SPL Set ID: 213dd2f4-4a71-456c-b3c7-b709c7bd7445

Ropinirole extended-release tablets contain ropinirole, a non-ergoline dopamine agonist as the hydrochloride salt. The chemical name of ropinirole hydrochloride is 4-[2-(dipropylamino)ethyl]-1,3-dihydro-2H-indol-2-one and the empirical formula is C 16 H 24 N 2 O•HCl. The molecular weight is 296.84 (260.38 as the free base). The structural formula is: Ropinirole hydrochloride, USP is a white to yellow solid with a melting range of 243°C to 250°C and a solubility of 133 mg/mL in water. Ropinirole extended-release tablets are formulated as a 2-layered tablet with an active-containing, slow-release layer, and 1 placebo layer acting as a barrier layer which controls the surface area available for drug release. Each biconvex, round tablet contains 2.28, 4.56, 6.84, 9.12, or 13.68 mg ropinirole hydrochloride, USP, equivalent to ropinirole 2, 4, 6, 8, or 12 mg, respectively. Inactive ingredients of the core tablets consist of carboxymethylcellulose sodium, colloidal silicon dioxide, hypromellose, lactose monohydrate, magnesium stearate, yellow ferric oxide. Inactive ingredients of the film coats are slightly different among the 5 strengths of tablets and are tabulated below: Strength Inactive ingredients of the film coat 2 mg D&C red #27 aluminum lake, FD&C blue #1 aluminum lake, polyethylene glycol, polyvinyl alcohol-partially hydrolyzed, talc and titanium dioxide 4 mg D&C yellow #10 aluminum lake, polyethylene glycol, polyvinyl alcohol-partially hydrolyzed, red ferric oxide, talc and titanium dioxide 6 mg polyethylene glycol, polyvinyl alcohol-partially hydrolyzed, talc and titanium dioxide 8 mg polyethylene glycol, polyvinyl alcohol-partially hydrolyzed, red ferric oxide, talc and titanium dioxide 12 mg FD&C blue #2 aluminum lake, polyethylene glycol, polyvinyl alcohol-partially hydrolyzed, talc, titanium dioxide and yellow ferric oxide USP dissolution test is pending. 0925224a-figure-01