Stability of erythropoietin repackaging in polypropylene syringes for clinical use

• Main Authors: Angela Marsili (Author), Giorgia Puorro (Author), Chiara Pane (Author), Anna de Rosa (Author), Giovanni Defazio (Author), Carlo Casali (Author), Antonio Cittadini (Author), Giuseppe de Michele (Author), Brunello Ettore Florio (Author), Alessandro Filla (Author), Francesco Saccà (Author)
• Format: Book
• Published: Elsevier, 2017-02-01T00:00:00Z.
• Subjects: article
• Online Access: Connect to this object online.

Summary

Introduction: Epoetin alfa (Eprex®) is a subcutaneous, injectable formulation of short half-life recombinant human erythropoietin (rHuEPO). To current knowledge there are no published studies regarding the stability of rHuEPO once repackaging occurs (r-EPO) for clinical trial purposes. Materials and methods: We assessed EPO concentration in Eprex® and r-EPO syringes at 0, 60, 90, and 120 days after repackaging in polypropylene syringes. R-EPO was administered to 56 patients taking part in a clinical trial in Friedreich Ataxia. Serum EPO levels were measured at baseline and 48 h after r-EPO administration. Results: No differences were found between r-EPO and Eprex® syringes, but both globally decreased in total EPO content during storage at 4 °C. Patients receiving r-EPO had similar levels in EPO content as expected from previous trials in Friedreich Ataxia and from pharmacokinetics studies in healthy volunteers. Discussion: We demonstrate that repackaging of EPO does not alter its concentration if compared to the original product (Eprex®). This is true both for repackaging procedures and for the stability in polypropylene tubes. The expiration date of r-EPO can be extended from 1 to 4 months after repackaging, in accordance with pharmacopeia rules.

Item Description

1319-0164
10.1016/j.jsps.2016.01.003