Extended Stability of Reconstituted Lyophilized Erwinia L-asparaginase in Vials

In Vivo. 2020 Sep-Oct;34(5):2419-2421. doi: 10.21873/invivo.12055.

Abstract

Background/aim: L-Asparaginase (L-ASNase) is used as a tumor-inhibitory drug on paediatric acute lymphoblastic leukemia (ALL). ERW-ASNase is commercialised as a lyophilized powder stable only for 8 hours once reconstituted and, consequently, the leftover is usually discarded. The aim of this study will be to analyse the stability of the reconstituted lyophilised ERW-ASNase.

Materials and methods: In the present study, we analysed the enzymatic stability of reconstituted ERW-ASNase after conservation in three different temperature conditions for 2 and 5 days.

Results: Our results show that ERW-ASNase is stable at 4°C, -20°C and -80°C for up to 5 days, retaining 95% of the initial enzymatic activity in all three storage temperatures tested.

Conclusion: It is feasible to reuse the remaining content of ERW-ASNase vial after reconstitution, which allows the optimization of the content of ERW-ASNase vials use and reduces the cost of this formulation usage, making it more accessible.

Keywords: L-Asparaginase; acute lymphoblastic leukemia; erwinia.

MeSH terms

  • Antineoplastic Agents* / therapeutic use
  • Asparaginase / therapeutic use
  • Child
  • Erwinia*
  • Humans
  • Precursor Cell Lymphoblastic Leukemia-Lymphoma* / drug therapy
  • Temperature

Substances

  • Antineoplastic Agents
  • Asparaginase