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Related Experiment Videos

Controlled release from triple layer, donut-shaped tablets with enteric polymers.

Cherng-ju Kim1

  • 1College of Pharmacy, University of Arkansas for Medical Sciences, 4301 W Markham St, Little Rock, AR 72205, USA. ckim@uams.edu

AAPS Pharmscitech
|December 16, 2005
PubMed
Summary
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Triple layer, donut-shaped tablets (TLDSTs) offer a promising extended-release dosage form. This design achieves zero-order or near-zero-order drug release kinetics across various drug solubilities.

Area of Science:

  • Pharmaceutical Technology
  • Drug Delivery Systems
  • Materials Science

Background:

  • Extended-release dosage forms are crucial for improving patient compliance and therapeutic outcomes.
  • Controlling drug release profiles remains a significant challenge in pharmaceutical formulation.
  • Novel tablet designs are continuously explored to achieve predictable and sustained drug delivery.

Purpose of the Study:

  • To evaluate the potential of triple layer, donut-shaped tablets (TLDSTs) as an extended-release dosage form.
  • To investigate the influence of drug properties and loading on drug release kinetics from TLDSTs.
  • To develop a mathematical model describing drug release from TLDSTs.

Main Methods:

  • TLDSTs were fabricated by sequentially layering three powders around a central punch.

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  • The core layer utilized enteric polymers (hydroxypropyl methylcellulose acetate succinate), while outer layers used ethyl cellulose.
  • Drug release profiles were assessed across various pH conditions, drug types, salt forms, and drug loading levels (10% to 30%).

    • Main Results:

    • Drug release kinetics were pH-dependent and influenced by drug solubility, salt form, and loading.
    • At 10% drug loading, consistent release profiles were observed for all drug types.
    • Increasing drug loading to 30% altered release rates, with variations based on drug ionization and salt form, while neutral drugs generally showed increased release.
    • The release mechanism was primarily governed by erosion and ionization, with minimal diffusion, and a mathematical expression for erosion-controlled release was derived.

    Conclusions:

    • TLDSTs represent a viable formulation strategy for achieving zero-order or near-zero-order drug release.
    • The TLDST design demonstrates adaptability for a wide spectrum of drug solubilities and properties.
    • The developed mathematical model aids in predicting and optimizing drug release from TLDSTs.