Drugs Similar to NAPROXEN AND ESOMEPRAZOLE MAGNESIUM

The active ingredients of naproxen and esomeprazole magnesium delayed-release tablets are naproxen, USP which is an NSAID and esomeprazole magnesium, USP which is a Proton Pump Inhibitor (PPI). Naproxen and esomeprazole magnesium delayed-release tablets are combination of a nonsteroidal anti-inflammatory drug and a PPI available as an oval, yellow, multi-layer, delayed-release tablet combining an enteric-coated naproxen core and an immediate-release esomeprazole magnesium layer surrounding the core. Each strength contains either 375 mg of naproxen, USP and 20 mg of esomeprazole (equivalent to 21.75 mg esomeprazole magnesium dihydrate) or 500 mg of naproxen and 20 mg of esomeprazole (equivalent to 21.75 mg esomeprazole magnesium dihydrate) for oral administration. The inactive ingredients are microcrystalline cellulose, croscarmellose sodium, povidone, colloidal silicon dioxide, magnesium stearate, methacrylic acid and ethyl acrylate copolymer, talc, triethy citrate, hypromellose, macrogol, sodium lauryl sulfate, magnesium oxide, polyethylene glycol, ferric oxide yellow. The imprinting ink contains shellac glaze, black iron oxide, propylene glycol, ammonium hydroxide. The chemical name for naproxen, USP is (S)-2-(6-Methoxy-naphth-2-yl) propionic acid. Naproxen, USP has the following structure: Naproxen, USP has a molecular weight of 230.26 and a molecular formula of C 14 H 14 O 3 . Naproxen, USP is an odorless, white to off-white crystalline powder. It is practically insoluble in water and soluble in ethanol and methanol. The octanol/water partition coefficient of naproxen is 3.18. The chemical name for esomeprazole is Magnesium bis [5-methoxy-2-[(S)-[(4-methoxy-3,5-dimethylpyridin-2-yl)methyl]sulphinyl]-1Hbenzimidazol-1- ide]dihydrate. Esomeprazole is the S-isomer of omeprazole, which is a mixture of the S-and R-isomers. Its molecular formula is C 34 H 36 N 6 O 6 S 2 Mg.2H 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 slightly colored powder. It contains 2 moles of water of solvation and is slightly soluble in methanol, practically insoluble in water and heptane. 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. naproxen-structure esomeprazole-structure

The active ingredients of naproxen and esomeprazole magnesium delayed-release tablets are naproxen which is an NSAID and esomeprazole magnesium which is a Proton Pump Inhibitor (PPI). Naproxen and esomeprazole magnesium delayed-release tablets are combination of a nonsteroidal anti-inflammatory drug and a PPI available as modified capsule shaped, off white to yellow colored 375 mg/20 mg and 500 mg/20 mg, multi-layer, delayed-release tablet combining an enteric-coated naproxen core and an immediate-release esomeprazole magnesium layer surrounding the core. Each strength contains either 375 mg of naproxen USP and 20 mg of esomeprazole (equivalent to 20.71 mg esomeprazole magnesium USP amorphous form) or 500 mg of naproxen USP and 20 mg of esomeprazole (equivalent to 20.71 mg esomeprazole magnesium USP amorphous form) for oral administration. The inactive ingredients are ammonium hydroxide, croscarmellose sodium, ferric oxide yellow, hypromellose, iron oxide black, lactose monohydrate, magnesium oxide, magnesium stearate, methacrylic acid copolymer, poloxamer, polyethylene glycol 400, povidone, propylene glycol, shellac glaze, simethicone, sodium hydroxide, sodium lauryl sulphate, talc, titanium dioxide and triethyl citrate. The chemical name for naproxen is (S)-6-methoxy-α-methyl-2-naphthaleneacetic acid. Naproxen has the following structure: Naproxen has a molecular weight of 230.26 and a molecular formula of C 14 H 14 O 3 . Naproxen USP is white to off-white practically odourless crystalline powder. It is soluble in chloroform, in dehydrated alcohol and in alcohol, sparingly soluble in ether and practically insoluble in water. The octanol/water partition coefficient of naproxen at pH 6.48 is 1.5. The chemical name for esomeprazole is bis(5-methoxy-2-[(S)-[(4-methoxy-3,5-dimethyl-2-pyridinyl)methyl]sulfinyl]-1H-benzimidazole-1-yl) magnesium amorphous. Esomeprazole is the S-isomer of omeprazole, which is a mixture of the S- and R- isomers. Its molecular formula is (C 17 H 18 N 3 O 3 S) 2 Mg with molecular weight of 713.1. The structural formula is: The esomepraozle magnesium USP is a white to pale cream colored powder. It is slightly soluble in methanol and soluble in N,N-Dimethyl formamide and practically insoluble in heptane and 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.

The active ingredients of naproxen and esomeprazole magnesium delayed-release tablets are naproxen, USP which is an NSAID and esomeprazole magnesium, USP which is a Proton Pump Inhibitor (PPI). Naproxen, USP and esomeprazole magnesium, USP is combination of a nonsteroidal anti-inflammatory drug and a PPI available as an oval, yellow, multi-layer, delayed-release tablet combining an enteric-coated naproxen core and an immediate-release esomeprazole magnesium layer surrounding the core. Each strength contains either 375 mg of naproxen, USP and 20 mg of esomeprazole (equivalent to 21.75 mg esomeprazole magnesium dihydrate) or 500 mg of naproxen and 20 mg of esomeprazole (equivalent to 21.75 mg esomeprazole magnesium dihydrate) for oral administration. The inactive ingredients are microcrystalline cellulose, croscarmellose sodium, povidone, colloidal silicon dioxide, magnesium stearate, methacrylic acid and ethyl acrylate copolymer, talc, triethy citrate, hypromellose, macrogol, sodium lauryl sulfate, magnesium oxide, polyethylene glycol, ferric oxide yellow. The imprinting ink contains shellac glaze, black iron oxide, propylene glycol, ammonium hydroxide. The chemical name for naproxen, USP is (S)-2-(6-Methoxy-naphth-2-yl) propionic acid. Naproxen, USP has the following structure: Naproxen, USP has a molecular weight of 230.26 and a molecular formula of C 14 H 14 O 3 . Naproxen, USP is an odorless, white to off-white crystalline powder. It is practically insoluble in water and soluble in ethanol and methanol. The octanol/water partition coefficient of naproxen is 3.18. The chemical name for esomeprazole is Magnesium bis [5-methoxy-2-[(S)-[(4-methoxy-3,5-dimethylpyridin-2-yl)methyl]sulphinyl]-1Hbenzimidazol-1- ide]dihydrate. Esomeprazole is the S-isomer of omeprazole, which is a mixture of the S-and R-isomers. Its molecular formula is C 34 H 36 N 6 O 6 S 2 Mg.2H 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 slightly colored powder. It contains 2 moles of water of solvation and is slightly soluble in methanol, practically insoluble in water and heptane. 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.

The active ingredients of naproxen and esomeprazole magnesium delayed-release tablets are naproxen which is an NSAID and esomeprazole magnesium which is a Proton Pump Inhibitor (PPI). Naproxen and esomeprazole magnesium delayed-release tablets are combination of a nonsteroidal anti-inflammatory drug and a PPI available as modified capsule shaped, off white to yellow colored 375 mg/20 mg and 500 mg/20 mg, multi-layer, delayed-release tablet combining an enteric-coated naproxen core and an immediate-release esomeprazole magnesium layer surrounding the core. Each strength contains either 375 mg of naproxen USP and 20 mg of esomeprazole (equivalent to 20.71 mg esomeprazole magnesium USP amorphous form) or 500 mg of naproxen USP and 20 mg of esomeprazole (equivalent to 20.71 mg esomeprazole magnesium USP amorphous form) for oral administration. The inactive ingredients are ammonium hydroxide, croscarmellose sodium, ferric oxide yellow, hypromellose, iron oxide black, lactose monohydrate, magnesium oxide, magnesium stearate, methacrylic acid copolymer, poloxamer, polyethylene glycol 400, povidone, propylene glycol, shellac glaze, simethicone, sodium hydroxide, sodium lauryl sulphate, talc, titanium dioxide and triethyl citrate. The chemical name for naproxen is (S)-6-methoxy-α-methyl-2-naphthaleneacetic acid. Naproxen has the following structure: Naproxen has a molecular weight of 230.26 and a molecular formula of C 14 H 14 O 3 . Naproxen USP is white to off-white practically odourless crystalline powder. It is soluble in chloroform, in dehydrated alcohol and in alcohol, sparingly soluble in ether and practically insoluble in water. The octanol/water partition coefficient of naproxen at pH 6.48 is 1.5. The chemical name for esomeprazole is bis(5-methoxy-2-[(S)-[(4-methoxy-3,5-dimethyl-2-pyridinyl)methyl]sulfinyl]-1H-benzimidazole-1-yl) magnesium amorphous. Esomeprazole is the S-isomer of omeprazole, which is a mixture of the S- and R- isomers. Its molecular formula is (C 17 H 18 N 3 O 3 S) 2 Mg with molecular weight of 713.1. The structural formula is: The esomepraozle magnesium USP is a white to pale cream colored powder. It is slightly soluble in methanol and soluble in N,N-Dimethyl formamide and practically insoluble in heptane and 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.

