SPL Set ID: 4ab335d1-19ee-4cd9-9776-8086645d19e4

Rivastigmine transdermal system contains rivastigmine, a reversible cholinesterase inhibitor known chemically as ( S )-3-[1-(Dimethylamino) ethyl]phenyl ethyl(methyl)carbamate. It has a molecular formula of C 14 H 22 N 2 O 2 as the base and a molecular weight of 250.34 g/mol (as the base). Rivastigmine, USP is a viscous, clear, and colorless to yellow to very slightly brown liquid that is sparingly soluble in water and very soluble in ethanol, acetonitrile, n-octanol and ethyl acetate. The distribution coefficient at 37°C in n-octanol/phosphate buffer solution pH 7 is 4.27. Rivastigmine transdermal system is for transdermal administration. The transdermal system is a 4-layer laminate containing the backing layer, drug matrix, adhesive matrix and slit protective release liner (see Figure 1). The release liner is removed and discarded prior to use. Figure 1: Cross Section of the Rivastigmine Transdermal System Excipients within the formulation include acrylic adhesive, dimethicone, poly(butylmethacrylate, methylmethacrylate), silicone adhesive, and flexible polymer backing film printed with brown ink. The brown ink contains acrylic polymers, carbon black, iron oxides (yellow and red), polyethylene wax, polytetrafluoroethylene, polyvinylpyrrolidone, and sodium dioctyl sulfosuccinate. Rivastigmine transdermal systems are packaged with an additional piece of protective film below the system within each pouch. This piece of protective film is removed and discarded at the time of use. Rivastigmine Structural Formula Figure 1: Cross Section of the Rivastigmine Transdermal System