Pharmaceutical compositions of dimethyl fumarate
View Patent ↗Pharmaceutical compositions and dosage forms of dimethyl fumarate containing low levels of certain impurities are disclosed.
1. A pharmaceutical composition, comprising:
(a) dimethyl fumarate in solid form; and
(b) one or more compounds of Formula (III):
isomers thereof and salts of any of the foregoing, wherein:
each of R 9 and R 10 is independently chosen from hydrogen and methyl.
2. The pharmaceutical composition of claim 1 , wherein the one or more compounds of Formula (III) are selected from: dimethyl oxirane-2,3-dicarboxylate; 3-(methoxycarbonyl)oxirane-2-carboxylic acid; oxirane-2,3-dicarboxylic acid; isomers thereof and salts of any of the foregoing.
3. The pharmaceutical composition of claim 1 , in the form of a powder.
4. The pharmaceutical composition of claim 1 , comprising a pharmaceutically acceptable vehicle.
5. The pharmaceutical composition of claim 4 , wherein the pharmaceutically acceptable vehicle is selected from the group consisting of a carrier, a diluent, an excipient, a wetting agent, an emulsifier, a buffer, a stabilizer, a thickener, a lubricant, a coloring agent and combinations thereof.
6. The pharmaceutical composition of claim 1 , wherein the composition is substantially free of PVP, PEG and polysorbate surfactant.
7. The pharmaceutical composition of claim 1 , comprising an antioxidant.
8. The pharmaceutical composition of claim 1 , comprising a free radical scavenger.
9. The pharmaceutical composition of claim 1 , wherein the one or more compounds of Formula (III) comprises dimethyl oxirane-2,3-dicarboxylate.
10. A dosage form for treating multiple sclerosis, comprising:
(a) a therapeutically effective amount of dimethyl fumarate in solid form;
(b) one or more compounds of Formula (III):
isomers thereof and salts of any of the foregoing, wherein:
each of R 9 and R 10 is independently chosen from hydrogen and methyl; and
(c) a pharmaceutically acceptable vehicle.
11. The dosage form of claim 10 , wherein the one or more compounds of Formula (III) are selected from dimethyl oxirane-2,3-dicarboxylate; 3-(methoxycarbonyl)oxirane-2-carboxylic acid; oxirane-2,3-dicarboxylic acid; isomers thereof and salts of any of the foregoing.
12. The dosage form of claim 10 , in the form of a tablet or capsule.
13. The dosage form of claim 10 , wherein the dosage form is substantially free of PVP, PEG and polysorbate surfactant.
14. The dosage form of claim 10 , comprising an antioxidant.
15. The dosage form of claim 10 , comprising a free radical scavenger.
16. The dosage form of claim 10 , wherein the one or more compounds of Formula (III) comprises dimethyl oxirane-2,3-dicarboxylate.