Oral Dosage Form Containing A PDE 4 Inhibitor as an Active Ingredient and Polyvinylpyrrolidon as Excipient

Abstract

Dosage forms for oral administration of a PDE 4 inhibitor whose solubility is slight are described. They contain PVP as binder.

1 .- 11 . (canceled) 
     
     
         12 . A method for the treatment of chronic obstructive pulmonary disease (COPD), comprising:
 orally administering to a patient suffering from chronic obstructive pulmonary disease an immediate release solid dosage form including between 250 and 500 μg of a PDE 4 inhibitor that is N-(3,5-dichloropyrid-4-yl)-3-cyclopropylmethoxy-4-difluoromethoxybenzamide (roflumilast) or a salt thereof, and one or more suitable pharmaceutical excipients.   
     
     
         13 . The method of treatment according to  claim 12 , wherein the PDE 4 inhibitor is roflumilast. 
     
     
         14 . The method of treatment according to  claim 12 , wherein the immediate release solid dosage form is a tablet. 
     
     
         15 . The method of treatment of  claim 14 , wherein the PDE4 inhibitor is roflumilast. 
     
     
         16 . A method for the treatment of chronic obstructive pulmonary disease (COPD), comprising:
 orally administering to a patient suffering from chronic obstructive pulmonary disease an immediate release oral solid dosage form in tablet or pellet form including between 250 and 500 μg of N-(3,5-dichloropyrid-4-yl)-3-cyclopropylmethoxy-4-difluoromethoxybenzamide (roflumilast) or a salt thereof, and one or more suitable pharmaceutical excipients.   
     
     
         17 . The method of treatment of  claim 16  wherein said immediate release oral dosage form is administered once per day. 
     
     
         18 . The method of treatment of  claim 16 , wherein said immediate release oral solid dosage form in tablet or pellet form contains 500 μg of N-(3,5-dichloropyrid-4-yl)-3-cyclopropylmethoxy-4-difluoromethoxybenzamide (roflumilast). 
     
     
         19 . The method of treatment of  claim 17 , wherein said immediate release oral solid dosage form in tablet or pellet form contains 500 μg of N-(3,5-dichloropyrid-4-yl)-3-cyclopropylmethoxy-4-difluoromethoxybenzamide (roflumilast). 
     
     
         20 . The method of treatment of  claim 12 , wherein said immediate release oral solid dosage form contains 500 μg of N-(3,5-dichloropyrid-4-yl)-3-cyclopropylmethoxy-4-difluoromethoxybenzamide (roflumilast). 
     
     
         21 . The method of treatment of  claim 12  wherein said immediate release oral dosage form is administered once per day. 
     
     
         22 . The method of treatment of  claim 21 , wherein said immediate release oral solid dosage form contains 500 μg of N-(3,5-dichloropyrid-4-yl)-3-cyclopropylmethoxy-4-difluoromethoxybenzamide (roflumilast).