Antiarrhythmic formulation
AssigneeInCarda Therapeutics, Inc.
InventorsMichael Laird Hurrey, Luiz Belardinelli, Prashanti Madhavapeddi, Carlos Schuler
Life of this patent
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Abstract
Pharmaceutical compositions comprising an antiarrhythmic agent for treatment of a heart condition via inhalation. 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. A nebulized drug product and kits thereof are also disclosed.
Claims24
A pharmaceutical composition, comprising:
- (1) a therapeutically effective amount of flecainide acetate,
- (2) a cyclodextrin, and
- (3) acetic acid,
- wherein said pharmaceutical composition is in the form of a liquid solution that has said flecainide acetate at a concentration above 60 mg/mL, said cyclodextrin at a concentration of from about 5% (w/v) to about 50% (w/v) of said liquid solution, and a pH from 5.5 to 6.5 when measured at room temperature.
A unit dose of a pharmaceutical composition that comprises flecainide acetate, a cyclodextrin, and acetic acid,
- wherein said pharmaceutical composition is in the form of a liquid solution that has said flecainide acetate at a concentration above 60 mg/mL, said cyclodextrin at a concentration of from about 5% (w/v) to about 50% (w/v) of said liquid solution, and a pH from 5.5 to 6.5 when measured at room temperature, and
- wherein said unit dose comprises from about 50 mg to about 350 mg of said flecainide acetate.
The unit dose of claim, comprising from about 100 mg to about 250 mg of said flecainide acetate.
The unit dose of claim, wherein said concentration of flecainide acetate is from about 65 mg/mL to about 95 mg/mL.
The unit dose of claim, wherein said cyclodextrin is hydroxypropyl-β-cyclodextrin, and said concentration of said cyclodextrin is from about 15% (w/v) to about 25% (w/v) of said liquid solution.
The unit dose of claim, wherein said pH is about 5.8 to about 6.2 when measured at room temperature.
A kit, comprising:
- (1) a pharmaceutical composition that comprises:
- (a) flecainide acetate,
- (b) a cyclodextrin, and
- (c) acetic acid;
- (2) a receptacle containing said pharmaceutical composition;
- and
- (3) instructions for use to administer a dose of said pharmaceutical composition to a subject via an injection, wherein said dose contains from about 50 mg to about 250 mg of said flecainide acetate;
- and
- wherein said pharmaceutical composition is in the form of a liquid solution that has:
- (i) said flecainide acetate at a concentration of from about 65 mg/mL to about 95 mg/mL;
- (ii) said cyclodextrin at a concentration of from about 10% (w/v) to about 30% (w/v) of said liquid solution;
- (iii) said acetic acid;
- and
- (iv) a pH of from about 5.5 to about 6.5 when said pH is measured at room temperature.
The kit of claim, wherein said receptacle is a syringe containing said pharmaceutical composition.
The kit of claim, wherein said instructions comprise instructions for administering said pharmaceutical composition by an injection.
The kit of claim, wherein said instructions comprise instructions for self-administering said pharmaceutical composition.
The kit of claim, wherein said concentration of said flecainide acetate is from about 60 mg/mL to about 120 mg/mL.
The kit of claim, wherein said concentration of said flecainide acetate is about 75 mg/mL.
The kit of claim, wherein said pH of said liquid solution is about 5.9 when measured at room temperature.
The kit of claim, wherein said cyclodextrin is hydroxypropyl-β-cyclodextrin.
The kit of claim, wherein said concentration of said cyclodextrin is from about 15% (w/v) to about 25% (w/v) of said liquid solution.
The kit of claim, wherein said concentration of said cyclodextrin is about 20% (w/v) of said liquid solution.
The kit of claim, wherein said dose contains from about 150 mg to about 250 mg of said flecainide acetate.
The kit of claim, wherein:
- (a) said flecainide acetate is flecainide acetate, and said concentration of said flecainide acetate is about 75 mg/mL;
- (b) said acetic acid;
- (c) said cyclodextrin is hydroxypropyl-β-cyclodextrin, and said concentration of said cyclodextrin is about 20% (w/v) of said liquid solution;
- and
- (d) said pH of said liquid solution is about 5.9 when measured at room temperature.
Dependencies are inferred from the claim text.