IP Library Granted Patent US 11,013,702
Granted Patent B2
US 11,013,702 · App. 16/469,101 · Granted May 25, 2021

Midodrine hydrochloride oral solution and uses thereof

Inventors: Indranil Nandi (Bridgewater, NJ); Ketan Hippalgaonkar (Mount Laurel, NJ); Sunil Vandse (Basking Ridge, NJ); Rish J. Vachhani (Parisppany, NJ)
Assignee: Vertice Pharma, LLC
A61K31/165A61K9/0053A61K47/26
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Quick Facts
Patent No.
US 11,013,702
App. No.
16/469,101
Granted
May 25, 2021
Kind
B2
Abstract

The invention provides oral liquid midodrine formulation and uses thereof.

Claims (16)

1. A stable, oral liquid formulation of midodrine comprising midodrine and 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 wherein no more than about 10% by weight of a degradation product of midodrine is present after being stored for 1 month at 50 degrees Centigrade over a range of pH from 2.5 to 8.0.

2. A stable, oral liquid formulation of midodrine comprising midodrine and 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 wherein no more than about 3.5% by weight of the degradation product of midodrine is present after being stored for 3 month at 25 degrees Centigrade over a range of pH from about 2.5 to 8.0.

3. The formulation of claim 1 or 2 , wherein the ratio (w/w) of midodrine HCl to sucralose is about 1:4.

4. The formulation of claim 1 or 2 , having a ratio of moles of midodrine to sucralose of less than 3:1.

5. The formulation of claim 1 or 2 , having a ratio of moles of midodrine to sucralose of greater than 1:25.

6. The formulation of claim 1 or 2 , having a ratio of moles of midodrine to sucralose of about 1:3.

7. The formulation of claim 1 or 2 , wherein midodrine is midodrine HCl and wherein the formulation has about 0.5 mg/ml of midodrine HCl.

8. The formulation of claim 1 or 2 , wherein midodrine is midodrine HCl and wherein the formulation has about 1.72×10 −3 M midodrine HCl.

9. The formulation of claim 1 or 2 , wherein midodrine is midodrine HCl and wherein the formulation has about 0.5 mg/ml of midodrine HCl and 2 mg/ml sucralose.

10. The formulation of claim 1 or 2 , wherein midodrine is midodrine HCl and wherein a ratio of moles of midodrine HCl to sucralose is greater than 1:4.

11. The formulation of claim 1 or 2 , wherein a ratio of moles of midodrine to sucralose is less than 3:2.

12. The formulation of claim 1 or 2 , wherein a ratio of moles of midodrine to sucralose is greater than 1:4 and less than 3:2.

13. The formulation of claim 1 or 2 , wherein midodrine HCl is the only active agent or active pharmaceutical ingredient in the formulation.

14. The formulation of claim 1 or 2 , wherein the formulation is essentially free of desglymidodrine added to the formulation, wherein any desglymidodrine in the formulation is formed by hydrolysis of midodrine in situ to desglymidodrine, and wherein hydrolysis of midodrine in situ to desglymidodrine is less than 10% of total midodrine used in the formulation.

15. The formulation of claim 2 , wherein midodrine is midodrine HCl and wherein no more than about 3.0% by weight of the degradation product of midodrine HCl is present after being stored for 3 month at 25 degrees Centigrade at over a range of pH from about 3.5 to 8.0.

16. The formulation of claim 2 , wherein midodrine is midodrine HCl and wherein no more than about 0.5% by weight of the degradation product of midodrine HCl is present after being stored for 3 month at 25 degrees Centigrade at over a range of pH from about 3.5 to 5.0.

Assignments (5)
CONFIRMATORY GRANT OF SECURITY INTEREST IN UNITED STATES PATENTS Recorded Mar 17, 2025
From: ARBOR PHARMACEUTICALS, LLC; AZURITY PHARMACEUTICALS, INC.; AZURITY PHARMACEUTICALS IRELAND LIMITED; SILVERGATE PHARMACEUTICALS, INC.
To: HPS INVESTMENT PARTNERS, LLC, AS ADMINISTRATIVE AGENT
Reel/Frame 070531/0487 →
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded Aug 21, 2023
From: VISTAPHARM, LLC
To: AZURITY PHARMACEUTICALS, INC.
Reel/Frame 064646/0903 →
PATENT ASSIGNMENT AGREEMENT Recorded Jun 30, 2022
From: VERTICE PHARMA, LLC
To: VISTAPHARM, INC.
Reel/Frame 060557/0561 →
CONFIRMATION OF NAME CHANGE Recorded Jun 30, 2022
From: VISTAPHARM, INC.
To: VISTAPHARM, LLC
Reel/Frame 060558/0076 →
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded Mar 10, 2020
From: NANDI, INDRANIL; HIPPALGAONKAR, KETAN; VANDSE, SUNIL; VACHHANI, RISH J.
To: VERTICE PHARMA, LLC
Reel/Frame 052074/0095 →
Continuity (2)
Provisional Application 62570470 · Oct 10, 2017
Related Publication 20200113851A1 · Apr 16, 2020