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Last Updated: October 31, 2020

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Claims for Patent: 9,561,204

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Summary for Patent: 9,561,204
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:15/222,232
Patent Claims: 1. A method of treating acetaminophen poisoning comprising administering an effective amount of 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 is 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 method of treating acetaminophen poisoning according to claim 1 wherein the oral effervescent composition is in an unit dose of N-acetylcysteine of 0.5 or 2.5 g.

3. The method of treating acetaminophen poisoning according to claim 1 wherein the unit doses of 0.5 g and 2.5 g are combined to provide therapeutically effective dosages of N-acetylcysteine according to the Prescott therapy protocol, wherein the protocol is based on the body weight of a patient to be treated, starting from a loading dose followed by a maintenance dose.

4. The method of treating acetaminophen poisoning according to claim 1 wherein the amount of N-acetylcysteine in the oral effervescent composition is from 50% to 80% w/w of the composition.

5. The method of treating acetaminophen poisoning according to claim 4 wherein the amount of N-acetylcysteine in the oral effervescent composition is from 50% to 60% w/w of the composition.

6. The method of treating acetaminophen poisoning according to claim 5 wherein the amount of N-acetylcysteine in the oral effervescent composition is from 54 to 55% w/w of the composition.

7. The method of treating acetaminophen poisoning according to claim 1 wherein the amount of sweetener in the oral effervescent composition is from 0.2% to 10% w/w of the mixture of pharmaceutically acceptable excipients.

8. The method of treating acetaminophen poisoning according to claim 7 wherein the amount of sweetener in the oral effervescent composition is from 0.5 to 1% w/w of the mixture of pharmaceutically acceptable excipients.

9. The method of treating acetaminophen poisoning according to claim 1 wherein the amount of flavorant in the oral effervescent composition is from 1% to 3% w/w of the mixture of pharmaceutically acceptable excipients.

10. The method of treating acetaminophen poisoning according to claim 9 wherein the amount of flavorant in the oral effervescent composition is 2% w/w of the mixture of pharmaceutically acceptable excipients.

11. The method of treating acetaminophen poisoning according to claim 1 wherein the amount of diluent in the oral effervescent composition is from 2% to 20% w/w of the mixture of pharmaceutically acceptable excipients.

12. The method of treating acetaminophen poisoning according to claim 1 wherein the the carbonate or bicarbonate salt in the oral effervescent composition is selected from the group consisting of sodium bicarbonate, sodium carbonate, potassium bicarbonate, potassium carbonate, sodium sesquicarbonate, sodium glycine carbonate.

13. The method of treating acetaminophen poisoning according to claim 1 wherein the amount of carbonate or bicarbonate salt in the oral effervescent composition is from 20% to 45% w/w of the composition.

14. The method of treating acetaminophen poisoning according to claim 1 wherein the amount of carbonate or bicarbonate salt in the oral effervescent composition is from 30% to 35% w/w of the composition.

15. The method of treating acetaminophen poisoning according to claim 1 wherein the sweetener in the oral effervescent composition is selected from the group consisting of sugars and artificial sweeteners.

16. The method of treating acetaminophen poisoning according to claim 15 wherein the sweetener is an artificial sweetener selected from the group consisting of sodium saccharin, acesulfame potassium, cyclamates, and sucralose.

17. The method of treating acetaminophen poisoning according to claim 16 wherein the artificial sweetener is sucralose.

18. The method of treating acetaminophen poisoning according to claim 1 wherein the diluent in the oral effervescent composition is selected from the group consisting of polyols, cellulose, starch and maltodextrin.

19. The method of treating acetaminophen poisoning according to claim 18 wherein the diluent is maltodextrin.

20. The method of treating acetaminophen poisoning according to claim 1 wherein the oral effervescent composition further comprises a lubricant.

21. The method of treating acetaminophen poisoning according to claim 20 wherein the lubricant is sodium benzoate.

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