Seventy-two-hour stability of Taxol in 5% dextrose or 0.9% sodium chloride in Viaflo, Freeflex, Ecoflac and Macoflex N non-PVC bags

J Clin Pharm Ther. 2005 Oct;30(5):455-8. doi: 10.1111/j.1365-2710.2005.00669.x.

Abstract

Background and objectives: Taxol (paclitaxel), is an antimicrotubule agent widely prescribed for the treatment of many tumoral diseases. Taxol must be used in non-polyvinyl chloride bags, diluted to concentrations of 0.3-1.2 mg/mL in 5% dextrose or in 0.9% sodium chloride. Under these conditions, Taxol is chemically and physically stable for 27 h at 25 degrees C. The aim of the study was to evaluate the 72-h stability of Taxol under common clinical use conditions.

Methods: Taxol was diluted with 5% dextrose and 0.9% sodium chloride to final concentrations of 0.3 and 1.2 mg/mL in four polyolefin bags (Viaflo, Freeflex, Ecoflac and Macoflex N). Taxol-stability, was assessed by turbidimetry and by high-performance liquid chromatography using solutions stored in the dark, over 72 h at +4 degrees C.

Results: No haze, turbidity, or precipitate was observed. Paclitaxel concentration remained above 95% of the initial value whatever the solvent or container used.

Conclusion: Paclitaxel at 0.3 and 1.2 mg/mL in 5% dextrose and in 0.9% sodium chloride is stable in Viaflo, Freeflex, Ecoflac and Macoflex N non-PVC bags for 72 h in the dark at +4 degrees C. The longer stability should make the use of Taxol in clinical practice easier.

MeSH terms

  • Antineoplastic Agents, Phytogenic / administration & dosage
  • Antineoplastic Agents, Phytogenic / chemistry*
  • Chromatography, High Pressure Liquid
  • Drug Contamination / prevention & control
  • Drug Packaging
  • Drug Stability
  • Drug Storage
  • Glucose
  • Nephelometry and Turbidimetry
  • Paclitaxel / administration & dosage
  • Paclitaxel / chemistry*
  • Pharmaceutical Solutions
  • Sodium Chloride

Substances

  • Antineoplastic Agents, Phytogenic
  • Pharmaceutical Solutions
  • Sodium Chloride
  • Glucose
  • Paclitaxel