Pharmacokinetics of combined release formulations of a gamma-hydroxybutyric acid derivative
AssigneeXwpharma Ltd.
InventorsDaniel M. CANAFAX, William W. XIANG, Leonard BLUM, Jia-Ning XIANG
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Abstract
Pharmaceutical compositions comprising an immediate release component comprising 4-((L-valyl)oxy)butanoic acid and a modified release component comprising 4-((L-valyl)oxy)butanoic acid and the pharmacokinetics of 4-((L-valyl)oxy)butanoic acid and γ-hydroxybutyrate following oral administration of the pharmaceutical compositions is disclosed.
Claims20
A method of treating idiopathic hypersomnia in a patient comprising administering to a patient in need of such treatment a therapeutically effective amount of a pharmaceutical composition comprising:
- an immediate release component, wherein the immediate release component comprises from 2 g of γ-((L-valyl)oxy)butanoic acid to 7 g of γ-((L-valyl)oxy)butanoic acid;
- and
- a modified release component, wherein the modified release component comprises from 6 g of γ-((L-valyl)oxy)butanoic acid to 16 g of γ-((L-valyl)oxy)butanoic acid.
A method of treating idiopathic hypersomnia in a patient comprising administering to a patient in need of such treatment a therapeutically effective amount of a pharmaceutical composition comprising:
- an immediate release component, wherein the immediate release component comprises γ-((L-valyl)oxy)butanoic acid;
- and
- a modified release component, wherein the modified release component comprises γ-((L-valyl)oxy)butanoic acid,
- wherein a molar ratio of γ-((L-valyl)oxy)butanoic acid in the immediate release component to γ-((L-valyl)oxy)butanoic acid in the modified release component is from 1:1 to 1:10.
A method of treating idiopathic hypersomnia in a patient comprising administering to a patient in need of such treatment a therapeutically effective amount of a pharmaceutical composition comprising:
- an immediate release component, wherein the immediate release component comprises from 10 mol % to 40 mol % of γ-((L-valyl)oxy)butanoic acid;
- and
- a modified release component, wherein the modified release component comprises from 60 mol % to 90 mol % γ-((L-valyl)oxy)butanoic acid,
- wherein mol % is based on the total moles of γ-((L-valyl)oxy)butanoic acid in the pharmaceutical composition.
A method of treating idiopathic hypersomnia in a patient comprising administering to a patient in need of said treatment a therapeutically effective amount of a pharmaceutical composition comprising:
- the immediate release component, wherein the immediate release component comprises from 10 wt % to 50 wt % γ-((L-valyl)oxy)butanoic acid, and
- the modified release component wherein the modified release component comprises from 50 wt % to 90 wt % of γ-((L-valyl)oxy)butanoic acid,
- wherein wt % is based on the total weight of γ-((L-valyl)oxy)butanoic acid in the pharmaceutical composition.
Dependencies are inferred from the claim text.