Unit dosage form

Abstract

The present invention relates to highly selective phosphodiesterase (PDE) enzyme inhibitors and to their use in pharmaceutical articles of manufacture. In particular, the present invention relates to potent inhibitors of cyclic guanosine 3′,5′-monophosphate specific phosphodiesterase type 5 (PDES) that when incorporated into a pharmaceutical product at about 1 to about 20 mg unit dosage are useful for the treatment of sexual dysfunction.

What is claimed is:  
     
         1 . A pharmaceutical unit dosage composition comprising about 1 to about 20 mg of a compound having the structural formula:  
       
         
           
           
               
               
           
         
       
       said unit dosage form suitable for oral administration.  
     
     
         2 . The dosage form of  claim 1  comprising about 2 to about 20 mg of the compound in unit dosage form.  
     
     
         3 . The dosage form of  claim 1  comprising about 5 to about 20 mg of the compound in unit dosage form.  
     
     
         4 . The dosage form of  claim 2  comprising about 2.5 mg of the compound in unit dosage form.  
     
     
         5 . The dosage form of  claim 3  comprising about 5 mg of the compound in unit dosage form.  
     
     
         6 . The dosage form of  claim 3  comprising about 10 mg of the compound in unit dosage form.  
     
     
         7 . The dosage form of claims  1  through  6  wherein the unit dose is in a form selected from the group consisting of a liquid, a tablet, a capsule, and a gelcap.  
     
     
         8 . The dosage form of claims  1  through  6  wherein the unit dose is in the form of a tablet.  
     
     
         9 . The dosage form of claims  1  through  6  for use in treating a condition where inhibition of PDE5 is desirable.  
     
     
         10 . The dosage form of  claim 9  wherein the condition is a sexual dysfunction.  
     
     
         11 . The dosage form of  claim 10  wherein the sexual dysfunction is male erectile dysfunction.  
     
     
         12 . The dosage form of  claim 10  wherein the sexual dysfunction is female arousal disorder.  
     
     
         13 . A method of treating sexual dysfunction in a patient in need thereof comprising administering one or more unit dose containing about 1 to about 20 mg, up to a maximum total dose of 20 mg per day, of a compound having the structure  
       
         
           
           
               
               
           
         
       
     
     
         14 . The method of  claim 13  wherein the unit dose contains about 2 to about 20 mg of the compound.  
     
     
         15 . The method of  claim 13  wherein the unit dose contains about 5 mg of the compound.  
     
     
         16 . The method of  claim 13  wherein the unit dose contains about 10 mg of the compound and is administered once per day.  
     
     
         17 . The method of  claim 13  wherein the unit dose is in a form selected from the group consisting of a liquid, a tablet, a capsule, and a gelcap.  
     
     
         18 . The invention as hereinbefore described.  
     
     
         19 . Use of a unit dose containing about 1 to about 20 mg of a compound having the structure  
       
         
           
           
               
               
           
         
       
       for the manufacture of a medicament for the treatment of sexual dysfunction in a patient in need thereof.