EMSAM®
(SELEGILINE TRANSDERMAL SYSTEM)
CONTINUOUS DELIVERY FOR ONCE-DAILY APPLICATION
Rx only
DESCRIPTION
EMSAM® (selegiline transdermal system) is a transdermally administered antidepressant. When applied to intact skin, EMSAM is designed to continuously deliver selegiline over a 24-hour period.
Selegiline base is a colorless to yellow liquid, chemically described as (-)-(N)-Methyl- N -[(1 R)-1-methyl-2-phenylethyl]prop-2-yn-1-amine. It has an empirical formula of C13H17N and a molecular weight of 187.30. The structural formula is:
EMSAM systems are transdermal patches that contain 1 mg of selegiline per cm2 and deliver approximately 0.3 mg of selegiline per cm2 over 24 hours. EMSAM systems are available in three sizes: 20 mg/20 cm2, 30 mg/30 cm2, and 40 mg/40 cm2 that deliver, on average, doses of 6 mg, 9 mg, or 12 mg, respectively, of selegiline over 24 hours.
EMSAM is a matrix-type transdermal system composed of three layers as illustrated in Figure 1 below. Layer 1 is the Backing Film that provides the matrix system with occlusivity and physical integrity and protects the adhesive/drug layer. Layer 2 is the Adhesive/Drug Layer. Layer 3 consists of side-by-side release liners that are peeled off and discarded by the patient prior to applying EMSAM. The inactive ingredients are acrylic adhesive, ethylene vinyl acetate/polyethylene, polyester, polyurethane, and silicon coated polyester.
Figure 1: Side view of EMSAM system. (Not to scale.)
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