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Last Updated: April 28, 2024

Claims for Patent: 9,636,319

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Summary for Patent: 9,636,319

Title:	Fumarate ester dosage forms
Abstract:	Described herein are pharmaceutical compositions comprising fumarate esters, methods for making the same, and methods for treating subjects in need thereof. In particular, oral controlled release pharmaceutical compositions comprising fumarate esters suspended in liquid matrices are described. One embodiment described herein is a pharmaceutical composition comprising fumarate esters suspended in a lipid or lipophilic liquid with enhanced bioavailability.
Inventor(s):	Vaughn; Jason M. (Browns Summit, NC), Hughey; Justin R. (Asheboro, NC), Roberts; Tanesha (Greensboro, NC), Dyakonov; Tatyana (Greensboro, NC), Agnihotri; Sunil (Scarborough, ME), Fatmi; Aqeel A. (High Point, NC)
Assignee:	BANNER LIFE SCIENCES LLC (High Point, NC)
Application Number:	15/386,133
Patent Claims:	1. An oral pharmaceutical composition comprising one or more fumarate esters in an immediate releasing single phase non-aqueous liquid vehicle. 2. The composition of claim 1, wherein the composition comprises about 80 mg to about 230 mg of the fumarate ester. 3. The composition of claim 1, wherein the liquid vehicle comprises mono- and di-glycerides, polyvinylpyrrolidone, and polyoxyl 40 hydrogenated castor oil. 4. The composition of claim 1, wherein the composition comprises: about 30% to about 40% by weight of the one or more fumarate esters; and about 55% to about 65% by weight of the liquid vehicle. 5. The composition of claim 1, wherein the composition comprises about 5% by weight of lactic acid. 6. The composition of claim 1, wherein the composition is encapsulated in a capsule. 7. The composition of claim 1, wherein the composition is encapsulated in an enterically coated soft capsule. 8. The composition of claim 1, wherein the fumarate ester is a prodrug of monomethyl fumarate. 9. The composition of claim 1, wherein the fumarate ester is dimethyl fumarate. 10. The composition of claim 1, wherein the fumarate ester is monomethyl fumarate. 11. The composition of claim 1, wherein the composition comprises about 80 mg to about 115 mg or about 160 mg to about 230 mg of the fumarate ester. 12. The composition of claim 1, wherein the composition is encapsulated in a capsule comprising one or more subcoatings, enteric coatings, top coatings, or combinations thereof. 13. The composition of claim 12, wherein the capsule provides delayed release of the fumarate ester. 14. The composition of claim 1, wherein upon administration to a subject, the composition activates a nuclear factor erythroid-derived 2-like (Nrf2) dependent pathway. 15. The composition of claim 1, wherein about 180 mg to about 200 mg of fumarate ester is bioequivalent to a 240 mg dose of dimethyl fumarate. 16. An oral pharmaceutical composition comprising about 80 mg to about 230 mg of one or more of a prodrug of monomethyl fumarate, dimethyl fumarate, or monomethyl fumarate in an immediate releasing single phase non-aqueous liquid vehicle. 17. The composition of claim 16, wherein the composition is encapsulated in a capsule. 18. The composition of claim 17, wherein the capsule provides delayed release of the prodrug of monomethyl fumarate, dimethyl fumarate, or monomethyl fumarate. 19. An oral pharmaceutical composition comprising one or more fumarate esters in an immediate releasing single phase non-aqueous liquid vehicle where upon administration to a subject, the fumarate ester activates a nuclear factor erythroid-derived 2-like (Nrf2) dependent pathway in the subject. 20. The composition of claim 19, wherein the composition comprises about 80 mg to about 230 mg of a prodrug of monomethyl fumarate, dimethyl fumarate, or monomethyl fumarate.

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