ABSTRACT - 591940 Disclosed herein is a unit dosage form for oral administration of a naturally occurring or recombinant form of barley EP-B2 protease zymogen, the dosage form comprising: barley EP-B2 protease zymogen； and an acid or buffer excipient that provides a pH from about 3 to about 5 which is suitable for activation of barley EP-B2 protease zymogen when the formulation is exposed to gastric fluid, wherein the excipient is one or more of citric, maleic, malic, and fumaric acid or buffer present at a dose from about 25 to about 250mg, wherein the dosage may further comprise an antioxidant sodium metabisulfite and a polymer selected from the group consisting of dextran sulfate, chondroitin, chondroitin sulfate, heparin, heparin sulfate, cellulose sulfate, xanthan, hyaluronic acid, polyacrylic acid, polyacrylamide, carboxymethylcellulose, polypropanesulfonic acid, polyglutamates, anionic chitosan derivatives, and anionic maleic anhydride copolymers.