The active ingredients of naproxen and esomeprazole magnesium delayed-release tablets are naproxen, USP which is an NSAID and esomeprazole magnesium, USP which is a Proton Pump Inhibitor (PPI). Naproxen and esomeprazole magnesium delayed-release tablets are combination of a nonsteroidal anti-inflammatory drug and a PPI available as an oval, yellow, multi-layer, delayed-release tablet combining an enteric-coated naproxen core and an immediate-release esomeprazole magnesium layer surrounding the core. Each strength contains either 375 mg of naproxen, USP and 20 mg of esomeprazole (equivalent to 21.75 mg esomeprazole magnesium dihydrate) or 500 mg of naproxen and 20 mg of esomeprazole (equivalent to 21.75 mg esomeprazole magnesium dihydrate) for oral administration. The inactive ingredients are microcrystalline cellulose, croscarmellose sodium, povidone, colloidal silicon dioxide, magnesium stearate, methacrylic acid and ethyl acrylate copolymer, talc, triethy citrate, hypromellose, macrogol, sodium lauryl sulfate, magnesium oxide, polyethylene glycol, ferric oxide yellow. The imprinting ink contains shellac glaze, black iron oxide, propylene glycol, ammonium hydroxide. The chemical name for naproxen, USP is (S)-2-(6-Methoxy-naphth-2-yl) propionic acid. Naproxen, USP has the following structure: Naproxen, USP has a molecular weight of 230.26 and a molecular formula of C 14 H 14 O 3 . Naproxen, USP is an odorless, white to off-white crystalline powder. It is practically insoluble in water and soluble in ethanol and methanol. The octanol/water partition coefficient of naproxen is 3.18. The chemical name for esomeprazole is Magnesium bis [5-methoxy-2-[(S)-[(4-methoxy-3,5-dimethylpyridin-2-yl)methyl]sulphinyl]-1Hbenzimidazol-1- ide]dihydrate. Esomeprazole is the S-isomer of omeprazole, which is a mixture of the S-and R-isomers. Its molecular formula is C 34 H 36 N 6 O 6 S 2 Mg.2H 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 slightly colored powder. It contains 2 moles of water of solvation and is slightly soluble in methanol, practically insoluble in water and heptane. 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. naproxen-structure esomeprazole-structure

The active ingredients of naproxen and esomeprazole magnesium delayed-release tablets are naproxen which is an NSAID and esomeprazole magnesium which is a Proton Pump Inhibitor (PPI). Naproxen and esomeprazole magnesium delayed-release tablets (naproxen and esomeprazole magnesium) is combination of a nonsteroidal anti-inflammatory drug and a PPI available as an oval, yellow, multi-layer, delayed-release tablet combining an enteric-coated naproxen core and an immediate-release esomeprazole magnesium layer surrounding the core. Each strength contains either 375 mg of naproxen and 20 mg of esomeprazole (equivalent to 22.3 mg esomeprazole magnesium trihydrate) or 500 mg of naproxen and 20 mg of esomeprazole (equivalent to 22.3 mg esomeprazole magnesium trihydrate) for oral administration. The inactive ingredients are colloidal silicon dioxide, croscarmellose sodium, hypromellose, iron oxide yellow, magnesium oxide, magnesium stearate, methacrylic acid and ethyl acrylate copolymer dispersion, talc, plasacryl, polyethylene glycol, polysorbate 80, povidone, titanium dioxide. The imprinting ink contains ammonium hydroxide, iron oxide black, propylene glycol, shellac glaze. The chemical name for naproxen is (S)-6-methoxy-α-methyl-2-naphthaleneacetic acid. Naproxen has the following structure: Naproxen has a molecular weight of 230.26 and a molecular formula of C 14 H 14 O 3 . Naproxen, USP is an odorless, white to off-white crystalline substance. It is lipid soluble, practically insoluble in water at low pH and freely soluble in water at high pH. The octanol/water partition coefficient of naproxen at pH 7.4 is 1.6 to 1.8. The chemical name for esomeprazole, USP is bis(5-methoxy-2-[(S)-[(4-methoxy-3,5-dimethyl-2-pyridinyl)methyl]sulfinyl]-1 H -benzimidazole-1-yl) magnesium trihydrate. Esomeprazole, USP is the S-isomer of omeprazole, which is a mixture of the S- and R- isomers. Its molecular formula is (C 17 H 18 N 3 O 3 S)2Mg x 3 H 2 O with molecular weight of 767.2 as a trihydrate and 713.1 on an anhydrous basis. The structural formula is: The magnesium salt is a white to slightly colored crystalline powder. It contains 3 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. structure1 structure2

The active ingredients of naproxen and esomeprazole magnesium delayed-release tablets are naproxen which is an NSAID and esomeprazole magnesium which is a Proton Pump Inhibitor (PPI). Naproxen and esomeprazole magnesium delayed-release tablets are combination of a nonsteroidal anti-inflammatory drug and a PPI available as modified capsule shaped, off white to yellow colored 375 mg/20 mg and 500 mg/20 mg, multi-layer, delayed-release tablet combining an enteric-coated naproxen core and an immediate-release esomeprazole magnesium layer surrounding the core. Each strength contains either 375 mg of naproxen USP and 20 mg of esomeprazole (equivalent to 20.71 mg esomeprazole magnesium USP amorphous form) or 500 mg of naproxen USP and 20 mg of esomeprazole (equivalent to 20.71 mg esomeprazole magnesium USP amorphous form) for oral administration. The inactive ingredients are ammonium hydroxide, croscarmellose sodium, ferric oxide yellow, hypromellose, iron oxide black, lactose monohydrate, magnesium oxide, magnesium stearate, methacrylic acid copolymer, poloxamer, polyethylene glycol 400, povidone, propylene glycol, shellac glaze, simethicone, sodium hydroxide, sodium lauryl sulphate, talc, titanium dioxide and triethyl citrate. The chemical name for naproxen is (S)-6-methoxy-α-methyl-2-naphthaleneacetic acid. Naproxen has the following structure: Naproxen has a molecular weight of 230.26 and a molecular formula of C 14 H 14 O 3 . Naproxen USP is white to off-white practically odourless crystalline powder. It is soluble in chloroform, in dehydrated alcohol and in alcohol, sparingly soluble in ether and practically insoluble in water. The octanol/water partition coefficient of naproxen at pH 6.48 is 1.5. The chemical name for esomeprazole is bis(5-methoxy-2-[(S)-[(4-methoxy-3,5-dimethyl-2-pyridinyl)methyl]sulfinyl]-1H-benzimidazole-1-yl) magnesium amorphous. Esomeprazole is the S-isomer of omeprazole, which is a mixture of the S- and R- isomers. Its molecular formula is (C 17 H 18 N 3 O 3 S) 2 Mg with molecular weight of 713.1. The structural formula is: The esomepraozle magnesium USP is a white to pale cream colored powder. It is slightly soluble in methanol and soluble in N,N-Dimethyl formamide and practically insoluble in heptane and 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. structure1 structure2

The active ingredients of naproxen and esomeprazole magnesium delayed-release tablets are naproxen which is an NSAID and esomeprazole magnesium which is a Proton Pump Inhibitor (PPI). Naproxen and esomeprazole magnesium delayed-release tablets (naproxen and esomeprazole magnesium) is combination of a nonsteroidal anti-inflammatory drug and a PPI available as an oval, yellow, multi-layer, delayed-release tablet combining an enteric-coated naproxen core and an immediate-release esomeprazole magnesium layer surrounding the core. Each strength contains either 375 mg of naproxen and 20 mg of esomeprazole (equivalent to 22.3 mg esomeprazole magnesium trihydrate) or 500 mg of naproxen and 20 mg of esomeprazole (equivalent to 22.3 mg esomeprazole magnesium trihydrate) for oral administration. The inactive ingredients are colloidal silicon dioxide, croscarmellose sodium, hypromellose, iron oxide yellow, magnesium oxide, magnesium stearate, methacrylic acid and ethyl acrylate copolymer dispersion, talc, plasacryl, polyethylene glycol, polysorbate 80, povidone, titanium dioxide. The imprinting ink contains ammonium hydroxide, iron oxide black, propylene glycol, shellac glaze. The chemical name for naproxen is (S)-6-methoxy-α-methyl-2-naphthaleneacetic acid. Naproxen has the following structure: Naproxen has a molecular weight of 230.26 and a molecular formula of C 14 H 14 O 3 . Naproxen, USP is an odorless, white to off-white crystalline substance. It is lipid soluble, practically insoluble in water at low pH and freely soluble in water at high pH. The octanol/water partition coefficient of naproxen at pH 7.4 is 1.6 to 1.8. The chemical name for esomeprazole, USP is bis(5-methoxy-2-[(S)-[(4-methoxy-3,5-dimethyl-2-pyridinyl)methyl]sulfinyl]-1 H -benzimidazole-1-yl) magnesium trihydrate. Esomeprazole, USP is the S-isomer of omeprazole, which is a mixture of the S- and R- isomers. Its molecular formula is (C 17 H 18 N 3 O 3 S)2Mg x 3 H 2 O with molecular weight of 767.2 as a trihydrate and 713.1 on an anhydrous basis. The structural formula is: The magnesium salt is a white to slightly colored crystalline powder. It contains 3 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. structure1 structure2

