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Claims for Patent: 8,747,894

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Claims for Patent: 8,747,894

Title:Effervescent compositions containing N-acetylcysteine
Abstract: Effervescent pharmaceutical compositions containing a high amount of N-acetylcysteine and a method of treating acetaminophen poisoning with effervescent pharmaceutical compositions containing a high amount of N-acetylcysteine are described.
Inventor(s): Stroppolo; Federico (Aldesago, CH), Granata; Gabriele (Leggiuno, IT), Ardalan; Shahbaz (Massagno, CH)
Assignee: Alpex Pharma S.A. (Meezovico, CH)
Application Number:13/466,721
Patent Claims: 1. An oral effervescent composition comprising at least 50% w/w of N-acetylcysteine, at least 20% w/w of a carbonate or bicarbonate salt, without an additional organic or inorganic acid, and a mixture of pharmaceutically acceptable excipients comprising a sweetener, a flavor, and a diluent, wherein the carbonate or bicarbonate salt is selected from the group consisting of sodium bicarbonate, sodium carbonate, potassium bicarbonate, potassium carbonate, sodium sesquicarbonate, and sodium glycine carbonate.

2. The effervescent composition according to claim 1 wherein the amount of N-acetylcysteine is from 50% to 80% w/w.

3. The effervescent composition according to claim 2 wherein the amount of N-acetylcysteine is from 50% to 60% w/w.

4. The effervescent composition according to claim 3 wherein the amount of N-acetylcysteine is from 54% to 55% w/w.

5. The effervescent composition according to claim 1 wherein the bicarbonate salt is sodium bicarbonate.

6. The effervescent composition according to claim 1 wherein the amount of carbonate or bicarbonate salt is from 20% to 45% w/w.

7. The effervescent composition according to claim 6 wherein the amount of carbonate or bicarbonate salt is from 30% to 35% w/w.

8. The effervescent composition according to claim 1 wherein the sweetener is selected from the group consisting of sugars and artificial sweeteners.

9. The effervescent composition according to claim 8 wherein the artificial sweetener is selected from the group consisting of sodium saccharin, acesulfame potassium, cyclamates, and sucralose.

10. The effervescent composition according to claim 9 wherein the artificial sweetener is sucralose.

11. The effervescent composition according to claim 1 wherein the diluent is selected from the group consisting off polyols, cellulose, starch and maltodextrin.

12. The effervescent composition according to claim 11 wherein the diluent is maltodextrin.

13. The effervescent composition according to claim 1 further comprising a lubricant.

14. The effervescent composition according to claim 13 wherein the lubricant is sodium benzoate.

15. A method of treating acetaminophen poisoning, comprising administering an effective amount of effervescent composition containing at least 50% w/w of N-acetylcysteine, at least 20% w/w of a carbonate or bicarbonate salt, without an additional organic or inorganic acid, and a mixture of pharmaceutically acceptable excipients comprising a sweetener, a flavor, and a diluent to a patient in need thereof, wherein the carbonate or bicarbonate salt is selected from the group consisting of sodium bicarbonate, sodium carbonate, potassium bicarbonate, potassium carbonate, sodium sesquicarbonate, and sodium glycine carbonate.

16. The method according to claim 15 wherein the effervescent composition contains a unit-dose of N-acetylcysteine of 0.5 g, 1.0 g, 1.5 g, 2.0 g, or 2.5 g.

17. The method according to claim 16 wherein the unit-dose is 0.5 or 2.5 g.
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