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Co-Processed Excipients for Dispersible Tablets-Part 2: Patient Acceptability.

Karolina Dziemidowicz1, Felipe L Lopez1, Ben J Bowles1

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

AAPS Pharmscitech
|June 27, 2018
PubMed
Summary

SmartEx QD100 and F-Melt Type C are the most preferred co-processed excipients for directly compressible dispersible tablets, offering superior palatability and patient acceptability. Particle size above 250 μm negatively impacts acceptability.

Keywords:
co-processed excipientsdispersible tabletspalatabilitypatient acceptabilitytaste

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Area of Science:

  • Pharmaceutical Sciences
  • Materials Science

Background:

  • Palatability and patient acceptability are crucial for dispersible tablet formulations.
  • Co-processed excipients offer potential for improved organoleptic profiles through optimized composition and manufacturing.

Purpose of the Study:

  • To identify the optimal co-processed excipient for directly compressible dispersible tablets.
  • To evaluate patient preference and acceptability of various co-processed excipients.

Main Methods:

  • Nine selected co-processed excipients were tested in a randomized preference and acceptability study.
  • Twenty-four healthy adult volunteers participated, rating excipients on a five-point hedonic scale.
  • Organoleptic properties and particle size in water were analyzed.

Main Results:

  • SmartEx QD100 was the most preferred excipient, rated 'very acceptable'.
  • F-Melt Type C, F-Melt Type M, and MicroceLac were rated 'acceptable'.
  • Excipients with particle size >200-250 μm in water were poorly accepted, indicating a critical threshold.

Conclusions:

  • SmartEx QD100 and F-Melt Type C are highly suitable co-processed excipients for directly compressible dispersible tablets.
  • Particle size control is essential for achieving good patient acceptability in dispersible formulations.
  • The study identified key excipients and a particle size guideline for improved dispersible tablet design.