| 主权项 |
1. An oral dosage form comprising:
a core comprising a therapeutically effective amount of a compound selected from (i) methyl hydrogen fumarate (MHF), (ii) a prodrug of MHF, (iii) pharmaceutically acceptable salts of (i) or (ii), and (iv) combinations of any of the foregoing; a barrier layer surrounding said core, the barrier layer comprising a material that is (i) a weakly acidic (proton-donating) material having a pKa of greater than 8, (ii) a weakly basic (proton-accepting) material having a pKa of less than 2, (iii) a natural gum or polysaccharide derivative, (iv) a neutral polymer salt, (v) a sugar, (vi) a lipid, or (vii) combinations of any of the foregoing; the barrier layer preventing direct contact between the core and an enteric coating; and the enteric coating surrounding said barrier layer and comprising an enteric polymer having carboxylic acid moieties, the enteric polymer (i) being soluble in aqueous solutions having a pH above 7.5, and (ii) starting to become soluble in an aqueous solution at a pH in the range of 4.5 to 7.5. |
