SPL Set ID: 684850eb-d889-4370-a0a7-4a5c3113266a
1 drug(s) with this SPL Set ID
Estradiol transdermal system, USP is designed to provide nominal in vivo delivery of 0.014 mg of estradiol per day continuously upon application to intact skin. The period of use is 7 days. The transdermal system has a contact surface area of 3.9 cm 2 , and contains 0.982 mg of estradiol USP. Estradiol USP is a white, crystalline powder, chemically described as estra-1,3,5(10)-triene-3, 17ß-diol. It has an empirical formula of C 18 H 24 O 2 and molecular weight of 272.38. The structural formula is: The estradiol transdermal system, USP comprises three layers. Proceeding from the visible surface toward the surface attached to the skin, these layers are: 1. a translucent polyethylene film. 2. an acrylate adhesive matrix containing estradiol USP. 3. A protective liner of silicon coated polyester film is attached to the adhesive surface and must be removed before the transdermal system can be used. Cross Section of the System: Estradiol transdermal system, USP is packaged with additional pieces of protective film above and below the system within each pouch. These are discarded at the time of use. The active component of the transdermal system is estradiol USP. The remaining components of the transdermal system (acrylic adhesive, colloidal silicon dioxide, ethyl oleate, glyceryl monolaurate, isopropyl myristate, povidone, and polyethylene backing) are pharmacologically inactive. FDA approved drug release test specifications differ from USP. Estradiol Transdermal System, 14 mcg/day Estradiol Transdermal System, 14 mcg/ day