IP Library › Granted Patent US 10,537,523
Granted Patent B2
US 10,537,523 · App. 16/394,610 · Granted Jan 21, 2020

Oral suspension comprising telmisartan

Inventors: Detlef Mohr (Biberarch an der Riss, DE); Stefan Lehner (Wiesbaden, DE)
A61K9/0095A61K9/08A61K31/4184A61K47/10A61K47/26
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Quick Facts
Patent No.
US 10,537,523
App. No.
16/394,610
Granted
Jan 21, 2020
Kind
B2
Abstract

A drinkable pharmaceutical solution includes telmisartan or a pharmaceutically acceptable salt, hydrate or polymorph thereof, where the telmisartan has a concentration of 1 to 10 mg/ml within the drinkable pharmaceutical solution, and the drinkable pharmaceutical solution has a pH of 10.

Claims (22)

1. A drinkable pharmaceutical solution comprising:

telmisartan or a pharmaceutically acceptable salt, hydrate or polymorph thereof, wherein the telmisartan is present in a concentration of 1 to 10 mg/ml within the drinkable pharmaceutical solution;

sodium hydroxide;

one or more sugar alcohols selected from the group consisting of maltitol, xylitol, sorbitol, and mannitol, wherein the one or more sugar alcohols have a total concentration of 40 wt. % to 70 wt. % within the drinkable pharmaceutical solution and a maximum content of 2000 ppm of reducing sugar before addition to the drinkable pharmaceutical solution;

optionally saccharin-Na;

optionally benzalkonium chloride; and

water;

wherein the drinkable pharmaceutical solution has a pH of 10.

2. The drinkable pharmaceutical solution of claim 1 , further comprising one or more consistency-providing components selected from the group consisting of hydroxyethylcellulose, hydroxypropylcellulose, methylcellulose, hydroxypropylmethylcellulose, hypromellose, and polyvinylpyrrolidone (PVP).

3. The drinkable pharmaceutical solution of claim 1 , wherein the one or more sugar alcohols have a maximum content of 1000 ppm of reducing sugar before addition to the drinkable pharmaceutical solution.

4. The drinkable pharmaceutical solution of claim 1 , wherein the solution comprises saccharin-Na.

5. The drinkable pharmaceutical solution of claim 1 , wherein the solution comprises benzalkonium chloride.

6. A kit comprising a container and the drinkable pharmaceutical solution of claim 1 .

7. The kit of claim 6 , further comprising a dosing aid for the drinkable pharmaceutical solution.

8. The kit of claim 6 , wherein the container is glass or plastic.

9. A method of preparing a drinkable pharmaceutical solution of claim 1 , comprising:

(a) dissolving telmisartan or a pharmaceutically acceptable salt, hydrate or polymorph thereof and one or more sugar alcohols in water and NaOH so as to obtain a pH of 10; and

(b) adjusting the concentration of telmisartan in the solution to 1 to 10 mg/ml.

10. A method of treating hypertension or kidney disease comprising administering the drinkable pharmaceutical solution of claim 1 to a cat.

11. The method of claim 10 , wherein the drinkable pharmaceutical solution further comprises:

one or more consistency-providing components selected from the group consisting of hydroxyethylcellulose, hydroxypropylcellulose, methylcellulose, hydroxypropylmethylcellulose, hypromellose, and polyvinylpyrrolidone (PVP).

12. The method of claim 10 , wherein telmisartan is at a concentration of 1 to 5 mg/ml within the pharmaceutical solution.

Assignments (1)
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded Aug 27, 2019
From: MOHR, DETLEF; LEHNER, STEFAN
To: BOEHRINGER INGELHEIM VETMEDICA GMBH
Reel/Frame 050183/0683 →
Priority Claims (1)
EP 09160771 · May 20, 2009 · regional
Continuity (3)
Continuation 14469750 · Aug 27, 2014
Continuation 13321216
Related Publication 20190247305A1 · Aug 15, 2019
Cited By (1)
US 12,605,366