engleski

Dissolution kinetics of omeprazole tablets produced via wet granulation

Tablets are the most frequently used dosage forms for drug delivery. Controlled-release profile of active ingredient is a highly important end-use property of many tablets. Modifications of excipients significantly affect the final properties of tablets. With this, the targeted dissolution profile of active ingredient could be reached. Our primary goal is to investigate the effect of properties of mixtures for tableting on the uniformity of content and the dissolution pattern of the drug. In addition, our intention here is to describe the release profile of omeprazole, the drug that works for controlled decreasing of the stomach acid amount. Various mixtures for tableting were prepared of: omeprazole (active pharmaceutical ingredient), PanExcea, magnesium stearate and saccharose (excipients). One mixture was built up of saccharose granulated in a fluid-bed. Four mixtures were using saccharose granulated in an inclined disc unit, and the last was prepared by granulation of all components in a fluid-bed unit. Mixtures were compressed using a single punch tableting machine. Tablets were characterized using standard tests on: weight, thickness, diameter, hardness, friability, moisture content and uniformity of drug content. Dissolution kinetics was studied on the tablets that fulfill high quality requirements. The results revealed a significant effect of pretreatment processes on the characteristics of tablets. Granulation of all components in a fluid-bed environment results in tablets with less friability, of greater hardness and with a more uniform composition of omeprazole. Thus, tablets showed less erosion occurrence and slower release profile of omeprazole. Dissolution kinetics of omeprazole tablets was efficiently described using Higuchi and Hopfenberg models.

omeprazole tablets, dissolution kinetics, wet granulation

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