Fumarate ester pharmaceutical compositions
Described herein are pharmaceutical compositions comprising fumarate esters, methods for making the same, and methods for treating subjects in need thereof. In particular, oral pharmaceutical compositions comprising fumarate esters are described.
1. A method of treating or reducing symptoms of a multiple sclerosis or psoriasis in a subject, the method comprising administering an oral pharmaceutical composition comprising an immediate releasing single phase non-aqueous liquid vehicle comprising a suspension of a fumarate ester or a salt thereof having the formula:
wherein R 1 and R 2 , may be the same or different, and independently represent hydrogen or methyl.
2. The composition of claim 1 , wherein R 1 is hydrogen.
3. The composition of claim 1 , wherein R 1 is methyl.
4. The composition of claim 1 , wherein R 2 is methyl.
5. The composition of claim 1 , wherein R 1 is hydrogen and R 2 is methyl.
6. The composition of claim 1 , wherein R 1 is methyl and R 2 is methyl.
7. The method of claim 1 , wherein the fumarate ester is:
or a salt thereof.
8. The method of claim 1 , wherein the fumarate ester is:
9. The method of claim 1 , wherein the composition comprises about 60 mg to about 200 mg of the fumarate ester or salt thereof.
10. The method of claim 1 , wherein the composition comprises about 90 mg to about 100 mg or about 100 mg to about 200 mg of the fumarate ester or salt thereof.
11. The method of claim 1 , wherein the liquid vehicle comprises mono- and di-glycerides, polyvinylpyrrolidone, and polyoxyl 40 hydrogenated castor oil.
12. The method of claim 1 , wherein the composition comprises:
about 30% to about 40% of the fumarate ester or salt thereof by weight of the composition; and
about 55% to about 65% of the liquid vehicle by weight of the composition.
13. The method of claim 1 , wherein the liquid vehicle comprises about 5% of lactic acid by weight of the composition.
14. The method of claim 1 , wherein the composition is encapsulated in a capsule.
15. The method of claim 14 , wherein the capsule provides delayed release of the fumarate ester or salt thereof.
16. The method of claim 1 , wherein upon administration to a subject, the composition activates a nuclear factor erythroid-derived 2-like (Nrf2) dependent pathway.