SPL Set ID: c1319da6-bf0d-4dd6-a713-1677bfbfbdae
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 a white to slightly colored powder and is insoluble in water and freely soluble in dimethyl sulphoxide. Each packet of esomeprazole magnesium for delayed release oral suspension contains 20 mg and 40 mg of esomeprazole, in the form of the enteric-coated granules, and also inactive granules. 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, methyl acrylic acid and ethyl acrylate copolymer dispersion, plasACRYL ® HTP-20, polysorbate 80, purified water, sugar sphere, 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. figure-1