Claims for Patent: 11,000,498

Summary for Patent: 11,000,498

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):	Megret Claire, Guillard Herve, Dubuisson Jean-Francois, Grassot Julien
Assignee:	Flamel Ireland Limited
Application Number:	US16431219
Patent Claims:	2. The oral pharmaceutical composition of claim 1 , wherein the composition is suitable for administration in the evening.3. The oral pharmaceutical composition of claim 1 , wherein the composition is suitable for administration in the morning.4. The oral pharmaceutical composition of claim 1 , wherein the composition is dose proportional across 4.5 g claim 1 , 7.5 g claim 1 , and 9 g doses of the composition.5. The oral pharmaceutical composition of claim 1 , wherein the Cmax of the composition is proportional across 4.5 g claim 1 , 7.5 g claim 1 , and 9 g doses of the composition.6. The oral pharmaceutical composition of claim 1 , wherein the composition is dose proportional by a factor of 1 to 1.3.7. The oral pharmaceutical composition of claim 4 , wherein median Tis between about 1.5 and 2 hours across the increasing doses.8. The oral pharmaceutical composition of claim 1 , wherein the mean Cis between about 42.9 and 84.5 μg/mL across the increasing doses.9. The oral pharmaceutical composition of claim 4 , wherein the mean AUCis about 191 claim 4 , 358 and 443 μg·h/mL for the 4.5 claim 4 , 7.5 and 9 g doses claim 4 , respectively.10. The oral pharmaceutical composition of claim 4 , wherein the mean concentrations at 8 hours are about 4.8 claim 4 , 19.7 and 25.5 μg/mL for the 4.5 claim 4 , 7.5 and 9 g doses claim 4 , respectively.11. A method of treating narcolepsy and associated disorders and symptoms in a patient in need thereof comprising:administering an oral pharmaceutical composition comprising gamma-hydroxybutyrate once daily to a human patient in need thereof, wherein the composition is dose proportional.12. The method of claim 11 , wherein the composition is administered in the evening.13. The method of claim 11 , wherein the composition is administered in the morning.14. The method of claim 11 , wherein the composition is dose proportional across 4.5 g claim 11 , 7.5 g claim 11 , and 9 g doses of the composition.15. The method of claim 11 , wherein the Cof the composition is proportional across 4.5 g claim 11 , 7.5 g claim 11 , and 9 g doses of the composition.16. The method of claim 11 , wherein the composition is dose proportional by a factor of 1 to 1.3.17. The method of claim 14 , wherein median Tis between about 1.5 and 2 hours across the increasing doses.18. The method of claim 14 , wherein the mean Cis between about 42.9 and 84.5 μg/mL across the increasing doses.19. The method of claim 14 , wherein the mean AUCis about 191 claim 14 , 358 and 443 μg·h/mL for the 4.5 claim 14 , 7.5 and 9 g doses claim 14 , respectively.20. The method of claim 14 , wherein the mean concentrations at 8 hours are about 4.8 claim 14 , 19.7 and 25.5 μg/mL for the 4.5 claim 14 , 7.5 and 9 g doses claim 14 , respectively.