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A new solution for a chronic problem; aqueous enteric coating.

Hasan Rafati1, Alireza Ghassempour, Mohammad Barzegar-Jalali

  • 1Medicinal Plants and Drugs Research Institute (MPDRI), Shahid Beheshti University, Evin 19835-389, Tehran, Iran. rafati@sina.tums.ac.ir

Journal of Pharmaceutical Sciences
|August 4, 2006
PubMed
Summary

This study introduces a novel enteric coating method using ammonium hydrogen carbonate (AHC) to enhance drug delivery. The technique effectively creates durable, pH-sensitive coatings for delayed-release tablets.

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Area of Science:

  • Pharmaceutical Technology
  • Drug Delivery Systems
  • Polymer Science

Background:

  • Current enteric coating methods face challenges in achieving optimal delayed release.
  • pH-sensitive polymers are crucial for enteric coatings but require specific processing.
  • Solubilization of polymers via salt formation is a key consideration in coating formulation.

Purpose of the Study:

  • To develop and validate a new enteric coating technique using ammonium hydrogen carbonate (AHC).
  • To investigate the mechanism of polymer solubilization and subsequent non-ionization for delayed release.
  • To evaluate the efficacy of the novel coating on model tablets for delayed-release aspirin (ASA).

Main Methods:

  • Theoretical and practical approaches were employed to design the coating formulation.

Related Experiment Videos

  • Ammonium hydrogen carbonate (AHC) was utilized as a buffering agent for its dual salting-in and desalting properties.
  • Pan coating technique was applied to model ASA tablets, followed by drying to induce polymer non-ionization.
  • Fourier Transform Infrared (FT-IR) spectroscopy and Scanning Electron Microscopy (SEM) were used for characterization.

    • Main Results:

    • FT-IR studies confirmed the proposed mechanism of polymer conversion to its non-ionized form.
    • Successful application of pH-sensitive polymers onto model ASA tablets was achieved.
    • SEM revealed dense and rigid coating layers despite minimal polymer usage.
    • Coated tablets demonstrated stability in acidic media and met USP dissolution standards for delayed-release formulations.

    Conclusions:

    • The novel enteric coating technique using AHC offers an effective method for producing delayed-release tablets.
    • The dual action of AHC facilitates polymer solubilization and subsequent non-ionization, crucial for enteric functionality.
    • This approach yields robust, thin coatings with excellent performance in simulated physiological conditions.