Brockmeier D
Arzneimittelforschung. 1981;31(10):1746-51.
The influence of drug bioavailability on therapeutic regimens has increased the interest in in vitro dissolution testing and the quantitative interpretation of dissolution profiles. The mean and variance of in vitro dissolution times are appropriate parameters for discriminating different dissolution profiles. This article demonstrates that both parameters can easily and immediately be derived from dissolution data. Moreover, it is shown that the mean and variance of in vitro dissolution times define the parameters which appear in the model equation of a linear transport process. This model equation is proved to be valid for five formulations of N-carboxy-3-morpholinosydnone imine ethyl ester (molsidomine, Corvaton). It is applicable to dissolution data from a great variety of pharmaceutical formulations, provided that the dissolution process consists of a sequence of independent events. The model parameters are found by two different methods: by direct computation from the mean and variance of the dissolution times and by non-linear least-square parameter estimation. Both methods are compared on the basis of their resulting sum of squares (F-Test). The new pragmatic, statistical approach of data examination proves to be as effective as established routines.
药物生物利用度对治疗方案的影响使得人们对体外溶出度测试以及溶出曲线的定量解释越来越感兴趣。体外溶出时间的均值和方差是区分不同溶出曲线的合适参数。本文表明这两个参数都可以轻松且直接地从溶出数据中得出。此外，研究表明体外溶出时间的均值和方差定义了线性传输过程模型方程中出现的参数。该模型方程被证明对N-羧基-3-吗啉代亚磺酰亚胺乙酯（吗多明，可文通）的五种制剂有效。只要溶出过程由一系列独立事件组成，它就适用于来自各种药物制剂的溶出数据。通过两种不同方法找到模型参数：通过从溶出时间的均值和方差直接计算以及通过非线性最小二乘参数估计。基于所得平方和（F检验）对这两种方法进行比较。新的数据检验实用统计方法被证明与既定程序一样有效。
