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.

What is claimed is: 
     
         1 . An effervescent composition comprising at least 50% w/w of N-acetylcysteine, at least 20% w/w of a carbonate or bicarbonate salt and a mixture of pharmaceutically acceptable excipients comprising a sweetener, a flavor, and a diluent. 
     
     
         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 about 54-55% w/w. 
     
     
         5 . The 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, sodium glycine carbonate. 
     
     
         6 . The effervescent composition according to  claim 5  wherein the bicarbonate salt is sodium bicarbonate. 
     
     
         7 . The effervescent composition according to  claim 1  wherein the amount of carbonate or bicarbonate salt is from 20% to 45% w/w. 
     
     
         8 . The effervescent composition according to  claim 7  wherein the amount of carbonate or bicarbonate salt is from 30% to 35% w/w. 
     
     
         9 . The effervescent composition according to  claim 1  wherein the sweetener is selected from the group consisting of sugars and artificial sweeteners. 
     
     
         10 . The effervescent composition according to  claim 9  wherein the artificial sweetener is selected from the group consisting of sodium saccharin, acesulfame potassium, cyclamates, sucralose. 
     
     
         11 . The effervescent composition according to  claim 10  wherein the artificial sweetener is sucralose. 
     
     
         12 . The effervescent composition according to  claim 1  wherein the diluent is selected from the group consisting of polyols, cellulose, starch and maltodextrin. 
     
     
         13 . The effervescent composition according to  claim 12  wherein the diluent is maltodextrin. 
     
     
         14 . The effervescent composition according to  claim 1  further comprising a lubricant. 
     
     
         15 . The effervescent composition according to  claim 14  wherein the lubricant is sodium benzoate. 
     
     
         16 . 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 and a mixture of pharmaceutically acceptable excipients comprising a sweetener, a flavor, and a diluent to a patient in need thereof. 
     
     
         17 . The method according to  claim 16  wherein the effervescent composition contains a unit-dose of N-acetylcysteine of 0.5 g, 1.0 g, 1.5 g, 2.0 g, 2.5 g and combinations thereof. 
     
     
         18 . The method according to  claim 17  wherein the unit-dose is 0.5 g, 2.5 g and combinations thereof.