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Pharmacotechnical Evaluation by SeDeM Expert System to Develop Orodispersible Tablets

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The Sediment Delivery Model (SeDeM) system represents an innovative tool designed to establish correlations between the micromeritic properties of powders and their compressibility. This system involves the computation of indices that directly assess the compressibility of solids, allowing for corrective measures through particle engineering. The study had multiple objectives: (i) enhancing the solubility of BCS class II nevirapine through the use of solid dispersions; (ii) conducting SeDeM analyses of excipients and solid dispersions to evaluate direct compressibility; and (iii) preparing orodispersible tablets (ODT). Solid dispersions were prepared via solvent evaporation, and both superdisintegrants and solid dispersions underwent analysis for primary indices derived from micromeritic properties, including dimension, compressibility, flowability, stability, and disgregability. Radar diagrams were constructed to visually highlight deficient properties affecting direct compressibility. ODTs were then formulated using excipients that met the criteria for direct compressibility and were subsequently evaluated for tablet properties. Solid dispersions incorporating Eudragit S100 exhibited a significant 6 to 10-fold increase in solubility across various dissolution media, including biorelevant media, compared to the plain drug. Solubility was found to be pH-dependent. SeDeM analyses facilitated the identification of superdisintegrants and excipients with unfavorable compressibility, with radar diagrams providing clear visual evidence of deficiencies in powder properties. Based on SeDeM results, tablets were formulated through direct compression using crosspovidone, croscarmellose sodium, and mannitol. All batches demonstrated a 40% release within the first minute in simulated salivary fluid.
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