Comparative bioavailability study of an once-a-week matrix versus a twice-a-week reservoir transdermal estradiol delivery systems in postmenopausal women.
An open-label, randomised, crossover study was conducted with in healthy postmenopausal women to compare the relative bioavailability of a matrix transdermal estradiol delivery system worn for 7 consecutive days, versus a reservoir transdermal patch worn for 4 days followed by its immediate replacement by another patch worn for further 3 consecutive days. There was a minimum 7-day washout period between the two study periods. Both systems were labelled to release approximately 50 micrograms/day of estradiol. Twenty-six subjects were evaluated with regard to estradiol serum levels. Blood samples were taken immediately before and at regular intervals until 192 h after the initiation of each study treatment (patch application) and assayed for estradiol. There was no difference between the patches with regard to Cmax. Based on the relative bioavailability, one matrix patch proved to be bioequivalent to two reservoir patches worn consecutively for 7 days. These results demonstrate the ability of one matrix patch to deliver consistent therapeutic levels of estradiol over a 7-day period.
Baracat
E
E
Department of Gynaecology, Escola Paulista de Medicina, Universidade Federal de São Paulo, Brazil.
Haidar
M
M
Castelo
A
A
Tufik
S
S
de Lima
G R
GR
Vieira
J G
JG
Peloso
U
U
Casoy
J
J
D000279:Administration, Cutaneous; D001682:Biological Availability; D018592:Cross-Over Studies; D004334:Drug Administration Schedule; D004958:Estradiol / Q000008:administration & dosage* / Q000493:pharmacokinetics; D015914:Estrogen Replacement Therapy / Q000379:methods*; D005260:Female; D006801:Humans; D008875:Middle Aged; D017698:Postmenopause; D011446:Prospective Studies
D004958:Estradiol