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Excipients for orally disintegrating tablets: compaction data analysis and study of tableting properties of lubricated co-processed excipients

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The selection of an appropriate co-processed excipient (CPE) is a critical aspect in the development of orally disintegrating tablets (ODTs). This study assessed five commonly used CPEs (Ludiflash®, Ludipress®, Ludipress® LCE, Pearlitol® 200 SD, and GalenIQ™721) in ODT formulations through dynamic compaction data analysis. The investigation involved the examination of Heckel plots, force-displacement (F-D) curves, and compaction energy data generated by a compaction simulator during powder compression. Compaction force and the composition of CPE emerged as the primary influencers on tablet properties and the energies required for compaction. According to Heckel analysis, all examined CPEs exhibited relatively higher resistance to plastic deformation, categorizing them as intermediate or brittle. F-D analysis indicated that GalenIQ™721 leans toward a more plastic behavior. In conclusion, this research underscores that the critical quality attributes of ODTs are significantly impacted by excipient characteristics, particularly their deformability, compressibility, and tabletability capacity.
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