Patent ID: 8592366

Claim:
A pharmaceutical composition for oral delivery of a physiologically active peptide agent comprising: an active peptide agent intermixed with coated acid particles, the coated acid particles comprising at least one pharmaceutically acceptable acid that is coated with a pharmaceutically acceptable protective coating to separate the acid from the active peptide agent in the composition; a cellulose filler; a pharmaceutical binder for dry compression; an acid-resistant protective vehicle effective to transport the pharmaceutical composition through the stomach of a patient while preventing contact between the active peptide agent and stomach proteases; and a water-soluble barrier layer that separates the coated acid particles from the protective vehicle, wherein the active peptide agent and the coated acid particles are in the same layer of the composition, wherein total acid in said pharmaceutical composition is in a quantity which, if added to ten milliliters of 0.1 M aqueous sodium bicarbonate solution, would be sufficient to lower the pH of said solution to no higher than 5.5, and wherein the composition does not include an amount of base which, if released together with the acid, would prevent the pH of said solution from dropping to 5.5 or below.