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Development and Evaluation of Cetirizine HCl Taste-Masked Oral Disintegrating Tablets

AAPS PharmSciTech volume 12, pages 141–151 (2011)Cite this article

Abstract

The purpose of the current study was to mask the taste of cetirizine HCl and to incorporate the granules produced in oral disintegrating tablets (ODT). The bitter, active substance was coated by fluidized bed coating using Eudragit® RL30-D at levels between 15% and 40% w/w. The ODTs were developed by varying the ratio of superdisintegrants such as sodium croscarmellose, crospovidone grades and low substituted hydroxypropyl cellulose (L-HPC). A direct compression process was used to compress the ODTs under various compaction forces to optimize tablet robustness. The properties of the compressed tablets including porosity, hardness, friability and dissolution profiles were further investigated. The in vitro and in vivo evaluation of the tablet disintegration times showed almost identical rapid disintegration below 10 s at the optimal levels of each superdisintegrant. Finally, the taste and sensory evaluation in human volunteers demonstrated excellence in masking the bitter active and tablet palatability.

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Affiliations

  1. Department of Pharmaceutical, Chemical and Environmental Sciences, School of Science, University of Greenwich, Medway Campus, Chatham Maritime, ME4 4TB, Kent, UK

    Dionysios Dennis Douroumis

  2. Evonik Röhm GmbH, Kirschenalle, 64293, Darmstadt, Germany

    Andreas Gryczke & Silke Schminke

Authors
  1. Dionysios Dennis Douroumis
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  2. Andreas Gryczke
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  3. Silke Schminke
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Correspondence to Dionysios Dennis Douroumis.

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Douroumis, D.D., Gryczke, A. & Schminke, S. Development and Evaluation of Cetirizine HCl Taste-Masked Oral Disintegrating Tablets. AAPS PharmSciTech 12, 141–151 (2011). https://doi.org/10.1208/s12249-010-9569-7

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  • DOI: https://doi.org/10.1208/s12249-010-9569-7

Keywords

  • Fluidized bed coating
  • oral disintegrating tablets
  • superdisintegrants
  • taste masking