Study on the influence of excipients on pharmaco-technological properties of tablet cores of dexketoprofen
Among the group of nonsteroidal anti-inflammatory drugs, the active substance dexketoprofen trometamol is released. Its pharmacological and pharmacological and technological characteristics are induced in the article. The feasibility of using the wet granulation method in the development of tablets with dexketoprofen is substantiated.
The purpose of this work was selecting the optimal excipients for obtaining a high-quality medicinal product.
The excipients were selected and grouped into 4 functional groups. For the planning of the experiment, a matrix was based on the hyper-Greek-Latin parallelepiped. The tablets were prepared by wet granulation. The effect of the excipients for the granulate, tablet mass and core tablets was studied by such factors as loss on during of the granulate, bulk density of the tablet mass, resistance to crushing, friability, disintegration. The experimental data were subjected to statistical analysis by the method of dispersion analysis. The results were expressed using ranked rows of benefits and bar charts.
The results of the study of the effect of excipients from groups of fillers, disintegrants, sliding, binding substances on the quality of granulate, tablet mass and tablet cores are provided.
The results of the study show that the loss on drying is most influenced by fillers. The quality of the tablet mass depends more on the solution used for wetting, so the nature of the binder and the method of moistening have a determining effect on the bulk density of the tablet mass. Fillers have the most significant effect on the resistance to crushing of the core tablets. The hardness of the dexketoprofen tablet cores characterizes friability, the leading position on the influence is occupied by a group of disintegrants, namely: a mixture of sodium starch and corn starch. The most significant influence on disintegration is exerted by a binder and a moistening method.
The generalized results of the study showed that leaders from the four groups of the excipients are appeared by the influence on the technological indicators of granulate, tablet mass and tablet cores.
In the result of the work the excipients were selected for development of the composition of the tablet cores, their influence on the pharmaco- technological indicators was also investigated. The excipients were selected for further optimization of the composition of the tablets with dexketoprofen, namely: MCC 102, a mixture of sodium starch glycolate and corn starch, corn starch and the use of a 40% dexketoprofen trometamol.
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