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Related Experiment Videos

EO-9 bladder instillations: formulation selection based on stability characteristics and in vitro simulation studies.

S C van der Schoot1, L D Vainchtein, J H Beijnen

  • 1Department of Pharmacy & Pharmacology, Slotervaart Hospital, The Netherlands Cancer Institute, Louwesweg 6, 1066 EC Amsterdam, The Netherlands. apsvs@slz.nl

International Journal of Pharmaceutics
|October 3, 2006
PubMed
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Researchers developed improved formulations for EO-9 (EOquin), a bladder cancer treatment. The most stable freeze-dried formulation containing EO-9, HPbetaCD, and Tris was selected for further development based on stability testing.

Area of Science:

  • Pharmaceutical Sciences
  • Oncology
  • Drug Delivery

Background:

  • Superficial bladder cancer is treated with EO-9 (EOquin) via bladder instillation.
  • Current EO-9 formulations require improvement for pharmaceutical properties and clinical acceptability.

Purpose of the Study:

  • To develop and evaluate alternative EO-9 formulations for enhanced stability and clinical use.
  • To identify the most stable EO-9 formulation for further pharmaceutical development.

Main Methods:

  • Three freeze-dried EO-9 formulations using HPbetaCD, Tris, and NaHCO(3) were prepared.
  • Stability studies included freeze-dried products, reconstituted/diluted solutions, and simulated bladder instillation with urine.
  • Degradation products were identified.

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Main Results:

  • The EO-9/HPbetaCD/Tris (4/600/1mg/vial) formulation demonstrated the highest stability as a freeze-dried product.
  • All formulations were stable for at least 8 hours after reconstitution and dilution.
  • Formulations were unstable in urine at pH 4 and 6, degrading into EO-5a and EO-9-Cl, but stable at pH 8.

Conclusions:

  • The EO-9/HPbetaCD/Tris formulation is the most promising for further pharmaceutical development.
  • Formulation stability is influenced by pH, particularly in urine.
  • Optimized formulations can improve the clinical viability of EO-9 for bladder cancer treatment.