The active ingredients of naproxen and esomeprazole magnesium delayed-release tablets are naproxen which is an NSAID and esomeprazole magnesium which is a Proton Pump Inhibitor (PPI). Naproxen and esomeprazole magnesium delayed-release tablets (naproxen and esomeprazole magnesium) is combination of a nonsteroidal anti-inflammatory drug and a PPI available as an oval, yellow, multi-layer, delayed-release tablet combining an enteric-coated naproxen core and an immediate-release esomeprazole magnesium layer surrounding the core. Each strength contains either 375 mg of naproxen and 20 mg of esomeprazole (equivalent to 22.3 mg esomeprazole magnesium trihydrate) or 500 mg of naproxen and 20 mg of esomeprazole (equivalent to 22.3 mg esomeprazole magnesium trihydrate) for oral administration. The inactive ingredients are colloidal silicon dioxide, croscarmellose sodium, hypromellose, iron oxide yellow, magnesium oxide, magnesium stearate, methacrylic acid and ethyl acrylate copolymer dispersion, talc, plasacryl, polyethylene glycol, polysorbate 80, povidone, titanium dioxide. The imprinting ink contains ammonium hydroxide, iron oxide black, propylene glycol, shellac glaze. The chemical name for naproxen is (S)-6-methoxy-α-methyl-2-naphthaleneacetic acid. Naproxen has the following structure: Naproxen has a molecular weight of 230.26 and a molecular formula of C 14 H 14 O 3 . Naproxen, USP is an odorless, white to off-white crystalline substance. It is lipid soluble, practically insoluble in water at low pH and freely soluble in water at high pH. The octanol/water partition coefficient of naproxen at pH 7.4 is 1.6 to 1.8. The chemical name for esomeprazole, USP is bis(5-methoxy-2-[(S)-[(4-methoxy-3,5-dimethyl-2-pyridinyl)methyl]sulfinyl]-1 H -benzimidazole-1-yl) magnesium trihydrate. Esomeprazole, USP is the S-isomer of omeprazole, which is a mixture of the S- and R- isomers. Its molecular formula is (C 17 H 18 N 3 O 3 S)2Mg x 3 H 2 O with molecular weight of 767.2 as a trihydrate and 713.1 on an anhydrous basis. The structural formula is: The magnesium salt is a white to slightly colored crystalline powder. It contains 3 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.

The active ingredients of naproxen and esomeprazole magnesium delayed-release tablets are naproxen, USP which is an NSAID and esomeprazole magnesium, USP which is a Proton Pump Inhibitor (PPI). Naproxen and esomeprazole magnesium delayed-release tablets are combination of a nonsteroidal anti-inflammatory drug and a PPI available as an oval, yellow, multi-layer, delayed-release tablet combining an enteric-coated naproxen core and an immediate-release esomeprazole magnesium layer surrounding the core. Each strength contains either 375 mg of naproxen, USP and 20 mg of esomeprazole (equivalent to 21.75 mg esomeprazole magnesium dihydrate) or 500 mg of naproxen and 20 mg of esomeprazole (equivalent to 21.75 mg esomeprazole magnesium dihydrate) for oral administration. The inactive ingredients are microcrystalline cellulose, croscarmellose sodium, povidone, colloidal silicon dioxide, magnesium stearate, methacrylic acid and ethyl acrylate copolymer, talc, triethy citrate, hypromellose, macrogol, sodium lauryl sulfate, magnesium oxide, polyethylene glycol, ferric oxide yellow. The imprinting ink contains shellac glaze, black iron oxide, propylene glycol, ammonium hydroxide. The chemical name for naproxen, USP is (S)-2-(6-Methoxy-naphth-2-yl) propionic acid. Naproxen, USP has the following structure: Naproxen, USP has a molecular weight of 230.26 and a molecular formula of C 14 H 14 O 3 . Naproxen, USP is an odorless, white to off-white crystalline powder. It is practically insoluble in water and soluble in ethanol and methanol. The octanol/water partition coefficient of naproxen is 3.18. The chemical name for esomeprazole is Magnesium bis [5-methoxy-2-[(S)-[(4-methoxy-3,5-dimethylpyridin-2-yl)methyl]sulphinyl]-1Hbenzimidazol-1- ide]dihydrate. Esomeprazole is the S-isomer of omeprazole, which is a mixture of the S-and R-isomers. Its molecular formula is C 34 H 36 N 6 O 6 S 2 Mg.2H 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 slightly colored powder. It contains 2 moles of water of solvation and is slightly soluble in methanol, practically insoluble in water and heptane. 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. naproxen-structure esomeprazole-structure

The active ingredients of naproxen and esomeprazole magnesium delayed-release tablets are naproxen, USP which is an NSAID and esomeprazole magnesium, USP which is a Proton Pump Inhibitor (PPI). Naproxen and esomeprazole magnesium delayed-release tablets are combination of a nonsteroidal anti-inflammatory drug and a PPI available as an oval, yellow, multi-layer, delayed-release tablet combining an enteric-coated naproxen core and an immediate-release esomeprazole magnesium layer surrounding the core. Each strength contains either 375 mg of naproxen, USP and 20 mg of esomeprazole (equivalent to 21.75 mg esomeprazole magnesium dihydrate) or 500 mg of naproxen and 20 mg of esomeprazole (equivalent to 21.75 mg esomeprazole magnesium dihydrate) for oral administration. The inactive ingredients are microcrystalline cellulose, croscarmellose sodium, povidone, colloidal silicon dioxide, magnesium stearate, methacrylic acid and ethyl acrylate copolymer, talc, triethy citrate, hypromellose, macrogol, sodium lauryl sulfate, magnesium oxide, polyethylene glycol, ferric oxide yellow. The imprinting ink contains shellac glaze, black iron oxide, propylene glycol, ammonium hydroxide. The chemical name for naproxen, USP is (S)-2-(6-Methoxy-naphth-2-yl) propionic acid. Naproxen, USP has the following structure: Naproxen, USP has a molecular weight of 230.26 and a molecular formula of C 14 H 14 O 3 . Naproxen, USP is an odorless, white to off-white crystalline powder. It is practically insoluble in water and soluble in ethanol and methanol. The octanol/water partition coefficient of naproxen is 3.18. The chemical name for esomeprazole is Magnesium bis [5-methoxy-2-[(S)-[(4-methoxy-3,5-dimethylpyridin-2-yl)methyl]sulphinyl]-1Hbenzimidazol-1- ide]dihydrate. Esomeprazole is the S-isomer of omeprazole, which is a mixture of the S-and R-isomers. Its molecular formula is C 34 H 36 N 6 O 6 S 2 Mg.2H 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 slightly colored powder. It contains 2 moles of water of solvation and is slightly soluble in methanol, practically insoluble in water and heptane. 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. naproxen-structure esomeprazole-structure

The active ingredients of naproxen and esomeprazole magnesium delayed-release tablets are naproxen which is an NSAID and esomeprazole magnesium which is a Proton Pump Inhibitor (PPI). Naproxen and esomeprazole magnesium delayed-release tablets (naproxen and esomeprazole magnesium) is combination of a nonsteroidal anti-inflammatory drug and a PPI available as an oval, yellow, multi-layer, delayed-release tablet combining an enteric-coated naproxen core and an immediate-release esomeprazole magnesium layer surrounding the core. Each strength contains either 375 mg of naproxen and 20 mg of esomeprazole (equivalent to 22.3 mg esomeprazole magnesium trihydrate) or 500 mg of naproxen and 20 mg of esomeprazole (equivalent to 22.3 mg esomeprazole magnesium trihydrate) for oral administration. The inactive ingredients are colloidal silicon dioxide, croscarmellose sodium, hypromellose, iron oxide yellow, magnesium oxide, magnesium stearate, methacrylic acid and ethyl acrylate copolymer dispersion, talc, plasacryl, polyethylene glycol, polysorbate 80, povidone, titanium dioxide. The imprinting ink contains ammonium hydroxide, iron oxide black, propylene glycol, shellac glaze. The chemical name for naproxen is (S)-6-methoxy-α-methyl-2-naphthaleneacetic acid. Naproxen has the following structure: Naproxen has a molecular weight of 230.26 and a molecular formula of C 14 H 14 O 3 . Naproxen, USP is an odorless, white to off-white crystalline substance. It is lipid soluble, practically insoluble in water at low pH and freely soluble in water at high pH. The octanol/water partition coefficient of naproxen at pH 7.4 is 1.6 to 1.8. The chemical name for esomeprazole, USP is bis(5-methoxy-2-[(S)-[(4-methoxy-3,5-dimethyl-2-pyridinyl)methyl]sulfinyl]-1 H -benzimidazole-1-yl) magnesium trihydrate. Esomeprazole, USP is the S-isomer of omeprazole, which is a mixture of the S- and R- isomers. Its molecular formula is (C 17 H 18 N 3 O 3 S)2Mg x 3 H 2 O with molecular weight of 767.2 as a trihydrate and 713.1 on an anhydrous basis. The structural formula is: The magnesium salt is a white to slightly colored crystalline powder. It contains 3 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. structure1 structure2

