METHOD FOR MODEL-DISCRIMINATIVE ESTIMATION OF PHARMACEUTICAL EQUIVALENCE OF DRUGS WITH ENTERIC COATING Russian patent published in 2017 - IPC G01N33/15 

FIELD: pharmacology.

SUBSTANCE: invention relates to a method for model-discriminative estimation of pharmaceutical equivalence of enteric coated drugs comprising determination of dissolution kinetics of the studied drugs and the reference drug by sequentially placing one unit of the solid dosage form in a 500 ml phosphate buffer at a pH of 1.05±0.05 and at a temperature of 37±0.05°C, stirring with a paddle stirrer at a speed of 100 rpm, aliquot selection after 2 hours and filtering, determining the active ingredient in the aliquot, dosage form transfer to a phosphate buffer at pH of 7.0±0.05, stirring with a paddle stirrer at a speed of 100 rpm, selection of 5 ml of aliquots at 10, 15, 20, 30, 45, 60 minutes and in an additional design time, replenishing the volume with the dissolution medium; aliquots are filtered, 400 μl of 0.25 mol/l of sodium hydroxide is added to 2 ml of the aliquot filtrate, the amount of the active substance converted to the solution is determined, the second stage of a comparative dissolution kinetics test is carried out simultaneously, comprising sequential placement of one unit of the solid dosage form into a dissolution medium with a pH of 4.0±0.05, volume of 500 ml, stirring with a paddle stirrer at a speed of 100 rpm, sampling after 10, 15, 20, 30, 45, 60 minutes with a volume of 5 ml, replenishing this volume with the dissolution medium, aliquots filtering, addition of 400 μl of 0.25 mol/l of sodium hydroxide to 2 ml of aliquot filtrate, determination of the amount of the active substance converted to solution at a pH of 7.0±0.05, volume 900 ml, stirring with a paddle stirrer at a speed of 100 rpm, sampling after 10, 15, 20, 30, 45, 60 minutes. Further, the point of aliquot selection from the dissolution medium with a pH of 7.0±0.05 is determined by the formula Tp=(Tk×0.121)+t(1).

EFFECT: increased accuracy of determination of the pharmaceutical equivalence of the reconstituted drugs with enteric coating.

5 dwg, 2 tbl