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US 2024/0180862 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.
Claims30
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.
3 more elements
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.
2 more elements
Dependencies are inferred from the claim text.