The active ingredients of naproxen and esomeprazole magnesium delayed-release tablets are naproxen which is an NSAID and esomeprazole magnesium which is a Proton Pump Inhibitor (PPI). Naproxen and esomeprazole magnesium delayed-release tablets are combination of a nonsteroidal anti-inflammatory drug and a PPI available as modified capsule shaped, off white to yellow colored 375 mg/20 mg and 500 mg/20 mg, multi-layer, delayed-release tablet combining an enteric-coated naproxen core and an immediate-release esomeprazole magnesium layer surrounding the core. Each strength contains either 375 mg of naproxen USP and 20 mg of esomeprazole (equivalent to 20.71 mg esomeprazole magnesium USP amorphous form) or 500 mg of naproxen USP and 20 mg of esomeprazole (equivalent to 20.71 mg esomeprazole magnesium USP amorphous form) for oral administration. The inactive ingredients are ammonium hydroxide, croscarmellose sodium, ferric oxide yellow, hypromellose, iron oxide black, lactose monohydrate, magnesium oxide, magnesium stearate, methacrylic acid copolymer, poloxamer, polyethylene glycol 400, povidone, propylene glycol, shellac glaze, simethicone, sodium hydroxide, sodium lauryl sulphate, talc, titanium dioxide and triethyl citrate. The chemical name for naproxen is (S)-6-methoxy-α-methyl-2-naphthaleneacetic acid. Naproxen has the following structure: Naproxen has a molecular weight of 230.26 and a molecular formula of C 14 H 14 O 3 . Naproxen USP is white to off-white practically odourless crystalline powder. It is soluble in chloroform, in dehydrated alcohol and in alcohol, sparingly soluble in ether and practically insoluble in water. The octanol/water partition coefficient of naproxen at pH 6.48 is 1.5. The chemical name for esomeprazole is bis(5-methoxy-2-[(S)-[(4-methoxy-3,5-dimethyl-2-pyridinyl)methyl]sulfinyl]-1H-benzimidazole-1-yl) magnesium amorphous. Esomeprazole is the S-isomer of omeprazole, which is a mixture of the S- and R- isomers. Its molecular formula is (C 17 H 18 N 3 O 3 S) 2 Mg with molecular weight of 713.1. The structural formula is: The esomepraozle magnesium USP is a white to pale cream colored powder. It is slightly soluble in methanol and soluble in N,N-Dimethyl formamide and practically insoluble in heptane and 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.

The active ingredients of naproxen and esomeprazole magnesium delayed-release tablets are naproxen which is an NSAID and esomeprazole magnesium which is a Proton Pump Inhibitor (PPI). Naproxen and esomeprazole magnesium delayed-release tablets are combination of a nonsteroidal anti-inflammatory drug and a PPI available as modified capsule shaped, off white to yellow colored 375 mg/20 mg and 500 mg/20 mg, multi-layer, delayed-release tablet combining an enteric-coated naproxen core and an immediate-release esomeprazole magnesium layer surrounding the core. Each strength contains either 375 mg of naproxen USP and 20 mg of esomeprazole (equivalent to 20.71 mg esomeprazole magnesium USP amorphous form) or 500 mg of naproxen USP and 20 mg of esomeprazole (equivalent to 20.71 mg esomeprazole magnesium USP amorphous form) for oral administration. The inactive ingredients are ammonium hydroxide, croscarmellose sodium, ferric oxide yellow, hypromellose, iron oxide black, lactose monohydrate, magnesium oxide, magnesium stearate, methacrylic acid copolymer, poloxamer, polyethylene glycol 400, povidone, propylene glycol, shellac glaze, simethicone, sodium hydroxide, sodium lauryl sulphate, talc, titanium dioxide and triethyl citrate. The chemical name for naproxen is (S)-6-methoxy-α-methyl-2-naphthaleneacetic acid. Naproxen has the following structure: Naproxen has a molecular weight of 230.26 and a molecular formula of C 14 H 14 O 3 . Naproxen USP is white to off-white practically odourless crystalline powder. It is soluble in chloroform, in dehydrated alcohol and in alcohol, sparingly soluble in ether and practically insoluble in water. The octanol/water partition coefficient of naproxen at pH 6.48 is 1.5. The chemical name for esomeprazole is bis(5-methoxy-2-[(S)-[(4-methoxy-3,5-dimethyl-2-pyridinyl)methyl]sulfinyl]-1H-benzimidazole-1-yl) magnesium amorphous. Esomeprazole is the S-isomer of omeprazole, which is a mixture of the S- and R- isomers. Its molecular formula is (C 17 H 18 N 3 O 3 S) 2 Mg with molecular weight of 713.1. The structural formula is: The esomepraozle magnesium USP is a white to pale cream colored powder. It is slightly soluble in methanol and soluble in N,N-Dimethyl formamide and practically insoluble in heptane and 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.

The active ingredients of naproxen and esomeprazole magnesium delayed-release tablets are naproxen, USP which is an NSAID and esomeprazole magnesium, USP which is a Proton Pump Inhibitor (PPI). Naproxen and esomeprazole magnesium delayed-release tablets are combination of a nonsteroidal anti-inflammatory drug and a PPI available as an oval, yellow, multi-layer, delayed-release tablet combining an enteric-coated naproxen core and an immediate-release esomeprazole magnesium layer surrounding the core. Each strength contains either 375 mg of naproxen, USP and 20 mg of esomeprazole (equivalent to 21.75 mg esomeprazole magnesium dihydrate) or 500 mg of naproxen and 20 mg of esomeprazole (equivalent to 21.75 mg esomeprazole magnesium dihydrate) for oral administration. The inactive ingredients are microcrystalline cellulose, croscarmellose sodium, povidone, colloidal silicon dioxide, magnesium stearate, methacrylic acid and ethyl acrylate copolymer, talc, triethy citrate, hypromellose, macrogol, sodium lauryl sulfate, magnesium oxide, polyethylene glycol, ferric oxide yellow. The imprinting ink contains shellac glaze, black iron oxide, propylene glycol, ammonium hydroxide. The chemical name for naproxen, USP is (S)-2-(6-Methoxy-naphth-2-yl) propionic acid. Naproxen, USP has the following structure: Naproxen, USP has a molecular weight of 230.26 and a molecular formula of C 14 H 14 O 3 . Naproxen, USP is an odorless, white to off-white crystalline powder. It is practically insoluble in water and soluble in ethanol and methanol. The octanol/water partition coefficient of naproxen is 3.18. The chemical name for esomeprazole is Magnesium bis [5-methoxy-2-[(S)-[(4-methoxy-3,5-dimethylpyridin-2-yl)methyl]sulphinyl]-1Hbenzimidazol-1- ide]dihydrate. Esomeprazole is the S-isomer of omeprazole, which is a mixture of the S-and R-isomers. Its molecular formula is C 34 H 36 N 6 O 6 S 2 Mg.2H 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 slightly colored powder. It contains 2 moles of water of solvation and is slightly soluble in methanol, practically insoluble in water and heptane. 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. naproxen-structure esomeprazole-structure

The active ingredients of naproxen and esomeprazole magnesium delayed-release tablets are naproxen which is an NSAID and esomeprazole magnesium which is a Proton Pump Inhibitor (PPI). Naproxen and esomeprazole magnesium delayed-release tablets (naproxen and esomeprazole magnesium) is combination of a nonsteroidal anti-inflammatory drug and a PPI available as an oval, yellow, multi-layer, delayed-release tablet combining an enteric-coated naproxen core and an immediate-release esomeprazole magnesium layer surrounding the core. Each strength contains either 375 mg of naproxen and 20 mg of esomeprazole (equivalent to 22.3 mg esomeprazole magnesium trihydrate) or 500 mg of naproxen and 20 mg of esomeprazole (equivalent to 22.3 mg esomeprazole magnesium trihydrate) for oral administration. The inactive ingredients are colloidal silicon dioxide, croscarmellose sodium, hypromellose, iron oxide yellow, magnesium oxide, magnesium stearate, methacrylic acid and ethyl acrylate copolymer dispersion, talc, plasacryl, polyethylene glycol, polysorbate 80, povidone, titanium dioxide. The imprinting ink contains ammonium hydroxide, iron oxide black, propylene glycol, shellac glaze. The chemical name for naproxen is (S)-6-methoxy-α-methyl-2-naphthaleneacetic acid. Naproxen has the following structure: Naproxen has a molecular weight of 230.26 and a molecular formula of C 14 H 14 O 3 . Naproxen, USP is an odorless, white to off-white crystalline substance. It is lipid soluble, practically insoluble in water at low pH and freely soluble in water at high pH. The octanol/water partition coefficient of naproxen at pH 7.4 is 1.6 to 1.8. The chemical name for esomeprazole, USP is bis(5-methoxy-2-[(S)-[(4-methoxy-3,5-dimethyl-2-pyridinyl)methyl]sulfinyl]-1 H -benzimidazole-1-yl) magnesium trihydrate. Esomeprazole, USP is the S-isomer of omeprazole, which is a mixture of the S- and R- isomers. Its molecular formula is (C 17 H 18 N 3 O 3 S)2Mg x 3 H 2 O with molecular weight of 767.2 as a trihydrate and 713.1 on an anhydrous basis. The structural formula is: The magnesium salt is a white to slightly colored crystalline powder. It contains 3 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.

