SPL Set ID: 190a4c5b-1547-45d7-b00b-10da4131e2e2

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 dihydrate. 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 x 2 H 2 O with molecular weight of 749.15 as a dihydrate and 713.15 on an anhydrous basis. The structural formula is: The magnesium salt is a white to creamish colored hygroscopic powder. It contains 2 moles of water of solvation and is slightly soluble in water and methanol, practically in soluble in heptane and soluble in N, N-dimethyl formamide. The stability of esomeprazole magnesium 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. Each packet of esomeprazole magnesium for delayed-release oral suspension contains 20 mg, or 40 mg of esomeprazole (present as 21.8 mg and 43.5 mg esomeprazole magnesium dihydrate USP, respectively), in the form of the enteric-coated pellets and inactive granules. The enteric-coated pellets are composed of following inactive ingredients: hydroxypropyl cellulose, magnesium stearate, mannitol, methacrylic acid copolymer dispersion, mono-and di-glycerides, polysorbate 80, povidone, talc, triethyl citrate and sugar spheres (source: sucrose and maize starch). The inactive granules are composed of the following ingredients: anhydrous citric acid, crospovidone, dextrose, ferric oxide red, strawberry flavor and xanthan gum. The esomeprazole pellets and inactive granules are constituted with water to form a suspension and are given by oral, nasogastric, or gastric administration. Esomeprazole Magnesium For Delayed-Release Oral Suspension