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Related Experiment Videos

Kinetics of release from enteric-coated tablets.

S S Ozturk1, B O Palsson, B Donohoe

  • 1Department of Chemical Engineering, University of Michigan, Ann Arbor 48109.

Pharmaceutical Research
|September 1, 1988
PubMed
Summary

A new mathematical model quantifies drug release from enteric-coated tablets, improving formulation design. This model predicts drug release kinetics and coating disintegration times for better intestinal drug delivery.

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Area of Science:

  • Pharmaceutical Sciences
  • Physical Chemistry
  • Chemical Engineering

Background:

  • Enteric coating enables controlled intestinal drug release, but its design is empirical due to a lack of quantitative kinetic descriptions.
  • Understanding drug release kinetics from enteric-coated tablets is crucial for effective drug delivery and formulation development.

Purpose of the Study:

  • To present a mathematical model describing polymer coating dissolution and weakly acidic drug release from enteric-coated tablets.
  • To predict the onset time of core disintegration for enteric-coated drug delivery systems.
  • To establish explicit relationships between drug release rates and formulation/medium properties.

Main Methods:

  • Developed a mathematical model based on diffusion-limited release and reversible, instantaneous reactions.

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  • Applied the classical film theory approach, considering dissolution and reaction in the polymer layer and adjacent stagnant film.
  • Validated the model by comparing its predictions with experimental data for enteric-coated tablets.

    • Main Results:

    • Coating dissolution depends on drug/polymer solubilities and pKa, and medium properties.
    • Drug release rate is influenced by solubilities, pKa, medium pH, buffer capacity, and mass transfer coefficient.
    • The model successfully predicted experimental drug release data, demonstrating its adequacy.

    Conclusions:

    • The developed mathematical model provides a quantitative description of enteric coating dissolution and drug release kinetics.
    • The model can guide the design of enteric-coated tablets and optimize in vitro testing conditions.
    • This approach moves beyond empirical methods, enabling more rational formulation design for targeted intestinal drug delivery.