The active ingredients of naproxen and esomeprazole magnesium delayed-release tablets are naproxen, USP which is an NSAID and esomeprazole magnesium, USP which is a Proton Pump Inhibitor (PPI). Naproxen, USP and esomeprazole magnesium, USP is combination of a nonsteroidal anti-inflammatory drug and a PPI available as an oval, yellow, multi-layer, delayed-release tablet combining an enteric-coated naproxen core and an immediate-release esomeprazole magnesium layer surrounding the core. Each strength contains either 375 mg of naproxen, USP and 20 mg of esomeprazole (equivalent to 21.75 mg esomeprazole magnesium dihydrate) or 500 mg of naproxen and 20 mg of esomeprazole (equivalent to 21.75 mg esomeprazole magnesium dihydrate) for oral administration. The inactive ingredients are microcrystalline cellulose, croscarmellose sodium, povidone, colloidal silicon dioxide, magnesium stearate, methacrylic acid and ethyl acrylate copolymer, talc, triethy citrate, hypromellose, macrogol, sodium lauryl sulfate, magnesium oxide, polyethylene glycol, ferric oxide yellow. The imprinting ink contains shellac glaze, black iron oxide, propylene glycol, ammonium hydroxide. The chemical name for naproxen, USP is (S)-2-(6-Methoxy-naphth-2-yl) propionic acid. Naproxen, USP has the following structure: Naproxen, USP has a molecular weight of 230.26 and a molecular formula of C 14 H 14 O 3 . Naproxen, USP is an odorless, white to off-white crystalline powder. It is practically insoluble in water and soluble in ethanol and methanol. The octanol/water partition coefficient of naproxen is 3.18. The chemical name for esomeprazole is Magnesium bis [5-methoxy-2-[(S)-[(4-methoxy-3,5-dimethylpyridin-2-yl)methyl]sulphinyl]-1Hbenzimidazol-1- ide]dihydrate. Esomeprazole is the S-isomer of omeprazole, which is a mixture of the S-and R-isomers. Its molecular formula is C 34 H 36 N 6 O 6 S 2 Mg.2H 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 slightly colored powder. It contains 2 moles of water of solvation and is slightly soluble in methanol, practically insoluble in water and heptane. 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.

The active ingredients of naproxen and esomeprazole magnesium delayed-release tablets are naproxen which is an NSAID and esomeprazole magnesium which is a Proton Pump Inhibitor (PPI). Naproxen and esomeprazole magnesium delayed-release tablets are combination of a nonsteroidal anti-inflammatory drug and a PPI available as modified capsule shaped, off white to yellow colored 375 mg/20 mg and 500 mg/20 mg, multi-layer, delayed-release tablet combining an enteric-coated naproxen core and an immediate-release esomeprazole magnesium layer surrounding the core. Each strength contains either 375 mg of naproxen USP and 20 mg of esomeprazole (equivalent to 20.71 mg esomeprazole magnesium USP amorphous form) or 500 mg of naproxen USP and 20 mg of esomeprazole (equivalent to 20.71 mg esomeprazole magnesium USP amorphous form) for oral administration. The inactive ingredients are ammonium hydroxide, croscarmellose sodium, ferric oxide yellow, hypromellose, iron oxide black, lactose monohydrate, magnesium oxide, magnesium stearate, methacrylic acid copolymer, poloxamer, polyethylene glycol 400, povidone, propylene glycol, shellac glaze, simethicone, sodium hydroxide, sodium lauryl sulphate, talc, titanium dioxide and triethyl citrate. The chemical name for naproxen is (S)-6-methoxy-α-methyl-2-naphthaleneacetic acid. Naproxen has the following structure: Naproxen has a molecular weight of 230.26 and a molecular formula of C 14 H 14 O 3 . Naproxen USP is white to off-white practically odourless crystalline powder. It is soluble in chloroform, in dehydrated alcohol and in alcohol, sparingly soluble in ether and practically insoluble in water. The octanol/water partition coefficient of naproxen at pH 6.48 is 1.5. The chemical name for esomeprazole is bis(5-methoxy-2-[(S)-[(4-methoxy-3,5-dimethyl-2-pyridinyl)methyl]sulfinyl]-1H-benzimidazole-1-yl) magnesium amorphous. Esomeprazole is the S-isomer of omeprazole, which is a mixture of the S- and R- isomers. Its molecular formula is (C 17 H 18 N 3 O 3 S) 2 Mg with molecular weight of 713.1. The structural formula is: The esomepraozle magnesium USP is a white to pale cream colored powder. It is slightly soluble in methanol and soluble in N,N-Dimethyl formamide and practically insoluble in heptane and 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. structure1 structure2

The active ingredients of naproxen and esomeprazole magnesium delayed-release tablets are naproxen, USP which is an NSAID and esomeprazole magnesium, USP which is a Proton Pump Inhibitor (PPI). Naproxen and esomeprazole magnesium delayed-release tablets are combination of a nonsteroidal anti-inflammatory drug and a PPI available as an oval, yellow, multi-layer, delayed-release tablet combining an enteric-coated naproxen core and an immediate-release esomeprazole magnesium layer surrounding the core. Each strength contains either 375 mg of naproxen, USP and 20 mg of esomeprazole (equivalent to 21.75 mg esomeprazole magnesium dihydrate) or 500 mg of naproxen and 20 mg of esomeprazole (equivalent to 21.75 mg esomeprazole magnesium dihydrate) for oral administration. The inactive ingredients are microcrystalline cellulose, croscarmellose sodium, povidone, colloidal silicon dioxide, magnesium stearate, methacrylic acid and ethyl acrylate copolymer, talc, triethy citrate, hypromellose, macrogol, sodium lauryl sulfate, magnesium oxide, polyethylene glycol, ferric oxide yellow. The imprinting ink contains shellac glaze, black iron oxide, propylene glycol, ammonium hydroxide. The chemical name for naproxen, USP is (S)-2-(6-Methoxy-naphth-2-yl) propionic acid. Naproxen, USP has the following structure: Naproxen, USP has a molecular weight of 230.26 and a molecular formula of C 14 H 14 O 3 . Naproxen, USP is an odorless, white to off-white crystalline powder. It is practically insoluble in water and soluble in ethanol and methanol. The octanol/water partition coefficient of naproxen is 3.18. The chemical name for esomeprazole is Magnesium bis [5-methoxy-2-[(S)-[(4-methoxy-3,5-dimethylpyridin-2-yl)methyl]sulphinyl]-1Hbenzimidazol-1- ide]dihydrate. Esomeprazole is the S-isomer of omeprazole, which is a mixture of the S-and R-isomers. Its molecular formula is C 34 H 36 N 6 O 6 S 2 Mg.2H 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 slightly colored powder. It contains 2 moles of water of solvation and is slightly soluble in methanol, practically insoluble in water and heptane. 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. naproxen-structure esomeprazole-structure

