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<p>This study investigates the functionality and performance of microcrystalline cellulose (MCC) grades—MCC 101 and MCC 102, sourced from six different manufacturers, using the SeDeM expert system towards suitability for direct compression tablet formulations. The SeDeM methodology applies twelve critical powder properties to generate three key indices: “Parameter Index (IP), Parameter Profile Index (IPP), and Index of Good Compression (IGC)”, offering a quantitative framework to evaluate compressibility and flowability. While MCC 102 grades demonstrated improved flow characteristics due to their larger particle size, inter-manufacturer variability was observed through the index-based evaluation. To further validate the SeDeM analysis, 250&#xa0;mg tablets of Metformin HCl and Ibuprofen were formulated using selected MCC 102 samples and evaluated for key performance parameters. Results revealed that disintegration times were influenced by both the excipient type and the physicochemical nature of the active pharmaceutical ingredient (API). The dissolution profiles indicated that Acecel<sup>®</sup> 102 enabled the fastest release of Metformin HCl, while Hicel™ 102 facilitated the most rapid dissolution of Ibuprofen. These findings highlight the importance of excipient selection in tablet development and demonstrate the utility of the SeDeM system as a predictive strategy for optimizing direct compression formulations.</p> Graphical Abstract <p></p>

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Assessment of Microcrystalline Cellulose Grades Using the SeDeM System: Implications for Direct Compression Tablet Performance

  • 期刊论文

  • 发表日期：

    2026年4月25日

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  • Srushti Tambe,
  • Madhuri Kshirsagar,
  • Tareque Masood,
  • Nikita Harbale,
  • Shubhada Mane,
  • Ritik Ramdhani,
  • Sukesh Padamwar,
  • Purnima D. Amin

摘要

This study investigates the functionality and performance of microcrystalline cellulose (MCC) grades—MCC 101 and MCC 102, sourced from six different manufacturers, using the SeDeM expert system towards suitability for direct compression tablet formulations. The SeDeM methodology applies twelve critical powder properties to generate three key indices: “Parameter Index (IP), Parameter Profile Index (IPP), and Index of Good Compression (IGC)”, offering a quantitative framework to evaluate compressibility and flowability. While MCC 102 grades demonstrated improved flow characteristics due to their larger particle size, inter-manufacturer variability was observed through the index-based evaluation. To further validate the SeDeM analysis, 250 mg tablets of Metformin HCl and Ibuprofen were formulated using selected MCC 102 samples and evaluated for key performance parameters. Results revealed that disintegration times were influenced by both the excipient type and the physicochemical nature of the active pharmaceutical ingredient (API). The dissolution profiles indicated that Acecel® 102 enabled the fastest release of Metformin HCl, while Hicel™ 102 facilitated the most rapid dissolution of Ibuprofen. These findings highlight the importance of excipient selection in tablet development and demonstrate the utility of the SeDeM system as a predictive strategy for optimizing direct compression formulations.

Graphical Abstract