Oral fast-dissolving compositions for dopamine agonists

Abstract

The present invention discloses the use of a pharmaceutical composition for oral administration comprising a carrier and active ingredient selected from a dopamine agonist, testosterone and mixtures thereof, the composition being in the form of a fast-dispersing dosage form designed to release the active ingredient rapidly in the oral cavity for the manufacture of a medicament for treatment of male erectile dysfunction.

What is claimed is:  
     
         1 . A method for the treatment of male erectile dysfunction comprising the step of oral administration of a pharmaceutical composition comprising a carrier and an active ingredient selected from the group consisting of a dopamine agonist, testosterone and mixtures thereof, the composition being in the form of a fast-dispersing dosage form designed to release the active ingredient rapidly in the oral cavity by disintegrating within 1 to 30 seconds of being placed in the oral cavity; and wherein said composition is a solid fast-dispersing dosage form comprising a network of the active ingredient and a carrier.  
     
     
         2 . The method of  claim 1  in which the dopamine agonist is apomorphine or a salt thereof.  
     
     
         3 . The method of  claim 1  in which the active ingredient is present in an amount of from 0.05 to 50 mg.  
     
     
         4 . The method of  claim 1  which further includes an anti-emetic.  
     
     
         5 . The method of  claim 1  in which the anti-emetic is present in an amount from 1 to 120 mg.  
     
     
         6 . The method of  claim 1  which further includes an opioid antagonist.  
     
     
         7 . The method of  claim 6  in which the opioid antagonist is present in an amount of from 0.5 to 100 mg.  
     
     
         8 . The method of  claim 1  in which the active ingredient comprises testosterone.  
     
     
         9 . The method of  claim 8  in which the testosterone is present in an amount of 10 to 100 mg.  
     
     
         10 . The method of  claim 3  in which further includes an anti-emetic present in an amount of from 1 to 120 mg.  
     
     
         11 . The method of  claim 6  in which the active ingredient comprises testosterone.  
     
     
         12 . The method of  claim 7  in which the active ingredient comprises testosterone.  
     
     
         13 . The method of  claim 11  in which the testosterone is present in an amount of 10 to 100 mg.  
     
     
         14 . The method of  claim 1  wherein said matrix forming agent comprises gelatin.