CONTROLLED RELEASE PHARMACEUTICAL COMPOSITIONS COMPRISING A FUMARIC ACID ESTER
The present invention relates to controlled release pharmaceutical compositions comprising fumaric acid ester(s) as active substance(s). The compositions are suitable for use in the treatment of e.g. psoriasis or other hyperproliferative, inflammatory or autoimmune disorders and are designated to release the fumaric acid ester in a controlled manner so that local high concentrations of the active substance within the gastrointestinal tract upon oral administration can be avoided and, thereby, enabling a reduction in gastro-intestinal related side-effects.
1 .- 45 . (canceled)
46 . A method of reducing a side effect associated with oral treatment with a fumaric acid ester selected from the group consisting of di-(C1-C5)alkylesters of fumaric acid and mono-(C1-C5)alkyl esters of fumaric acid or a pharmaceutically acceptable salt thereof, comprising administering to a patient an NSAID in combination with a controlled release composition comprising one or more fumaric acid ester.
47 . The method of claim 46 , wherein the fumaric acid ester is DMF, MMF or a combination thereof.
48 . The method of claim 47 , wherein the fumaric acid ester is DMF.
49 . The method of claim 47 , wherein the fumaric acid ester is MMF.
50 . The method of claim 46 , wherein the NSAID is aspirin.
51 . The method of claim 47 , wherein the NSAID is aspirin.
52 . The method of claim 48 , wherein the NSAID is aspirin.
53 . The method of claim 49 , wherein the NSAID is aspirin.