FIELD: allopregnanolone solution.
SUBSTANCE: pharmaceutically acceptable dilute aqueous solution of allopregnanolone contains (i) the first solution subjected to heat treatment and containing allopregnanolone, sulfo-butyl ether of beta-cyclodextrin and citrate buffer and (ii) diluent; wherein the diluted aqueous solution is made by mixing the first heat treated solution with a diluent, and wherein the first solution is autoclaved by subjecting it to cycles of heat sterilization for at least 10, 15, 20, 30 or 40 minutes at a temperature of 110 to 150 °C.
EFFECT: ensuring stable solution.
7 cl, 8 dwg, 16 tab, 8 ex
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Authors
Dates
2023-09-13—Published
2016-06-17—Filed