SPL Set ID: 992b1830-55cc-4e95-8d6d-e7f796d5b373

The active ingredient in esomeprazole magnesium for delayed-release oral suspension is bis(5-methoxy-2-[(S)-[(4-methoxy-3,5-dimethyl-2-pyridinyl)methyl]sulfinyl]-1 H -benzimidazole-1-yl) magnesium, a PPI. Esomeprazole is the S-isomer of omeprazole, which is a mixture of the S- and R- isomers. (Initial U.S. approval of esomeprazole magnesium: 2001). Its molecular formula is (C 17 H 18 N 3 O 3 S) 2 Mg with molecular weight of 713.1 on an anhydrous basis. The structural formula is: The magnesium salt is a white to slightly colored crystalline powder. The stability of esomeprazole magnesium USP is a function of pH; it rapidly degrades in acidic media, but it has acceptable stability under alkaline conditions. At pH 6.8 (buffer), the half-life of the magnesium salt is about 19 hours at 25°C and about 8 hours at 37°C. Esomeprazole magnesium for delayed-release oral suspension is supplied in packets. Each packet of Esomeprazole magnesium for delayed-release oral suspension contains esomeprazole magnesium USP equivalent to esomeprazole 2.5 mg, 5 mg, 20 mg, or 40 mg, in the form of enteric-coated pellets. Each packet of esomeprazole magnesium for delayed-release oral suspension contains esomeprazole, in the form of enteric-coated pellets, and also inactive granules: 2.5 mg esomeprazole (equivalent to 2.588 mg esomeprazole magnesium USP) 5 mg esomeprazole (equivalent to 5.176 mg esomeprazole magnesium USP) 20 mg esomeprazole (equivalent to 20.706 mg esomeprazole magnesium USP) 40 mg esomeprazole (equivalent to 41.411 mg esomeprazole magnesium USP) The inactive granules are composed of the following ingredients: citric acid monohydrate, colloidal silicon dioxide, crospovidone, dextrose monohydrate, ferric oxide yellow, hydroxy propyl cellulose and xanthan gum. Esomeprazole 2.5 mg, 5 mg, 20 mg, and 40 mg pellets contains following ingredients: ethyl cellulose, magnesium oxide (light), magnesium stearate, methacrylic acid and ethyl acrylate copolymer dispersion, mono and diglycerides, polysorbate 80, povidone, sugar spheres 60-80 mesh, talc and triethyl citrate. The esomeprazole pellets and inactive granules are constituted with water to form a suspension and are given by oral, nasogastric, or gastric administration. Image