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Compaction behavior of isomalt after roll compaction.

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This study shows that the new isomalt grade galenIQ™ 801 is suitable for dry granulation and tableting. While pure isomalt tablets exceeded friability limits, it remains a viable excipient option for pharmaceutical formulations.

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Area of Science:

  • Pharmaceutical Technology
  • Materials Science

Background:

  • Isomalt is a sugar substitute with potential applications in pharmaceutical formulations.
  • Evaluating new excipient grades is crucial for developing effective drug delivery systems.

Purpose of the Study:

  • To assess the suitability of galenIQ™ 801 isomalt for dry granulation and tableting.
  • To investigate the impact of compaction and tableting forces on tablet properties.

Main Methods:

  • Roll compaction of pure isomalt and an isomalt/dibasic calcium phosphate blend.
  • Tableting of granules and determination of particle size, flowability, friability, disintegration time, and tensile strength.
  • Analysis of the relationship between compaction forces and tablet tensile strength.

Main Results:

  • Tablet tensile strength increased with tableting force for both pure isomalt and the blend.
  • Pure isomalt tablets showed optimal tensile strength at specific compaction forces (2-6 kN/cm), decreasing at higher forces.
  • Pure isomalt tablets exceeded friability limits, and disintegration time correlated inversely with porosity and tensile strength.

Conclusions:

  • Isomalt galenIQ™ 801 is suitable for tableting after dry granulation, offering an alternative excipient.
  • Its binding capacity may be lower than other excipients, but it demonstrates potential for formulation scientists.
  • Further optimization of compaction and tableting parameters is needed to address friability issues.