Prodrugs of gamma-hydroxybutyric acid, compositions and uses thereof
The present disclosure discloses prodrugs of gamma-hydroxybutyric acid as well as compositions and uses thereof.
1. A pharmaceutical formulation comprising a compound having the structure of Formula II:
and
a pharmaceutically acceptable carrier.
2. The pharmaceutical formulation of claim 1 , wherein the pharmaceutical formulation is a solid.
3. The pharmaceutical formulation of claim 1 , wherein the pharmaceutically acceptable carrier comprises a solvent for dissolving or dispersing the compound.
4. The pharmaceutical formulation of claim 3 , wherein the solvent comprises water.
5. The pharmaceutical formulation of claim 1 , wherein the formulation is in a liquid dosage form.
6. The pharmaceutical formulation of claim 1 , wherein the pharmaceutically acceptable carrier comprises a flavoring agent, sucrose, lactose, cellulose sugar, mannitol, maltitol, dextran, sorbitol, starch, agar, alginates, chitins, chitosans, pectins, tragacanth gum, gum arabic, gelatins, collagens, casein, albumin, synthetic or semi-synthetic polymers or glycerides, methyl cellulose, hydroxypropylmethyl-cellulose, or polyvinylpyrrolidone.
7. The pharmaceutical formulation of claim 1 , wherein the pharmaceutically acceptable carrier comprises a polymeric excipient.
8. The pharmaceutical formulation of claim 1 , wherein the formulation comprises a tablet, a caplet, a capsule, a gel cap, granules, a pill, a powder, a lozenge, a sachet, a cachet, a suspension, an emulsion, a solution, a slurry, or a syrup.
9. The pharmaceutical formulation of claim 1 , wherein the pharmaceutical formulation is formulated in a unit dosage form.
10. The pharmaceutical formulation of claim 9 , wherein the unit dosage form has a weight from 0.5 grams to 30 grams.
11. The pharmaceutical formulation of claim 10 , wherein the pharmaceutical formulation is in a liquid dosage form.
12. The pharmaceutical formulation of claim 11 , further comprising a pH adjusting agent selected from sodium hydroxide, hydrochloric acid, or malic acid.
13. The pharmaceutical formulation of claim 1 , wherein the pharmaceutical formulation is formulated in a form comprising a quick release form.
14. The pharmaceutical formulation of claim 1 , wherein the pharmaceutical formulation is formulated in a form comprising a delayed release form.
15. The pharmaceutical formulation of claim 1 , wherein the pharmaceutical formulation is formulated in a form comprising a sustained-release form.
16. A kit comprising:
the pharmaceutical formulation of claim 1 ; and
instructions for administering the pharmaceutical formulation orally to a subject.
17. The kit of claim 16 , wherein the pharmaceutical formulation is an oral solution.
18. A method of treating a subject in need thereof, wherein the method comprises administering to the subject a pharmaceutically effective amount of a compound having the structure of Formula II:
wherein the subject suffers from a disease or condition selected from narcolepsy, excessive daytime sleepiness, cataplexy, fibromyalgia, chronic fatigue, or tardive dyskinesia.
19. The method of claim 18 , wherein the disease or condition is narcolepsy.
20. The method of claim 18 , wherein the disease or condition is excessive daytime sleepiness.
21. The method of claim 18 , wherein the disease or condition is cataplexy.
22. The method of claim 18 , wherein administering to the subject the pharmaceutically effective amount of the compound comprises administering the compound no more than one time per day.
23. The method of claim 18 , wherein administering to the subject the pharmaceutically effective amount of the compound comprises administering the compound orally, nasally, intravenously, subcutaneously, or intramuscularly.
24. The method of claim 23 , wherein administering to the subject the pharmaceutically effective amount of the compound comprises administering the compound orally.
25. The method of claim 24 , wherein administering the compound orally comprises administering the compound in an emulsion, syrup, elixir, suspension, slurry, or solution.
26. The method of claim 25 , wherein administering the compound orally comprises administering the compound in a solution.
27. The method of claim 18 , wherein administering to the subject the pharmaceutically effective amount of the compound comprises administering from 0.5 grams to 30 grams of the compound.
28. The method of claim 18 , wherein administering to the subject the pharmaceutically effective amount of the compound comprises administering a quick-release form comprising the compound.
29. The method of claim 18 , wherein administering to the subject the pharmaceutically effective amount of the compound comprises administering a sustained-release form comprising the compound.
30. The method of claim 18 , wherein administering to the subject the pharmaceutically effective amount of the compound comprises administering a delayed-release form comprising the compound.