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.

What is claimed is: 
     
         1 . A unit dose comprising a liquid pharmaceutical composition, said pharmaceutical composition comprising 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: flecainide, a salt thereof, and a solvate thereof, and wherein said unit dose has a liquid volume of about 1 mL to about 10 mL. 
     
     
         2 . A kit comprising the unit dose of  claim 1  and an aerosolization device. 
     
     
         3 . The kit of  claim 2 , wherein the aerosolization device is a breath-activated nebulizer. 
     
     
         4 . The kit of  claim 2 , wherein the aerosolization device is a breath-actuated jet nebulizer. 
     
     
         5 . The unit dose of  claim 1 , wherein said liquid volume of said unit dose is about 1 mL to about 5 mL. 
     
     
         6 . The unit dose of  claim 1 , wherein a concentration of said antiarrhythmic agent in said unit dose is about 30 mg/mL. 
     
     
         7 . The unit dose of  claim 1 , wherein said therapeutically effective amount of said antiarrhythmic agent in said unit dose is between 60 mg and 200 mg. 
     
     
         8 . The unit dose of  claim 1 , wherein said atrial arrhythmia comprises paroxysmal atrial fibrillation. 
     
     
         9 . The unit dose of  claim 1 , wherein said atrial arrhythmia comprises recent onset paroxysmal atrial fibrillation. 
     
     
         10 . The unit dose of  claim 1 , wherein said atrial arrhythmia comprises paroxysmal supraventricular tachycardia. 
     
     
         11 . The unit dose of  claim 1 , wherein said atrial arrhythmia is selected from the group consisting of tachycardia, supraventricular tachycardia, paroxysmal supraventricular tachycardia, atrial fibrillation, paroxysmal atrial fibrillation, permanent atrial fibrillation, persistent atrial fibrillation, atrial flutter, paroxysmal atrial flutter, and lone atrial fibrillation. 
     
     
         12 . The unit dose of  claim 1 , wherein said pharmaceutical composition comprises flecainide acetate. 
     
     
         13 . The unit dose of  claim 1 , wherein said pharmaceutical composition is formulated for inhalation via a breath-actuated jet nebulizer. 
     
     
         14 . The unit dose of  claim 1 , wherein said pharmaceutical composition further comprises a pH buffer comprising acetic acid. 
     
     
         15 . The unit dose of  claim 1 , wherein said pharmaceutical composition further comprises a pH buffer comprising an organic acid. 
     
     
         16 . The unit dose of  claim 1 , wherein a pH of said pharmaceutical composition is from 5.0 to 6.5. 
     
     
         17 . The unit dose of  claim 1 , wherein said pharmaceutical composition has physiological isotonicity. 
     
     
         18 . The unit dose of  claim 1 , wherein said pharmaceutical composition comprises a racemic mixture of flecainide or a salt thereof. 
     
     
         19 . The unit dose of  claim 1 , wherein said pharmaceutical composition further comprises a pH buffer selected from the group consisting of: organic acid salts of citric acid, lactic acid, ascorbic acid, gluconic acid, carbonic acid, tartaric acid, succinic acid, acetic acid, phthalic acid, and any combination thereof, Tris buffer, tromethamine hydrochloride buffer, phosphate buffer, and combinations thereof. 
     
     
         20 . The unit dose of  claim 1 , wherein said pharmaceutical composition further comprises a pharmaceutically acceptable excipient selected from the group consisting of: lipids, metal ions, surfactants, amino acids, carbohydrates, buffers, salts, polymers, and combinations thereof.