Preparation and Characterization of Low Dosage Omeprazole Tablets
Five different mixtures of seven components were prepared for tableting. Saccharose, a basic ingredient in each mixture for tableting, was pretreated by top-spray fluid-bed granulation process using polyvinylpyrrolidone as a binder. Microcrystalline cellulose (MCC), mannitol, lactose and PanExcea MC200G, original and granulated, were used as fillers in prepared mixtures. Magnesium stearate was added in each mixture as a glidant. Each component and mixtures for tableting were characterized by particle size distribution, bulk and tapped density, angle of repose, as well as calculated compressibility index and Hausner ratio. Tablets were characterized using standard tests on disintegration, hardness, dimensions and friability. Omeprazole was added to the mixture using the process of simple powder blending in a tumbling bed unit and by wet fluid-bed granulation process. 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 granulated materials own suitable particle size distribution, better flowability, greater hardness of tablets and more uniform composition of omeprazole in tablets thus ensuring the targeted dosage content of the active ingredient in each tablet produced.
Omeprazole, Tableting, Fluid-Bed Granulation, Particle Size Distribution, Uniformity of Content
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