Patent ID: 8945621
Filing Date: 2015-02-03
Classification: A61K,A61P

Abstract:
1. A method of reducing the incidence of NSAID-associated gastric ulcers in patients taking low dose aspirin who are at risk of developing such ulcers, wherein the method comprises administering to said patient in need thereof a pharmaceutical composition in unit dose form comprising: (a) 20 mg of esomeprazole, or pharmaceutically acceptable salt thereof, in a form and route sufficient to raise the gastric pH of said patient to at least 3.5 upon administration of one or more of said unit dose forms, and (b) 500 mg of naproxen, or pharmaceutically acceptable salt thereof; wherein said unit dose form provides for coordinated release of the esomeprazole and the naproxen, wherein at least a portion of said esomeprazole, or pharmaceutically acceptable salt thereof, is released independent of the pH of the surrounding medium, wherein the unit dosage form releases less than 10% of the naproxen or a pharmaceutically acceptable salt thereof after 2 hours when tested using the USP Paddle Method in 1000 ml of 0.1N HCl at 75 rpm at 37° C.+/−0.5° C., wherein said pharmaceutical composition in unit dose form reduces the incidence of NSAID-associated ulcers in said patient and wherein administration of the unit dose form is more effective at reducing the incidence of the NSAID-associated ulcers in patients taking LDA than in patients not taking LDA who are administered the unit dose form.