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Functionality of disintegrants with different mechanisms after roll compaction.

Sabrina Berkenkemper1, Hannah Lou Keizer1, Marc Lindenberg2

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Summary

Dry granulation significantly impairs disintegrant functionality in tablets, affecting disintegration time and mechanism compared to direct compression. Crospovidone was more affected than croscarmellose sodium, highlighting process-excipient interactions.

Keywords:
Direct compressionDry granulationExcipientsManufacturing Classification SystemTablet disintegration

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Area of Science:

  • Pharmaceutical Technology
  • Materials Science

Background:

  • Tablet formulation relies on excipient functionality for drug release.
  • Manufacturing processes like dry granulation can alter excipient performance.

Purpose of the Study:

  • To evaluate the functionality of crospovidone and croscarmellose sodium as disintegrants.
  • To assess the impact of roll compaction (dry granulation) versus direct compression on tablet properties.
  • To investigate the influence of fillers and sodium lauryl sulfate on disintegrant efficacy.

Main Methods:

  • Full factorial design was employed to study formulation variables.
  • Tablets were manufactured using roll compaction and direct compression.
  • Key tablet characteristics including tensile strength, solid fraction, disintegration time/mechanism, and dissolution were analyzed.

Main Results:

  • Dry granulation impaired the functionality of both crospovidone and croscarmellose sodium.
  • Disintegration time and mechanism differed significantly between dry granulated and directly compressed tablets.
  • Crospovidone's functionality was more affected by dry granulation than croscarmellose sodium.
  • Sodium lauryl sulfate exhibited a lubricating effect, influencing tablet properties.
  • Filler variations also markedly affected tablet characteristics.

Conclusions:

  • Excipient functionality is process-dependent, impacting final drug product properties.
  • The study provides insights into extending the Manufacturing Classification System to include excipient characteristics.
  • Understanding these interactions is crucial for robust tablet formulation and manufacturing.