OCTANOIC ACID FORMULATIONS AND METHODS OF TREATMENT USING THE SAME

• US 20110112010A1
• Filed: 02/12/2009
• Published: 05/12/2011
• Est. Priority Date: 02/15/2008
• Status: Abandoned Application

• Current Assignee: United States Department Of Health And Human Services (Government of the United States of America), Ariston Pharmaceuticals, Incorporated (TG Therapeutics, Inc.)
• Original Assignee: Ariston Pharmaceuticals, The Government of The United States of America As Represented By The National Institutes of Health
• Inventors: Nahab, Fatta B., McLane, John A., Hallett, Mark
• Application Number:
  US12/867,702
• Publication Number:
  US 20110112010A1
• Time in Patent Office: Days
• US Class Current: 514/1.1
• CPC Class Codes: A61K 2300/00 Mixtures or combinations of active ingredients, wherein at least one active ingredient is fully defined in groups A61K31/00 - A61K41/00
• CPC Class Codes: A61K 31/201 having one or two double bonds, e.g. oleic, linoleic acids
• CPC Class Codes: A61K 31/23 of acids having a carboxyl group bound to a chain of seven or more carbon atoms
• CPC Class Codes: A61K 45/06 Mixtures of active ingredients without chemical characterisation, e.g. antiphlogistics and cardiaca
• CPC Class Codes: A61P 1/16 for liver or gallbladder disorders, e.g. hepatoprotective agents, cholagogues, litholytics
• CPC Class Codes: A61P 25/08 Antiepileptics; Anticonvulsants
• CPC Class Codes: A61P 25/16 Anti-Parkinson drugs
• CPC Class Codes: A61P 5/16 for decreasing, blocking or antagonising the activity of the thyroid hormones

Abstract

The invention features pharmaceutical formulations containing octanoic acid or a salt or ester thereof. The pharmaceutical formulations are useful for the treatment of involuntary tremors.

Claims

1. A pharmaceutical composition in unit dosage form comprising octanoic acid, or a salt or ester thereof, in an amount sufficient to treat involuntary tremors when administered to a subject.

2. The pharmaceutical composition of claim 1, wherein said unit dosage form comprises from 1 mg to 1.0 g of octanoic acid, or a salt or ester thereof.

3. The pharmaceutical composition of claim 2, wherein said unit dosage form comprises octanoic acid.

4. The pharmaceutical composition of claim 2, wherein said unit dosage form comprises an ester of octanoic acid.

5. The pharmaceutical composition of claim 4, wherein said ester is 1-methyl-1,2-ethanediyl octanoate (1,2-dicaprylin), methyl octanoate, ethyl octanoate, propyl octanoate, butyl octanoate, hexyl octanoate, heptyl octanoate, octyl octanoate, octanoylglucuronide, or 1,2,3-propanetriyl octanoate.

6. The pharmaceutical composition of claim 2, wherein said unit dosage form comprises a salt of octanoic acid.

7. The pharmaceutical composition of claim 6, wherein said salt is an alkali metal salt, an alkaline earth salt, or a basic addition salt.

8. The pharmaceutical composition of claim 1, wherein said unit dosage form is a tablet, pill, capsule, or caplet.

9. The pharmaceutical composition of claim 1, wherein said octanoic acid, or a salt or ester thereof, is substantially pure.

10. The pharmaceutical composition of claim 1, further comprising a second agent selected from beta blockers, anticonvulsants, benzodiazepines, or Botulinum toxin type A and/or B.

13. The method of claim 11, wherein said pharmaceutical composition is a pharmaceutical composition of any one of claims 1-10.

27. The kit of claim 26, wherein said pharmaceutical composition is a pharmaceutical composition of any one of claims 1-10.

11. A method of treating an involuntary tremor in a subject in need thereof, said method comprising administering to said subject a pharmaceutical composition comprising octanoic acid, or a salt or ester thereof, in an amount sufficient to treat said involuntary tremor.

12. The method of claim 11, wherein said pharmaceutical composition is administered one, two, or three times daily.

20. The method of claim 11, wherein said pharmaceutical composition is formulated as a syrup, or elixir.

23. The method of claim 11 any of claim 11, wherein said involuntary tremor is essential tremor, drug-induced tremor, or disease-induced tremor.

24. The method of claim 23, wherein said involuntary tremor is drug-induced tremor associated with the use of cysclosporine, antidepressants, amphetamines, antipsychotics, or caffeine.

25. The method of claim 23, wherein said involuntary tremor is disease-induced associated with Parkinson'"'"'s disease, Multiple Sclerosis, stroke, head injury, Wilson'"'"'s disease, mercury poisoning, over-active thyroid gland, or liver encephalopathy.

14-19. -19. (canceled)

21. (canceled)

22. (canceled)

26. A kit comprising (i) a pharmaceutical composition comprising octanoic acid, or a salt or ester thereof, and (ii) instructions for administering said pharmaceutical composition to a subject for the treatment of involuntary tremors.

28-38. -38. (canceled)

39. A method of treating an involuntary tremor in a subject in need thereof, said method comprising the steps of (i) diagnosing said subject as having involuntary tremor;

and (ii) administering to said subject a pharmaceutical composition comprising octanoic acid, or a salt or ester thereof, in an amount sufficient to treat said involuntary tremor.

40. The method of claim 39, wherein said involuntary tremor is essential tremor, drug-induced tremor, or disease-induced tremor.

41. The method of claim 39, wherein said involuntary tremor is disease-induced associated with Parkinson'"'"'s disease, Multiple Sclerosis, stroke, head injury, Wilson'"'"'s disease, mercury poisoning, over-active thyroid gland, or liver encephalopathy.