MODIFIED RELEASE GAMMA- HYDROXYBUTYRATE FORMULATIONS HAVING IMPROVED PHARMACOKINETICS
Modified release formulations of gamma-hydroxybutyrate having improved dissolution and pharmacokinetic properties are provided, and therapeutic uses thereof.
1 . A method of titrating a dose of a formulation for a human patient in need thereof, comprising adjusting the dose by about 1.5 g at weekly intervals, wherein the formulation is a powder suitable for administration to a human patient in need thereof, wherein the dose is equivalent to from 3.0 to 12.0 g of sodium oxybate, wherein the dose achieves a relative bioavailability (RBA) of greater than 85%, and wherein the formulation is suitable for administration once daily.
2 . The method of claim 1 , wherein the dose is 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.
3 . The method of claim 1 , where in the powder is suitable for reconstitution as a suspension.
4 . The method of claim 1 , where in the powder is suitable for oral administration.
5 . The method of claim 1 , wherein the dose achieves a relative bioavailability (RBA) of greater than 90%.
6 . The method of claim 1 , wherein the dose achieves a relative bioavailability (RBA) of greater than 95%.
7 . The method of claim 1 , wherein the dose achieves a relative bioavailability (RBA) of 100%.