Development of amlodipine and enalapril combined tablets based on quality by design and artificial neural network for confirming of qualitative composition

Abstract

Using approaches of Quality by design, namely dispersion analysis, random balance method, regression analysis and neural networks, the composition and technology tablets based on amlodipine besylate and enalapril maleate have been developed. Using dispersion analysis was determined the effect of 30 excipients on 10 pharmaco-technological parameters of tablets. With the help of the desirability function, the leaders of the excipients were selected from 6 functional groups. It was confirmed that the composition with the best pharmaco-technological parameters, determined by using statistical methods, coincides with the results studies the synthesized Feed-forward neural network. The quantities of preferable excipients at 3 levels were identified by the random balance method. The relationship between the studied factors and the quality of the tablets was described by regression equations. Based on the placement of equal output lines, the optimal composition of amlodipine tablets with enalapril was established.