Pharmaceutical compositions of dimethyl fumarate
Pharmaceutical compositions and dosage forms of dimethyl fumarate containing low levels of certain impurities are disclosed.
1. 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 (IV):
isomers thereof and salts of any of the foregoing, wherein:
each of R 11 and R 12 is independently chosen from hydrogen and methyl; and
wherein the one or more compounds of Formula (IV) are impurities and are present in a combined total amount of about 0.001% to 2% by weight based on total weight of the dimethyl fumarate; and
(c) a pharmaceutically acceptable vehicle.
2. The dosage form of claim 1 , wherein the one or more compounds of Formula (IV) are present in a combined total amount of about 0.001% to 1% by weight based on total weight of the dimethyl fumarate.
3. The dosage form of claim 1 , wherein the one or more compounds of Formula (IV) are selected from dimethyl succinate; 4-methoxy-4-oxobutanoic acid; succinic acid; isomers thereof and salts of any of the foregoing.
4. The dosage form of claim 1 , wherein each of the one or more compounds of Formula (IV) is present in an amount of about 0.001% to 0.3% by weight based on total weight of the dimethyl fumarate.
5. The dosage form of claim 1 , wherein each of the one or more compounds of Formula (IV) is present in an amount of about 0.001% to 0.2% by weight based on total weight of dimethyl fumarate.
6. The dosage form of claim 1 , wherein the dosage form is substantially free of any compound capable of facilitating the reduction of the double bond of DMF.
7. The dosage form of claim 1 , wherein the dosage form is substantially free of any compounds containing a hydrazino group.