IP Library Granted Patent US 9,216,162
Granted Patent B2
US 9,216,162 · App. 14/632,089 · Granted Dec 22, 2015

N-acetylcysteine amide (NAC amide) in the treatment of diseases and conditions associated with oxidative stress

Inventor: Glenn A. Goldstein (New York, NY)
A61K31/16A61K9/007A61K9/0014A61K9/0019A61K9/0043A61K31/167A61K31/375C07C233/18C07C233/26C07C233/36C07C323/41C07C323/60
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Quick Facts
Patent No.
US 9,216,162
App. No.
14/632,089
Granted
Dec 22, 2015
Kind
B2
Abstract

Methods and compositions comprising N-acetylcysteine amide (NAC amide) and derivatives thereof are used in treatments and therapies for human and non-human mammalian diseases, disorders, conditions and pathologies. Pharmaceutically or physiologically acceptable compositions of NAC amide or derivatives thereof are administered alone, or in combination with other suitable agents, to reduce, prevent, or counteract oxidative stress and free radical oxidant formation and overproduction in cells and tissues, as well as to provide a new source of glutathione.

Claims (25)

1. A method for blocking or reducing hepatic toxicity of acetaminophen in a human subject, comprising administering to the human subject an effective dose of N-acetylcysteine amide (NAC Amide), or a pharmaceutically acceptable salt or ester thereof, thereby blocking or reducing hepatic toxicity of acetaminophen in the human subject.

2. The method according to claim 1 , wherein the NAC Amide is administered as a prophylactic.

3. The method according to claim 1 , wherein the dose for administration is 50-10,000 mg per dose.

4. The method of claim 1 , wherein the dose for administration is 25-500 mg per dose.

5. The method of claim 1 , wherein NAC Amide is delivered orally via a capsule.

6. The method of claim 1 , wherein NAC Amide is administered subcutaneously, intravenously, intramuscularly, and intrasternally and intraperitoneally.

7. The method of claim 1 , wherein NAC Amide is administered orally, via inhalation, topically, or intranasally.

8. The method of claim 1 , wherein NAC Amide is administered before, concurrently with, and/or after an administration of acetaminophen.

9. A method of treating a human subject for hepatic toxicity of acetaminophen, comprising administering to the human subject an effective dose of N-acetylcysteine amide (NAC Amide), or a pharmaceutically acceptable salt or ester thereof, thereby treating the human subject in need of treatment for hepatic toxicity of acetaminophen.

10. The method according to claim 9 , wherein the NAC Amide is administered as a prophylactic.

11. The method according to claim 9 , wherein the dose for administration is 50-10,000 mg per dose.

12. The method of claim 9 , wherein the dose for administration is 25-500 mg per dose.

13. The method of claim 9 , wherein NAC Amide is delivered orally via a capsule.

14. The method of claim 9 , wherein NAC Amide is administered subcutaneously, intravenously, intramuscularly, and intrasternally and intraperitoneally.

15. The method of claim 9 , wherein NAC Amide is administered orally, via inhalation, topically, or intranasally.

16. The method of claim 9 , wherein NAC Amide is administered before after exposure to acetaminophen.

17. A combination pharmaceutical composition comprising N-acetylcysteine amide (NAC Amide), and acetaminophen.

18. The combination pharmaceutical composition of claim 17 , further comprising ascorbic acid.

19. The combination pharmaceutical composition of claim 17 , comprising about 500 mg NAC Amide.

20. The combination pharmaceutical composition of claim 18 , comprising about 250 mg ascorbic acid.

21. The combination pharmaceutical composition of claim 17 , comprising about 350 mg acetaminophen.

22. The combination pharmaceutical composition of claim 17 , comprising about 50-10,000 mg NAC Amide.

23. The combination pharmaceutical composition of claim 17 , comprising about 25-500 mg NAC Amide.

24. The combination pharmaceutical composition of claim 17 , comprising about 500 mg NAC Amide, and about 350 mg acetaminophen.

25. The combination pharmaceutical composition of claim 18 , comprising about 500 mg NAC Amide, about 250 mg ascorbic acid, and about 350 mg acetaminophen.

Continuity (6)
Continuation 13952028 · Jul 26, 2013
Continuation In Part 12707092 · Feb 17, 2010
Continuation 11912293
Provisional Application 60705967 · Aug 5, 2005
Provisional Application 60673561 · Apr 21, 2005
Related Publication 20150164830A1 · Jun 18, 2015