US2014031397A1PendingUtilityA1

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

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Assignee: TAKEDA GMBHPriority: Feb 20, 2002Filed: Sep 26, 2013Published: Jan 30, 2014
Est. expiryFeb 20, 2022(expired)· nominal 20-yr term from priority
A61P 43/00A61P 11/08A61P 11/06A61P 11/00A61K 9/0053A61K 9/2027A61K 31/166A61K 9/20A61K 9/2018A61K 9/0002A61K 9/2059A61K 31/44A61K 9/2054A61K 9/2013
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Claims

Abstract

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

Claims

exact text as granted — not AI-modified
1 .- 41 . (canceled) 
     
     
         42 . A method for the treatment of chronic obstructive pulmonary disease (COPD), comprising:
 orally administering daily to a patient in need thereof an immediate release solid dosage form of 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.   
     
     
         43 . The method of treatment according to  claim 42 , wherein the PDE 4 inhibitor is roflumilast. 
     
     
         44 . The method of treatment according to  claim 42 , wherein the immediate release solid dosage form is a tablet. 
     
     
         45 . The method of treatment of  claim 44 , wherein the PDE 4 inhibitor is roflumilast. 
     
     
         46 . A method for the treatment of chronic obstructive pulmonary disease (COPD), comprising:
 orally administering to a patient in need thereof an immediate release oral solid dosage form in tablet or pellet form containing 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.   
     
     
         47 . The method of treatment of  claim 46  wherein said immediate release oral dosage form is administered once per day. 
     
     
         48 . The method of treatment of  claim 46  wherein said patient is suffering from chronic obstructive pulmonary disease. 
     
     
         49 . The method of treatment of  claim 46 , 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). 
     
     
         50 . The method of treatment of  claim 47 , 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). 
     
     
         51 . The method of treatment of  claim 48 , 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).

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