Abstract:

The aim of the work. Study of the influence of excipients on pharmaco-technological properties of the tablets with the purpose of development of a new combined pill drug with hypoglycemic activity on the basis of dry extracts of the bilberry leaves, goat’s rue herbs and taurine obtained by direct compression method. Materials and Methods. The main active substances are dry extracts of Vaccinium myrtillus L. leaves, Galega officinalis L. Herbs, taurine and 30 excipients grouped into 6 qualitative factors according to the properties and purposes. The mathematical planning of the experiment on the basis of the 4x4 hyper-Greek-Latin square was used in the work. It makes possible to establish the relationship between the composition of the tablets and the basic pharmaco-technological parameters (the process of compression, uniformity of the mass, the resistance of the tablets to crushing, friability, time of disintegration), in accordance with the requirements of SPFU 2. Results and Discussion. The influence of 30 excipients on the pharmaco-technological properties of tablets (compression process, uniformity of mass, resistance to crushing, friability, time of disintegration) on the basis of dry bilberry leaf extract, extract of goat’s rue herbs and taurine was studied. The influence of 6 qualitative factors on the pharmaco-technological parameters of the studied tablets was studied with the help of a six-factor experiment of the 4x4 hyper-Greek-Latin square. Ranks of the advantages of the studied excipients were constructed for each of the indicators. The dispersion analysis of experimental data showed that the best process for pressing tablets of bilberry leaf extract, extract of goat’s rue herb and taurine is carried out with the use of parlitol 100SD + mannitol, stearin acid, neusel in UFL and sodium carboxymethyl starch.The most uniformity mass of tablets is obtained with the use of neuselinum USand neuselinum UFL, sodium carboxymethyl starch, prosolveODTG 2, magnesium stearate and lubritabe. The most resistant to crushing tablets were obtained with the use of MCC 200, MCCburst, magnesium stearate, neuselinum US 2, sodium croskarmellose and sodium carboxymethyl starch. The studied tablets that included MCCburst, neuselinum US 2, MCC 200, crospovidone CL 10, stearin asid and ludipress had the least friability. The tablets based on extracts of Vaccinium myrtillus L. leaves, Galega officinalis L. herbs and taurine with the use of manit, tabletose, sodium croskarmellose, calcium carbonate, sodium stearyl fumarate, MCC 102, prosolve ODTG 2 had the least disintegration time.Conclusions. The influence of 30 excipients on the pharmaco-technological properties of leaf bilberry extract, extract of goat’s rue herbs and taurine (compression process, uniformity of mass, resistance to crushing, friability, time of disintegration) have been investigated. The influence of 6 qualitative factors on the main responses (indexes) of tablets based on dry extracts of Vaccinium myrtillus L. leaves, Galega officinalis L. herbs and taurine was studied with the help ofthe 4x4hyper-Greek-Latin square. The ranks of the advantages of excipients influence on 5 responses (indexes) of tablets based on dry extracts of Vaccinium myrtillus L. leaves, Galega officinalis L. herbs and taurine were constructed.

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