stability of erythropoietin repackaging in polypropylene syringes for clinical use
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2017
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Abstract
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.
| Reference Key |
marsili2017saudistability
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| Authors | ;Angela Marsili;Giorgia Puorro;Chiara Pane;Anna de Rosa;Giovanni Defazio;Carlo Casali;Antonio Cittadini;Giuseppe de Michele;Brunello Ettore Florio;Alessandro Filla;Francesco Saccà |
| Journal | International journal for quality in health care : journal of the International Society for Quality in Health Care |
| Year | 2017 |
| DOI |
10.1016/j.jsps.2016.01.003
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| URL | |
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