SPL Set ID: 163accb7-45e6-4d97-844d-72b606677008

Scopolamine transdermal system is designed for continuous release of scopolamine following application to an area of intact skin on the head, behind the ear. Each system contains 1.5 mg of scopolamine base. Scopolamine is (9-methyl-3-oxa-9-azatricyclo[3.3.1.0 2,4 ]nonan-7-yl) 3-hydroxy-2-phenylpropanoate. The empirical formula is C 17 H 21 NO 4 and its structural formula is: Scopolamine has a molecular weight of 303.35 and a pKa of 7.55-7.81. The scopolamine transdermal system is a circular, 1.8 cm 2 film with four layers. Proceeding from the visible surface towards the surface attached to the skin, these layers are: (1) a backing layer of peach-colored polyethylene/polyester film printed with brown ink; (2) a solid matrix drug reservoir layer of silicone adhesive, scopolamine and povidone; (3) a microporous polypropylene membrane; and (4) an adhesive formulation of silicone adhesive, povidone and scopolamine. A protective, oversized release liner of fluoropolymer-coated polyester, which covers the adhesive formulation layer, is removed before the system is used. The brown ink contains acrylic polymers, carbon black, iron oxides (red and yellow), polydimethylsiloxane, polyethylene wax, polytetrafluoroethylene, polyvinylpyrrolidone, sodium dioctyl sulfosuccinate and triethanolamine. Scopolamine transdermal systems are packaged with an additional piece of protective film covering the system within each pouch. This piece of protective film is removed and discarded at the time of use. Cross section of the system: Scopolamine Structural Formula Cross section of the system