

1.2

3.4

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

A polypropylene Hilltop Chamber (HTC) was applied but several holes were bored into the plastic, so that the chamber protected the site but did not occlude it. The HTC was removed after 24h and the skin was washed, then a new HTC was added for the duration of the experiment. The Dose left at the surface was determined by adding the amount left in both HTCs to the amount obtained in the wash. Tape stripping of the SC was done at the end of the experiment to determine the amount left in the SC. % Absorption was calculated by measuring the amount exctreted in the urine (not given). This was corrected for incomplete urinary excretion by comparing with the amount excreted after a parenteral dose.

REFERENCE

Bioavailability Of Topically Administered Steroids:: A "Mass Balance" Technique (1988) J. Investig. Dermatol., :29-33