The active ingredients of naproxen and esomeprazole magnesium delayed-release tablets are naproxen, USP which is an NSAID and esomeprazole magnesium, USP which is a Proton Pump Inhibitor (PPI). Naproxen and esomeprazole magnesium delayed-release tablets are combination of a nonsteroidal anti-inflammatory drug and a PPI available as an oval, yellow, multi-layer, delayed-release tablet combining an enteric-coated naproxen core and an immediate-release esomeprazole magnesium layer surrounding the core. Each strength contains either 375 mg of naproxen, USP and 20 mg of esomeprazole (equivalent to 21.75 mg esomeprazole magnesium dihydrate) or 500 mg of naproxen and 20 mg of esomeprazole (equivalent to 21.75 mg esomeprazole magnesium dihydrate) for oral administration. The inactive ingredients are microcrystalline cellulose, croscarmellose sodium, povidone, colloidal silicon dioxide, magnesium stearate, methacrylic acid and ethyl acrylate copolymer, talc, triethy citrate, hypromellose, macrogol, sodium lauryl sulfate, magnesium oxide, polyethylene glycol, ferric oxide yellow. The imprinting ink contains shellac glaze, black iron oxide, propylene glycol, ammonium hydroxide. The chemical name for naproxen, USP is (S)-2-(6-Methoxy-naphth-2-yl) propionic acid. Naproxen, USP has the following structure: Naproxen, USP has a molecular weight of 230.26 and a molecular formula of C 14 H 14 O 3 . Naproxen, USP is an odorless, white to off-white crystalline powder. It is practically insoluble in water and soluble in ethanol and methanol. The octanol/water partition coefficient of naproxen is 3.18. The chemical name for esomeprazole is Magnesium bis [5-methoxy-2-[(S)-[(4-methoxy-3,5-dimethylpyridin-2-yl)methyl]sulphinyl]-1Hbenzimidazol-1- ide]dihydrate. Esomeprazole is the S-isomer of omeprazole, which is a mixture of the S-and R-isomers. Its molecular formula is C 34 H 36 N 6 O 6 S 2 Mg.2H 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 slightly colored powder. It contains 2 moles of water of solvation and is slightly soluble in methanol, practically insoluble in water and heptane. 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. naproxen-structure esomeprazole-structure

The active ingredients of naproxen and esomeprazole magnesium delayed-release tablets are naproxen which is an NSAID and esomeprazole magnesium which is a Proton Pump Inhibitor (PPI). Naproxen and esomeprazole magnesium delayed-release tablets (naproxen and esomeprazole magnesium) is combination of a nonsteroidal anti-inflammatory drug and a PPI available as an oval, yellow, multi-layer, delayed-release tablet combining an enteric-coated naproxen core and an immediate-release esomeprazole magnesium layer surrounding the core. Each strength contains either 375 mg of naproxen and 20 mg of esomeprazole (equivalent to 22.3 mg esomeprazole magnesium trihydrate) or 500 mg of naproxen and 20 mg of esomeprazole (equivalent to 22.3 mg esomeprazole magnesium trihydrate) for oral administration. The inactive ingredients are colloidal silicon dioxide, croscarmellose sodium, hypromellose, iron oxide yellow, magnesium oxide, magnesium stearate, methacrylic acid and ethyl acrylate copolymer dispersion, talc, plasacryl, polyethylene glycol, polysorbate 80, povidone, titanium dioxide. The imprinting ink contains ammonium hydroxide, iron oxide black, propylene glycol, shellac glaze. The chemical name for naproxen is (S)-6-methoxy-α-methyl-2-naphthaleneacetic acid. Naproxen has the following structure: Naproxen has a molecular weight of 230.26 and a molecular formula of C 14 H 14 O 3 . Naproxen, USP is an odorless, white to off-white crystalline substance. It is lipid soluble, practically insoluble in water at low pH and freely soluble in water at high pH. The octanol/water partition coefficient of naproxen at pH 7.4 is 1.6 to 1.8. The chemical name for esomeprazole, USP is bis(5-methoxy-2-[(S)-[(4-methoxy-3,5-dimethyl-2-pyridinyl)methyl]sulfinyl]-1 H -benzimidazole-1-yl) magnesium trihydrate. Esomeprazole, USP is the S-isomer of omeprazole, which is a mixture of the S- and R- isomers. Its molecular formula is (C 17 H 18 N 3 O 3 S)2Mg x 3 H 2 O with molecular weight of 767.2 as a trihydrate and 713.1 on an anhydrous basis. The structural formula is: The magnesium salt is a white to slightly colored crystalline powder. It contains 3 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. structure1 structure2

The active ingredients of naproxen and esomeprazole magnesium delayed-release tablets are naproxen, USP which is an NSAID and esomeprazole magnesium, USP which is a Proton Pump Inhibitor (PPI). Naproxen and esomeprazole magnesium delayed-release tablets are combination of a nonsteroidal anti-inflammatory drug and a PPI available as an oval, yellow, multi-layer, delayed-release tablet combining an enteric-coated naproxen core and an immediate-release esomeprazole magnesium layer surrounding the core. Each strength contains either 375 mg of naproxen, USP and 20 mg of esomeprazole (equivalent to 21.75 mg esomeprazole magnesium dihydrate) or 500 mg of naproxen and 20 mg of esomeprazole (equivalent to 21.75 mg esomeprazole magnesium dihydrate) for oral administration. The inactive ingredients are microcrystalline cellulose, croscarmellose sodium, povidone, colloidal silicon dioxide, magnesium stearate, methacrylic acid and ethyl acrylate copolymer, talc, triethy citrate, hypromellose, macrogol, sodium lauryl sulfate, magnesium oxide, polyethylene glycol, ferric oxide yellow. The imprinting ink contains shellac glaze, black iron oxide, propylene glycol, ammonium hydroxide. The chemical name for naproxen, USP is (S)-2-(6-Methoxy-naphth-2-yl) propionic acid. Naproxen, USP has the following structure: Naproxen, USP has a molecular weight of 230.26 and a molecular formula of C 14 H 14 O 3 . Naproxen, USP is an odorless, white to off-white crystalline powder. It is practically insoluble in water and soluble in ethanol and methanol. The octanol/water partition coefficient of naproxen is 3.18. The chemical name for esomeprazole is Magnesium bis [5-methoxy-2-[(S)-[(4-methoxy-3,5-dimethylpyridin-2-yl)methyl]sulphinyl]-1Hbenzimidazol-1- ide]dihydrate. Esomeprazole is the S-isomer of omeprazole, which is a mixture of the S-and R-isomers. Its molecular formula is C 34 H 36 N 6 O 6 S 2 Mg.2H 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 slightly colored powder. It contains 2 moles of water of solvation and is slightly soluble in methanol, practically insoluble in water and heptane. 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. naproxen-structure esomeprazole-structure

Uses • treats frequent heartburn (occurs 2 or more days a week) • not intended for immediate relief of heartburn; this drug may take 1 to 4 days for full effect

The active ingredient in esomeprazole magnesium delayed-release capsules for oral administration is bis(5-methoxy-2-[(S)-[(4-methoxy-3,5dimethyl-2-pyridinyl)methyl]sulfinyl]-1 H -benzimidazole-1-yl) magnesium trihydrate, 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 3 H 2 O with molecular weight of 767.2 as a trihydrate and 713.1 on an anhydrous basis. The structural formula is: The magnesium salt is a white to slightly colored crystalline powder. It contains 3 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, USP are supplied in delayed-release capsules. Each esomeprazole magnesium delayed-release capsules contains 20 mg of esomeprazole (equivalent to 22.3 mg esomeprazole magnesium trihydrate) or 40 mg of esomeprazole (equivalent to 44.5 mg esomeprazole magnesium trihydrate) in the form of enteric-coated pellets with the following inactive ingredients: hydroxypropyl cellulose, hypromellose, magnesium stearate, methacrylic acid and ethyl acrylate copolymer dispersion, sugar spheres, talc, and triethyl citrate. The capsule shells have the following inactive ingredients: Black iron oxide, FD&C Blue #1, FD&C Red #3, gelatin, potassium hydroxide, propylene glycol, shellac, and titanium dioxide. Meets USP dissolution test 3. structural formula

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 trihydrate, 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 3 H 2 O with molecular weight of 767.2 as a trihydrate and 713.1 on an anhydrous basis. The structural formula is: The magnesium salt is a white to slightly colored powder. It contains 3 moles of water of solvation and is soluble in methanol, slightly soluble in water, practically insoluble in heptane. 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 is supplied in packets for a delayed-release oral suspension. Each packet of esomeprazole magnesium for delayed-release oral suspension contains 10 mg of esomeprazole (equivalent to 11.1 mg esomeprazole magnesium trihydrate USP) in the form of enteric-coated granules with the following inactive ingredients: hydroxypropyl cellulose, hypromellose, magnesium carbonate, magnesium oxide, methacrylic acid and ethyl acrylate copolymer dispersion (contains copolymer based on ethyl acrylate and methacrylic acid, polysorbate 80 and sodium lauryl sulfate), mono-and di-glycerides, polysorbate 80, sugar spheres (which contains liquid glucose, starch (maize) and sucrose), talc and triethyl citrate. Each packet of esomeprazole magnesium for delayed-release oral suspension contains esomeprazole, in the form of same enteric-coated granules used in NEXIUM delayed-release capsules, and also inactive granules. The inactive granules are composed of the following ingredients: citric acid anhydrous, crospovidone, dextrose, ferric oxide yellow, hydroxypropyl cellulose and xanthan gum. The esomeprazole granules and inactive granules are constituted with water to form a suspension and are given by oral, nasogastric, or gastric administration. str

