SPL Set ID: e89589f1-945e-429a-819e-61755cba77fa
1 drug(s) with this SPL Set ID
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 690.80 on an anhydrous basis. The structural formula is: The magnesium salt is an off-white to pale yellow colored crystalline powder and very slightly soluble in water and sparingly soluble in methanol and ethanol. Esomeprazole magnesium is supplied in packets for a delayed-release oral suspension. Each packet of esomeprazole magnesium for delayed-release oral suspension contains esomeprazole, in the form of enteric-coated granules and inactive granules: 2.5 mg esomeprazole (equivalent to 2.711 mg esomeprazole magnesium dihydrate) 5 mg esomeprazole (equivalent to 5.422 mg esomeprazole magnesium dihydrate) The inactive granules are composed of the following ingredients: anhydrous citric acid, crospovidone, dextrose anhydrous, ferric oxide yellow, hydroxypropyl cellulose, hydroxypropyl methyl cellulose E-15, magnesium stearate, methacrylic acid and ethyl acrylate copolymer dispersion, plasACRYL ® HTP-20, polysorbate 80, purified water, sugar spheres, talc and xanthan gum. The plasticizer plasACRYL ® HTP-20 have the following inactive ingredients: glyceryl monostearate, polysorbate 80, triethyl citrate. The esomeprazole granules and inactive granules are constituted with water to form a suspension and are given by oral, nasogastric, or gastric administration. structure