Newton J M, Razzo F N
J Pharm Pharmacol. 1977 Apr;29(4):205-8. doi: 10.1111/j.2042-7158.1977.tb11289.x.
A factorially designed experiment has been carried out to study the influence of various additives on the in vitro release of drug from hard gelatin capsules. Analysis of variance confirms previous findings that, although the main factors of diluent type, diluent concentration, the absence and presence of both magnesium stearate and sodium lauryl sulphate, were highly significant, the existence of interactions between the factors prevented exact quantitative prediction of the influence of each factor. There appears however, to be a strong indication that the in vitro drug release of capsule formulations (y), expressed as the % of the drug content of the capsule which dissolves, can be related to the solubility of the drug (cs) by the expression y = 21-2 log cs + 31.2.
进行了一项析因设计实验，以研究各种添加剂对药物从硬明胶胶囊中的体外释放的影响。方差分析证实了先前的研究结果，即尽管稀释剂类型、稀释剂浓度、硬脂酸镁和月桂基硫酸钠的有无等主要因素具有高度显著性，但各因素之间的相互作用使得无法对每个因素的影响进行精确的定量预测。然而，似乎有强烈迹象表明，以溶解的胶囊药物含量百分比表示的胶囊制剂的体外药物释放（y），可以通过表达式y = 21 - 2 log cs + 31.2与药物的溶解度（cs）相关。
