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• W1579173109 abstract "ABSTRACT Objective: This study evaluated the stability of a recently marketed formulation of docetaxel in polysorbate 80 diluted with 13% ethanol in water for injection and stored in vials at different temperatures. The stability of docetaxel further diluted in 0.9% sodium chloride (NS) and stored in polypropylene–polyethylene copolymer bags (also known as partial additive bags [PABs]) at room temperature was also evaluated. Methods: A reverse-phase stability-indicating liquid chromatographic method was developed and validated before the study. On study day 0, 10 vials of the new formulation of the commercially available product were prepared according to the manufacturer’s instructions. Six of the vials were stored for 21 days (3 vials at 23°C and 3 vials at 4°C), with drug concentration evaluated several times over the storage period. The remaining 4 vials were further diluted in NS to prepare concentrations equivalent to docetaxel 0.4 mg/mL and 0.8 mg/mL for storage in PABs. A solution of the older formulation of docetaxel at 0.8 mg/mL was also prepared and stored at 23°C in a PAB. All docetaxel solutions stored in PABs at room temperature were unprotected from light. The concentration of docetaxel in the PABs was evaluated over a period of 35 days. Results: During the study period, all of the study samples retained more than 95.0% of their initial concentration. The concentration changed by less than 5% over the 21-day period for samples stored in vials and by less than 5% over the 35-day study period for samples stored in PABs. Inspection of chromatograms during the stability study failed to reveal any degradation products that were observed during the accelerated degradation. Conclusion: Solutions of docetaxel 0.4 mg/mL and 0.8 mg/mL prepared in NS and stored in PABs retained more than 95% of the initial drug concentration when stored for 35 days at 23°C. Similarly, docetaxel 10 mg/mL prepared in the ethanol and polysorbate 80 diluent provided by the manufacturer retained more than 95% of the initial docetaxel concentration when stored in vials at either 23°C or 4°C for 21 days. RESUME Objectif : Cette etude a evalue la stabilite d’une solution recemment commercialisee de docetaxel dans du polysorbate 80 dilue avec de l’ethanol a 13 % dans de l’eau pour injection et entreposee dans des flacons a differentes temperatures. La stabilite d’une preparation de docetaxel diluee a nouveau dans du chlorure de sodium a 0,9 % (NS) puis entreposee dans des sacs de copolymere de polypropylene-polyethylene (aussi connus sous le nom de sacs pour additifs partiels [SAP]) a la temperature ambiante a egalement ete evaluee. Methodes : Une epreuve de stabilite par chromatographie liquide en phase inverse a ete mise au point et validee avant l’etude. Au jour 0 de l’etude, 10 flacons de la nouvelle solution du produit commercial ont ete prepares selon les instructions du fabricant. Six des flacons ont ete entreposes pendant 21 jours (trois flacons a 23 °C et les trois autres a 4 °C), et on a evalue la concentration en medicament de ces flacons plusieurs fois pendant la periode d’entreposage. Les preparations des quatre autres flacons ont ete diluees a nouveau dans du NS afin de preparer des concentrations de docetaxel equivalant a 0.4 mg/mL et a 0.8 mg/mL dans des SAP. Une solution de l’ancienne composition de docetaxel a 40 mg/50 mL a egalement ete preparee, puis entreposee a 23 °C dans des SAP. Toutes les preparations de docetaxel entreposees dans des SAP a la temperature ambiante n’ont pas ete protegees de la lumiere. Les concentrations de docetaxel dans les SAP ont ete evaluees sur une periode de 35 jours. Resultats : Au cours de la periode de l'etude, tous les echantillons ont conserve plus de 95,0 % de leur concentration initiale. La concentration a varie de moins de 5 % au cours de la periode de 21 jours pour les echantillons conserves dans les flacons, et egalement au cours de la periode de 35 jours pour les echantillons conserves dans des SAP. L’inspection des chromatogrammes obtenus par l'epreuve de stabilite n'a pu reveler aucun des produits de degradation qui avaient ete generes durant la degradation acceleree. Conclusion : Les solutions de docetaxel a 0,4 mg/mL et a 0,8 mg/mL preparees dans du NS et conservees dans des SAP ont retenu plus de 95 % de leur concentrations initiales de medicament lorsqu’elles etaient entreposees a 23 °C pendant une periode de 35 jours. De la meme maniere, les solutions de docetaxel a 10 mg/mL preparees avec le diluant de polysorbate 80 et d’ethanol fourni par le fabricant ont conserve plus de 95 % de leur concentration initiale de docetaxel lorsqu’elles etaient entreposees a 23 °C ou a 4 °C pendant 21 jours." @default.
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• W1579173109 date "2007-01-01" @default.
• W1579173109 modified "2023-09-23" @default.
• W1579173109 title "Stability of Docetaxel Solution after Dilution in Ethanol and Storage in Vials and after Dilution in Normal Saline and Storage in Bags" @default.
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• W1579173109 doi "https://doi.org/10.4212/cjhp.v60i4.184" @default.
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