Stability of oxaliplatin in infusion bags containing 5% dextrose injection

André, Pascal; Cisternino, Salvatore; Roy, Anne-Lise; Chiadmi, Fouad; Schlatter, Joël; Agranat, Pascal; Fain, Olivier; Fontan, Jean-Eudes

doi:10.2146/ajhp060369

Cited by 12 publications

(10 citation statements)

References 9 publications

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“…This is very important for dose banding practice since the formulation is very important for in-use stability. The extended stability established with a liquid formulation of oxaliplatin2–4 should not be taken into account when preparing with a lyophilised formulation in advance.…”

Section: Discussionmentioning

confidence: 99%

“…In fact, lyophilised formulation is still widely commercialised, mainly as a generic product available at a reduced cost. Several publications have shown that solutions for infusion in the concentration range 0.2–1.3 mg/mL, prepared with the 5 mg/mL oxaliplatin aqueous concentrate in 5% dextrose injection, are stable for at least 14, 30 and 90 days in polyolefin bags under refrigeration, or at room temperature without controlled light exposure 2 – 4. Nevertheless, the manufacturers still guarantee chemical and physical in-use stability for 24–48 h under refrigeration (2–8°C) for the concentrate solution and lyophilised oxaliplatin formulations 5.…”

Section: Introductionmentioning

confidence: 99%

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Stability of lyophilised oxaliplatin formulation in polyolefin infusion bags containing 5% dextrose injection

et al. 2013

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Objective The in-use stability of lyophilised oxaliplatin and lactose formulation diluted in 5% dextrose injection was studied to assess the feasibility of preparing oxaliplatin solutions in advance in hospital pharmacy settings. The available in-use stability data of oxaliplatin solutions are based on infusions prepared with 5mg/mL concentrated solutions. Methods Oxaliplatin solutions of 0.5mg/mL (n=6), 0.7mg/mL (n=6) and 5mg/mL (n=6) were prepared using oxaliplatin 100mg powder and 100mL of 5% dextrose injection in polyolefin infusion bags. The samples were stored at 2-8 degrees C without light protection and were analysed at 1, 2, 4, 7, 14, 21 and 60days. The in-use stability was studied using the high-performance liquid chromatography stability indicating method. The solutions were checked for colour, particulate matter and pH. Results The mean concentrations of 0.5mg/mL and 0.7mg/mL oxaliplatin solutions decreased to less than 90%, within 7 and 14days, respectively, compared with the initial drug concentration in the solutions. The concentrated solution of 5mg/mL oxaliplatin was stable (over 90%) for at least 60days. The colour, clarity and pH remained unchanged throughout the storage period. Sterility and apirogenicity standards, as defined in the European Pharmacopoeia, were met. Conclusion Infusion solutions of oxaliplatin prepared with lyophilised oxaliplatin 100mg, 0.5mg/mL and 0.7mg/mL which were stored in polyolefin infusion bags, were chemically unstable within 7days and 14days, respectively, at 2-8 degrees C without light protection. The poor stability of the diluted solutions does not allow oxaliplatin to be prepared in advance and stored in pharmacy departments

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Section: Discussionmentioning

confidence: 99%

Section: Introductionmentioning

confidence: 99%

Stability of lyophilised oxaliplatin formulation in polyolefin infusion bags containing 5% dextrose injection

et al. 2013

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“…The instability of oxaliplatin in NaCl 0.9 % solution was described therefore G5 % serum was used [31]. Typically, we started with a 250 mL perfusion of G5 % on each catheter.…”

Section: Intraperitoneal and Systemic Regimensmentioning

confidence: 99%

“…The demographic, clinical and histological characteristics of the patients are shown in Table 1. The median PCI was 29.5 (range [25][26][27][28][29][30][31][32][33][34][35][36][37][38][39]. One patient developed a recurrence of already treated PC associated with a midline parietal metastasis.…”

Section: Patient Characteristicsmentioning

confidence: 99%

Preoperative intraperitoneal oxaliplatin for unresectable peritoneal carcinomatosis of colorectal origin: a pilot study

Sgarbură

Samalin

Carrère

et al. 2016

Pleura and Peritoneum

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Background: Peritoneal carcinomatosis in colorectal cancer is an advanced stage of the disease where improved survival can be attained whenever the resection associated with hyperthermic intreperitoneal chemotherapy is possible. In unresectable cases, systemic chemotherapy is administered to obtain conversion to resectability but results have not yet been clearly evaluated. Local chemotherapy in this setting has been proven useful in several similar situations. The aim of the present pilot study was to evaluate the feasibility of preoperative intraperitoneal chemotherapy with oxaliplatin in these patients. Methods: Six patients with unresectable peritoneal disease of colorectal origin were included in the study. An intraperitoneal implantable chamber catheter was inserted during the laparotomy that evaluated the extent of the peritoneal disease (peritoneal

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“…8 However, the manufacturer's information about the stability of this formulation is limited (stored no longer than 24 hours at 2-8 °C or 6 hours at 20-25 °C after dilution). 9 The stability of 0.7-mg/mL oxaliplatin solution in infusion bags containing 5% dextrose injection stored at 3-7 °C and 20-24 °C was studied by André et al, 10 who concluded that oxaliplatin was chemically stable for at least 30 days in polyvinyl chloride (PVC) infusion bags. More recently, Junker et al 11 found the stability to be extended to 90 days in PVC-free bags at a low concentration (oxaliplatin 0.25 mg/mL).…”

Section: P R a C T I C E R E P O R Tmentioning

confidence: 99%

Physicochemical stability of oxaliplatin in 5% dextrose injection stored in polyvinyl chloride, polyethylene, and polypropylene infusion bags

Eiden

Bekhtari

Poujol

et al. 2009

American Journal of Health-System Pharmacy

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Stability of oxaliplatin in infusion bags containing 5% dextrose injection

Abstract: Oxaliplatin 0.7 mg/mL in infusion bags containing 5% dextrose injection was chemically stable for at least 30 days at both 3-7 degrees C and 20-24 degrees C without regard to light exposure.

Cited by 12 publications

References 9 publications

Stability of lyophilised oxaliplatin formulation in polyolefin infusion bags containing 5% dextrose injection

Stability of lyophilised oxaliplatin formulation in polyolefin infusion bags containing 5% dextrose injection

Preoperative intraperitoneal oxaliplatin for unresectable peritoneal carcinomatosis of colorectal origin: a pilot study

Physicochemical stability of oxaliplatin in 5% dextrose injection stored in polyvinyl chloride, polyethylene, and polypropylene infusion bags

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