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Last Updated: December 19, 2025

Claims for Patent: 12,115,142

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Summary for Patent: 12,115,142

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:	US18/537,318
Patent Claims:	1. A pharmaceutical formulation for the treatment of narcolepsy or a symptom thereof, comprising: an immediate release portion comprising gamma-hydroxybutyrate; a modified release portion comprising gamma-hydroxybutyrate, a polymer carrying free carboxylic groups, and a hydrophobic compound having a melting point equal or greater than 40° C., wherein the weight ratio of the hydrophobic compound to the polymer carrying free carboxylic groups is from 0.6 to 2.5; and an acidifying agent, wherein the formulation is designed to be administered orally only once nightly, and wherein the formulation comprises an amount of gamma-hydroxybutyrate equivalent to from 3.0 g to 12 g of sodium oxybate. 2. The pharmaceutical formulation of claim 1, wherein the weight ratio of the hydrophobic compound to the polymer carrying free carboxylic groups is from 0.6 to 2.33. 3. The pharmaceutical formulation of claim 1, wherein the weight ratio of the hydrophobic compound to the polymer carrying free carboxylic groups is about 1.5. 4. The pharmaceutical formulation of claim 1, wherein the modified release portion comprises a pH triggering release from 5.5 up to 6.97. 5. The pharmaceutical formulation of claim 1, wherein the modified release portion comprises a pH triggering release from 6.5 up to 6.97. 6. The pharmaceutical formulation of claim 1, further comprising hydrogenated vegetable oil. 7. A pharmaceutical formulation for the treatment of narcolepsy or a symptom thereof, comprising: an immediate release portion comprising gamma-hydroxybutyrate; a modified release portion comprising gamma-hydroxybutyrate and a coating, the coating comprising a methacrylic acid copolymer carrying free carboxylic groups having a pH trigger of from 5.5 to 6.97, and a hydrophobic compound having a melting point equal or greater than 40° C., wherein the weight ratio of the hydrophobic compound to the polymer carrying free carboxylic groups is from 0.4 to 4, wherein the coating is from 10 to 50% of the weight of the particles, and wherein the ratio of gamma-hydroxybutyrate in the immediate release portion and the modified release portion is from 10/90 to 65/35; and an acidifying agent, wherein the formulation comprises an amount of gamma-hydroxybutyrate equivalent to from 3.0 g to 12 g of sodium oxybate. 8. The pharmaceutical formulation of claim 7, wherein the coating further comprises hydrogenated vegetable oil. 9. The pharmaceutical formulation of claim 7, wherein the formulation comprises an amount of gamma-hydroxybutyrate equivalent to 4.5 g of sodium oxybate and achieves a ratio of AUC8h to AUCinf of 0.83. 10. The pharmaceutical formulation of claim 7, wherein the formulation comprises an amount of gamma-hydroxybutyrate equivalent to 6.0 g of sodium oxybate and achieves a ratio of AUC8h to AUCinf of 0.93. 11. The pharmaceutical formulation of claim 7, wherein the formulation comprises an amount of gamma-hydroxybutyrate equivalent to 7.5 g of sodium oxybate and achieves a ratio of AUC8h to AUCinf of 0.89. 12. The pharmaceutical formulation of claim 7, wherein the immediate release portion comprises immediate release particles comprising gamma-hydroxybutyrate, the modified release portion comprises modified release particles comprising gamma-hydroxybutyrate and the coating. 13. The pharmaceutical formulation of claim 12, wherein the weight percentage of the immediate release particles relative to the total weight of immediate release particles and modified release particles ranges from 7.2% to 58.2%. 14. The pharmaceutical formulation of claim 12, wherein the weight percentage of the immediate release particles relative to the total weight of immediate release particles and modified release particles ranges from 11.0% to 52.9%. 15. The pharmaceutical formulation of claim 12, wherein the weight percentage of the immediate release particles relative to the total weight of immediate release particles and modified release particles ranges from 14.9% to 47.8%. 16. The pharmaceutical formulation of claim 12, wherein the weight percentage of the immediate release particles relative to the total weight of immediate release particles and modified release particles ranges from 18.9% to 47.8%. 17. The pharmaceutical formulation of claim 12, wherein the weight percentage of the immediate release particles relative to the total weight of immediate release particles and modified release particles ranges from 23.1% to 47.8%. 18. The pharmaceutical formulation of claim 12, wherein the weight percentage of the immediate release particles relative to the total weight of immediate release particles and modified release particles ranges from 27.4% to 47.8%. 19. The pharmaceutical formulation of claim 12, wherein the weight percentage of the immediate release particles relative to the total weight of immediate release particles and modified release particles ranges from 31.8% to 47.8%. 20. The pharmaceutical formulation of claim 12, wherein the weight percentage of the immediate release particles relative to the total weight of immediate release particles and modified release particles ranges from 31.8% to 52.9%. 21. The pharmaceutical formulation of claim 12, wherein the weight percentage of the immediate release particles relative to the total weight of immediate release particles and modified release particles ranges from 36.4% to 47.8%. 22. The pharmaceutical formulation of claim 12, wherein the weight percentage of the immediate release particles relative to the total weight of immediate release particles and modified release particles ranges from 5.9% to 63.2%. 23. The pharmaceutical formulation of claim 12, wherein the weight percentage of the immediate release particles relative to the total weight of immediate release particles and modified release particles ranges from 9.1% to 58.1%. 24. The pharmaceutical formulation of claim 12, wherein the weight percentage of the immediate release particles relative to the total weight of immediate release particles and modified release particles ranges from 12.4% to 53.1%. 25. The pharmaceutical formulation of claim 12, wherein the weight percentage of the immediate release particles relative to the total weight of immediate release particles and modified release particles ranges from 19.9% to 53.1%. 26. The pharmaceutical formulation of claim 12, wherein the weight percentage of the immediate release particles relative to the total weight of immediate release particles and modified release particles ranges from 19.6% to 53.1%. 27. The pharmaceutical formulation of claim 12, wherein the weight percentage of the immediate release particles relative to the total weight of immediate release particles and modified release particles ranges from 23.4% to 53.1%. 28. The pharmaceutical formulation of claim 12, wherein the weight percentage of the immediate release particles relative to the total weight of immediate release particles and modified release particles ranges from 27.4% to 53.1%. 29. The pharmaceutical formulation of claim 12, wherein the weight percentage of the immediate release particles relative to the total weight of immediate release particles and modified release particles ranges from 27.4% to 58.1%. 30. The pharmaceutical formulation of claim 12, wherein the weight percentage of the immediate release particles relative to the total weight of immediate release particles and modified release particles ranges from 31.7% to 53.1%.

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