Effects of vehicle supplementation on total estradiol absorption from a transdermal estradiol delivery system.
OBJECTIVE
To evaluate the effects of vehicle supplementation on serum estradiol (E2) delivery pharmacokinetics from the Ciba-Geigy (Summit, NJ) 0.1-mg Estraderm Patch.


METHODS
Postmenopausal women were randomized to a 28-day crossover treatment protocol separated by a 14-day wash out period.


METHODS
Normal human volunteers were studied in an academic research environment.


METHODS
The subject pool included eight healthy postmenopausal women between 32 and 60 years of age.


METHODS
In treatment A, a 0.1-mg Estraderm Patch was worn for 7 days; in treatment B, and identical patch was worn into which 0.6 mL of ethanol was injected on day 3 of use.


METHODS
Serum E2 levels were measured in both groups.


RESULTS
Although E2 absorption showed characteristic interpatient variability, addition of ethanol significantly extended the mean time for serum E2 levels to return to baseline, without increasing peak absorption. The mean extension was 50 hours.


CONCLUSIONS
The addition of ethanol to the Estraderm Patch increased the duration of elevated serum E2 levels measured in menopausal women, thus potentially increasing the effective life span of the transdermal therapeutic system.
Smith
R D
RD
Department of Obstetrics and Gynecology, Georgetown University School of Medicine, Washington, D.C. 20007.
Robinson
D E
DE
Delignieres
B
B
Albertson
B D
BD
Tomai
T P
TP
Zinaman
M J
MJ
Simon
J A
JA
D000042:Absorption; D000279:Administration, Cutaneous; D000328:Adult; D004958:Estradiol / Q000008:administration & dosage* / Q000097:blood / Q000493:pharmacokinetics; D000431:Ethanol / Q000008:administration & dosage / Q000494:pharmacology; D005260:Female; D006801:Humans; D008875:Middle Aged; D009994:Osmolar Concentration; D014677:Pharmaceutical Vehicles; D013997:Time Factors
D014677:Pharmaceutical Vehicles; D000431:Ethanol; D004958:Estradiol