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Diffuse-interface theory for structure formation and release behavior in controlled drug release systems.

David M Saylor1, Chang-Soo Kim, Dinesh V Patwardhan

  • 1Food and Drug Administration, Center for Devices and Radiological Health, Office of Science and Engineering Laboratories, Silver Spring, MD 20903, USA.

Acta Biomaterialia
|June 8, 2007
PubMed
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Controlling drug release involves polymer composites, but manufacturing impacts structure and release. Our theory links processing, microstructure, and release, revealing significant effects of processing time on drug delivery uniformity and rate.

Area of Science:

  • Materials Science
  • Chemical Engineering
  • Pharmaceutical Sciences

Background:

  • Drug release is often controlled by incorporating drugs into polymer matrices.
  • The internal microstructure of drug-polymer composites significantly influences drug release rates.
  • Understanding the impact of manufacturing processing conditions on composite structure and drug release is crucial but limited.

Purpose of the Study:

  • To develop a diffuse-interface theory for microstructure evolution in drug-polymer systems.
  • To elucidate and quantify the relationships between processing, microstructure, and drug release response.
  • To investigate the effects of processing conditions on drug loading and evaporation rate on microstructure and release behavior.

Main Methods:

  • Developed a diffuse-interface theory based on interactions between drug, polymer, and solvent species.

Related Experiment Videos

  • Applied the theory to model microstructure evolution in controlled drug release systems.
  • Performed calculations to demonstrate the impact of processing variations on microstructure and release kinetics.

    • Main Results:

    • Variations in microstructure due to drug loading or processing time significantly impact bulk release kinetics and uniformity.
    • Changes in process time alone can alter bulk drug release by nearly a factor of two.
    • Typical non-uniformities of +/-30% were observed during initial release periods.

    Conclusions:

    • Processing conditions critically influence drug-polymer composite microstructure and drug release behavior.
    • Significant variations in release kinetics and uniformity can arise from seemingly small changes in processing.
    • Careful control of microstructure is essential for ensuring the safety and efficacy of controlled drug release devices.