Introduction: A new pemetrexed salt, pemetrexed diarginine (PDA), was marketed by Mylan company. The product is a ready-to-dilute 25 mg/mL solution. The manufacturer indicates a 24-hour stability after dilution in dextrose 5% (D5W). The objectives were to study the stability of: PDA in D5W and 0.9% sodium chloride (0.9% NaCl) polyolefin bags at 3 and 12 mg/mL protected from light (PFL) between 2 to 8°C and at 25°C, and not PFL at room temperature; PDA vials at 25 mg/mL partially used perforated with a plastic spike PFL between 2 to 8°C and at 25°C and not PFL at room temperature. Methods: The stability study was performed by high-performance liquid chromatography coupled to a photodiode array detector. The method was validated according to International Council for Harmonisation guideline Q2(R1). Physical stability was evaluated by visual and subvisual inspection. pH values were measured. Results: PDA solutions PFL in D5W and in 0.9% NaCl at 3 and 12 mg/mL retained more than 95% of the initial concentration after 7 days at 25°C and after 28 days at 2 to 8°C. PDA ready-to-dilute 25 mg/mL solutions PFL retained more than 95% of the initial concentration after 28 days at 25°C and 2 to 8°C. PDA solutions in D5W and in 0.9% NaCl at 3 mg/mL and 12 mg/mL and PDA ready-to-dilute 25 mg/mL solutions not PFL retained more than 95% of the initial concentration after 7 days at room temperature. All samples had a pH in the range of 8.05 to 8.77. A light colouration, described in SPC, to an intense yellow-brown colouration, appeared depending on concentration and time. No precipitate was observed. Conclusion: According to the manufacturer's specifications and to the chemical stability defined as more than 95% of the initial concentration, PDA solutions in D5W and in 0.9% NaCl at 3 and 12 mg/mL and PDA ready-to-dilute 25 mg/mL solutions PFL at 25°C and not PFL at room temperature were stable for 7 days and for 28 days at 2 to 8°C. The absence of a color change as an acceptance criterion for the 25 mg/mL ready-to-dilute solution perforated with a plastic spike leads to a stability of 7 days at 2 to 8°C and 4 days at room temperature allowing the use of the vial for a preparation in advance with an optimal stability.
Objectives To the best of our knowledge, few studies have been published on the stability of cabazitaxel in infusion bags. Stabilis® database has selected a study demonstrating the stability of this molecule at 0.15 mg/mL for 28 days at 4 °C and 25 °C in polyolefin bags. The aim of this work was to study the physicochemical stability of Cabazitaxel Zentiva® solutions in vials after “opening” with a vented ChemoClave® Spike, at 25 °C, protected from light and in solutions diluted at 0.1 and 0.26 mg/mL in 0.9 % sodium chloride (0.9 % NaCl) or dextrose 5 % (D5W) in 3 types of infusion bags (Easyflex® and Viaflo® at 25 °C, Freeflex® between 2 and 8 °C, protected from light). Methods The chemical stability was analyzed after preparation and then after 14 and 28 days of storage by high performance liquid chromatography (HPLC), coupled to a diode array detector, at the analysis wavelength of 232 nm. The method has been validated according to ICH Q2 (R1) standards. For the study in infusion bags, three preparations were realised for each condition. At each time of analysis, for each bag, a sample was prepared and analyzed by HPLC. Two vials after “openings” were kept at 25 °C and three samples per vial were prepared and analyzed at the three analysis times (D0, D14 and D28). Physical stability was assessed by visual examination (change in colour, appearance of precipitate, gas formation). The pH of the solutions prepared in infusion bags was evaluated at each analysis time. Results Cabazitaxel solutions at 0.1 and 0.26 mg/mL diluted in 0.9 % NaCl or D5W in Easyflex® (polyolefin), Viaflo® (multilayer high density polyethylene, polyamide, polypropylene) bags retained more than 95 % of the concentration after 28 days at 25 °C. In the Freeflex® bag (polypropylene multilayers), cabazitaxel solutions at 0.1 and 0.26 mg/mL diluted in 0.9 % NaCl or D5W retained more than 95 % of the initial concentration between 2 and 8 °C for 28 days. In vials with a Spike, cabazitaxel solutions at 20 mg/mL retained more than 95 % of the initial concentration for 28 days at 25 °C. For all the conditions studied, no visual modification was observed. The pH of solutions in bags were constant during the stability study. Conclusions Cabazitaxel Zentiva® diluted at 0.1 and 0.26 mg/mL in 0.9 % NaCl or D5W was stable for 28 days at 25 °C and between 2 and 8 °C. These stability data allow preparations to be made in advance. The remainder of the cabazitaxel vial fitted with a Spike was stable for 28 days at 25 °C, allowing the remainder of the vial to be used over several days.
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