Abstract:
OBJECTIVE To develop a new dissolution method of anastrozole tables, study the dissolution behavior, and evaluate the dissolution behavior of consistency between Chinese three companies and the original tablet. And to establish
in vivo-in vitro correlation model, predict of anastrozole tablets oral pharmacokinetic parameters and evaluate its bioequivalence.
METHODS Apparatus 2 was used with 50 r·min
-1, the dissolutive medium was water 900 mL, the dissolutive solution was taken and analyzed by HPLC when 30 min and the limitation was 80% in the new method for dissolution test. Combined with the results of
in vitro dissolution curve, establish
in vivo correlation model by GastroPlus
TM.
RESULTS The new method of dissolution test had good linear relationship with the peak area in the range of 0.22-1.10 μg·mL
-1, and the average recovery rate was 99.3% (RSD=0.8%,
n=9), which was highly accurate and could be used for the determination of dissolution curve. The three domestic pharmaceutical company products were all in line with the original research sample in the dissolution curve similarities of the four media. The dissolution curve was similar to the
in vivo behavior of the software, and the coincidence was high.
CONCLUTION The quality of this product can be effectively controlled by Apparatus 2 used with 50 r·min
-1. Through the analysis of
in vivo-in vitro correlation, the dissolution behavior
in vitro can better reflect the dissolution behavior
in vivo.