SPL Set ID: 939e28c5-f3a9-42c0-9a2d-8d471d82a6e0

NEUPRO is a transdermal system that provides continuous delivery of rotigotine, a non-ergoline dopamine agonist, for 24 hours following application to intact skin. NEUPRO is available in six strengths as shown in Table 4. Table 4 Nominal Dose, Drug Content, and Transdermal System Size NEUPRO Nominal Dose Rotigotine Content per System NEUPRO System Size 1 mg/24 hours 2.25 mg 5 cm 2 2 mg/24 hours 4.5 mg 10 cm 2 3 mg/24 hours 6.75 mg 15 cm 2 4 mg/24 hours 9 mg 20 cm 2 6 mg/24 hours 13.5 mg 30 cm 2 8 mg/24 hours 18 mg 40 cm 2 The chemical name of rotigotine is (6S)-6-{propyl[2-(2-thienyl)ethyl]amino}-5,6,7,8-tetrahydro-1-naphthalenol. The empirical formula is C 19 H 25 NOS. The molecular weight is 315.48. The structural formula for rotigotine is: The asterisk designates the chiral center. Chemical Structure System Components and Structure NEUPRO is a thin, matrix-type transdermal system composed of three layers as shown in Figure 1: Backing film Drug matrix Protective liner Figure 1: System Schematic A flexible, tan-colored backing film, consisting of an aluminized polyester film coated with a pigment-layer on the outer side. The backing provides structural support and protection of the drug-loaded adhesive layer from the environment. A self-adhesive drug matrix layer, consisting of the active component rotigotine and the following inactive components: ascorbyl palmitate, povidone, silicone adhesive, sodium metabisulfite, and dl-alpha-tocopherol. A protective liner, consisting of a transparent fluoropolymer-coated polyester film. This liner protects the adhesive layer during storage and is removed just prior to application. Figure 1