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Co-Processed Excipients for Dispersible Tablets-Part 1: Manufacturability.

Ben J Bowles1, Karolina Dziemidowicz1, Felipe L Lopez1

  • 1UCL School of Pharmacy, 29-39 Brunswick Square, London, WC1N 1AX, UK.

AAPS Pharmscitech
|June 20, 2018
PubMed
Summary

This study evaluated 16 co-processed excipients for direct compression dispersible tablets. CombiLac, F-Melt type C, and SmartEx QD100 demonstrated superior performance, offering rapid disintegration and fine dispersion for robust tablet manufacturing.

Keywords:
co-processed excipientscompaction simulatordirect compressiondispersible tabletstablet disintegration

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Area of Science:

  • Pharmaceutical Technology
  • Materials Science

Background:

  • Traditional excipients present challenges in large-scale tablet manufacturing.
  • Co-processed excipients offer potential improvements in functionality and reduced drawbacks.

Purpose of the Study:

  • To characterize co-processed excipients for suitability in dispersible tablet formulations.
  • To identify optimal excipients for direct compression manufacturing of dispersible tablets.

Main Methods:

  • Sixteen co-processed excipients were lubricated and compressed into tablets using a Phoenix compaction simulator.
  • Tablets were characterized for hardness, friability, disintegration time, and fineness of dispersion.
  • Compression profiles were generated by varying compression force.

Main Results:

  • CombiLac, F-Melt type C, and SmartEx QD100 were identified as the most suitable excipients.
  • These top excipients exhibited excellent flow, tabletability, low friability, rapid disintegration (27-49s), and fine dispersion (<250 μm).
  • Other excipients showed potential but required mitigation of specific disintegration and dispersion risks.

Conclusions:

  • Robust, rapidly disintegrating dispersible tablets can be manufactured using various co-processed excipients via direct compression.
  • Co-processed excipients like CombiLac, F-Melt type C, and SmartEx QD100 are highly promising for pharmaceutical applications.
  • Further risk assessment is recommended for other evaluated co-processed excipients before commercialization.