Title: Utjecaj sastava mješavina na svojstva gotovih tableta
Abstract: Tablets are the most suitable dosage forms due to the simplicity of use and the possibility of precise dosage of the active ingredient in the tablet during production as well as in treatment. Good selection of excipients and process technologies formulate different types of pharmaceutical dosage forms and affects the properties of the tablet. The aim of this study was to investigate the influence of the mixture composition on tablet properties and to ensure that each tablet contains the correct amount of active ingredient, omeprazole. Five different mixtures were prepared for tableting from seven components. All mixtures contained sucrose that was granulated in fluid-bed with a binder polyvinylpyrrolidone (PVP). Microcrystalline cellulose (MCC), mannitol, lactose and PanExcea MC200G, original and granulated, were used as fillers in prepared mixtures. Magnesium stearate (3 %) was added in each mixture as a glidant. The individual components and mixtures were characterized by the particle size distribution, angle of repose, bulk density and tapped density as well as calculated compressibility index and Hausner ratio. The tableting process was carried out in an eccentric tableting machine with a pair of pistons. Obtained tablets were tested on dissolution, hardness, dimensions and friability. The most appropriate mixture and the tablets of best quality were chosen as the basis for the addition of active substance, omeprazole. Omeprazole was added to the mixture in the process of simple powder blending and granulation process in a fluid-bed. Tablets were subjected to standard characterization tests, and additionally, omeprazole content was determined in 10 randomly selected tablets. The results revealed a significant effect of particle size distribution on the properties of a mixture, and thus the characteristics of tablets. It was shown that the granulation is a crucial step in the tableting process. Granulated materials achieved suitable particle size distribution, better flowability, greater hardness of tablets and more uniform composition of omeprazole in tablets thus ensuring the accuracy of dosage of the active ingredient.
Publication Year: 2015
Publication Date: 2015-07-17
Language: en
Type: dissertation
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