Emulsions are an effective approach to increase the bioavailability of poorly water-soluble active ingredients, but we often come across occurrence of flotation, coalescence and Ostwald ripping, as well as phase inversion, which causes problems with the stability of these two-phase systems. One of the strategies for improving the disadvantages of classical emulsions is their transformation into dried emulsions. As part of the master's thesis, pellets were coated with an O/W emulsion using the fluidized bed method, in which the active ingredient simvastatin was incorporated into the oil phase and the hydrophilic matrix of the emulsion framework was dissolved in the aqueous phase. The aim of the master's thesis was to develop and produce dried emulsion coated pellets that will show adequate physical and chemical stability and as such in a separate study potentially show improved biopharmaceutical properties compared to the classically designed product on the market. Preliminary tests were used to determine the composition of the emulsion and to determine the most optimal process parameters. To achieve optimization of the composition of emulsion formulations, we used two critical product properties - responses (ability to reconstitute emulsion and one-month stability parameter of the active ingredient) and showed them with mathematical models according to the concept of experimental design. Pellets coated with dried emulsion showed a correspondingly low size distribution width, round shape and water content less than 1.5 %. After reconstitution in aqueous medium, the optimized formulations showed a narrow distribution of oil droplet size with the active ingredient, adequate stability, effective drug incorporation and an improved release profile compared to the non-lipid tablet formulation currently available on the market and compared to the the pure active ingredient.
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