Stability of pemetrexed diarginine concentrates for solution in vials and diluted in 0.9% sodium chloride and dextrose 5% polyolefin infusion bags

Vidal, Fabrice; Cotteret, Camille; Negbane, Abdel; Sebti, Maria; Hinterlang, Mélanie; Cisternino, Salvatore; Schlatter, Joël

doi:10.1136/ejhpharm-2020-002620

Cited by 2 publications

(3 citation statements)

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“…The chemical stability results in this study are consistent with the previous results obtained by Vidal et al The differences in the conclusions depend on the choice of the definition of stability. Vidal et al [8] defined physical stability as no change in the colour of the solution, whereas in the study, slight coloration was defined as acceptable in accordance with the summary of product characteristics. [9] Figure 3.…”

Section: Physical Stability Of Solutionsmentioning

confidence: 99%

“…Pemetrexed diarginine diluted at 4, 9, and 12 mg/mL in D5W and NaCl 0.9% was physicochemically stable for up to 4 days when stored under refrigeration and for 1 day at room temperature in polyolefin bags. [8] A pemetrexed diarginine product was recently marketed by Mylan company. The product is a ready-to-dilute 25 mg/mL solution.…”

Section: Introductionmentioning

confidence: 99%

“…Vidal et al demonstrated that pemetrexed diarginine concentrate solutions of 1000 mg/40 mL and 500 mg/20 mL in vials spiked with a closed system were physicochemically stable for up to 14 days under refrigeration storage. Pemetrexed diarginine diluted at 4, 9, and 12 mg/mL in D5W and NaCl 0.9% was physicochemically stable for up to 4 days when stored under refrigeration and for 1 day at room temperature in polyolefin bags [8] …”

Section: Introductionmentioning

confidence: 99%

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Physicochemical stability of pemetrexed diarginine at 25 mg/mL in partially-used vials and at 3 and 12 mg/mL diluted in dextrose 5% or in sodium chloride 0.9% in polyolefin bags

Nisse¹,

Sobalak²,

Vigneron³

et al. 2022

European Journal of Oncology Pharmacy

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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.

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Section: Physical Stability Of Solutionsmentioning

confidence: 99%

Section: Introductionmentioning

confidence: 99%

Section: Introductionmentioning

confidence: 99%

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