SELECTION OF COMPOSITION OF EXCIPIENTS IN CREATION OF NATURAL ZEOLITE TABLETS (CLINOPTILOLITE)
DOI:
https://doi.org/10.11603/2312-0967.2018.2.9013Keywords:
natural zeolite, clinoptilolite, tablets, excipients, wet granulation, quantitative factors.Abstract
The aim of the work. Studying the influence of the amounts of auxiliary substances on the pharmaco-technological properties of natural zeolite tablets (clinoptilolite) and to optimize the composition of the finished dosage form.
Materials and Methods. The objects of research were natural zeolite (tablets of average weight 0.55 g and diameter of 10 mm, obtained by pressing with pre-wet granulation. In the studies natural zeolite (clinoptilolite) of Sokirnitsky deposit (Zakarpattia region, Ukraine) was used. To select the pharmaceutical factors that significantly affect the object of the study, a full factor experiment 23 was used with equal duplication of experiments. Three quantitative factors were studied, the relationship between the factors and the pharmaco-technological parameters of the tablets was expressed and interpreted using regression equations. The experiments used modern equipment. For tests used the methods of the State Pharmacopoeia of Ukraine.
Results and Discussion. According to the data obtained, it was found that the homogeneity of the weight of the tablets is most affected by the concentration of the moisturizer, the mechanical resistance to crushing – by the concentration of the filler, the resistance to abrasion – by the content of the mixture of lactose monohydrate with MCC-101 and potato starch, and at the disintegration time – by the content of potato starch. With the help of regression analysis and additional research according to the "steep climb" scheme, an optimal composition of natural zeolite tablets (clinoptilolite) was established: natural zeolite (clinoptilolite) –0.4 g; mixtures of lactose monohydrate with MCC-101 (1:1) –0.085 g; potato starch –0,047 g; 7 % starch potato paste –0.1 g (0.007 g of dry); calcium stearate –0.003 g.
Conclusion. The research was carried out on the selection of quantitative content of auxiliary substances for obtaining zeolite tablets by natural pressing with pre-wet granulation, and the optimal composition of the tablets was proposed, the properties of which correspond to the current requirements of the StPh.References
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