SPL Set ID: 62d8332e-b8d2-4d13-8071-978d57e51928

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 1.237 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 molecular formula is C 17 H 21 NO 4 and its structural formula is: Scopolamine has a molecular weight of 303.4 and a pKa of 7.55-7.81. The scopolamine transdermal system is a circular, 0.2 mm thick, 1.57 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 tan-colored polyethylene/polyester film; (2) a drug layer of scopolamine, povidone and silicone adhesive; (3) a microporous polypropylene membrane that controls the rate of delivery of scopolamine from the system to the skin surface; and (4) a contact layer formulation of scopolamine, povidone and silicone adhesive. A protective, oversized release liner of fluorosilicone-coated polyester, which covers the adhesive formulation layer, is removed before the system is used. 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: Image Image