Claims for Patent: 11,583,542

Summary for Patent: 11,583,542

Title:	Compositions of bile acids and phenylbutyrate compounds
Abstract:	The present disclosure relates to compositions including a phenylbutyrate compound and a bile acid, and methods of processing such compositions.
Inventor(s):	Joshua Cohen, Justin Klee, David Wai Fung Ma
Assignee:	Amylyx Pharmaceuticals Inc
Application Number:	US16/940,102
Patent Claims:	1. A composition comprising: (a) about 27% to about 32% w/w of sodium phenylbutyrate; (b) about 8% to about 12% w/w of taurursodiol (TURSO); (c) about 14% to about 17% w/w of dextrates; (d) about 3.5% to about 4.5% w/w of sorbitol; (e) about 25% to about 32% w/w of maltodextrin; and (f) about 0.05% to about 1.5% w/w of porous silica, wherein the sodium phenylbutyrate and the TURSO have a ratio by weight of about 3:1, and wherein the composition has a measurable Carr's index of about 24 or less. 2. The composition of claim 1, comprising about 9% to about 10% w/w of TURSO. 3. The composition of claim 1, wherein the maltodextrin is pea maltodextrin. 4. The composition of claim 1, further comprising about 0.5% to about 5% w/w of sucralose. 5. The composition of claim 4, comprising about 1% to about 3% w/w of sucralose. 6. The composition of claim 1, further comprising about 2% to about 15% w/w of one or more flavorants. 7. The composition of claim 1, wherein the porous silica has an average pore volume of about 0.1 cc/gm to about 2.0 cc/gm. 8. The composition of claim 1, wherein the porous silica has a bulk density of about 100 g/L to about 600 g/L. 9. The composition of claim 1, further comprising about 0.5% to about 5% w/w of a buffering agent. 10. The composition of claim 9, wherein the buffering agent is sodium phosphate dibasic. 11. The composition of claim 10, comprising about 1% to about 4% w/w of sodium phosphate dibasic. 12. The composition of claim 1, further comprising about 0.05% to about 1% w/w of one or more lubricants. 13. The composition of claim 12, wherein the one or more lubricants are selected from the group consisting of: sodium stearyl fumarate, magnesium stearate, stearic acid, polyethylene glycol, glyceryl behenate, and hydrogenated oil. 14. The composition of claim 13, wherein the one or more lubricants is sodium stearyl fumarate. 15. The composition of claim 14, comprising about 0.2% to about 0.8% w/w of sodium stearyl fumarate. 16. The composition of claim 1, wherein the composition has a measurable Carr's index of about 20 or less. 17. The composition of claim 1, wherein the composition has a Carr's index of about 21. 18. The composition of claim 1, wherein the composition has a Carr's index of about 22. 19. The composition of claim 1, wherein the composition has a Carr's index of about 23. 20. The composition of claim 1, wherein the composition has a Carr's index of about 24. 21. A composition comprising: about 29.2% w/w of sodium phenylbutyrate; about 9.7% w/w of taurursodiol (TURSO); about 15.6% w/w of dextrates; about 3.9% w/w of sorbitol; about 1.9% w/w of sucralose; about 28.3% w/w of maltodextrin; about 7.3% w/w of flavorants; about 0.9% w/w of porous silica; about 2.7% w/w of sodium phosphate dibasic; and about 0.5% w/w of sodium stearyl fumarate, wherein the composition has a measurable Carr's index of about 24 or less.