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Last Updated: November 22, 2024

Claims for Patent: 10,918,617

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Summary for Patent: 10,918,617

Title:	Fumarate ester pharmaceutical compositions
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 pharmaceutical compositions comprising fumarate esters are described.
Inventor(s):	Dyakonov; Tatyana (Greensboro, NC), Agnihotri; Sunil (Scarborough, ME), Fatmi; Aqeel A. (High Point, NC)
Assignee:	BANNER LIFE SCIENCES LLC (High Point, NC)
Application Number:	16/129,908
Patent Claims:	1. An oral immediate release pharmaceutical composition comprising a single phase non-aqueous liquid vehicle comprising a suspension of a fumarate esters or a salt thereof having the formula: ##STR00002## wherein R.sub.1 and R.sub.2, may be the same or different, and independently represent hydrogen or methyl. 2. The composition of claim 1, wherein R.sub.1 is hydrogen. 3. The composition of claim 1, wherein R.sub.1 is methyl. 4. The composition of claim 1, wherein R.sub.2 is methyl. 5. The composition of claim 1, wherein R.sub.1 is hydrogen and R.sub.2 is methyl. 6. The composition of claim 1, wherein R.sub.1 is methyl and R.sub.2 is methyl. 7. The composition of claim 1, wherein the fumarate ester is: ##STR00003## or a salt thereof. 8. The composition of claim 1, wherein the fumarate ester is: ##STR00004## 9. The composition of claim 1, wherein the liquid vehicle comprises mono- and di-glycerides, polyvinylpyrrolidone, and polyoxyl 40 hydrogenated castor oil. 10. The composition of claim 1, wherein the liquid vehicle comprises lactic acid. 11. The composition of claim 1, wherein the composition comprises: about 25% to about 50% by weight of the composition of the one or more fumarate esters or salts thereof; about 40% to about 54% by weight of the composition of mono- and di-glycerides; about 1% to about 10% by weight of the composition of polyvinylpyrrolidone; about 2% to about 10% by weight of the composition of polyoxyl 40 hydrogenated castor oil; and about 5% b weight of the composition of lactic acid. 12. The composition of claim 1, wherein the composition is encapsulated in a capsule. 13. The composition of claim 1, wherein the composition is encapsulated in an enteric soft capsule. 14. The composition of claim 13, wherein the enteric soft capsule provides delayed release of the fumarate ester. 15. The composition of claim 1, wherein the fumarate ester is in the form of milled or micronized particles. 16. The composition of claim 11, wherein the composition is stable for at least 1 year at 25.degree. C.

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