Ebook Optimization of Tablets Containing High Dose of Spray-Dried Plant Extract: A Technical Note
The development and production of tablets containing high dose of active ingredients is a complex and extensive technological challenge. Dried plant extracts are often used as therapeutically active material in the manufacture of tablets. They are quite often very fine, poorly compressible and very hygroscopic powders. Additionally, tablets containing a high amount of dried extract show prolonged disintegrate times; therefore, the release of the active constituents is affected. Some alternatives have been proposed to minimize these problems.
The granulation seems to be the most appropriated technique to improve the technological properties of these products. However, due to their high hygroscopicity, extracts cannot be granulated using aqueous systems. Thus, dry granulation is a possible technique to produce granules from dried herbal extracts. Slugging is a simple dry granulation process, by which material is compacted in tablet press with subsequent milling process. Previously work showed that the use of lubricants during direct compression of vegetable dried extracts increasing the disintegration time. On the other hand, Rocksloh et al.and von Eggelkraut-Gottanka et al. showed that the incorporation of a high amount of magnesium stearate into the granules shortened the disintegration times compared to tablets containing the powdered mixture. Experimental design is a widely used tool for the systematic and effective evaluation of differences among formulations.
The Central Composite Design (CCD) is the most employed second-order design to study and optimize tablet formulations. With CCD, it is possible to create response surfaces, which allow the ranking of each variable according to its significance on the responses studied. Therefore, it may be possible to predict the formulation composition to reach a desired response with a reduced time and experimental effort. The aim of this study was to evaluate the concentration of CMC-Na and CSD on the crushing strength, disintegration time and friability of tablets containing high doses of spray dried extract dry granulations, using a CCD.
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