Unit doses, aerosols, kits, and methods for treating heart conditions by pulmonary administration

Abstract

Methods of treating a heart condition include administering by inhalation an effective amount of at least one antiarrhythmic pharmaceutical agent to a patient in need thereof. Nebulized drug product and kits are also contemplated.

1 . A method of treating atrial arrhythmia, comprising: administering to a pulmonary vein through pulmonary airways by inhalation an effective amount of at least one antiarrhythmic pharmaceutical agent selected from the group consisting of class I, class II, class III, and class IV antiarrhythmics, to a subject in need thereof, wherein the effective amount of the at least one antiarrhythmic pharmaceutical agent is a total amount from 0.1 mg to 200 mg and has:
 i) a T max  of from about 0.1 to about 30 minutes;   ii) a C max  of from about 10 ng/mL to about 5000 ng/mL;   iii) an AUC Last  of from about 100 hr*ng/mL to about 10000 hr*ng/mL;   iv) a distribution t 1/2  of from about 0.1 to about 15 minutes;   v) an elimination t 1/2  of from about 1 hour to about 25 hours;   vi) a maximum ΔQRS of from about 0.01 msec to about 100 msec;   or any combination thereof.   
     
     
         2 - 40 . (canceled) 
     
     
         41 . A method of treating a heart condition, comprising administering a pharmaceutically effective amount of an antiarrhythmic pharmaceutical agent via inhalation to a patient in need thereof, wherein T max  of the pharmaceutically effective amount of the antiarrhythmic pharmaceutical agent after inhalation is from about 0.1 minute to about 30 minutes; C max  of the pharmaceutically effective amount of the antiarrhythmic pharmaceutical agent after inhalation is from about 10 ng/mL to about 5000 ng/mL; or AUC Last  of the pharmaceutically effective amount of the antiarrhythmic pharmaceutical agent after inhalation is from about 100 hr*ng/mL to about 10000 hr*ng/mL. 
     
     
         42 - 52 . (canceled) 
     
     
         53 . A nebulized drug product, comprising a pharmaceutically effective amount of an antiarrhythmic pharmaceutical agent, wherein T max  of the pharmaceutically effective amount of the antiarrhythmic pharmaceutical agent after inhalation is from about 0.1 minute to about 30 minutes; C max  of the pharmaceutically effective amount of the antiarrhythmic pharmaceutical agent after inhalation is from about 10 ng/mL to about 5000 ng/mL; or AUC Last  of the pharmaceutically effective amount of the antiarrhythmic pharmaceutical agent after inhalation is from about 100 hr*ng/mL to about 10000 hr*ng/mL. 
     
     
         54 - 80 . (canceled)