V. Sautou-miranda et al., Compatibility of paclitaxel in 5% glucose solution with ECOFLAC (R) low-density polyethylene containers stability under different storage conditions, INT J PHARM, 178(1), 1999, pp. 77-82
The compatibility of paclitaxel with low-density polyethylene containers (E
COFLAC(R)) was studied under different temperature and light conditions. So
lutions of 0.4 and 1.2 mg/ml of paclitaxel in 5% glucose solution were prep
ared, put into ECOFLAC(R) containers and stored: (i) at ambient temperature
(20-25 degrees C) and in ambient light; (ii) at ambient temperature in the
dark; and (iii) at +4 degrees C in the dark. Paclitaxel was assayed by hig
h-performance liquid chromatography after Visual inspection of the solution
s. The results show that solutions of TAXOL(R) in 5% glucose should not be
stored for more than 5 days in glass or ECOFLAC(R) containers because a whi
tish precipitate tends to form, lowering the paclitaxel concentration. The
decrease in the paclitaxel concentration observed after chromatographic ana
lysis ranged very widely (from 12 to 83% of the initial concentration). How
ever solutions of TAXOL(R) diluted in 5% glucose was stable for 5 days in E
COFLAC(R) containers under all the storage conditions tested. These additiv
e-free low-density polyethylene containers offer the advantage of not relea
sing DEHP into the paclitaxel solutions. (C) 1999 Elsevier Science B.V. All
rights reserved.