A dissolution test method for solid steroidal pharmaceutical...

Details A dissolution test method for solid steroidal pharmaceutical... A dissolution test method for solid steroidal pharmaceutical...

G - Physics

01

N

G01N 33/15 (2006.01) A61K 9/00 (2006.01) A61K 9/14 (2006.01) G01N 13/00 (2006.01)

Patent

CA 2270951

The invention provides for a method of determining the dissolution rate of a steroid from its solid pharmaceutical formulation. Said method comprises: adding a steroidal formulation to a paddle assembly containing an aqueous solution of polysorbate 20, where the concentration of polysorbate 20 is about 0.025 to about 0.15 % weight/volume and the temperature of the assembly is about 37 ~C; removing aliquots and measuring the percentage of steroid in each aliquot.

L'invention concerne une méthode pour déterminer la vitesse de dissolution d'un stéroïde à partir de sa formulation pharmaceutique solide. Cette méthode consiste à ajouter une formulation stéroïdienne à un agitateur à ailettes contenant une solution aqueuse de polysorbate 20, dans laquelle la concentration de polysorbate 20 est d'environ 0,025 à environ 0,15 % en poids/volume et la température de l'agitateur est d'environ 37 ·C, à prélever des aliquotes et à mesurer le pourcentage de stéroïde dans chaque aliquote.

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