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Moisture plasticization for enteric Eudragit® L30D-55-coated pellets prior to compression into tablets.

Soravoot Rujivipat1, Roland Bodmeier

  • 1College of Pharmacy, Freie Universität Berlin, Kelchstrasse 31, Berlin, Germany.

European Journal of Pharmaceutics and Biopharmaceutics : Official Journal of Arbeitsgemeinschaft Fur Pharmazeutische Verfahrenstechnik E.V
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Humidity treatment effectively plasticizes brittle Eudragit® L enteric polymer coatings, enabling successful compression of coated pellets into tablets. This moisture-induced flexibility significantly improves mechanical properties and compressibility.

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Area of Science:

  • Pharmaceutical Technology
  • Materials Science

Background:

  • Enteric polymers like Eudragit® L are brittle when dry, hindering their use in compressed tablet formulations.
  • Pellet coatings require sufficient mechanical integrity for subsequent compression processes.

Purpose of the Study:

  • To investigate humidity treatment as a method for moisture plasticization of enteric polymer coatings.
  • To enable successful compression of enterically coated pellets into tablets.

Main Methods:

  • Storage of enteric polymer-coated pellets at controlled high humidity levels.
  • Evaluation of mechanical properties (e.g., elongation) and glass transition temperature.
  • Dynamic Vapor Sorption (DVS) analysis to determine glass transition relative humidity.
  • Single pellet compression testing to assess compressibility.

Main Results:

  • Eudragit® L100-55 showed dramatic improvement in mechanical properties, with elongation increasing from ~3% to ~140% due to hydration/plasticization.
  • Glass transition temperature of Eudragit® L films decreased below room temperature at 75-84% relative humidity.
  • Moisture plasticization was more effective for Eudragit® L than triethyl citrate.
  • Compressed and uncompressed pellets exhibited comparable drug release profiles after storage at 84% relative humidity.

Conclusions:

  • Humidity treatment is a highly effective strategy for moisture plasticization of brittle enteric polymers like Eudragit® L.
  • Plasticized Eudragit® L coatings demonstrate improved flexibility and compressibility, facilitating pellet compression.
  • This approach enhances the pharmaceutical processing of enteric-coated pellets for oral dosage forms.