Oral suspension comprising telmisartan
View Patent ↗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.
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.