(Z)-2-cyano-3-hydroxy-but-2-enoic acid-(4'-trifluoromethylphenyl)-amide tablet formulations with improved stability
AssigneeSanofi
InventorGerrit Hauck
Life of this patent
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Abstract
The invention relates to solid pharmaceutical compositions comprising (Z)-2-cyano-3-hydroxy-but-2-enoic acid-(4′-trifluoromethylphenyl)-amide, as well as a process for the preparation of the same, methods of using such compositions to treat subjects suffering from autoimmune diseases in particular systemic lupus erythematosus or chronic graft-versus-host disease, multiple sclerosis or rheumatoid arthritis.
Claims12
(canceled)
A solid pharmaceutical composition comprising a) 1 percent to 30 percent weight:weight teriflunomide, or a pharmaceutically acceptable basic addition salt thereof, b) 5 percent to 20 percent weight:weight disintegrant, c) 0 percent to 40 percent weight:weight binder, d) 0.1 percent to 2 percent weight:weight lubricant, and e) the remaining percentage comprising diluents;
- wherein the solid pharmaceutical composition contains no more than about 0.5 percent by weight of 2-cyano-N-(4-trifluoromethyl-phenyl)-acetamide.
Dependencies are inferred from the claim text.