The active ingredient in the esomeprazole magnesium delayed-release capsules, USP for oral administration is 1H-Benzimidazole, 5-methoxy-2-[(S)-[(4-methoxy-3,5-dimethyl- 2-pyridinyl]methyl] Sulfinyl], Magnesium Salt (2:1) Trihydrate. Esomeprazole is S-enantiomer of omeprazole. (Initial U.S. approval of esomeprazole magnesium: 2001). Its molecular formula is C 34 H 36 MgN 6 O 6 S 2 .3H 2 O with molecular weight of 767.17 as a trihydrate. The structural formula is: Figure 1 The magnesium salt is a white to slightly colored powder. It contains 3 moles of water. Slightly soluble in methanol, insoluble in water and in n-Heptane. The stability of esomeprazole magnesium is a function of pH; it rapidly degrades in acidic media, but it has acceptable stability under alkaline conditions. Esomeprazole magnesium is supplied in delayed-release capsules. Each delayed-release capsule contains 20 mg, or 40 mg of esomeprazole (equivalent to 22.25 mg esomeprazole magnesium trihydrate, USP) or 40 mg of esomeprazole (equivalent to 44.5 mg esomeprazole magnesium trihydrate, USP) in the form of enteric-coated granules with the following inactive ingredients: glyceryl monostearate, hydroxy propyl cellulose, hypromellose, magnesium stearate, methacrylic acid ethyl acrylate copolymer, polysorbate 80, simethicone, sugar spheres (contains sucrose and starch), talc and triethyl citrate. The capsule shells have the following inactive ingredients: gelatin, titanium dioxide and sodium lauryl sulfate. The printing ink contains shellac, propylene glycol, strong ammonia solution, black iron oxide and potassium hydroxide. Esomeprazolemagnesiumfigure1

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]-1H-benzimidazole-1-yl) magnesium trihydrate, 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 3 H 2 O with molecular weight of 767.2 as a trihydrate and 713.1 on an anhydrous basis. The structural formula is: The magnesium salt is a white to slightly colored crystalline powder. It contains 3 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 is supplied in delayed-release capsules. Each esomeprazole magnesium delayed-release capsule contains 20 mg of esomeprazole (equivalent to 22.3 mg esomeprazole magnesium trihydrate) or 40 mg of esomeprazole (equivalent to 4.5 mg esomeprazole magnesium trihydrate) in the form of entericcoatedgranules with the following inactive ingredients: FD&C Blue #1, gelatin, glyceryl monostearate, hydroxypropyl cellulose, hypromellose, methacrylic acid and ethyl acrylate copolymer, polysorbate 80, sodium bicarbonate, sodium lauryl sulfate, sugar spheres (which contain sucrose and corn starch), talc, titanium dioxide, triethyl citrate, ferrosoferric oxide, potassium hydroxide, propylene glycol and shellac. esomeprazole-structure

Uses treats frequent heartburn (occurs 2 or more days a week) not intended for immediate relief of heartburn; this drug may take 1 to 4 days for full effect

The active ingredient in the proton pump inhibitor esomeprazole magnesium delayed-release capsules for oral administration is bis(5-methoxy-2-[(S)-[(4-methoxy-3,5-dimethyl-2-pyridinyl)methyl]sulfinyl]-1 H -benzimidazole-1-yl) magnesium trihydrate. 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 3 H 2 O with molecular weight of 767.17 as a trihydrate and 713.1 on an anhydrous basis. The structural formula is: Figure 1 The magnesium salt is a white or slightly colored powder. It contains 3 moles of water of solvation and is slightly soluble in methanol, insoluble in water and in n-Heptane. 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 22.25 mg, or 44.50 mg esomeprazole magnesium trihydrate) in the form of enteric-coated granules with the following inactive ingredients: hydroxypropyl cellulose, hypromellose 2910, magnesium stearate, methacrylic acid and ethyl acrylate copolymer dispersion, mono-and di-glycerides, polysorbate 80, sugar spheres, talc and triethyl citrate. The capsule shells have the following inactive ingredients: gelatin, sodium lauryl sulfate and titanium dioxide. The imprinting ink also contains ferric oxide black, shellac, strong ammonium solution, potassium hydroxide and propylene glycol. Image

The active ingredient in the proton pump inhibitor 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 trihydrate. 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 3 H 2 O with molecular weight of 767.2 as a trihydrate and 713.1 on an anhydrous basis. The structural formula is: The magnesium salt is a white to slightly cream or slightly yellow colored powder. It contains 3 moles of water of solvation and is soluble in methanol. 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 is supplied in delayed-release capsules. Each delayed-release capsule contains 20 mg, or 40 mg of esomeprazole (present as 22.3 mg, or 44.5 mg esomeprazole magnesium trihydrate USP) in the form of enteric-coated granules with the following inactive ingredients: glyceryl monostearate, hydroxypropyl cellulose, hypromellose, magnesium stearate, methacrylic acid copolymer, polysorbate 80, simethicone, sugar spheres, talc and triethyl citrate. The capsule shells have the following inactive ingredients: gelatin, FD&C Blue #1, titanium dioxide, ammonia solution, black iron oxide, butyl alcohol, dehydrated alcohol, isopropyl alcohol, propylene glycol, potassium hydroxide and shellac. Figure1

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 trihydrate, 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 3 H 2 O with molecular weight of 767.2 as a trihydrate and 713.1 on an anhydrous basis. The structural formula is: The magnesium salt is a white to slightly colored powder. It contains 3 moles of water of solvation and is soluble in methanol, slightly soluble in water, practically insoluble in heptane. 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 is supplied in packets for a delayed-release oral suspension. Each packet of esomeprazole magnesium for delayed-release oral suspension contains 5 mg of esomeprazole (equivalent to 5.6 mg esomeprazole magnesium trihydrate USP) or 20 mg of esomeprazole (equivalent to 22.3 mg esomeprazole magnesium trihydrate USP) or 40 mg of esomeprazole (equivalent to 44.5 mg esomeprazole magnesium trihydrate USP) in the form of enteric-coated granules with the following inactive ingredients: hydroxypropyl cellulose, hypromellose, magnesium carbonate, magnesium oxide, methacrylic acid and ethyl acrylate copolymer dispersion (contains copolymer based on ethyl acrylate and methacrylic acid, polysorbate 80 and sodium lauryl sulfate), mono-and di-glycerides, polysorbate 80, sugar spheres (which contains liquid glucose, starch (maize) and sucrose), talc and triethyl citrate. Each packet of esomeprazole magnesium for delayed-release oral suspension contains esomeprazole, in the form of same enteric-coated granules used in NEXIUM delayed-release capsules, and also inactive granules. The inactive granules are composed of the following ingredients: citric acid anhydrous, crospovidone, dextrose, ferric oxide yellow, hydroxypropyl cellulose and xanthan gum. The esomeprazole granules and inactive granules are constituted with water to form a suspension and are given by oral, nasogastric, or gastric administration. str

Uses treats frequent heartburn (occurs 2 or more days a week) not intended for immediate relief of heartburn; this drug may take 1 to 4 days for full effect

Uses • treats frequent heartburn (occurs 2 or more days a week) • not intended for immediate relief of heartburn; this drug may take 1 to 4 days for full effect

Uses treats frequent heartburn (occurs 2 or more days a week) not intended for immediate relief of heartburn; this drug may take 1 to 4 days for full effect

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 trihydrate, 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 × 3 H 2 O with molecular weight of 767.2 as a trihydrate and 713.1 on an anhydrous basis. The structural formula is: The magnesium salt is a white to slightly colored crystalline powder. It contains 3 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 is supplied in delayed-release capsules. Each Esomeprazole Magnesium Delayed-Release Capsule, USP contains 20 mg of esomeprazole (equivalent to 22.3 mg esomeprazole magnesium trihydrate) or 40 mg of esomeprazole (equivalent to 44.5 mg esomeprazole magnesium trihydrate) in the form of enteric-coated granules with the following inactive ingredients: glyceryl monostearate, hypromellose, magnesium oxide, magnesium stearate, methacrylic acid and ethyl acrylate copolymer, polysorbate 80, sodium lauryl sulfate, sugar spheres (composed of corn starch and sucrose), talc, and triethyl citrate. The capsule shells have the following inactive ingredients: FD&C Blue 1, FD&C Red 3, ferrosoferric oxide, gelatin, potassium hydroxide, shellac, sodium lauryl sulfate and titanium dioxide. Esomeprazole Magnesium Delayed-Release Capsules, USP meets USP Dissolution Test 2. structure

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 trihydrate, 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 3 H 2 O with molecular weight of 767.2 as a trihydrate and 713.1 on an anhydrous basis. The structural formula is: The magnesium salt is a white to slightly colored powder. It contains 3 moles of water of solvation and is soluble in methanol, slightly soluble in water, practically insoluble in heptane. 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 is supplied in delayed-release capsules. Each esomeprazole magnesium delayed-release capsule contains 20 mg of esomeprazole (equivalent to 22.3 mg esomeprazole magnesium trihydrate USP) or 40 mg of esomeprazole (equivalent to 44.5 mg esomeprazole magnesium trihydrate USP) in the form of enteric-coated granules with the following inactive ingredients: colloidal silicon dioxide, hydroxypropyl cellulose, hypromellose, magnesium carbonate, magnesium oxide, methacrylic acid and ethyl acrylate copolymer dispersion, mono and di glycerides, polysorbate 80, sugar spheres (which contains starch (maize) and sucrose), talc, titanium dioxide, and triethyl citrate. In addition, the empty hard gelatin capsule shells contain gelatin and sodium lauryl sulfate. The capsule shells are imprinted with edible ink containing butyl alcohol, dehydrated alcohol, isopropyl alcohol, propylene glycol, shellac, strong ammonia solution and yellow iron oxide. Meets USP Dissolution Test 2. Chemical Structure

