US2018296480A1PendingUtilityA1

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

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Assignee: INCARDA THERAPEUTICS INCPriority: Mar 18, 2009Filed: Jun 20, 2018Published: Oct 18, 2018
Est. expiryMar 18, 2029(~2.7 yrs left)· nominal 20-yr term from priority
A61P 9/06A61P 9/00A61K 31/4458A61K 31/554A61K 31/7076A61K 9/0078A61K 31/445A61K 31/216A61K 31/18A61K 31/55A61M 11/00Y10S514/821
62
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Claims

Abstract

Methods of treating atrial arrhythmia include administering an effective amount of at least one antiarrhythmic 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 heart at a time ranging from 10 seconds to 30 minutes from initiation of the administering. Unit doses, aerosols, and kits are also contemplated.

Claims

exact text as granted — not AI-modified
What is claimed is: 
     
         1 . A liquid aerosolizable pharmaceutical composition, comprising an amount of flecainide, a salt, a solvate, or an enantiomer thereof, wherein the amount of flecainide is effective when the pharmaceutical composition is administered to a subject experiencing atrial arrhythmia via aerosolization for cardioversion of the atrial arrhythmia in the subject. 
     
     
         2 . The pharmaceutical composition of  claim 1 , wherein the cardioversion converts the atrial arrhythmia in the subject to normal sinus rhythm. 
     
     
         3 . The pharmaceutical composition of  claim 1 , wherein the atrial arrhythmia comprises paroxysmal atrial fibrillation. 
     
     
         4 . The pharmaceutical composition of  claim 1 , wherein the amount of flecainide is less than a second amount of flecainide that is effective when administered intravenously for cardioversion of the atrial arrhythmia in the subject. 
     
     
         5 . The pharmaceutical composition of  claim 1 , wherein the amount of flecainide, when inhaled, is equivalent to a second amount of flecainide for intravenous administration. 
     
     
         6 . The pharmaceutical composition of  claim 1 , wherein the amount of flecainide is between 0.5 mg and 150 mg. 
     
     
         7 . The pharmaceutical composition of  claim 1 , wherein the amount of flecainide is between 1 mg and 100 mg. 
     
     
         8 . The pharmaceutical composition of  claim 1 , wherein a concentration of flecainide is higher than a second concentration of flecainide that is effective when administered intravenously for cardioversion of the atrial arrhythmia in the subject. 
     
     
         9 . The pharmaceutical composition of  claim 1 , wherein a concentration of flecainide is at least about 30 mg/mL. 
     
     
         10 . The pharmaceutical composition of  claim 1 , comprising the solvate of flecainide, wherein the solvate comprises a solvent selected from the group consisting of: water, isopropanol, ethanol, methanol, DMSO, ethyl acetate, acetic acid, ethanolamine, and combinations thereof. 
     
     
         11 . The pharmaceutical composition of  claim 1 , further comprising a pharmaceutically acceptable excipient. 
     
     
         12 . The pharmaceutical composition of  claim 11 , wherein the pharmaceutically acceptable excipient comprises acetic acid, sodium hydroxide, or both. 
     
     
         13 . The pharmaceutical composition of  claim 1 , wherein a pH of the pharmaceutical composition is between 4.5 to 7.0. 
     
     
         14 . The pharmaceutical composition of  claim 1 , wherein a volume of the pharmaceutical composition is between 1 to 3 mL. 
     
     
         15 . The pharmaceutical composition of  claim 1 , comprising flecainide acetate. 
     
     
         16 . The pharmaceutical composition of  claim 1 , wherein the subject is human. 
     
     
         17 . A kit, comprising: the pharmaceutical composition of  claim 1  and a unit dose receptacle. 
     
     
         18 . The kit of  claim 17 , further comprising an aerosolization device. 
     
     
         19 . A method of treating atrial arrhythmia, comprising: administering the pharmaceutical composition of  claim 1  to the subject experiencing atrial arrhythmia via aerosolization for cardioversion of the atrial arrhythmia in the subject. 
     
     
         20 . The method of  claim 19 , wherein a dosing time of the administering is less than 10 minutes.

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