Studies on the Tablet Product Design : Effects of Anhydrous Lactose and Corn Starch on the Preparation of Prednisolone Tablet by Direct Compression Method

정제의 제조설계에 관한 연구 : 직타법에 의한 Prednisolone 정제의 제조에 있어서 무수유당 및 옥수수전분의 영향

Prednisolone tablet product design problem was structured as constrained optimization problem and subsequently solved by multiple regression analysis and Lagrangian method of optimixation. Prednisolone was the drug chosen and anhydrous lactose and corn starch were the adjuvants. The effect of anhydrous lactose and corn starch concentrations on tablet hardness, volume, disintegration time and in vitro release rate was studied. The concentrations of anhydrous lactose and corn starch used in this experiment were 30-60 percent and 5-30 percent, respectively. A full second-order (quadratic) model with all possible two-factor interactions was employed. To obtain the values of anhydrous lactose and corn starch which miniumize the in vitro : release time (t$_{60%}$) subject to the constraint on tablet hardness, disintegration time and volume, we solved the Lagrange function. Multiple correlation coefficients for the regression models were correlated at less than 0.05 level and it was found that the optimum concentrations of anhydrous lactose and corn starch were 45 percent and 21 percent, respectively.