USE OF DISSOLUTION TEST FOR EVALUATION OF PHARMACEUTICAL EQUIVALENCE OF ATORVASTATIN GENERICS

Abstract

This article shows the results of a study of pharmaceutical equivalence of atorvastatin generics using Dissolution test. A significant difference in the intensity of atorvastatin release from tablets from different manufacturers has been established. From 10 to 97% of atorvastatin was released from tablets of different manufacturers by the 15th minute of the test. In the similitude of the dissolution profiles, 6 generics out of 13 studied were pharmaceutically equivalent to the reference drug in doses 10 mg and 20 mg. It is shown that the inclusion of disintegrants and solubilizers in the formulation leads to an increase in the release rate of the active pharmaceutical substance from the dosage form.

Keywords

• тест «растворение»
• фармацевтическая эквивалентность
• таблетки
• покрытые пленочной оболочкой
• аторвастатин