Claims for Patent: 12,115,145

Summary for Patent: 12,115,145

Title:	Modified release gamma-hydroxybutyrate formulations having improved pharmacokinetics
Abstract:	Modified release formulations of gamma-hydroxybutyrate having improved dissolution and pharmacokinetic properties are provided, and therapeutic uses thereof.
Inventor(s):	Jordan Dubow, Hervé Guillard, Claire Mégret, Jean-François DUBUISSON
Assignee:	Flamel Ireland Ltd
Application Number:	US18/539,960
Patent Claims:	1. A pharmaceutical formulation for the treatment of narcolepsy or a symptom thereof comprising: an immediate release portion and a modified release portion, the modified release portion comprising gamma-hydroxybutyrate, and the immediate release portion comprising: gamma-hydroxybutyrate; povidone; and microcrystalline cellulose, wherein the formulation is designed to be administered orally only once nightly. 2. The pharmaceutical formulation of claim 1, wherein the formulation comprises an amount of gamma-hydroxybutyrate equivalent to from 3.0 g to 12 g of sodium oxybate. 3. The pharmaceutical formulation of claim 1, wherein the formulation comprises 3.33% povidone (w/w). 4. The pharmaceutical formulation of claim 1, wherein the formulation comprises 11.75% microcrystalline cellulose (w/w). 5. The pharmaceutical formulation of claim 1, wherein the formulation comprises hydrogenated vegetable oil. 6. The pharmaceutical formulation of claim 5, wherein the formulation comprises 10.07% hydrogenated vegetable oil (w/w). 7. The pharmaceutical formulation of claim 1, wherein the formulation comprises an acidifying agent. 8. The pharmaceutical formulation of claim 7, wherein the acidifying agent comprises 1.2% to 15% (w/w) of the formulation. 9. The pharmaceutical formulation of claim 7, wherein the acidifying agent comprises 1.2% to 10% (w/w) of the formulation. 10. The pharmaceutical formulation of claim 7, wherein the acidifying agent comprises 1.2% to 5% (w/w) of the formulation. 11. The pharmaceutical formulation of claim 7, wherein the acidifying agent comprises 1.6% to 3.2% (w/w) of the formulation. 12. The pharmaceutical formulation of claim 7, wherein the acidifying agent comprises malic acid. 13. The pharmaceutical formulation of claim 12, wherein the formulation comprises 1.58% malic acid (w/w). 14. The pharmaceutical formulation of claim 1, wherein the formulation comprises carrageenan gum. 15. The pharmaceutical formulation of claim 14, wherein the formulation comprises 1.05% carrageenan gum (w/w). 16. The pharmaceutical formulation of claim 1, wherein the formulation comprises hydroxyethyl cellulose. 17. The pharmaceutical formulation of claim 16, wherein the formulation comprises 1.05% hydroxyethyl cellulose (w/w). 18. The pharmaceutical formulation of claim 1, wherein the formulation comprises carrageenan and hydroxyethyl cellulose in equal amounts. 19. The pharmaceutical formulation of claim 1, wherein the formulation comprises xanthan gum. 20. The pharmaceutical formulation of claim 19, wherein the formulation comprises 0.70% xanthan gum (w/w). 21. The pharmaceutical formulation of claim 1, wherein the immediate release portion comprises 81% sodium oxybate (w/w). 22. The pharmaceutical formulation of claim 1, wherein the immediate release portion comprises 15% microcrystalline cellulose (w/w). 23. The pharmaceutical formulation of claim 1, wherein the formulation comprises one or more suspending or viscosifying agents. 24. The pharmaceutical formulation of claim 23, wherein the one or more suspending or viscosifying agents comprises 1% to 15% (w/w) of the formulation. 25. The pharmaceutical formulation of claim 23, wherein the one or more suspending or viscosifying agents comprises 2% to 10% (w/w) of the formulation. 26. The pharmaceutical formulation of claim 23, wherein the one or more suspending or viscosifying agents comprises 2% to 5% (w/w) of the formulation. 27. The pharmaceutical formulation of claim 23, wherein the one or more suspending or viscosifying agents comprises 2% to 3% (w/w) of the formulation. 28. The pharmaceutical formulation of claim 1, wherein the modified release portion further comprises: povidone; microcrystalline cellulose; hydrogenated vegetable oil; methacrylic acid copolymer type C; and methacrylic acid copolymer type B. 29. The pharmaceutical formulation of claim 1, wherein the modified release portion further comprises: povidone; microcrystalline cellulose; a polymer carrying free carboxylic groups; and a hydrophobic compound having a melting point equal or greater than 40° C.