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US 2024/0180861 A1Published application
Modified release gamma-hydroxybutyrate formulations having improved pharmacokinetics
AssigneeFlamel Ireland Limited
InventorsJordan Dubow, Hervé Guillard, Claire Mégret, Jean-François Dubuisson
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Abstract
Modified release formulations of gamma-hydroxybutyrate having improved dissolution and pharmacokinetic properties are provided, and therapeutic uses thereof.
Claims12
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 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 formulation is designed to be administered orally only once nightly.
5 more elements
A pharmaceutical formulation for the treatment of narcolepsy or a symptom thereof, comprising:
- (a) an amount of gamma-hydroxybutyrate equivalent to 3.0 g, 4.5 g, 6.0 g, 7.5 g, 9.0 g, 10.5 g, or 12.0 g of sodium oxybate;
- (b) microcrystalline spheres;
- (c) methacrylic acid and methyl methacrylate copolymer;
- (d) methacrylic acid and ethyl acrylate copolymer,
- (e) hydrogenated vegetable oil;
- and
- (f) malic acid, wherein the formulation is designed to be administered orally only once nightly.
4 more elements
A pharmaceutical formulation for the treatment of narcolepsy or a symptom thereof, comprising:
- an immediate release portion comprising gamma-hydroxybutyrate;
- a delayed release portion comprising gamma-hydroxybutyrate and a coating, the coating comprising:
- about 4.48% (w/w) methacrylic acid and methyl methacrylate copolymer;
- about 2.23% (w/w) methacrylic acid and ethyl acrylate copolymer;
- about 10.07% (w/w) hydrogenated vegetable oil;
- and
- an acidifying agent.
4 more elements
A pharmaceutical formulation for the treatment of narcolepsy or a symptom thereof, comprising:
- an immediate release portion comprising gamma-hydroxybutyrate;
- and
- a delayed release portion comprising gamma-hydroxybutyrate and a coating, the coating comprising:
- about 0.318 g methacrylic acid and methyl methacrylate copolymer;
- about 0.159 g methacrylic acid and ethyl acrylate copolymer;
- and
- about 0.716 g hydrogenated vegetable oil;
- and
- malic acid, wherein the amount of gamma-hydroxybutyrate in the formulation is equivalent to 3.0 g, 4.5 g, 6.0 g, 7.5 g, 9.0 g, 10.5 g, 12.0 g of sodium oxybate.
6 more elements
Dependencies are inferred from the claim text.