US 12,109,186 B2
Modified release gamma-hydroxybutyrate formulations having improved pharmacokinetics
Jordan Dubow, Lyons (FR); Hervé Guillard, Villeurbanne (FR); Claire Mégret, Lyons (FR); and Jean-François Dubuisson, Lyons (FR)
Assigned to Flamel Ireland Limited, Dublin (IE)
Filed by Flamel Ireland Limited, Dublin (IE)
Filed on Dec. 6, 2023, as Appl. No. 18/531,095.
Application 18/531,095 is a continuation of application No. 18/231,581, filed on Aug. 8, 2023, granted, now 11,896,572.
Application 18/231,581 is a continuation of application No. 18/075,980, filed on Dec. 6, 2022, granted, now 11,766,418.
Application 18/075,980 is a continuation of application No. 17/497,393, filed on Oct. 8, 2021, granted, now 11,602,513, issued on Mar. 14, 2023.
Application 17/497,393 is a continuation in part of application No. 17/178,117, filed on Feb. 17, 2021.
Application 17/178,117 is a continuation in part of application No. 16/527,633, filed on Jul. 31, 2019, granted, now 11,065,224, issued on Jul. 20, 2021.
Application 16/527,633 is a continuation of application No. 16/281,235, filed on Feb. 21, 2019, granted, now 10,736,866, issued on Aug. 11, 2020.
Application 16/281,235 is a continuation of application No. 15/655,924, filed on Jul. 21, 2017, granted, now 10,272,062, issued on Apr. 30, 2019.
Claims priority of provisional application 62/474,330, filed on Mar. 21, 2017.
Claims priority of provisional application 62/399,413, filed on Sep. 25, 2016.
Claims priority of provisional application 62/365,812, filed on Jul. 22, 2016.
Prior Publication US 2024/0180861 A1, Jun. 6, 2024
This patent is subject to a terminal disclaimer.
Int. Cl. A61K 31/22 (2006.01); A61K 9/14 (2006.01); A61K 9/16 (2006.01); A61K 9/50 (2006.01); A61K 31/19 (2006.01)
CPC A61K 31/22 (2013.01) [A61K 9/14 (2013.01); A61K 9/1676 (2013.01); A61K 9/5015 (2013.01); A61K 9/5026 (2013.01); A61K 9/5042 (2013.01); A61K 9/5078 (2013.01); A61K 9/5084 (2013.01); A61K 31/19 (2013.01)] 11 Claims
 
1. A pharmaceutical formulation for the treatment of narcolepsy or a symptom thereof, comprising:
(a) an amount of gamma-hydroxybutyrate equivalent to from 3.0 g to 12.0 g of sodium oxybate;
(b) microcrystalline cellulose spheres;
(c) methacrylic acid and methyl methacrylate copolymer;
(d) methacrylic acid and ethyl acrylate copolymer,
(e) hydrogenated vegetable oil; and
(f) an acidifying agent,
wherein the weight ratio of the methacrylic acid and methyl methacrylate copolymer to the methacrylic acid and ethyl acrylate copolymer is about 2:1 (w/w), and
wherein the formulation is designed to be administered orally only once nightly.