정제의 제조설계에 관한 연구 : 직타법에 의한 Prednisolone 정제의 제조에 있어서 무수유당 및 옥수수전분의 영향
Studies on the Tablet Product Design : Effects of Anhydrous Lactose and Corn Starch on the Preparation of Prednisolone Tablet by Direct Compression Method
약학회지 1976년 20권 2호 p.63 ~ 69
권종원, 민신홍, 이상의, 김용배,
소속 상세정보
권종원 ( Kwon Jong-Won )
동아제약주식회사
민신홍 ( Min Shin-Hong )
동아제약주식회사
이상의 ( Rhee Sang-Hi )
동아제약주식회사
김용배 ( Kim Yong-Bae )
동아제약주식회사
KMID : 0370219760200020063
Abstract
Prednisolone tablet product design problem was structured as constrained optimization problem and subsequently solved by multiple regression analysis and Lagrangian method of optimization. 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 minimize the in vitro release time (t60%) 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.
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