Oral Dosage Form Containing A Pde 4 Inhibitor As An Active Ingredient And Polyvinylpyrrolidon As Excipient

Abstract

An immediate release solid dosage form in tablet or pellet form for oral administration of a PDE 4 inhibitor, comprising 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; wherein said dosage form contains 500 μg of the roflumilast or salt thereof.

1 - 11 . (canceled) 
     
     
         12 . An immediate release solid dosage form in tablet or pellet form for oral administration of a PDE 4 inhibitor, comprising 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;
 wherein said dosage form contains 500 μg of the roflumilast or salt thereof.   
     
     
         13 . The dosage form according to  claim 12 , wherein the PDE 4 inhibitor is roflumilast. 
     
     
         14 . The dosage form according to  claim 12 , wherein the dosage form is a tablet. 
     
     
         15 . The dosage form according to  claim 12 , wherein the dosage form is a tablet and the PDE 4 inhibitor is roflumilast. 
     
     
         16 . The dosage form according to  claim 12 , wherein the dosage form provides about 78% release of the roflumilast or salt thereof from said dosage form within about 15 minutes as determined by methods described in the US Pharmacopeia at USP XXV, apparatus 2. 
     
     
         17 . The dosage form according to  claim 16 , wherein the PDE 4 inhibitor is roflumilast. 
     
     
         18 . The dosage form according to  claim 16 , wherein the dosage form is a tablet. 
     
     
         19 . The dosage form according to  claim 16 , wherein the dosage form is a tablet and the PDE 4 inhibitor is roflumilast. 
     
     
         20 . The dosage form according to  claim 12 , wherein the dosage form provides about quantitative release of the roflumilast or salt thereof from said dosage form within about 60 minutes as determined by a method described in the US Pharmacopeia at USP XXV, apparatus 2. 
     
     
         21 . The dosage form according to  claim 20 , wherein the PDE inhibitor is roflumilast. 
     
     
         22 . The dosage form according to  claim 20 , wherein the dosage form is a tablet. 
     
     
         23 . The dosage form according to  claim 20 , wherein the dosage form is a tablet and the PDE inhibitor is roflumilast. 
     
     
         24 . The immediate release solid dosage form of  claim 12 , wherein the PDE 4 inhibitor is roflumilast and said roflumilast is provided as a solid solution. 
     
     
         25 . The immediate release solid dosage form of  claim 24 , wherein said solid solution of roflumilast is provided in granulated form. 
     
     
         26 . An immediate release solid dosage form in tablet or pellet form for oral administration of a PDE 4 inhibitor, comprising 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;
 wherein said dosage form contains 500 μg of the roflumilast or salt thereof; and   wherein said dosage form provides a plasma concentration of the roflumilast or salt thereof having a Cmaxof more than about 6.5 μg/l.