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Evaluation of solid dispersion particles prepared with SEDS.

Anne Mari Juppo1, Catherine Boissier, Cynthia Khoo

  • 1AstraZeneca R&D Mölndal, S-431 83, Mölndal, Sweden. anne.juppo@astrazeneca.com

International Journal of Pharmaceutics
|January 16, 2003
PubMed
Summary

The Solution Enhanced Dispersion by Supercritical fluids (SEDS) process effectively created solid solutions and intimate blends of a model drug with mannitol and Eudragit E100 carriers. These formulations showed enhanced dissolution rates due to altered crystal structures and molecular interactions.

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Area of Science:

  • Pharmaceutical Sciences
  • Materials Science
  • Chemical Engineering

Background:

  • Developing amorphous solid dispersions is crucial for improving the bioavailability of poorly soluble drugs.
  • The Solution Enhanced Dispersion by Supercritical fluids (SEDS) process offers a promising method for particle engineering.

Purpose of the Study:

  • To evaluate the formation of solid solution particles using the SEDS process with a model drug and two carriers: mannitol and Eudragit E100.
  • To investigate the impact of carrier type on drug crystallization, molecular interactions, and dissolution rate.

Main Methods:

  • The SEDS process was employed to co-process a model drug with mannitol and Eudragit E100.
  • Differential Scanning Calorimetry (DSC) and Fourier Transform Infrared Spectroscopy (FTIR) were used to analyze crystal properties and molecular interactions.

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  • Dissolution rates of the resulting formulations were assessed.

    • Main Results:

    • SEDS produced co-precipitates with mannitol where drug and carrier crystal structures were mutually affected, leading to a less crystalline drug form and increased dissolution.
    • Hydrogen bonding was identified between the drug and mannitol.
    • A true solid solution was achieved with Eudragit E100, showing clear interactions between the drug and carrier, resulting in an effective intimate blend.

    Conclusions:

    • The SEDS process is effective for creating intimate blends and solid solutions of drugs with carriers like mannitol and Eudragit E100.
    • The observed interactions and changes in crystal structure are directly linked to enhanced drug dissolution rates.
    • SEDS demonstrates potential for pharmaceutical particle design to improve drug delivery.