The active ingredient in the esomeprazole magnesium delayed-release capsules, USP for oral administration is 1H-Benzimidazole, 5-methoxy-2-[(S)-[(4-methoxy-3,5-dimethyl- 2-pyridinyl]methyl] Sulfinyl], Magnesium Salt (2:1) Trihydrate. Esomeprazole is S-enantiomer of omeprazole. (Initial U.S. approval of esomeprazole magnesium: 2001). Its molecular formula is C 34 H 36 MgN 6 O 6 S 2 .3H 2 O with molecular weight of 767.17 as a trihydrate. The structural formula is: Figure 1 The magnesium salt is a white to slightly colored powder. It contains 3 moles of water. Slightly soluble in methanol, insoluble in water and in n-Heptane. The stability of esomeprazole magnesium is a function of pH; it rapidly degrades in acidic media, but it has acceptable stability under alkaline conditions. Esomeprazole magnesium is supplied in delayed-release capsules. Each delayed-release capsule contains 20 mg, or 40 mg of esomeprazole (equivalent to 22.25 mg esomeprazole magnesium trihydrate, USP) or 40 mg of esomeprazole (equivalent to 44.5 mg esomeprazole magnesium trihydrate, USP) in the form of enteric-coated granules with the following inactive ingredients: glyceryl monostearate, hydroxy propyl cellulose, hypromellose, magnesium stearate, methacrylic acid ethyl acrylate copolymer, polysorbate 80, simethicone, sugar spheres (contains sucrose and starch), talc and triethyl citrate. The capsule shells have the following inactive ingredients: gelatin, titanium dioxide and sodium lauryl sulfate. The printing ink contains shellac, propylene glycol, strong ammonia solution, black iron oxide and potassium hydroxide. Esomeprazolemagnesiumfigure1

The active ingredient in the proton pump inhibitor 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 trihydrate. 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 3 H 2 O with molecular weight of 767.2 as a trihydrate and 713.1 on an anhydrous basis. The structural formula is: The magnesium salt is a white to slightly cream or slightly yellow colored powder. It contains 3 moles of water of solvation and is soluble in methanol. 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 is supplied in delayed-release capsules. Each delayed-release capsule contains 20 mg, or 40 mg of esomeprazole (present as 22.3 mg, or 44.5 mg esomeprazole magnesium trihydrate USP) in the form of enteric-coated granules with the following inactive ingredients: glyceryl monostearate, hydroxypropyl cellulose, hypromellose, magnesium stearate, methacrylic acid copolymer, polysorbate 80, simethicone, sugar spheres, talc and triethyl citrate. The capsule shells have the following inactive ingredients: gelatin, FD&C Blue #1, titanium dioxide, ammonia solution, black iron oxide, butyl alcohol, dehydrated alcohol, isopropyl alcohol, propylene glycol, potassium hydroxide and shellac. Figure1

The active ingredient in NEXIUM ® (esomeprazole magnesium) delayed-release capsules for oral administration and NEXIUM (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 trihydrate, 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 3 H 2 O with molecular weight of 767.2 as a trihydrate and 713.1 on an anhydrous basis. The structural formula is: The magnesium salt is a white to slightly colored crystalline powder. It contains 3 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. NEXIUM is supplied in delayed-release capsules and in packets for a delayed-release oral suspension. Each NEXIUM delayed-release capsule contains 20 mg of esomeprazole (equivalent to 22.3 mg esomeprazole magnesium trihydrate) or 40 mg of esomeprazole (equivalent to 44.5 mg esomeprazole magnesium trihydrate) in the form of enteric-coated granules with the following inactive ingredients: glyceryl monostearate 40-55, hydroxypropyl cellulose, hypromellose, magnesium stearate, methacrylic acid copolymer type C, polysorbate 80, sugar spheres, talc, and triethyl citrate. The capsule shells have the following inactive ingredients: D&C Red #28, D&C Yellow #10, ethyl alcohol, FD&C Blue #1, FD&C Red #40, gelatin, isopropyl alcohol, n-butyl alcohol, polyvinyl pyrrolidone, propylene glycol, shellac, sodium hydroxide, and titanium dioxide. Each packet of NEXIUM for delayed-release oral suspension contains esomeprazole, in the form of same enteric-coated granules used in NEXIUM delayed-release capsules, and also inactive granules: • 2.5 mg esomeprazole (equivalent to 2.8 mg esomeprazole magnesium trihydrate) • 5 mg esomeprazole (equivalent to 5.6 mg esomeprazole magnesium trihydrate) • 10 mg esomeprazole (equivalent to 11.1 mg esomeprazole magnesium trihydrate) • 20 mg esomeprazole (equivalent to 22.3 mg esomeprazole magnesium trihydrate) • 40 mg esomeprazole (equivalent to 44.5 mg esomeprazole magnesium trihydrate) The inactive granules are composed of the following ingredients: citric acid, crospovidone, dextrose, hydroxypropyl cellulose, iron oxide, and xanthan gum. The esomeprazole granules and inactive granules are constituted with water to form a suspension and are given by oral, nasogastric, or gastric administration. Structural Formula

Uses • treats frequent heartburn (occurs 2 or more days a week) • not intended for immediate relief of heartburn; this drug may take 1 to 4 days for full effect

NAPROXEN (naproxen) tablets, EC-NAPROXEN (naproxen) delayed-release tablets and NAPROXEN SODIUM (naproxen sodium) tablets are nonsteroidal anti-inflammatory drugs available as follows: NAPROXEN tablets are available as yellow tablets containing 500 mg of naproxen for oral administration. EC-NAPROXEN delayed-release tablets are available as enteric-coated white tablets containing 375 mg of naproxen or 500 mg of naproxen for oral administration. NAPROXEN SODIUM tablets are available as dark blue tablets containing 550 mg of naproxen sodium for oral administration. Naproxen is a propionic acid derivative related to the arylacetic acid group of nonsteroidal anti-inflammatory drugs. The chemical names for naproxen and naproxen sodium are (S)-6-methoxy-α-methyl-2-naphthaleneacetic acid and (S)-6-methoxy-α-methyl-2-naphthaleneacetic acid, sodium salt, respectively. Naproxen has a molecular weight of 230.26 and a molecular formula of C 14 H 14 O 3 . Naproxen sodium has a molecular weight of 252.23 and a molecular formula of C 14 H 14 NaO 3 . Naproxen and naproxen sodium have the following structures, respectively: Naproxen is an odorless, white to off-white crystalline substance. It is lipid-soluble, practically insoluble in water at low pH and freely soluble in water at high pH. The octanol/water partition coefficient of naproxen at pH 7.4 is 1.6 to 1.8. Naproxen sodium is a white to creamy white, crystalline solid, freely soluble in water at neutral pH. The inactive ingredients in NAPROXEN tablets include: croscarmellose sodium, iron oxides, povidone and magnesium stearate. The inactive ingredients in EC-NAPROXEN delayed release tablets include: croscarmellose sodium, povidone and magnesium stearate. The enteric coating dispersion contains methacrylic acid copolymer, talc, triethyl citrate, sodium hydroxide and purified water. The imprinting on the tablets is black ink. The dissolution of this enteric-coated naproxen tablet is pH dependent with rapid dissolution above pH 6. There is no dissolution below pH 4. The inactive ingredients in NAPROXEN SODIUM tablets include: magnesium stearate, microcrystalline cellulose, povidone and talc. The coating suspension may contain hydroxypropyl methylcellulose 2910, Opaspray K-1-4227, polyethylene glycol 8000 or Opadry YS-1-4216.

Naproxen tablets, USP are nonsteroidal anti-inflammatory drugs and available as follows: Naproxen tablets, USP are available as light yellow round shaped tablets containing 250 mg naproxen, light yellow capsule shaped tablets containing 375 mg naproxen, and light yellow oblong shaped tablets containing 500 mg naproxen for oral administration. Naproxen is a propionic acid derivative related to the arylacetic acid group of nonsteroidal anti-inflammatory drugs. The chemical name for naproxen is (S)-6-methoxy-α-methyl-2-naphthaleneacetic acid. Naproxen has a molecular weight of 230.26 and a molecular formula of C 14H 14O 3. It has the following structural formula: Naproxen is white or almost white crystalline powder. It is insoluble in water, soluble in chloroform, dehydrated ethanol and methanol. Sparingly soluble in ether. The octanol/water partition coefficient of Naproxen at pH < 2.18 is 3.18. Each naproxen tablet, USP contains the following inactive ingredients: croscarmellose sodium, yellow iron oxide, povidone and magnesium stearate Struct