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Characterization of mannitol granules and powder: A comparative study using two flowability testers.

Yoshiko Takeuchi1, Tomoka Tomita1, Junko Kuroda1

  • 1Laboratory of Pharmaceutical Engineering, Gifu Pharmaceutical University, 1-25-4 Daigaku-nishi, Gifu 501-1196, Japan.

International Journal of Pharmaceutics
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PubMed
Summary

Flowability of mannitol excipients is crucial for tablet manufacturing. Spherical mannitol granules exhibit superior flow properties, essential for developing orally disintegrating tablets (ODTs).

Keywords:
Carr’s indexDynamic flowFlowability testerMannitol granulesPowder flowShear test

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Area of Science:

  • Pharmaceutical Technology
  • Materials Science

Background:

  • Excipient powder flowability is critical in direct tableting.
  • Orally disintegrating tablets (ODTs) are popular solid dosage forms, especially for the elderly.
  • Mannitol granules are widely used pharmaceutical excipients for ODTs due to mannitol's properties.

Purpose of the Study:

  • To evaluate and compare the flowability of various mannitol excipients.
  • To understand the flow behavior of mannitol powder, commercial granules, and mixture granules.

Main Methods:

  • Evaluated fine crystalline mannitol powder, eight commercial mannitol granules, and four mannitol mixture granules.
  • Utilized two flowability testers for comprehensive analysis.
  • Employed Carr's index, shear testing, and dynamic flow testing methodologies.

Main Results:

  • Mannitol powder demonstrated the lowest Carr's index, indicating poor flowability.
  • Spherical mannitol granules exhibited the lowest angle of internal friction and minimal basic flow energy.
  • Larger granules showed higher Carr's index values but also increased total flow energy.

Conclusions:

  • Spherical mannitol granules possess optimal flow characteristics for pharmaceutical applications.
  • Flowability assessment is essential for selecting appropriate mannitol excipients in tablet formulation.
  • Understanding granule properties ensures efficient direct tableting processes for ODTs.