Sterilisation of biopharmaceuticals: Effect of gamma irradiation, e-beam irradiation and nitrogen dioxide on human insulin.

Autor: Van den Bergh S; KU Leuven - University of Leuven, Department of Pharmaceutical and Pharmacological Sciences, Pharmaceutical Analysis, Herestraat 49, O&N2, PB 923, 3000 Leuven, Belgium., Croonenborghs B; Sterigenics NV, a Sotera Health Division, 2015 Spring Road 650, Oak Brook, IL 60523, United States., Gillet A; Sterigenics NV, a Sotera Health Division, 2015 Spring Road 650, Oak Brook, IL 60523, United States., Schlecht J; Sterigenics NV, a Sotera Health Division, 2015 Spring Road 650, Oak Brook, IL 60523, United States., DeMent A; Sterigenics NV, a Sotera Health Division, 2015 Spring Road 650, Oak Brook, IL 60523, United States., Haghedooren E; Sterigenics NV, a Sotera Health Division, 2015 Spring Road 650, Oak Brook, IL 60523, United States., Cabooter D; KU Leuven - University of Leuven, Department of Pharmaceutical and Pharmacological Sciences, Pharmaceutical Analysis, Herestraat 49, O&N2, PB 923, 3000 Leuven, Belgium. Electronic address: deirdre.cabooter@kuleuven.be.
Jazyk: angličtina
Zdroj: International journal of pharmaceutics [Int J Pharm] 2023 Apr 05; Vol. 636, pp. 122867. Date of Electronic Publication: 2023 Mar 17.
DOI: 10.1016/j.ijpharm.2023.122867
Abstrakt: Biopharmaceuticals are administered parenterally and therefore sterility is required. Sterility can be obtained via different processes including exposure to steam or dry heat. Sterilisation studies on biopharmaceuticals, which are highly sensitive medicinal products, are scarce. This study investigates the effect of different sterilisation processes on recombinant human insulin in solid state (gamma and e-beam irradiation (w/wo dry ice), nitrogen dioxide (NO 2 )) and in aqueous solution (gamma irradiation (w/wo dry ice, w/wo glycerin)) using ultra-high performance liquid chromatography-diode array detection-mass spectrometry. It is observed that NO 2 substantially degrades the solid samples, while gamma and e-beam irradiation result in lower levels of degradation (mean normalized peak areas of 95.2-96.2 % with respect to the non-sterilised samples). Gamma irradiation of insulin solutions with and without dry ice at 2.5 kGy results in mean normalised peak areas of 85 % and <40 % with respect to the non-sterilised samples, respectively. It is concluded that sterilisation using ionising radiation of liquid biopharmaceuticals with insulin and sterilisation of insulin dry powder using NO 2 is less suitable with the set-ups used here because of substantial degradation. In contrast, evidence is presented in favour of sterilisation of insulin dry powder using ionising radiation.
Competing Interests: Declaration of Competing Interest The authors declare that they have no known competing financial interests or personal relationships that could have appeared to influence the work reported in this paper.
(Copyright © 2023 The Authors. Published by Elsevier B.V. All rights reserved.)
Databáze: MEDLINE
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