Patent ID: 8501228
Filing Date: 2013-08-06
Classification: A61K,A61P

Abstract:
1. A method for reducing the risk of developing ibuprofen-induced ulcers in a human patient requiring ibuprofen for an ibuprofen-responsive condition, said method comprising: administering to the human patient a first dose of famotidine, administering to the human patient a second dose of famotidine, and administering to the human patient a third dose of famotidine, and wherein for each administration, the famotidine is administered as a separate pharmaceutical composition in the form of a single tablet unit dosage form comprising: from 750 mg to 850 mg ibuprofen as an active pharmaceutical ingredient and from 24 mg to 28 mg famotidine as an active pharmaceutical ingredient, wherein the pharmaceutical composition is in the form of a bilayer tablet, wherein the ibuprofen active pharmaceutical ingredient is present in a first layer and the famotidine active pharmaceutical ingredient is present in a second layer, wherein the ibuprofen and famotidine are in direct physical contact, wherein at least one binder is present in the first layer and/or the second layer, wherein the pharmaceutical composition is formulated for immediate release, wherein none of the composition, the first layer, the second layer, the famotidine active pharmaceutical ingredient or the ibuprofen active pharmaceutical ingredient is enterically coated or formulated for sustained or delayed release, wherein the pharmaceutical composition is formulated so that release of the ibuprofen active pharmaceutical ingredient and the famotidine active pharmaceutical ingredient begins to occur at about the same time, and wherein no more than about 1% of a sulfamide is present when the composition is stored at 40° C. and 75% relative humidity for a period of one month or at least 90% of the amount of ibuprofen initially present and at least 90% of the amount of famotidine initially present remains after the composition is stored at 40° C. and 75% relative humidity for a period of one month, provided that the pharmaceutical composition is not a tablet-in-tablet formulation having a famotidine shell completely surrounding an ibuprofen core.