The Vivelle estradiol transdermal system contains estradiol in a multipolymeric
adhesive. The system is designed to release 17b-estradiol
continuously upon application to intact skin.
Four systems are available to provide nominal in vivo delivery of 0.0375,
0.05, 0.075, or 0.1 mg of estradiol per day via skin of average permeability.
Each corresponding system having an active surface area of 11.0, 14.5,
22.0, or 29.0 cm2 contains 3.28, 4.33, 6.57, or 8.66 mg of
estradiol USP, respectively. The composition of the systems per unit area
Estradiol USP (17b-estradiol)
is a white, crystalline powder, chemically described as estra-1,3,5 (10)-triene-3,17b-diol.
The molecular formula of estradiol is C18H24O2.
The molecular weight is 272.39.
The Vivelle system comprises three layers. Proceeding from the visible
surface toward the surface attached to the skin, these layers are (1)
a translucent flexible film consisting of an ethylene vinyl alcohol copolymer
film, a polyurethane film, urethane polymer and epoxy resin, (2) an adhesive
formulation containing estradiol, acrylic adhesive, polyisobutylene, ethylene
vinyl acetate copolymer, 1,3 butylene glycol, styrene-butadiene rubber,
oleic acid, lecithin, propylene glycol, bentonite, mineral oil, and dipropylene
glycol, and (3) a polyester release liner that is attached to the adhesive
surface and must be removed before the system can be used.
The active component of the system is estradiol. The remaining components
of the system are pharmacologically inactive.