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Paclitaxel/beta-cyclodextrin complexes for hyperthermic peritoneal perfusion - formulation and stability.

Wim Bouquet1, Wim Ceelen, Bernd Fritzinger

  • 1Laboratory of Pharmaceutical Technology, Ghent University, Ghent, Belgium.

European Journal of Pharmaceutics and Biopharmaceutics : Official Journal of Arbeitsgemeinschaft Fur Pharmazeutische Verfahrenstechnik E.V
|January 24, 2007
PubMed
Summary

This study developed a stable, solvent-free paclitaxel formulation using randomly methylated beta-cyclodextrin (RAME-beta-CD) for hyperthermic intraperitoneal chemoperfusion (HIPEC). This new approach avoids Cremophor EL side-effects and improves paclitaxel solubility.

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Area of Science:

  • Pharmaceutical Sciences
  • Drug Delivery
  • Oncology

Background:

  • Paclitaxel's poor aqueous solubility necessitates Cremophor EL/ethanol formulation, leading to adverse side effects.
  • Hyperthermic intraperitoneal chemoperfusion (HIPEC) requires a stable, injectable paclitaxel solution free from surfactants and solvents.

Purpose of the Study:

  • To develop a surfactant-free and solvent-free paclitaxel solution for HIPEC.
  • To investigate the complexation of paclitaxel with chemically modified beta-cyclodextrins to enhance aqueous solubility.

Main Methods:

  • Screening of various beta-cyclodextrin derivatives for paclitaxel solubilization.
  • Preparation and characterization of paclitaxel/beta-cyclodextrin inclusion complexes using freeze-drying.
  • Stability studies of paclitaxel solutions under various conditions (storage, temperature, dilution).

Main Results:

  • Randomly methylated beta-cyclodextrin (RAME-beta-CD) demonstrated superior paclitaxel solubilization compared to other derivatives.
  • Optimal inclusion efficiency of 100% was achieved at a paclitaxel/RAME-beta-CD molar ratio of 1/20.
  • Paclitaxel/RAME-beta-CD inclusion complexes were stable for at least 6 months at 4°C.
  • Formulated paclitaxel solutions (5 mg/ml) showed no precipitation upon dilution.
  • Enhanced stability was observed at a 1/40 molar ratio under HIPEC conditions (41.5°C) and room temperature.
  • Addition of hydroxypropyl methylcellulose (HPMC) significantly increased formulation stability, potentially reducing RAME-beta-CD concentration.

Conclusions:

  • Chemically modified beta-cyclodextrins, particularly RAME-beta-CD, offer a promising strategy for developing stable, solvent-free paclitaxel formulations.
  • The developed paclitaxel/RAME-beta-CD system is suitable for HIPEC, mitigating side effects associated with conventional formulations.
  • Further optimization with HPMC could lead to more efficient and cost-effective paclitaxel delivery systems.