ANTIARRHYTHMIC FORMULATION
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.
1 . 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.
2 . The pharmaceutical composition of claim 1 , wherein said pH of said solution is about 5.9 when measured at room temperature.
3 . The pharmaceutical composition of claim 1 , wherein said concentration of said cyclodextrin is 10% (w/v) to 30% (w/v) of said liquid solution.
4 . The pharmaceutical composition of claim 1 , wherein said concentration of said cyclodextrin is about 20% (w/v) of said liquid solution.
5 . The pharmaceutical composition of claim 1 , wherein said cyclodextrin is hydroxypropyl-β-cyclodextrin.
6 . The pharmaceutical composition of claim 1 , wherein said concentration of said flecainide acetate is at a concentration from 60 mg/mL to 120 mg/mL.
7 . The pharmaceutical composition of claim 1 , wherein said concentration of said flecainide acetate is about 75 mg/mL.
8 . 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.
9 . The unit dose of claim, comprising from about 100 mg to about 250 mg of said flecainide acetate.
10 . The unit dose of claim, wherein said concentration of flecainide acetate is from about 65 mg/mL to about 95 mg/mL.
11 . 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.
12 . The unit dose of claim, wherein said pH is about 5.8 to about 6.2 when measured at room temperature.
13 . 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.
14 . The kit of claim, wherein said receptacle is a syringe containing said pharmaceutical composition.
15 . The kit of claim, wherein said instructions comprise instructions for administering said pharmaceutical composition by an injection.
16 . The kit of claim, wherein said instructions comprise instructions for self-administering said pharmaceutical composition.
17 . The kit of claim, wherein said concentration of said flecainide acetate is from about 60 mg/mL to about 120 mg/mL.
18 . The kit of claim, wherein said concentration of said flecainide acetate is about 75 mg/mL.
19 . The kit of claim, wherein said pH of said liquid solution is about 5.9 when measured at room temperature.
20 . The kit of claim, wherein said cyclodextrin is hydroxypropyl-β-cyclodextrin.
21 . 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.
22 . The kit of claim, wherein said concentration of said cyclodextrin is about 20% (w/v) of said liquid solution.
23 . The kit of claim, wherein said dose contains from about 150 mg to about 250 mg of said flecainide acetate.
24 . 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.