The methodological approach to determination of the optimal content of excipients in the composition of tablets

Abstract

Aim. To determine the algorithm of the optimal amount of excipients in the composition of tablets based on common ginger. Materials and methods. The study object was the regression equations determining the quantitative effect of excipients in the composition of the dosage form on the target pharmacopeial characteristics. The mathematical processing of these equations was carried out using the Mathcad 15 computer program according to the algorithm proposed. Results and discussion. It has been proposed to use the approximation function to determine the level of optimization. The approximation function is the sum of the squares of deviations of the objective functions from their optimal values. It has been proven that identification of mathematical models in pharmaceutical studies with three dependent factors, which total value is determined by the quantitative composition of a dosage form and is fixed at a certain level, is difficult to perform due to the complicated interpretation of multiple regression parameters as characteristics of factors in an isolated form through their correlation. The region for the optimal solution has been proposed with respect to the values of factors and effective indicators of a multiple regression model. The methodological approach to determining the optimal content of excipients in the composition of the given dosage form has been proposed. Conclusions. The optimal content of excipients – neusilin and colidone – has been determined while developing the composition of tablets based on common ginger with the necessary pharmacological and technological indicators that meet the requirements of the State Pharmacopoeia of Ukraine. The approach to the formation of the region offeasibility in two-way studies has been considered. Using the theory of multi-vector optimization a criterion has been developed; it allows determining the optimal feasible solution in the region under conditions of restrictions both by factors and target indicators.