Substituted n-aryl pyridones

Abstract

Disclosed herein are methods of administering deuterated pirfenidone and kits thereof.

What is claimed is: 
     
         1 . A method of administering a pharmaceutical composition comprising d-pirfenidone together with a pharmaceutically acceptable carrier, wherein the d-pirfenidone is administered orally between 30 minutes prior to and 2 hours after consuming food; and wherein at least one position of the d-pirfenidone has deuterium enrichment of no less than about 10%. 
     
     
         2 . The method as recited in  claim 1 , wherein the pharmaceutical composition is administered at the same time as consuming food. 
     
     
         3 . The method as recited in  claim 1 , wherein the pharmaceutical composition is administered at the same time as a meal. 
     
     
         4 . The method as recited in  claim 1 , wherein the d-pirfenidone is d 3 -pirfenidone. 
     
     
         5 . The method as recited in  claim 1 , wherein the incidence of adverse events is reduced. 
     
     
         6 . The method as recited in  claim 5 , wherein the adverse event is selected from the group consisting of gastrointestinal upset, nausea, fatigue, somnolence, dizziness, headache, and photosensitivity rash. 
     
     
         7 . The method as recited in  claim 6 , wherein the d-pirfenidone is d 3 -pirfenidone. 
     
     
         8 . The method as recited in  claim 1 , wherein the patient is advised that the administration of the pharmaceutical composition with food results in a reduced incidence of adverse events. 
     
     
         9 . The method as recited in  claim 8 , wherein the patient is advised orally. 
     
     
         10 . The method as recited in  claim 8 , wherein the patient is advised in writing. 
     
     
         11 . The method as recited in  claim 8 , wherein the adverse event is selected from the group consisting of nausea, somnolence, and dizziness. 
     
     
         12 . The method as recited in  claim 8 , wherein the d-pirfenidone is d 3 -pirfenidone. 
     
     
         13 . The method as recited in  claim 1 , wherein the patient is advised that the administration of the pharmaceutical composition with food reduces the mean maximum plasma concentration of d-pirfenidone in comparison with administering pirfenidone without food. 
     
     
         14 . The method as recited in  claim 13 , wherein the d-pirfenidone is d 3 -pirfenidone. 
     
     
         15 . The method as recited in  claim 1 , wherein the patient is advised that the administration of the pharmaceutical composition with food increases the mean absorption half-life of d-pirfenidone in comparison with administering pirfenidone without food. 
     
     
         16 . The method as recited in  claim 15 , wherein the d-pirfenidone is d 3 -pirfenidone. 
     
     
         17 . A kit comprising a pharmaceutical composition of d-pirfenidone, prescribing information, and a container, wherein the prescribing information advises the patient to take the pharmaceutical composition with food. 
     
     
         18 . The kit as recited in  claim 17 , wherein the d-pirfenidone is d 3 -pirfenidone.