Orally administered corticosteroid compositions
AssigneeAptalis Pharmatech, Inc.
InventorsStephen Perrett, Fredric Jay Cohen, Gopi Venkatesh
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Abstract
The present invention is directed to orally administered corticosteroid compositions. The present invention also provides a method for treating a condition associated with inflammation of the gastrointestinal tract in an individual. The method comprises administering to an individual in need thereof a pharmaceutical composition of the present invention.
Claims40
An orally disintegrating solid pharmaceutical composition comprising less than or equal to about 20 mg of a topically administrable corticosteroid and at least one disintegrant, wherein the solid pharmaceutical composition has no significant systemic glucocorticoid or mineralocorticoid activity after oral administration,
- wherein the solid pharmaceutical composition disintegrates within 60 seconds when tested using the USP <701> Disintegration Test, and
- wherein upon administration the corticosteroid is deposited topically in the upper gastrointestinal tract.
An orally disintegrating tablet comprising less than or equal to about 20 mg of a corticosteroid selected from the group consisting of fluticasone, budesonide, mometasone, and salts, solvates and esters thereof, and at least one disintegrant, wherein the orally disintegrating tablet disintegrates within 60 seconds when tested using the USP <701> Disintegration Test.
Dependencies are inferred from the claim text.