Optimization of the content of excipients in tablets

When developing a tablet drug technology, there is a need to find the optimal quantitative content of a number of excipients that should provide a set of required pharmacopeial characteristics. The quantitative composition of excipients affects several pharmaco-technological parameters under study, which leads to the need to solve the problem of multicriteria optimization. Materials and methods. To determine the optimal amount of three excipients, the amount of which is fixed in the tablet, we used the method of mathematical modeling with the application of statistical analysis and a multicriteria optimization. The following software tools were used to process the experimental data and perform calculations MS Excel and Mathcad 14. Results and discussion. A methodical approach to determining the optimal solution using statistical methods in pharma-technological research with quantitative factors is proposed in the example of establishing the optimal content of excipients with a fixed total amount in the development of tablet technology. The issues of building mathematical models that characterize the effect of the quantitative content of excipients on a number of pharma-technological parameters of tablets based on experimental data are considered. Attention is focused on the peculiarities of using static methods for processing experimental data in the case when the studied factors are correlated, which can lead to negative consequences when evaluating the results of regression analysis. A generalized optimization criterion is proposed that contains unit vectors - Y(X)=F(y1(X), y2(X), ..., yi(X)), where X=f(x1,x2,...xn) and is a multidimensional vector function. Minimization of this function leads to the determination of the coordinate of the point in the admissible decision domain that satisfies the condition of equal approximation of all individual criteria to their optimal values. Conclusions. The optimal number of excipients with a fixed total amount in the composition of tablets was determined, which will ensure the maximum approximation of the pharmacological and technological parameters of tablets under the study conditions.