Stability of erythropoietin repackaging in polypropylene syringes for clinical use.
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.
Department of Neurosciences, Odontostomatological and Reproductive Sciences, University Federico II, Naples, Italy.
Angela
A
Marsili
Department of Neurosciences, Odontostomatological and Reproductive Sciences, University Federico II, Naples, Italy.
Giorgia
G
Puorro
Department of Neurosciences, Odontostomatological and Reproductive Sciences, University Federico II, Naples, Italy.
Chiara
C
Pane
Department of Neurosciences, Odontostomatological and Reproductive Sciences, University Federico II, Naples, Italy.
Anna
A
de Rosa
Department of Basic Medical Sciences, Neuroscience and Sensory Organs, "Aldo Moro" University of Bari, Bari, Italy.
Giovanni
G
Defazio
Department of Medical-Surgical Sciences and Biotechnologies, Polo Pontino-Sapienza University of Rome, Latina, Italy.
Carlo
C
Casali
Department of Translational Medical Sciences, University Federico II, Naples, Italy.
Antonio
A
Cittadini
Department of Neurosciences, Odontostomatological and Reproductive Sciences, University Federico II, Naples, Italy.
Giuseppe
G
de Michele
Farmacia Florio Dr. Ettore SNC, Naples, Italy.
Brunello Ettore
BE
Florio
Department of Neurosciences, Odontostomatological and Reproductive Sciences, University Federico II, Naples, Italy.
Alessandro
A
Filla
Department of Neurosciences, Odontostomatological and Reproductive Sciences, University Federico II, Naples, Italy.
Francesco
F
Saccà
EPO; Erythropoietin; Pharmacopeia; Polypropylene; Repackaging