Chowhan Z T, Yang I C, Amaro A A, Chi L H
J Pharm Sci. 1982 Dec;71(12):1371-5. doi: 10.1002/jps.2600711215.
The friability and dissolution of a formulation of compressed tablets were studied by varying the granulation moisture and tablet crushing strength. A general quadratic response surface model was used to analyze the data. The response surface contour plots of tablet friability consisted of a series of ellipsoidal curves. The optimum friability corresponding to a granulation moisture content and a tablet crushing strength was a simple minimum. The in vitro dissolution contour plots showed a stationary ridge system. Along the ridge, a large number of combinations of tablet crushing strength and granulation moisture represented 100% drug dissolution. The contour overlays of friability and dissolution contour plots showed a region where both the friability and dissolution requirement could be met. The analysis of the data by means of multiple linear regression was helpful in understanding the role of granulation moisture and tablet crushing strength on tablet friability and in vitro dissolution.
通过改变制粒水分和片剂抗压强度，研究了一种压制片制剂的脆碎度和溶出度。采用通用二次响应面模型对数据进行分析。片剂脆碎度的响应面等高线图由一系列椭圆形曲线组成。对应于制粒水分含量和片剂抗压强度的最佳脆碎度为简单最小值。体外溶出度等高线图显示出一个稳定的脊状系统。沿着该脊，大量片剂抗压强度和制粒水分的组合代表100%药物溶出。脆碎度和溶出度等高线图的等高线叠加显示出一个既能满足脆碎度要求又能满足溶出度要求的区域。通过多元线性回归对数据进行分析，有助于理解制粒水分和片剂抗压强度对片剂脆碎度和体外溶出度的作用。
