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 treating cataplexy or excessive daytime sleepiness in a human subject with narcolepsy, the method comprising:
administering to the human subject a single dose of a formulation comprising gamma-hydroxybutyrate (GHB) in an amount equivalent to 6 g of sodium oxybate, wherein a ratio of GHB in an immediate-release portion of the formulation and a modified-release portion of the formulation is from 10/90 to 65/35, and wherein the administering results in a peak plasma concentration (C max ) of about 66 mcg/mL.
2. The method of claim 1 , wherein the time to peak plasma concentration (T max ) following the administering is about 1.5 hours.
3. The method of claim 1 , wherein the GHB of the formulation comprises a salt of GHB.
4. The method of claim 1 , wherein the GHB of the formulation comprises sodium oxybate.
5. The method of claim 1 , wherein the GHB of the formulation is sodium oxybate.
6. A method of treating cataplexy or excessive daytime sleepiness in a human subject with narcolepsy, the method comprising:
administering to the human subject a single dose of a formulation comprising GHB in an amount equivalent to 5 g of oxybate, wherein a ratio of GHB in an immediate-release portion of the formulation and a modified-release portion of the formulation is from 10/90 to 65/35; and
producing a peak plasma concentration (C max ) of about 66 mcg/mL as a result of the administering.
7. The method of claim 6 , wherein the time to peak plasma concentration (T max ) following the administering is about 1.5 hours.
8. The method of claim 6 , wherein the GHB of the formulation comprises a salt of GHB.
9. The method of claim 6 , wherein the GHB of the formulation comprises sodium oxybate.
10. The method of claim 6 , wherein the GHB of the formulation is sodium oxybate.