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

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.