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Development of hot-melt extrusion as a novel technique for the ...

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grades (3.5-5.5 g water/g polymer) and in combination with <strong>the</strong> smaller particle size, displayf<strong>as</strong>ter disintegration times.Fig. 3.5(a-d) depicts <strong>the</strong> tablet hardness versus <strong>the</strong> compaction <strong>for</strong>ce at varioussuperdisintegrant concentrations and compaction <strong>for</strong>ces. It can be seen that <strong>the</strong> hardnessincre<strong>as</strong>ed with concentrations up to 5% (wt/wt) <strong>for</strong> all superdisintegrants. When highdisintegrant concentrations (>10% wt/wt) were used, <strong>the</strong> tablets became s<strong>of</strong>ter and <strong>the</strong>hardness decre<strong>as</strong>ed (except CL 20% w/w) <strong>as</strong> a result <strong>of</strong> modest compressibility. Ano<strong>the</strong>rinteresting observation <strong>for</strong> all disintegrants is that <strong>the</strong> hardness incre<strong>as</strong>ed with an incre<strong>as</strong>e in<strong>the</strong> applied compaction <strong>for</strong>ce. The results obtained from friability studies indicate dissimilarbehaviour <strong>for</strong> each disintegrant. For instance, Kollidon CL and Viv<strong>as</strong>ol at 2-10% wt/wtdisplayed no impact <strong>of</strong> disintegrant level at 8-12 kN compaction <strong>for</strong>ces but displayed highfriability at concentrations <strong>of</strong> 20% w/w. On <strong>the</strong> o<strong>the</strong>r hand, XL and CL - SF showed very lowfriability at 2% levels and a slight incre<strong>as</strong>e from 5-20% levels. In <strong>the</strong> c<strong>as</strong>e <strong>of</strong> XL10, <strong>the</strong>optimum friability w<strong>as</strong> observed at 10% w/w levels.The rapid disintegration times described above are also related to tablet porosity <strong>as</strong> can beseen in Table 2. High porosity is a critical ODT parameter because it facilitates liquidpenetration into <strong>the</strong> tablet and results in f<strong>as</strong>ter disintegration. The estimated porosities <strong>for</strong> allODT <strong>for</strong>mulations were quite high, varying from approximately 0.13-0.16 without howevercompromising tablet mechanical properties. The hardness and friability studies demonstratedacceptable mechanical properties <strong>as</strong> mentioned above (Hardness about 7 Kp, friability

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