UNIT DOSES, AEROSOLS, KITS, AND METHODS FOR TREATING HEART CONDITIONS BY PULMONARY ADMINISTRATION
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 a subject suffering from atrial arrhythmia, comprising administering to the subject a liquid pharmaceutical composition via aerosolization, wherein said pharmaceutical composition comprises a therapeutically effective amount of an antiarrhythmic agent for cardioversion of atrial arrhythmia in said subject, wherein said antiarrhythmic agent is selected from the group consisting of: flecainide, a salt thereof, and a solvate thereof, and wherein said pharmaceutical composition has a volume of about 1 mL to about 10 mL.
2 . The method of claim 1 , wherein said pharmaceutical composition is aerosolized via a breath-activated nebulizer.
3 . The method of claim 1 , wherein said pharmaceutical composition is aerosolized via a breath-actuated jet nebulizer.
4 . The method of claim 1 , wherein said pharmaceutical composition is aerosolized via a vibrating mesh nebulizer or ultrasonic nebulizer.
5 . The unit dose of claim 1 , wherein said volume of said pharmaceutical composition is about 1 mL to about 5 mL.
6 . The method of claim 1 , wherein said subject self-administers said pharmaceutical composition.
7 . The method of claim 1 , wherein sinus rhythm of said subject is restored to normal sinus rhythm within 30 minutes of initiation of said administering.
8 . The method of claim 1 , wherein flecainide level peaks in the coronary sinus of the heart of said subject at a time between 0 minute and 10 minutes within completion of said administering.
9 . The method of claim 1 , wherein a concentration of said antiarrhythmic agent in said pharmaceutical composition is about 30 mg/mL.
10 . The method of claim 1 , wherein said atrial arrhythmia comprises paroxysmal atrial fibrillation.
11 . The method of claim 1 , wherein said atrial arrhythmia comprises recent onset paroxysmal atrial fibrillation.
12 . The method of claim 1 , wherein said atrial arrhythmia comprises paroxysmal supraventricular tachycardia.
13 . The method of claim 1 , wherein said atrial arrhythmia is selected from the group consisting of tachycardia, supraventricular tachycardia (SVT), paroxysmal supraventricular tachycardia (PSVT), atrial fibrillation (AF), paroxysmal atrial fibrillation (PAF), permanent atrial fibrillation, persistent atrial fibrillation, atrial flutter, paroxysmal atrial flutter, and lone atrial fibrillation.
14 . The method of claim 1 , wherein said pharmaceutical composition comprises flecainide acetate.
15 . The method of claim 1 , wherein said pharmaceutical composition further comprises a pH buffer prepared from acetic acid.
16 . The method of claim 1 , wherein said pharmaceutical composition further comprises a pH buffer prepared from an organic acid.
17 . The method of claim 1 , wherein a pH of said pharmaceutical composition is from 5.0 to 6.5.
18 . The method of claim 1 , wherein said pharmaceutical composition comprises a racemic mixture of flecainide or a salt thereof.
19 . The method 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 method 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.