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Last Updated: October 29, 2020

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Claims for Patent: 9,427,421

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Summary for Patent: 9,427,421
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 S. (Massagno, CH)
Assignee: ALPEX PHARMA S.A. (Mezzovico, CH)
Application Number:14/800,228
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 from 3.5% to 15% w/w of a mixture of pharmaceutically acceptable excipients comprising a sweetener, a flavorant, and a diluent, wherein the oral effervescent composition results in an unit dose of N-acetylcysteine selected from the group consisting of 0.5 g, 1.0 g, 1.5 g, 2.0 g and 2.5 g.

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

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

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

5. The oral effervescent composition according to claim 1, wherein the amount of the sweetener is from 0.2% to 10% w/w of the mixture of pharmaceutically acceptable excipients.

6. The oral effervescent composition according to claim 5, wherein the amount of the sweetener is from 0.5 to 1% w/w of the mixture of pharmaceutically acceptable excipients.

7. The oral effervescent composition according to claim 1, wherein the amount of the flavorant is from 1% to 3% w/w of the mixture of pharmaceutically acceptable excipients.

8. The oral effervescent composition according to claim 7, wherein the amount of the flavorant is about 2% w/w of the mixture of pharmaceutically acceptable excipients.

9. The oral effervescent composition according to claim 1, wherein the amount of the diluent is from 2% to 20% w/w of the mixture of pharmaceutically acceptable excipients.

10. The oral effervescent composition according to claim 1, 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.

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

12. The oral effervescent composition according to claim 11, wherein the amount of carbonate or bicarbonate salt is from 30% to 35% w/w of the composition.

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

14. The oral effervescent composition according to claim 13, wherein the artificial sweetener is selected from the group consisting of sodium saccharin, acesulfame potassium, cyclamates, and sucralose.

15. The oral effervescent composition according to claim 14, wherein the artificial sweetener is sucralose.

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

17. The oral effervescent composition according to claim 16, wherein the diluent is maltodextrin.

18. The oral effervescent composition according to claim 1, further comprising a lubricant.

19. The oral effervescent composition according to claim 18, wherein the lubricant is sodium benzoate.

20. The oral effervescent composition according to claim 1 obtained by wet granulation in a fluid bed granulator.

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