SPL Set ID: 01dcea95-b391-79da-bbfe-412f39022e9a
1 drug(s) with this SPL Set ID
Prucalopride tablets for oral use contain prucalopride succinate, a dihydrobenzofurancarboxamide that is a serotonin type 4 (5-HT4) receptor agonist. The IUPAC name is: 4-Amino-5-chloro- N -[1-(3-methoxypropyl)piperidin-4-yl]-2,3-dihydro-1-benzofuran-7-carboxamide monobutanedioate. The molecular formula is C 18 H 26 ClN 3 O 3 .C 4 H 6 O 4 and the molecular weight is 485.96. The structural formula is: Prucalopride succinate is a white to an off-white powder. It is soluble in dimethylsulfoxide, water, N,N -dimethylformamide, N,N -dimethylacetamide and sparingly soluble in methanol. It is freely soluble in acidic aqueous media. However, the solubility decreases with increasing pH. It is freely soluble in water (16% w/v) but less soluble in basic solution. Each 1 mg film-coated tablet of prucalopride contains 1 mg of prucalopride (equivalent to 1.32 mg prucalopride succinate), and the following inactive ingredients: hydroxypropyl cellulose, magnesium stearate, and microcrystalline cellulose. The coating for the 1 mg tablet contains hydroxypropyl cellulose, hydroxypropyl methylcellulose, titanium dioxide, and triethyl citrate. Each 2 mg film-coated tablet of prucalopride contains 2 mg of prucalopride (equivalent to 2.64 mg prucalopride succinate), and the following inactive ingredients: hydroxypropyl cellulose, magnesium stearate, and microcrystalline cellulose. The coating for the 2 mg tablet contains hydroxypropyl cellulose, hydroxypropyl methylcellulose, iron oxide red, iron oxide yellow, titanium dioxide, and triethyl citrate.