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

Abstract

Methods of treating atrial arrhyththmia include administering an effective amount of at least one antiarrthythmic pharmaceutical agent to a patient in need thereof, such that the at least one antiarrhythmic pharmaceutical agent first enters the heart through the pulmonary vein to the left atrium. Other methods of treating atrial arrhythmia include administering by inhalation an effective amount of at least one antiarrhythmic pharmaceutical agent to a patient in need thereof. An amount of the at least one antiarrhythmic pharmaceutical agent may peak in the coronary sinus of the heat at a time ranging from 10 seconds to 30 minutes from initiation of the administering. Unit does, aerosols, and kits are also contemplated.

What is claimed is: 
     
         1 . A kit comprising an aerosolization device and a unit dose comprising a pharmaceutical composition that comprises a therapeutically effective amount of an antiarrhythmic agent for cardioversion of atrial arrhythmia in a subject in need thereof when said pharmaceutical composition is inhaled by said subject via aerosolization, wherein said antiarrhythmic agent is selected from the group consisting of: class Ia, Ib, Ic, III, and IV antiarrhythmics, a salt, and a solvate thereof, and any combination thereof 
     
     
         2 . The kit of  claim 1 , wherein said aerosolization device comprises a jet nebulizer. 
     
     
         3 . The kit of  claim 1 , wherein said therapeutically effective amount of said antiarrhythmic agent in said unit dose is less than an amount of said antiarrhythmic agent in an intravenous dose that is effective for cardioversion. 
     
     
         4 . The kit of  claim 1 , wherein said therapeutically effective amount of said antiarrhythmic agent in said unit dose is between 1 mg and 100 mg. 
     
     
         5 . The kit of  claim 1 , wherein said pharmaceutical composition comprises a liquid solution of said antiarrhythmic agent. 
     
     
         6 . The kit of  claim 5 , wherein a volume of said unit dose is about 1 mL to about 10 mL. 
     
     
         7 . The kit of  claim 5 , wherein a volume of said unit dose is about 2 mL to about 6 mL. 
     
     
         8 . The kit of  claim 5 , wherein said therapeutically effective amount of said antiarrhythmic agent in said unit dose is between 1 mg and 100 mg, and a volume of said unit dose is about 1 mL to about 10 mL. 
     
     
         9 . The kit of  claim 1 , wherein said cardioversion restores sinus rhythm of said subject to normal within 30 min. 
     
     
         10 . The kit of  claim 1 , wherein a pH of said pharmaceutical composition is from 5.0 to 6.5. 
     
     
         11 . The kit of  claim 1 , wherein said pharmaceutical composition comprises aerosol of said antiarrhythmic agent. 
     
     
         12 . The kit of  claim 11 , wherein said pharmaceutical composition comprises particles that have a mass median aerodynamic diameter less than about 20 μm. 
     
     
         13 . The kit of  claim 11 , wherein said pharmaceutical composition comprises particles that have a mass median aerodynamic diameter less than about 5 μm. 
     
     
         14 . A kit comprising an aerosolization device and a unit dose of a pharmaceutical composition that comprises a therapeutically effective amount of an antiarrhythmic agent for cardioversion of atrial arrhythmia in a subject in need thereof when said pharmaceutical composition is inhaled by said subject via aerosolization, wherein said antiarrhythmic agent is selected from the group consisting of: class Ia, Ib, Ic, II, III, and IV antiarrhythmics, a salt, and a solvate thereof, and any combination thereof, and wherein a volume of said unit dose is from about 1 mL to about 10 mL. 
     
     
         15 . The kit of  claim 14 , wherein said aerosolization device comprises a jet nebulizer. 
     
     
         16 . The kit of  claim 14 , wherein said therapeutically effective amount of said antiarrhythmic agent in said unit dose is less than an amount of said antiarrhythmic agent in an intravenous dose that is effective for cardioversion. 
     
     
         17 . The kit of  claim 14 , wherein said therapeutically effective amount of said antiarrhythmic agent in said unit dose is between 1 mg and 100 mg. 
     
     
         18 . The kit of  claim 14 , wherein said cardioversion restores sinus rhythm of said subject to normal within 30 min. 
     
     
         19 . The kit of  claim 14 , wherein a pH of said pharmaceutical composition is from 5.0 to 6.5. 
     
     
         20 . The kit of  claim 14 , wherein a volume of said unit dose is about 2 mL to about 6 mL. 
     
     
         21 . The kit of  claim 14 , wherein said pharmaceutical composition comprises aerosol of said antiarrhythmic agent. 
     
     
         22 . The kit of  claim 21 , wherein said pharmaceutical composition comprises particles that have a mass median aerodynamic diameter less than about 20 μm. 
     
     
         23 . The kit of  claim 21 , wherein said pharmaceutical composition comprises particles that have a mass median aerodynamic diameter less than about 5 μm.