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IN VIVO STUDIES FURTHER DETAILS

In Vivo Study No: 658

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	86.2	3.1							0.00054	5.4	0.9	5.4

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

86.2

3.1

0.00054

5.4

0.9

5.4

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)
					5

NOTES

Elderly Caucasian Adults were used. (>65 years). The application site was covered with a protective but non-occlusive device. A Hilltop chamber was modified by boring 6 holes thtough the device and the cotton pads were removed and a goretex membrane was inserted. After 24 hours the site was washed and the protective patch removed. Another patch was added and urine collection continued for 7 days. Absorption values were obtained from the amount recovered in the urine corrected for incomplete excretion by comparison with the amount excreted after an iv dose. Results were given as SEM. I have converted these to SE for the purpose of this database.

REFERENCE

The Effect Of Aging On Percutaneous Absorption In Man (1989) J. Pharm. Biopharm., 17 :617-630