Modified release gamma-hydroxybutyrate formulations having improved pharmacokinetics
AssigneeFlamel Ireland Limited
InventorsClaire Mégret, Hervé Guillard, Jean-François Dubuisson, Jordan Dubow
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Abstract
Modified release formulations of gamma-hydroxybutyrate having improved dissolution and pharmacokinetic properties are provided, and therapeutic uses thereof.
Claims21
A powder suitable for administration to a human patient in need thereof, comprising a dose equivalent to from 3.0 to 12.0 g of sodium oxybate, wherein the powder comprises immediate-release (IR) particles and modified-release (MR) particles, and wherein the dose achieves a relative bioavailability (RBA) of greater than 85%, and wherein the powder is suitable for administration once daily.
A powder for suspension comprising oxybate in a unit dose suitable for administration once daily to a human patient in need thereof, wherein the powder comprises immediate-release (IR) particles and modified-release (MR) particles, wherein the unit dose is equivalent to from 3 g to 12 g of sodium oxybate, and wherein the suspension is suitable to achieve a relative bioavailability of gamma-hydroxybutyrate (GHB) of greater than 80% relative to a comparable amount of an immediate release liquid solution of sodium oxybate administered in equally divided doses.
Dependencies are inferred from the claim text.