SPL Set ID: eb8f8b81-d482-4b94-be87-c766f49e753f

The active ingredient in Esomeprazole Magnesium Delayed-release Capsules, USP for oral administration is bis(5-methoxy-2-[(S)-[(4-methoxy-3,5-dimethyl-2-pyridinyl)methyl]sulfinyl]-1 H -benzimidazole-1-yl) magnesium dihydrate, 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 x 2 H 2 O with molecular weight of 749.2 as a dihydrate and 713.1 on an anhydrous basis. The structural formula is: The magnesium salt is a white to slightly colored crystalline powder. It contains 2 moles of water of solvation and is slightly soluble in water. 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. Esomeprazole Magnesium Delayed-release Capsules are supplied in delayed-release capsules. Each delayed-release capsule contains 20 mg, or 40 mg of esomeprazole (present as 21.7 mg, or 43.4 mg esomeprazole magnesium dihydrate) in the form of enteric-coated pellets with the following inactive ingredients: diglycerin, hypromellose, magnesium stearate, methacrylic acid and ethyl acrylate copolymer dispersion, monoglycerides, polysorbate 80, sugar spheres, talc, and triethyl citrate. The capsule shells have the following inactive ingredients: gelatin, FD&C Blue #1, sodium lauryl sulfate, and titanium dioxide. In addition, the 20 mg capsule shell contains FD & C Red #40. The imprinting ink also contains ammonium hydroxide, butyl alcohol, black iron oxide, dehydrated alcohol, isopropyl alcohol, potassium hydroxide, propylene glycol and shellac. The 20 mg ink also contains titanium dioxide. The 40 mg ink may also contain n-butyl alcohol. Esomeprazole Magnesium Delayed-release Capsules meet USP Dissolution Test 4. Figure 1