Stability of Docetaxel Solution



Docetaxel is an antineoplastic agent that disrupts the microtubular network of cells. It is indicated for patients with locally advanced or metastatic breast cancer, advanced or metastatic non-small-cell lung cancer, or recurrent or metastatic squamous cell carcinoma of the head and neck. The indications for docetaxel have been expanded in recent years, such that in any comprehensive cancer program, docetaxel is likely to be administered every day of the week, primarily to patients with breast cancer, but also routinely to those with prostate and lung cancer.

In 2002, a new formulation of docetaxel (Taxotere, Aventis Pharma) was released on the Canadian market. The formulation previously in use and the new formula­tion have the same medicinal and nonmedicinal ingredi­ents, although in marginally different amounts, volumes, and concentrations. The new formulation does not require refrigerated storage and has a longer shelf life before dilution to 10 mg/mL with the 13% ethanol in water solution supplied by the manufacturer. However, the manufacturer recommends that after such dilution, the 10 mg/mL docetaxel solution be used within 8 h of preparation, regardless of the storage temperature. After further dilution with either 0.9% sodium chloride (NS) or 5% dextrose in water (to yield an infusion solution), the recommended expiry time is only 4 h. These expiry times are the same as those recommended by the manufacturer for the previously marketed formulation. However, before release of the new formulation, many Canadian pharmacists had adopted an extended stability period of 28 days at room temperature for infusions prepared with the older formulation, on the basis of data reported in 1999 by Thiesen and Kramer. Using the manufacturer’s shorter recommended expiry date for solutions prepared with the new formulation could contribute to wastage and an increase in overall drug expenditures. levitra 10 mg

The objective of this study was to evaluate the stability of infusions prepared with the newer formulation of docetaxel, in particular, 10 mg/mL solutions stored for 21 days in vials and 0.4 and 0.8 mg/mL solutions prepared by further dilution of the 10 mg/mL solution in 50 mL NS and stored for 35 days at room temperature in polypropylene-polyethylene copolymer bags (also known as partial additive bags [PABs]).


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