Suspensions and diluents for metronidazole and baclofen

Abstract

Suspensions of metronidazole or baclofen and/or salts or ester derivative thereof, such as metronidazole benzoate, are disclosed. The suspension may include metronidazole or baclofen, and/or a salt or ester derivative thereof a hydrocolloid stabilizer, simethicone emulsion, a buffer, such as sodium citrate, (dihydrate), a preservative, a thickening agent, a sweetener, and water.

1 . A suspension of metronidazole or a salt or ester derivative thereof, comprising metronidazole or a salt or ester derivative thereof; a hydrocolloid stabilizer, simethicone emulsion; sodium citrate, (dihydrate); a preservative, a thickening agent, a sweetener, and water. 
     
     
         2 . The suspension of  claim 1 , wherein the hydrocolloid stabilizer is microcrystalline cellulose and/or carboxymethylcellulose sodium. 
     
     
         3 . The suspension of  claim 1 , wherein the thickening agent is xanthan gum. 
     
     
         4 . The suspension of  claim 1 , wherein the suspension comprises metronidazole benzoate. 
     
     
         5 . The suspension of  claim 1 , wherein the sweetener is selected from the group consisting of ammonium glycyrrhizate, sucralose, and saccharin sodium. 
     
     
         6 . The suspension of  claim 1 , wherein the preservative is sodium benzoate. 
     
     
         7 . The suspension of  claim 1 , wherein the preservative is citric acid. 
     
     
         8 . The suspension of  claim 1 , further comprising flavor grape 59.266/A. 
     
     
         9 . The suspension of  claim 1 , wherein the pH of the formulation is between 3.6 and 4.6. 
     
     
         10 . The suspension of  claim 1 , wherein the formulation retains homogeneity of less than +/−5% of assay for active pharmaceutical ingredient after at least 30 days. 
     
     
         11 . The suspension of  claim 1 , wherein the suspension includes the following:
 a. 0.05% (w/v) ammonium glycyrrhizate, (magnasweet 100);   b. 1.50% (w/v) Avicel RC591;   c. 0.50% (w/v) citric acid, (anhydrous);   d. 0.05% (w/v) flavor grape 59.266/A;   e. 0.03% (w/v) saccharin sodium;   f. 0.2% (w/v) simethicone emulsion, (30%);   g. 0.15% (w/v) sodium benzoate, NF;   h. 0.20% (w/v) sodium citrate, (dihydrate);   i. 0.10% (w/v) sucralose;   j. 0.10% (w/v) xanthan gum; and   k. purified water,   
     
     
         12 . The suspension of  claim 1 , wherein the suspension includes the following:
 a. 0.12% (w/v) citric acid, (anhydrous);   b. 0.0002% (w/v) D&C Yellow No. 10;   c. 0.000038% (w/v) FD&C Red No. 40;   d. 0.0500% (w/v) flavor grape 59.266/A;   e. 0.5000% (wv) hydroxyethyl cellulose;   f. 5.000% (w/v) propylene glycol;   g. 0.1500% (w/v) simethicone emulsion, (30%);   h. 0.1000% (w/v) sodium benzoate;   i. 0.2000% (w/v) sucralose;   j. purified water.   
     
     
         13 . A liquid diluent comprising: 0.03-0.08% (w/v) ammonium glycyrrhizate; 1.0-2.0% (w/v) Avicel RC591; 0.1-0.9% (w/v) citric acid; 0.01-0.10% (w/v) flavoring; 0.01-0.05% (w/v) saccharin sodium; 0.1-0.3% (w/v) simethicone emulsion; 0.1-0.2% (w/v) sodium benzoate; 0.1-0.3% (w/v) sodium citrate, (dihydrate); 0.05-0.2% (w/v) sucralose; 0.05-0.2% (w/v) xanthan gum; and purified water. 
     
     
         14 . The liquid diluent of  claim 12 , comprising:
 0.05% (w/v) ammonium glycyrrhizate, (magnasweet 100); 1.50% (w/v) Avicel RC591; 0.50% (w/v) citric acid, (anhydrous); 0.05% (w/v) flavor grape 59.266/A; 0.03% (w/v) saccharin sodium; 0.2% (w/v) simethicone emulsion, (30%); 0.15% (w/v) sodium benzoate; 0.20% (w/v) sodium citrate, (dihydrate); 0.10% (w/v) sucralose; 0.10% (w/v) xanthan gum; and purified water.   
     
     
         15 . A suspension of metronidazole, comprising a salt or ester derivative of metronidazole; simethicone emulsion; sodium bicarbonate; and sodium citrate, (dihydrate), wherein the suspension is stable for at least 30 days when stored at 2-8 degrees celsius. 
     
     
         16 . The suspension of  claim 1 , wherein the suspension comprises a pH of no more than pH 4.6. 
     
     
         17 . The suspension of  claim 1 , wherein the formulation retains homogeneity of less than +/−5% of assay for active pharmaceutical ingredient after at least 30 days. 
     
     
         18 . The suspension of  claim 1 , wherein the formulation maintains homogeneity of the active pharmaceutical ingredient for at least 30 days after reconstitution. 
     
     
         19 - 28 . (canceled) 
     
     
         29 . A liquid diluent comprising: citric acid; flavoring; hydroxyethyl cellulose; simethicone emulsion; propylene glycol; sodium benzoate; sucralose; and purified water.