Midodrine hydrochloride oral solution and uses thereof

Abstract

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)