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High concentrated etoposide solutions, additional physical stability data in dextrose 5.

Marine Ravey1, Caroline Polo2, Elise D'Huart2

  • 1Pharmacy, Centre Hospitalier Universitaire de Nancy, Vandoeuvre-lès-Nancy, France marine.ravey@hotmail.fr.

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Etoposide solutions at 1.2 mg/mL in 5% dextrose (D5W) are physically stable, with rare precipitation observed in less than 2% of preparations. This stability is not affected by container type or manufacturing method.

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Area of Science:

  • Pharmaceutical Sciences
  • Oncology Drug Formulation
  • Intravenous Infusion Stability

Background:

  • Etoposide concentration limits are typically set at 0.4 mg/mL due to precipitation risks.
  • Previous studies indicated stability up to 1.75 mg/mL in 5% dextrose (D5W).
  • Clinical observations suggest precipitation can occur even at recommended concentrations.

Purpose of the Study:

  • To reassess the physical stability of highly concentrated etoposide solutions (1.2 mg/mL) in D5W.
  • To evaluate the impact of different manufacturing processes and container types on etoposide solution stability.
  • To validate the physical stability of etoposide at concentrations exceeding manufacturer recommendations.

Main Methods:

  • Etoposide was prepared in D5W at 1.2 mg/mL using three container types (Easyflex, Viaflo, Ecoflac).
  • Manufacturing processes included injection via spike or needle, with or without syringe rinse homogenization.
  • Physical stability was assessed visually for precipitate formation over 56 days.

Main Results:

  • 118 out of 120 solutions remained clear and colorless.
  • Precipitation occurred in only two solutions (one Easyflex, one Ecoflac) on days 4 and 35, respectively.
  • Precipitation was not correlated with container type or manufacturing process.

Conclusions:

  • Physical stability of etoposide at 1.2 mg/mL in D5W is validated.
  • Precipitation is rare (<2%) and not linked to specific manufacturing methods or containers.
  • Using an in-line micro-filter is recommended as a precautionary measure against potential precipitation.