Oral suspension comprising telmisartan
A pharmaceutical solution with a pH value of 10 or higher contains an angiotensin II receptor antagonist, where one or more sugar alcohols are present up to a total concentration of 40 wt. % to 70 wt. %.
1. A drinkable pharmaceutical solution
telmisartan or a pharmaceutically acceptable salt, hydrate or polymorph thereof, wherein telmisartan is present in a concentration of 1 mg/ml 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; and
one or more consistency-providing components selected from the group consisting of hydroxyethylcellulose, hydroxypropylcellulose, methylcellulose, hydroxypropylmethylcellulose, hypromellose, and polyvinylpyrrolidone (PVP);
optionally saccharin-Na;
optionally benzalkonium chloride; and
water;
wherein the drinkable pharmaceutical solution has a pH of 10.
2. The pharmaceutical solution of claim 1 , wherein the telmisartan is present in a concentration of 10 mg/ml.
3. The 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. A kit comprising a container and the drinkable pharmaceutical solution of claim 1 .
5. The kit of claim 4 , further comprising a dosing aid for the drinkable pharmaceutical solution.
6. The kit of claim 4 , wherein the container is glass or plastic.
7. A method of preparing the pharmaceutical solution of claim 1 , comprising:
dissolving telmisartan or a pharmaceutically acceptable salt, hydrate or polymorph thereof and the one or more sugar alcohols in water and NaOH so as to obtain a concentration of telmisartan in the solution of 1 mg/ml to 10 mg/ml and a pH of 10.
8. A method of treating hypertension or kidney disease comprising orally administering a drinkable pharmaceutical solution to a cat, the pharmaceutical solution comprising:
telmisartan or a pharmaceutically acceptable salt, hydrate or polymorph thereof, wherein telmisartan is present in a concentration of 1 mg/ml to 10 mg/ml within the drinkable pharmaceutical solution; and
one or more sugar alcohols, 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;
wherein the drinkable pharmaceutical solution has a pH of 10.
9. The method of claim 8 , wherein telmisartan is present in a concentration of 1 to 5 mg/ml within the drinkable pharmaceutical solution.
10. The method of claim 8 , wherein the one or more sugar alcohols have a maximum content of 1000 ppm of reducing sugar before addition to the drinkable pharmaceutical solution.
11. A method of treating hypertension or kidney disease comprising orally administering the drinkable pharmaceutical solution of claim 1 to a cat.