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Solid-state characterization of paclitaxel

R T Liggins1, W L Hunter, H M Burt

  • 1Faculty of Pharmaceutical Sciences, University of British Columbia, Vancouver, Canada.

Journal of Pharmaceutical Sciences
|January 10, 1998
PubMed
Summary
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This study characterizes anhydrous paclitaxel and its dihydrate form, revealing distinct solid-state properties. Paclitaxel dihydrate is the stable form in water at 37°C but dehydrates above 45°C.

Area of Science:

  • Pharmaceutical Sciences
  • Solid-State Chemistry

Background:

  • Paclitaxel is a crucial chemotherapy agent with variable solid-state forms.
  • Understanding these forms is vital for drug formulation and stability.

Purpose of the Study:

  • To characterize the solid-state properties of anhydrous paclitaxel and paclitaxel dihydrate.
  • To investigate the thermal behavior and hydration states of paclitaxel.

Main Methods:

  • Differential scanning calorimetry (DSC) and thermogravimetric analysis (TGA) were employed.
  • X-ray powder diffraction (XRPD) was used to analyze crystal structures.
  • Dissolution profiles were determined in water at 37°C.

Main Results:

  • Paclitaxel dihydrate undergoes dehydration below 100°C and a solid-solid transition at 168°C.

Related Experiment Videos

  • Anhydrous paclitaxel melts at 220°C, and quenching yields amorphous paclitaxel with a glass transition at 152°C.
  • XRPD confirmed distinct crystal structures for anhydrous paclitaxel, paclitaxel dihydrate, and dehydrated paclitaxel dihydrate.

    • Conclusions:

    • Paclitaxel dihydrate is the stable form in aqueous equilibrium at 37°C.
    • Dehydration of paclitaxel dihydrate occurs above 45°C.
    • Different solid forms exhibit unique thermal and structural characteristics impacting dissolution and stability.