Dinçer S, Ozdurmuş S
J Pharm Sci. 1977 Aug;66(8):1070-3. doi: 10.1002/jps.2600660804.
The enteric film coating of placebo tablets, using a methacrylic acid-methyl methacrylate copolymer as the film former in the coating solution, was studied by statistical techniques. The effects of four independent formulation and process variables on the disintegration time of the coated film in simulated intestinal fluid and on the resistance to disintegration of the coated film in simulated gastric fluid were studied. The results of a statistically designed set of experiments were used as the input data. Regression analysis of these data resulted in two first-order polynomial equations. The linear model obtained for the disintegration time of the coating in the simulated intestinal fluid was analyzed by the steepest descent method to determine the most suitable combination of the independent variables.
采用统计技术研究了以甲基丙烯酸 - 甲基丙烯酸甲酯共聚物为包衣液成膜剂的安慰剂片的肠溶薄膜包衣。研究了四个独立的处方和工艺变量对包衣膜在模拟肠液中的崩解时间以及在模拟胃液中抗崩解性的影响。一组经统计学设计的实验结果用作输入数据。对这些数据进行回归分析得到了两个一阶多项式方程。采用最速下降法分析模拟肠液中包衣崩解时间所获得的线性模型，以确定自变量的最合适组合。
