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Background <p>This study aimed to identify suitable excipients for the development of vitamin C orally disintegrating tablets (ODTs) using the SeDeM-ODT expert system as a systematic preformulation tool for direct compression. </p> Methods <p>Vitamin C and seven excipients, including both co-processed materials (Prosolv<sup>®</sup> ODT G2, Parteck<sup>®</sup> ODT, Ludiflash<sup>®</sup>, and Ludipress<sup>®</sup> LCE) and single-component excipients (EMDEX<sup>®</sup>, Ceolus™ UF-702, and Ceolus™ UF-711), were evaluated based on SeDeM-ODT parameters related to powder flowability, compressibility, lubricity/stability, lubricity/dosage, and disintegrability. The suitability of each material for direct compression was assessed using the Index of Good Compressibility and Bucodispersibility (IGCB). </p> Results <p>Vitamin C alone exhibited poor compressibility, flowability, and disintegrability, resulting in an IGCB value below the acceptable limit and confirming its unsuitability for direct compression ODT formulation. Among the investigated excipients, Ludiflash<sup>®</sup>, Parteck<sup>®</sup> ODT, and Ceolus™ UF-702 achieved IGCB values above the acceptance threshold and were therefore selected for tablet formulation studies. Tablets prepared with these excipients (100&#xa0;mg vitamin C, 200&#xa0;mg excipient, and 1% magnesium stearate) were produced by direct compression and evaluated for mechanical strength, friability, disintegration time, and dissolution performance. All formulations exhibited acceptable tablet characteristics, including uniform weight, adequate mechanical strength, and rapid disintegration within pharmacopeial limits for ODTs. Dissolution testing confirmed rapid drug release, with more than 75% of vitamin C released within 45&#xa0;min, and early-stage release occurring within the first minutes after disintegration. </p> Conclusion <p>Overall, the results demonstrate that the SeDeM-ODT expert system provides a reliable framework for excipient selection in ODT development, and confirm that Ludiflash<sup>®</sup>, Parteck<sup>®</sup> ODT, and Ceolus™ UF-702 are suitable excipients for the preparation of vitamin C orally disintegrating tablets by direct compression.</p>

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Study of Co-processed Excipient for Direct Compression Using the SeDeM-ODT Expert System

  • 期刊论文

  • 出版模式：

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  • 发表日期：

    2026年4月14日

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  • Mazen Al-Mohaya,
  • Eda Yeşilkaya,
  • Hazal Ulu,
  • Ayşegül Gezgin,
  • Burcu Demiralp

摘要

Background

This study aimed to identify suitable excipients for the development of vitamin C orally disintegrating tablets (ODTs) using the SeDeM-ODT expert system as a systematic preformulation tool for direct compression.

Methods

Vitamin C and seven excipients, including both co-processed materials (Prosolv® ODT G2, Parteck® ODT, Ludiflash®, and Ludipress® LCE) and single-component excipients (EMDEX®, Ceolus™ UF-702, and Ceolus™ UF-711), were evaluated based on SeDeM-ODT parameters related to powder flowability, compressibility, lubricity/stability, lubricity/dosage, and disintegrability. The suitability of each material for direct compression was assessed using the Index of Good Compressibility and Bucodispersibility (IGCB).

Results

Vitamin C alone exhibited poor compressibility, flowability, and disintegrability, resulting in an IGCB value below the acceptable limit and confirming its unsuitability for direct compression ODT formulation. Among the investigated excipients, Ludiflash®, Parteck® ODT, and Ceolus™ UF-702 achieved IGCB values above the acceptance threshold and were therefore selected for tablet formulation studies. Tablets prepared with these excipients (100 mg vitamin C, 200 mg excipient, and 1% magnesium stearate) were produced by direct compression and evaluated for mechanical strength, friability, disintegration time, and dissolution performance. All formulations exhibited acceptable tablet characteristics, including uniform weight, adequate mechanical strength, and rapid disintegration within pharmacopeial limits for ODTs. Dissolution testing confirmed rapid drug release, with more than 75% of vitamin C released within 45 min, and early-stage release occurring within the first minutes after disintegration.

Conclusion

Overall, the results demonstrate that the SeDeM-ODT expert system provides a reliable framework for excipient selection in ODT development, and confirm that Ludiflash®, Parteck® ODT, and Ceolus™ UF-702 are suitable excipients for the preparation of vitamin C orally disintegrating tablets by direct compression.