FIELD: medicine.
SUBSTANCE: invention refers to a new pharmaceutical composition in the form of spray for oral administration, containing an aqueous solution of sildenafil citrate as an active substance in the amount of 3-30 wt %. The composition contains stabilising agents in the form of pharmaceutically acceptable calcium salts taken in an amount required to reduce pH to 3.0 to 6.0. The calcium salts are specified in a group consisting of calcium lactate pentahydrate, calcium lactate trihydrate, calcium gluconate, calcium malate, calcium glycolate, calcium chloride hexahydrate and calcium chloride dihydrate. What is also described is a method for preparing the composition by introducing the pharmaceutically acceptable calcium salts as the stabilising agents into the aqueous solution of sildenafil citrate.
EFFECT: pharmaceutical composition in the form of oral spray is free from organic solvents and applicably for sexual dysfunction.
13 cl, 8 ex
Authors
Dates
2014-12-20—Published
2013-01-17—Filed