Pharmacy World and Science

, Volume 21, Issue 3, pp 137–141 | Cite as

Physico‐chemical stability of docetaxel premix solution and docetaxel infusion solutions in PVC bags and polyolefine containers

  • Judith Thiesen
  • Irene Krämer


We assessed the physical and chemical stability of docetaxel infusion solutions. Stability of the antineoplastic drug was determined 1.) after reconstitution of the injection concentrate and 2.) after further dilution in two commonly used vehicle‐solutions, 0.9% sodium chloride and 5% dextrose, in PVC bags and polyolefine containers. Chemical stability was measured by using a stability‐indicating HPLC assay with ultraviolet detection. Physical stability was determined by visual inspection. The stability tests revealed that reconstituted docetaxel solutions (= premix solutions) are physico‐chemically stable (at a level ≥ 95% docetaxel) for a minimum of four weeks, independent of the storage temperature (refrigerated, room temperature). Diluted infusion solutions (docetaxel concentration 0.3 mg/ml and 0.9 mg/ml), with either vehicle‐solution, proved physico‐chemically stable (at a level ≥ 95% docetaxel) for a minimum of four weeks, when prepared in polyolefine containers and stored at room temperature. However, diluted infusion solutions exhibited limited physical stability in PVC bags, because docetaxel precipitation occured irregularly, though not before day 5 of storage. In addition, time‐dependent DEHP‐leaching from PVC infusion bags by docetaxel infusion solutions must be considered.

Docetaxel Infusion solution Physico‐chemical stability Polyolefine container Premix solutions 


Unable to display preview. Download preview PDF.

Unable to display preview. Download preview PDF.


  1. 1.
    Bissery MC. Preclinical Pharmacology of Docetaxel. Eur J Cancer 1995;31(A) Suppl 4: S1-S6.Google Scholar
  2. 2.
    Hepperle M, Georg GI. Taxol analogs. Drugs Future 1994;19(6):573-84.Google Scholar
  3. 3.
    Duoaz JF, Andreu JM. Assembly of Purified GDP-Tubulin into Microtubules Induced by Taxol and Taxotere: Reversibility, Ligand Stoichiometry, and Competition. Biochemistry 1993;32:2747-55.Google Scholar
  4. 4.
    Guéritte-Voegelein F, Guénard D, Lavelle F, Le Goff MT, Mangatal L, Potier P. Relationships between the Structure of Taxol Analogues and Their Antimitotic Activity. J Med Chem 1991;34:992-8.Google Scholar
  5. 5.
    Lam YWF, Chan CYJ, Kuhn JG. Pharmacokinetics and pharmacodynamics of the taxanes. J Oncol Pharm Practice 1997;3(2):76-93.Google Scholar
  6. 6.
    Eckardt JR. Antitumor activity of docetaxel. Am J Health-Syst Pharm 1997;54(Suppl2):S2-S6.Google Scholar
  7. 7.
    Bissery MC, Nohynek G, Sanderink GJ, Lavelle F. Docetaxel (Taxotere®): a review of preclinical and clinical experience. Part I: preclinical experience. Anticancer Drugs 1995;6:339-68.Google Scholar
  8. 8.
    Kraynak MA. Pharmaceutical aspects of docetaxel. Am J Health-Syst Pharm 1997;54(Suppl2):S7-S10.Google Scholar
  9. 9.
    Extra JM, Rousseau F, Bruno R et al. Phase I and pharmakokinetic study of taxotere (RP 56976; NSC 628503) given as a short intravenous infusion. Cancer Res 1993;53:1037-42.Google Scholar
  10. 10.
    Xu Q, Trissel LA, Martinez JF. Stability of paclitaxel in 5% dextrose injection or 0.9% sodium chloride injection at 4, 22, or 32 °C. Am J Hosp Pharm 1994;51:3058-60.Google Scholar
  11. 11.
    Technical Dossier Docetaxel. Data on file. Rhône-Poulenc Rorer 1998.Google Scholar
  12. 12.
    Mazzo DJ, Nguyen-Huu JJ, Pagniez S, Denis P. Compatibility of docetaxel and paclitaxel in intravenous solutions with polyvinyl chloride infusion materials. Am J Health-Syst Pharm 1997;54:566-9.Google Scholar
  13. 13.
    Maas B, Huber C, Krämer I. Plasticizer extraction of Taxol®-infusion solutions from various infusion devices. Pharm World Science 1996;18(2):78-82.Google Scholar
  14. 14.
    Beijnen JH, Beijnen-Bandhoe AU, Dubbelmann AC, Van Gijn R, Underberg WJM. Chemical and Physical Stability of Etoposide and Teniposide in Commonly Used Infusion Fluids. J Parenter Sci Technol 1991;45(2):108-12.Google Scholar
  15. 15.
    Bogardus JB, Kaplan MA, Carpenter JP. Precipitation of teniposide during infusion. Am J Hosp Pharm 1990;47:512-9.Google Scholar
  16. 16.
    Mazzo D, Nguyen-Huu J, Pagniez S, Denis P. Compatibility of selected taxoids with PVC-based infusion equipment. Conference Abstracts-J Oncol Pharm Practice 1997;3:34Google Scholar

Copyright information

© Kluwer Academic Publishers 1999

Authors and Affiliations

  • Judith Thiesen
  • Irene Krämer

There are no affiliations available

Personalised recommendations