The choice of the quantitative composition of excipients when creating the natural zeolite paste
Keywords:natural zeolite, clinoptilolite, silicon dioxide, glycerol, paste, auxiliary substances, quantitative factors
The properties of pastes depend on a number of factors, the most important of them are the concentration of the solid phase and the nature of the dispersion medium.
Aim. To study the effect of the amounts of active substances and excipients on the pharmacotechnological properties of a natural zeolite paste (clinoptilolite) and to optimize the composition of the finished dosage form.
Materials and methods. The objects of the study were model compositions of pastes containing the active substance – natural zeolite powder (clinoptilolite) in the concentrations of 20-30 %, a thickener – silicon dioxide in the concentrations of 6.0-8.0 %, and a plasticizer – glycerol in the concentrations of 6.0-8.0 %. Samples of pastes also contained flavoring agents – sorbitol and apple flavoring of 3 % each, and 0.02 % of a preservative – sorbic acid. To select the pharmaceutical factors significantly affecting the study object the fractional factorial experiment 23 was used with equal duplication of experiments. Three quantitative factors were studied. The responses were consistency of the paste, effective viscosity at the shear rate Dr = 5.0 s-1, the thixotropic coefficient and the adsorption activity in relation to methylene blue. The relationship between factors and responses was expressed and interpreted using the regression equations.
Results and discussion. It has been determined that the samples studied belong to the thixotropically structured pseudoplastic systems with the structure of the coagulation type. It has been proven that natural zeolite (clinoptilolite) together with silicon dioxide has a structuring effect on the disperse system and the adsorption activity of the paste as a whole; the following composition is optimal (g): natural zeolite (clinoptilolite) 25.0; silicon dioxide 7.0; glycerol 5.0; sorbic acid 0.02; sorbitol 3.0; apple flavor 3.0; purified water 56.98.
Conclusions. The studies on the choice of the quantitative content of excipients for obtaining the natural zeolite paste have been conducted; the optimal composition of active substances and excipients has been proposed.
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