STUDY OF THE INFLUENCE OF QUANTITATIVE FACTORS IN CREATION OF TABLETS OF EXTRACTS BILBERRY LEAVES, GOAT’S RUE HERB AND TAURINE BY DIRECT COMPRESSION METHOD
DOI:
https://doi.org/10.11603/2312-0967.2018.4.9706Keywords:
tablets, pharmaco-technological parameters of powder masses for tabletting and tablets, extracts, Vaccinium myrtillus L., Galega officinalis L., taurine, diabetesAbstract
The aim of the work. The study of the influence of 7 quantitative factors on the properties of the powder masses and main parameters of tablets in the development of a new combined medicinal product in the form of tablets with hypoglycemic activity based on dry extracts of bilberry leaves and goat's rue herb in combination with taurine.
Materials and Methods. The active pharmaceutical ingredients were dry extracts of bilberry leaves and goat's rue herb, taurine, excipients. Investigation of the influence of the 7 quantitative factors of excipients on such parameters as the process of compression, uniformity of the tablets mass, tablets resistance to crushing, friability, disintegration of tablets of extract bilberry leaves, goat's rue herb and taurine by direct compression in accordance with the requirements of the State Pharmacopoeia of Ukraine, 2nd edition were carried out. The process of filling the matrix of the tablet machine with the powder masses for tabletting and the average mass of pressed tablets as parameters that most fully characterize the suitability of the powder mass to direct compression.
Results and Discussion. The effects of 7 quantitative factors on the pharmaco-technological properties of powder masses and main parameters of tablets of extracts of bilberry leaves and goat's rue herb and taurine have studied by using the random balance method. For each of the parameters scatter diagrams were constructed. The analysis of the scattering diagrams showed that the increase in the amount of lactose improves the uniformity of the tablets mass and decreases their disintegration. As the amount of mannitol increases, the uniformity of the tablets weight decreases and the disintegration process increases. An increase in the amount of sodium carboxymethyl starch in the form of tablets leads to a significant deterioration in the uniformity of the tablets mass and within the limits of the studied intervals, reduces the process of disintegration.
With the increase in the amount of neusilin US2 in the form of tablets of extract bilberry leaves, goat's rue herb and taurine, uniformity of the tablets mass improves, tablets resistance to crushing increases, friability decreases, but the disintegration time increases. Increasing the amount of calcium carbonate in the tablets leads to a deterioration in the disintegration time, increasing the tablets resistance to crushing, reducing their friability, but leads to a significant increase in the disintegration time. An increase in the amount of sodium croscarmellose in the form of tablets improves the uniformity of the tablets mass and significantly reduces the process of disintegration time of the tablets.
Conclusions. Using the random balance method, the influence of 7 quantitative factors on the pharmacological and technological parameters of tablets of extract bilberry leaves and goat's rue herb and taurine was studied. In the aggregate of the main parameters, the best excipients for the production of tablets based on extracts of bilberry leaves and goat's rue herb in combination with taurine was selected from tabletosе , neusilin US 2, sodium croscarmellose, MCC 200 and magnesium stearate.
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