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 for treating or reducing symptoms of multiple sclerosis in a subject comprising administering to the subject an oral immediate release pharmaceutical composition comprising one or more fumarate esters in a single phase non-aqueous vehicle.
2. The method of claim 1 , wherein the fumarate ester comprises dimethyl fumarate, monomethyl fumarate, or a combination thereof.
3. The method of claim 1 , wherein the fumarate ester comprises dimethyl fumarate.
4. The method of claim 1 , wherein the fumarate ester comprises monomethyl fumarate.
5. The method of claim 1 , wherein the composition further comprises polyvinylpyrrolidone, polyoxyl 40 hydrogenated castor oil, and lactic acid.
6. The method of claim 1 , wherein the composition comprises about 25% to about 50% of one or more fumarate esters and about 40% to about 54% of mono- and di-glycerides.
7. The method of claim 6 , wherein the composition further comprises about 1% to about 10% polyvinylpyrrolidone; about 2% to about 10% polyoxyl 40 hydrogenated castor oil; and about 5% lactic acid.
8. The method of claim 1 , wherein the composition comprises about 60 mg to about 200 mg of one or more fumarate esters.
9. The method of claim 1 , wherein about 120 mg to about 400 mg of the fumarate ester is administered per day.
10. The method of claim 1 , wherein two or more doses of the composition are administered at one time.
11. The method of claim 1 , wherein the composition is encapsulated in an enteric soft capsule that provides delayed release of the fumarate ester.
12. A method for treating or reducing symptoms of multiple sclerosis in a subject comprising administering to the subject an oral immediate release pharmaceutical composition comprising about 60 mg to about 200 mg of a fumarate ester in a single phase non-aqueous vehicle.
13. The method of claim 12 , wherein the fumarate ester comprises dimethyl fumarate, monomethyl fumarate, or a combination thereof.
14. The method of claim 12 , wherein the fumarate ester comprises dimethyl fumarate.
15. The method of claim 12 , wherein the fumarate ester comprises monomethyl fumarate.
16. The method of claim 12 , wherein the composition further comprises, polyvinylpyrrolidone, polyoxyl 40 hydrogenated castor oil, and lactic acid.
17. The method of claim 12 , wherein the composition comprises about 25% to about 50% of one or more fumarate esters and about 40% to about 54% of mono- and di-glycerides.
18. The method of claim 17 , wherein the composition further comprises about 1% to about 10% polyvinylpyrrolidone; about 2% to about 10% polyoxyl 40 hydrogenated castor oil; and about 5% lactic acid.
19. The method of claim 12 , wherein about 120 mg to about 400 mg of the fumarate ester is administered per day.
20. The method of claim 12 , wherein two or more doses of the pharmaceutical composition are administered at one time.
21. The method of claim 12 , wherein the composition is encapsulated in an enteric soft capsule that provides delayed release of the fumarate ester.
22. A method for treating or reducing symptoms of multiple sclerosis in a subject comprising administering to the subject an immediate release oral pharmaceutical composition comprising about 60 mg to about 200 mg of dimethyl fumarate, monomethyl fumarate, or a combination thereof in a single phase non-aqueous liquid vehicle.
23. The method of claim 22 , wherein the composition further comprises polyvinylpyrrolidone, polyoxyl 40 hydrogenated castor oil, and lactic acid.