Claims for Patent: 10,973,795

Summary for Patent: 10,973,795

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
Assignee:	Flamel Ireland Limited
Application Number:	US16419616
Patent Claims:	1. A once-nightly modified release formulation of gamma-hydroxybutyrate comprising immediate release and modified release portions , wherein the once-nightly formulation yields a plasma concentration versus time curve when administered once-nightly in a human subject at a dose of 4.5 g or 6.0 g approximately two hours after a standardized evening meal as depicted in for the corresponding dose.2. A once-nightly modified release formulation of gamma-hydroxybutyrate comprising immediate release and modified release portions , wherein the once-nightly formulation yields a plasma concentration versus time curve when administered once-nightly in a human subject at a dose of 4.5 g approximately two hours after a standardized evening meal as depicted in .3. A once-nightly modified release formulation of gamma-hydroxybutyrate comprising immediate release and modified release portions for a human subject in need thereof , wherein the once-nightly formulation yields a dissolution profile as depicted in:{'figref': [{'@idref': 'DRAWINGS', 'FIG. 7'}, {'@idref': 'DRAWINGS', 'FIG. 8'}], 'and ;'}{'figref': [{'@idref': 'DRAWINGS', 'FIG. 20'}, {'@idref': 'DRAWINGS', 'FIG. 21'}], 'and ;'}{'figref': {'@idref': 'DRAWINGS', 'FIG. 3'}, '; or'}{'figref': {'@idref': 'DRAWINGS', 'FIG. 16'}, '.'}4. The once-nightly modified release formulation of gamma-hydroxybutyrate of claim 3 , wherein the once-nightly formulation yields a dissolution profile as depicted in and .5. The once-nightly modified release formulation of gamma-hydroxybutyrate of claim 3 , wherein the once-nightly formulation yields a dissolution profile as depicted in and .6. The once-nightly modified release formulation of gamma-hydroxybutyrate of claim 3 , wherein the once-nightly formulation yields a dissolution profile as depicted in .7. The once-nightly modified release formulation of gamma-hydroxybutyrate of claim 3 , wherein the once-nightly formulation yields a dissolution profile as depicted in .8. The once-nightly modified release formulation of gamma-hydroxybutyrate of claim 3 , wherein the once-nightly formulation yields a dissolution profile as depicted in any one of .9. A once-nightly modified release formulation of gamma-hydroxybutyrate comprising immediate release and modified release portions for a human subject in need thereof claim 3 , wherein the once-nightly formulation yields a dissolution profile between the minimum and maximum values depicted in:{'figref': [{'@idref': 'DRAWINGS', 'FIG. 25'}, {'@idref': 'DRAWINGS', 'FIG. 26'}], 'and ;'}{'figref': [{'@idref': 'DRAWINGS', 'FIG. 27'}, {'@idref': 'DRAWINGS', 'FIG. 28'}], 'and ; or'}{'figref': [{'@idref': 'DRAWINGS', 'FIG. 26'}, {'@idref': 'DRAWINGS', 'FIG. 28'}], 'and .'}10. The once-nightly modified release formulation of gamma-hydroxybutyrate of claim 9 , wherein the once-nightly formulation yields a dissolution profile between the minimum and maximum values depicted in and .11. The once-nightly modified release formulation of gamma-hydroxybutyrate of claim 9 , wherein the once-nightly formulation yields a dissolution profile between the minimum and maximum values depicted in and .12. The once-nightly modified release formulation of gamma-hydroxybutyrate of claim 1 , wherein the once-nightly formulation yields a dissolution profile between the minimum and maximum values depicted in and .13. A once-nightly modified release formulation of gamma-hydroxybutyrate comprising immediate release and modified release portions claim 1 , wherein the once-nightly formulation yields a plasma concentration versus time curve when administered once-nightly in a human subject at a dose of 4.5 g claim 1 , 7.5 g or 9.0 g approximately two hours after a standardized evening meal as depicted in for the corresponding dose.14. A once-nightly modified release formulation of gamma-hydroxybutyrate comprising immediate release and modified release portions claim 1 , wherein the once-nightly formulation yields a plasma concentration versus time curve when administered once-nightly in a human subject at a dose of 4.5 g claim 1 , 6.0 g or 7.5 g approximately two hours after a standardized evening meal as depicted in for the corresponding dose.15. A once-nightly modified release formulation of gamma-hydroxybutyrate comprising immediate release and modified release portions claim 1 , wherein the once-nightly formulation yields a plasma concentration versus time curve when administered once-nightly in a human subject at a dose of 4.5 g or 6.0 g approximately two hours after a standardized evening meal that is bioequivalent to the plasma concentration versus time curve depicted in for the corresponding dose.16. A once-nightly modified release formulation of gamma-hydroxybutyrate comprising immediate release and modified release portions claim 1 , wherein the once-nightly formulation yields a plasma concentration versus time curve when administered once-nightly in a human subject at a dose of 4.5 g approximately two hours after a standardized evening meal that is bioequivalent to the plasma concentration versus time curve depicted in .17. A once-nightly modified release formulation of gamma-hydroxybutyrate comprising immediate release and modified release portions for a human subject in need thereof claim 1 , wherein the once-nightly formulation yields a dissolution profile bioequivalent to the profile as depicted in:{'figref': [{'@idref': 'DRAWINGS', 'FIG. 7'}, {'@idref': 'DRAWINGS', 'FIG. 8'}], 'and ;'}{'figref': [{'@idref': 'DRAWINGS', 'FIG. 20'}, {'@idref': 'DRAWINGS', 'FIG. 21'}], 'and ;'}{'figref': {'@idref': 'DRAWINGS', 'FIG. 3'}, '; or'}{'figref': {'@idref': 'DRAWINGS', 'FIG. 16'}, '.'}18. The once-nightly modified release formulation of gamma-hydroxybutyrate of claim 17 , wherein the once-nightly formulation yields a dissolution profile bioequivalent to the profile as depicted in and .19. The once-nightly modified release formulation of gamma-hydroxybutyrate of claim 17 , wherein the once-nightly formulation yields a dissolution profile bioequivalent to the profile as depicted in and .20. The once-nightly modified release formulation of gamma-hydroxybutyrate of claim 17 , wherein the once-nightly formulation yields a dissolution profile bioequivalent to the profile as depicted in .21. The once-nightly modified release formulation of gamma-hydroxybutyrate of claim 17 , wherein the once-nightly formulation yields a dissolution profile bioequivalent to the profile as depicted in .22. The once-nightly modified release formulation of gamma-hydroxybutyrate of claim 17 , wherein the once-nightly formulation yields a dissolution profile bioequivalent to the profile as depicted in any one of .23. A once-nightly modified release formulation of gamma-hydroxybutyrate comprising immediate release and modified release portions claim 17 , wherein the formulation yields a plasma concentration versus time curve when administered once-nightly in a human subject at a dose of 4.5 g claim 17 , 7.5 g or 9.0 g approximately two hours after a standardized evening meal that is bioequivalent to the plasma concentration versus time curve depicted in for the corresponding dose.24. A once-nightly modified release formulation of gamma-hydroxybutyrate comprising immediate release and modified release portions claim 17 , wherein the once-nightly formulation yields a plasma concentration versus time curve when administered once-nightly in a human subject at a dose of 4.5 g claim 17 , 6.0 g or 7.5 g approximately two hours after a standardized evening meal that is bioequivalent to the plasma concentration versus time curve depicted in for the corresponding dose.