GHB formulation and method for its manufacture
The present application relates to GHB formulations and methods for manufacturing the same.
1. A method of treating narcolepsy in a patient in need thereof, the method comprising:
administering a single daily dose to the patient, the single daily dose comprising an amount of oxybate equivalent to from 4.0 g to 12.0 g of sodium oxybate, wherein the administering comprises:
opening a sachet containing a solid oxybate formulation,
mixing the formulation with water, and
orally administering the mixture to the patient, wherein the oxybate formulation comprises an immediate release component and a controlled release component.
2. The method of claim 1 , wherein the orally administering occurs at night.
3. The method of claim 1 , wherein the oxybate formulation is mixed with water immediately prior to administration.
4. The method of claim 1 , wherein the oxybate is administered with food.
5. The method of claim 1 , wherein the administering promotes the patient to sleep for 6 to 8 hours.
6. The method of claim 1 , wherein the amount of oxybate administered to the patient is 35 mEq, 45 mEq, 60 mEq, or 70 mEq of oxybate.
7. The method of claim 1 , wherein the mixture is a suspension.
8. The method of claim 1 , wherein the oxybate formulation further comprises an acid.
9. The method of claim 8 , wherein the acid is selected from the group consisting of malic acid, citric acid, tartaric acid, boric acid, maleic acid, phosphoric acid, and benzoic acid.
10. A method of treating cataplexy or excessive daytime sleepiness associated with narcolepsy in a patient in need thereof, the method comprising:
administering a single daily dose to the patient, the single daily dose comprising an amount of oxybate equivalent to from 4.0 g to 12.0 g of sodium oxybate, wherein the administering comprises:
opening a sachet containing a solid oxybate formulation,
mixing the formulation with water, and
orally administering the mixture to the patient, wherein the oxybate formulation comprises an immediate release component and a controlled release component.
11. The method of claim 10 , wherein the orally administering occurs at night.
12. The method of claim 10 , wherein the oxybate formulation is mixed with water immediately prior to administration.
13. The method of claim 10 , wherein the oxybate is administered with food.
14. The method of claim 10 , wherein the administering promotes the patient to sleep for 6 to 8 hours.
15. The method of claim 10 , wherein the amount of oxybate administered to the patient is 35 mEq, 45 mEq, 60 mEq, or 70 mEq of oxybate.
16. The method of claim 10 , wherein the mixture is a suspension.
17. The method of claim 16 , wherein the oxybate formulation further comprises an acid.
18. The method of claim 17 , wherein the acid is selected from the group consisting of malic acid, citric acid, tartaric acid, boric acid, maleic acid, phosphoric acid, and benzoic acid.