Article Text

Download PDFPDF
Stability of pemetrexed diarginine concentrates for solution in vials and diluted in 0.9% sodium chloride and dextrose 5% polyolefin infusion bags
  1. Fabrice Vidal,
  2. Camille Cotteret,
  3. Abdel Negbane,
  4. Maria Sebti,
  5. Mélanie Hinterlang,
  6. Salvatore Cisternino,
  7. Joël Schlatter
  1. Hopital universitaire Necker-Enfants malades, Paris, Île-de-France, France
  1. Correspondence to Dr Joël Schlatter, Hopital universitaire Necker-Enfants malades, 75015 Paris, Île-de-France, France; joel.schlatter{at}aphp.fr

Abstract

Objectives To determine the physicochemical stability of pemetrexed diarginine in original vials, and after dilution in two commonly used infusion fluids (0.9% sodium chloride, 5% dextrose) in polyolefin bags, stored under refrigeration (2–8°C) or at ambient temperature (22–25°C) exposed to light.

Methods Stability of pemetrexed diarginine injection concentrate was determined in the original glass vials with closed-system transfer device. Diluted pemetrexed diarginine infusion solutions were aseptically prepared by dilution of pemetrexed diarginine concentrate with either 0.9% sodium chloride or dextrose 5% in polyolefin bags, in amounts yielding pemetrexed diarginine concentrations of 4, 9 and 12 mg/mL. Test solutions were stored under refrigeration (2–8°C) or at ambient temperature (22–25°C) exposed to light. Pemetrexed diarginine concentrations were determined throughout a 14-day storage period using a stability-indicating HPLC assay. In addition, test solutions were visually examined for colour change and precipitation.

Results Pemetrexed diarginine injection concentrate with closed-system transfer device is shown to be physicochemically stable for up to 4 days when stored under refrigeration and for 1 day at room temperature. A browning of the pemetrexed diarginine concentrate solutions appeared 0n day 2 when stored at ambient temperature and on day 5 under refrigeration. Pemetrexed diarginine diluted in dextrose 5% and 0.9% sodium chloride was physicochemically stable for up to 4 days when stored under refrigeration and for 1 day at room temperature. A browning of the diluted solutions appeared on day 2 when stored at room temperature and on day 5 when stored under refrigeration.

Conclusions Pemetrexed diarginine concentrate for solution stored under refrigeration with closed-system transfer device can be retained as a residual to reduce product losses. The analytical stability of pemetrexed diarginine in dextrose 5% and 0.9% sodium chloride under refrigeration enables our centralised unit to prepare this drug in advance.

  • antineoplastic agents
  • pharmaceutical preparations
  • pharmacy administration
  • medical oncology
  • drug compounding
  • pulmonary medicine

Statistics from Altmetric.com

Request Permissions

If you wish to reuse any or all of this article please use the link below which will take you to the Copyright Clearance Center’s RightsLink service. You will be able to get a quick price and instant permission to reuse the content in many different ways.