RESEARCH ON THE SELECTION OF EXCIPIENTS AS THE RATIONALE FOR THE COMPOSITION OF THE TABLETS WITH DRY EXTRACT OF SANGUISORBA OFFICINALIS

Abstract

The aim. The aim of the research was to study the effect of different groups of excipients on the pharmaco-technological propertiesof the powder mass for tabletting in the development of the composition of the tablets with dry extract of Sanguisorba officinalis for complex therapy of the gastrointestinal tract diseases. Materials and methods. Objects of study - dry extract Sanguisorba officinalis, 25 excipients used in the production of tablets by the method of direct compression, grouped into five groups of factors (fillers based on sugars and microcrystalline cellulose, disintegrants, glidants and lubricants), samples of powder masses. Studies on the determination of pharmaco-technological properties (fluidity, bulk density, bulk density after shrinkage, degree of compressibility, Hausner ratio, and angle of repose) of the obtained powder masses were carried out according to the methods of the State Pharmacopoeia of Ukraine, Second edition. The method of mathematical planning of the experiment was used in the work, the obtained results were subjected to variance analysis, and the ranked series of advantages were placed, in which the excipients were placed in the sequence of their influence on the studied pharmaco-tecnological parameters. Results and discussion. The influence of excipients (factors) on the pharmaco-technological properties (responses) of the powdered tablet masses with the construction of ranked benefits was studied using a five-factor experiment, a hyper-Graeco-Latin square. The results of the analysis of variance showed that glidants have the greatest influence on the fluidity, the bulk density and the bulk density after shrinkage. Neusilin US 2 significantly affects the fluidity of the powder masses and Hausner ratio, the talc having the greatest effect on the bulk density and the bulk density after shrinkage of the powder masses. The representative of the disintegrants group – Sodium starch glycolate most influences the compressibility index, the sugar-based filler – Pearlitol 500 DC – on the angle of repose. Conclusions. The effect of 25 excipients on the pharmaco-technological characteristics of the powdered tablet masses with dry extract of Sanguisorba officinalis was studied. It was found that among the sugars-based fillers equally good results were shown in the powder masses with Compri sugar, Tablettose 80 and Pearlitol 500 DC; among the microcrystalline cellulose based fillers is Prosolv 90; among glidants – Neusilin US 2; no comparison was made of the disintegrants and lubricant excipients from the studied list of leader substances. The results of the studies indicate the possibility of obtaining tablets by the direct compression method, and further study of their pharmaco-technological characteristics will allow to establish the optimal composition of excipients.