Stabilized antihistamine syrup

Abstract

An antihistaminic syrup is stabilized against degradation of the active ingredient, by the addition of about 0.05 to about 5 mg/mL of an aminopolycarboxylic acid, such as a salt of ethylenediaminetetraacetic acid.

1 . An antihistaminic syrup formulation containing about 0.05 to about 5 mg/mL of an aminopolycarboxylic acid, including salts thereof.  
   
   
       2 . The syrup of  claim 1 , which contains an antihistaminic ingredient selected from the group consisting of: loratadine; descarboethoxyloratadine; azatadine; and any combination of two or more thereof.  
   
   
       3 . The syrup of  claim 1 , which contains the antihistaminic ingredient loratadine.  
   
   
       4 . The syrup of  claim 1 , which contains the antihistaminic ingredient descarboethoxyloratadine.  
   
   
       5 . The syrup of  claim 1 , which contains the antihistaminic ingredient azatadine.  
   
   
       6 . The syrup of  claim 1 , wherein the aminopolycarboxylic acid is selected from the group consisting of: iminodiacetic acid; methyliminodiacetic acid; nitrilotriacetic acid; ethylenediaminetetraacetic acid; diethylenetriaminepentaacetic acid; 1,2-diaminocyclohexane-tetraacetic acid; N-hydroxyethylenediaminetriacetic acid; and any combination of two or more thereof.  
   
   
       7 . The syrup of  claim 1 , wherein the aminopolycarboxylic acid comprises ethylenediaminetetraacetic acid.  
   
   
       8 . The syrup of  claim 1 , in which the aminopolycarboxylic acid comprises about 0.1 to 1 mg/mL.  
   
   
       9 . The syrup of  claim 7 , in which the aminopolycarboxylic acid comprises about 0.25 to about 0.5 mg/mL.  
   
   
       10 . The syrup of  claim 1 , further containing a therapeutically effective amount of a decongestant, an analgesic, an antitussive, an expectorant, or any combination of two or more thereof.  
   
   
       11 . The syrup of  claim 1 , further containing a decongestant selected from the group consisting of pseudoephedrine and phenylpropanolamine.  
   
   
       12 . The syrup of  claim 1 , further containing the decongestant pseudoephedrine.  
   
   
       13 . The syrup of  claim 12 , which contains the antihistaminic ingredient loratadine.  
   
   
       14 . An antihistaminic syrup formulation containing loratadine or descarboethoxyloratadine and about 0.05 to about 5 mg/mL of an aminopolycarboxylic acid or a salt thereof.  
   
   
       15 . The syrup of  claim 14 , wherein the aminopolycarboxylic acid is selected from the group consisting of: iminodiacetic acid; methyliminodiacetic acid; nitrilotriacetic acid; ethylenediaminetetraacetic acid; diethylenetriaminepentaacetic acid; 1,2-diaminocyclohexane-tetraacetic acid; N-hydroxyethylenediaminetriacetic acid; and any combination of two or more thereof.  
   
   
       16 . The syrup of  claim 14 , wherein the aminopolycarboxylic acid comprises ethylenediaminetetraacetic acid.  
   
   
       17 . The syrup of  claim 14 , in which the aminopolycarboxylic acid comprises about 0.1 to 1 mg/mL.  
   
   
       18 . The syrup of  claim 14 , in which the aminopolycarboxylic acid comprises about 0.25 to about 0.5 mg/mL.  
   
   
       19 . The syrup of  claim 14 , further containing an analgesic.  
   
   
       20 . The syrup of  claim 14 , further containing a decongestant selected from the group consisting of pseudoephedrine and phenylpropanolamine.  
   
   
       21 . The syrup of  claim 20 , further containing an analgesic.  
   
   
       22 . An antihistaminic syrup formulation containing loratadine and about 0.05 to about 5 mg/mL of an aminopolycarboxylic acid or a salt thereof.  
   
   
       23 . An antihistaminic syrup formulation containing descarboethoxyloratadine and about 0.05 to about 5 mg/mL of an aminopolycarboxylic acid or a salt thereof.