The method of random balance for studying the influence of excipients quantities on technological parameters of tablets based on Origanum vulgare L. dry extract

Abstract

The aim. The aim of the research was to study the influence of excipients amount on the technological parameters of the compression mixture and tablets based on dry extract of Origanum vulgare L. herb using the method of random balance. Materials and methods. Objects of the study – Origanum vulgare L. herb dry extract, 8 excipients that have been studied at two quantitative levels. The tablets were prepared by direct compression method. The formulations were designed according to the method of random balance. The technological parameters of the compression mixture and tablets based on Origanum vulgare L. herb dry extract have been studied as a function of quantitative factors: silicon, magnesium carbonate basic, dioxide magnesium aluminometasilicate (Neusilin S1®), isomalt (GalenIQ™720), F-melt® Type C (co-spray dried excipients), sucralose, berry flavor and citric acid. Results and discussion. The increase in the amount of Neusilin S1®, GalenIQ™720 and F-melt®, and the decrease in the amount of magnesium carbonate basic and silicon dioxide improved the flowability expressed by the Hausner ratio. Results of bulk density and tapped density of the compression mixture depended on the quantities of GalenIQ™720 and F-melt®. All formulations of the prepared tablets had the rapid disintegration and ranging from 6 to 15 minutes. Resistance for crushing and friability tablets’ were improved with a decrease in the amount of silicon dioxide and increase in the amount of Neusilin S1®, F-melt® and sucralose. Higher resistance to moisture of tablets based on Origanum vulgare L. dry extract was obtained by using Neusilin S1®, F-melt® and sucralose on the upper levels. Conclusions. The tablets based on Origanum vulgare L. herb dry extract were successfully manufactured by direct compression method. The random balance method enabled us to identify the most significant quantitative factors to optimize their composition in the tablets based on the dry extract of Origanum vulgare L. herb.