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US 2024/0180863 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.
Claims25
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 particles, each particle comprising gamma-hydroxybutyrate and a coating, wherein the coating comprises a methacrylic acid and methyl methacrylate copolymer, and a methacrylic acid and ethyl acrylate copolymer;
- and
- one or more suspending or viscosifying agents,
- wherein the formulation comprises an amount of gamma-hydroxybutyrate equivalent to from 3.0 g to 12.0 g of sodium oxybate, and
- wherein the formulation is designed to be administered orally only once nightly.
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 particles, each particle comprising gamma-hydroxybutyrate and a coating, wherein the coating comprises a methacrylic acid and methyl methacrylate copolymer, a methacrylic acid and ethyl acrylate copolymer, and hydrogenated vegetable oil;
- and
- a suspending or viscosifying agent comprising one or more of carrageenan gum, hydroxyethyl cellulose or xanthan gum,
- wherein the formulation comprises an amount of gamma-hydroxybutyrate equivalent to from 3.0 g to 12.0 g of sodium oxybate.
2 more elements
A pharmaceutical formulation for the treatment of narcolepsy or a symptom thereof, comprising
- an immediate release portion comprising gamma-hydroxybutyrate;
- and
- a modified release portion comprising particles, each of the particles comprising gamma-hydroxybutyrate and a coating, wherein the coating comprises:
- a polymer carrying free carboxylic groups and 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 a weight ratio of the hydrophobic compound to the polymer carrying free carboxylic groups is from 0.4 to 4;
- and
- one or more suspending or viscosifying agents selected from the group consisting of xanthan gum, medium viscosity sodium carboxymethyl cellulose, mixtures of microcrystalline cellulose and sodium carboxymethyl cellulose, mixtures of microcrystalline cellulose and guar gum, medium viscosity hydroxyethyl cellulose, agar, sodium alginate, mixtures of sodium alginate and calcium alginate, gellan gum, carrageenan gum, medium viscosity hydroxypropylmethyl cellulose, and mixtures thereof.
5 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 particles comprising gamma-hydroxybutyrate, each particle comprising a coating, wherein the coating comprises a methacrylic acid and methyl methacrylate copolymer, a methacrylic acid and ethyl acrylate copolymer;
- and
- one or more suspending or viscosifying agents,
- wherein the coating is 25%-35% of the weight of the particles,
- wherein the ratio of gamma-hydroxybutyrate in the immediate release portion and the modified release portion is from 10/90 to 65/35, and
- wherein the formulation is designed to be administered orally only once nightly.
4 more elements
Dependencies are inferred from the claim text.