푸마르산철글리신 복합체의 약제학적 연구 (제2보) -지속성 푸마르산철글리신 정제의 최적화에 관한 연구-

Pharmaceutical Studies on Ferroglycine Fumarate (II) -Studies on Optimization of Controlled Release Ferroglycine Fumarate Tablets-

In order to reduce gastric irritation in the stomach of iron preparations, ferroglycine fumarate (FGF) granules coated with hydroxyethylcellulose was made by matrix granulator, and the constrained optimization method, employing the Lagrange equation, was successfully applied to the manufacturing process design of controlled release tablets. The effects of stearic acid and dried corn starch on tablet hardness, friability, dissolution rate $t_{50%}$ and tablet volume were found to be very significant. In rabbit test, pharmacokinetic parameters $(K_a,\;C_{max}\;and\;AUC^{0-12})$ and urinary excretion rate $(K_e)$ of the controlled release FGF tablets were higher than those of controlled release ferroglycine sulfate tablets which were manufactured in the same optimal conditions. Controlled release FGF tablets were more stable than controlled release ferroglycine sulfate tablets in accelerated storage conditions.