MIDODRINE HYDROCHLORIDE ORAL SOLUTION AND USES THEREOF
The invention provides oral liquid midodrine formulation and uses thereof.
1 . A stable, oral liquid formulation of midodrine comprising:
a. midodrine and
b. sucralose, wherein the midodrine is midodrine HCl and wherein midodrine HCl and sucralose are present in the formulation in a midodrine HCl:sucralose ratio (w/w) of about 1:1 to about 1:10.
2 .- 4 . (canceled)
5 . The formulation of claim 2 , wherein the ratio (w/w) of midodrine HCl to sucralose is about 1:4.
6 . The formulation of claim 1 , wherein the formulation has a pH anywhere in the range of 2.5 to 8.0.
7 . The formulation of claim 1 , wherein the formulation has a pH anywhere in the range of 3.0 to 7.0.
8 . The formulation of claim 1 , wherein the formulation has a pH anywhere in the range of 3.5 to 6.0.
9 . The formulation of claim 1 , wherein the formulation has a pH anywhere in the range of 3.0 to 6.0.
10 . The formulation of claim 1 , wherein the formulation has a pH anywhere in the range of 3.0 to 5.0.
11 . The formulation of claim 1 , wherein the formulation has a pH of about 4.0.
12 . The formulation of claim 1 , wherein the formulation has a pH of about 3.5.
13 . The formulation of claim 1 , having a ratio of moles of midodrine to sucralose of less than 3:1.
14 . The formulation of claim 1 , having a ratio of moles of midodrine to sucralose of greater than 1:25.
15 .- 64 . (canceled)
65 . A method of alleviating symptomatic orthostatic hypotension in a patient in need thereof comprising administering to the patient an effective amount of a stable, oral liquid formulation of midodrine comprising:
a. midodrine and
b. sucralose, wherein the midodrine is midodrine HCl and wherein midodrine HCl and sucralose are present in the formulation in a midodrine HCl:sucralose ratio (w/w) of about 1:1 to about 1:10.
66 . A method for treating a patient suffering from orthostatic hypotension and/or urinary incontinence, the method comprising administering an effective amount of a stable, oral liquid formulation of midodrine comprising:
a. midodrine and
b. sucralose, wherein the midodrine is midodrine HCl and wherein midodrine HCl and sucralose are present in the formulation in a midodrine HCl:sucralose ratio (w/w) of about 1:1 to about 1:10.
67 . The method of claim 66 , wherein urinary incontinence is urinary stress incontinence.
68 . The method of claim 65 , wherein an administration of the formulation takes place at wake-up time.
69 . The method of claim 65 , wherein an administration of the formulation takes place in the morning.
70 . The method of claim 65 , wherein an administration of the formulation takes place in the middle of the day.
71 . The method of claim 65 , wherein an administration of the formulation takes place at least 6 hours before bedtime.
72 .- 80 . (canceled)
81 . A method for treating a patient suffering from a condition responsive to alpha-1 adrenergic (A1) receptor stimulation, the method comprising administering an effective amount of a stable, oral liquid formulation of midodrine comprising:
a. midodrine and
b. sucralose, wherein the midodrine is midodrine HCl and wherein midodrine HCl and sucralose are present in the formulation in a midodrine HCl:sucralose ratio (w/w) of about 1:1 to about 1:10.
82 . A method for treating a patient suffering from syncope, the method comprising administering an effective amount of a stable, oral liquid formulation of midodrine comprising:
a. midodrine and
b. sucralose, wherein the midodrine is midodrine HCl and wherein midodrine HCl and sucralose are present in the formulation in a midodrine HCl:sucralose ratio (w/w) of about 1:1 to about 1:10.
83 .- 84 . (canceled)