AQUEOUS FORMULATIONS OF (2-HYDROXYMETHYL-INDANYL-4-OXY)-PHENYL-4,4,4-TRIFLUOROBUTANE-1-SULFONATE
The invention relates to aqueous formulations containing (−)-(R)-3-(2-hydroxymethylindanyl-4-oxy)phenyl 4,4,4-trifluorobutane-1-sulfonate. Said formulations are suitable as infusion solutions or as concentrate for producing these infusion solutions.
1 . An aqueous formulation comprising (−)-(R)-3-(2-hydroxymethylindanyl-4-oxy)phenyl 4,4,4-trifluorobutane-1-sulfonate (I) and cyclodextrin.
2 . The formulation of claim 1 , comprising from 0.00005 to 9.0 g/l of the compound (I) and from 0.1 to 550 g/l of cyclodextrin.
3 . The formulation of claim 1 , comprising from 0.0001 to 0.050 g/l of the compound (I) and from 0.2 to 200 g/l cyclodextrin.
4 . The formulation of claim 1 , comprising from 0.0005 to 0.025 g/l of the compound (I) and from 1 to 50 g/l cyclodextrin.
5 . The formulation of claim 1 , which has a pH of from 2 to 6.
6 . The formulation of claim 1 , comprising at least one physiologically tolerated acid.
7 . The formulation of claim 6 , which comprises citric acid as physiologically tolerated acid.
8 . The formulation of claim 1 , comprising from 8 to 10 g/l sodium chloride based on the formulation ready for use.
9 . The formulation of claim 1 , comprising from 0.05 to 2 g/l ethanol based on the formulation ready for use.
10 . An administration kit consisting of a) a container comprising the aqueous formulation of claim 1 , b) infusion apparatus, where at least the parts which come into contact with the product consist of polyethylene, polypropylene, polyester, polyamide, acrylonitrile-butadiene-styrene copolymers, polypropylene/styrene-ethylene-butylene-styrene or copolymers thereof.
11 . The formulation of claim 1 comprising about 50 g/l of cyclodextrin.
12 . The formulation of claim 1 comprising about 2 g/l of cyclodextrin.
13 . The formulation of claim 1 , wherein said formulation is suitable for parenteral administration.
14 . An aqueous formulation comprising (−)-(R)-3-(2-hydroxymethylindanyl-4-oxy)phenyl 4,4,4-trifluorobutane-1-sulfonate (I) and from 1 to 50 g/l of cyclodextrin.
15 . The formulation of claim 14 , wherein the compound (I) is at a concentration of from 0.0005 to 0.025 g/l.
16 . The formulation of claim 14 , further comprising from 8 to 10 g/l sodium chloride based on the formulation ready for use.
17 . The formulation of claim 14 , further comprising from 0.05 to 2 g/l ethanol based on the formulation ready for use.
18 . The formulation of claim 14 , further comprising ethanol, sodium chloride, and citric acid.