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The Radiation Sterilization of Ertapenem Sodium in the Solid State

1
Department of Pharmacognosy, Poznan University of Medical Sciences, Święcickiego 4, 60-781 Poznań, Poland
2
Department of Medicinal Chemistry, Medical University of Lublin, Jaczewskiego 4, 20-090 Lublin, Poland
3
Department of Biotechnology and Food Microbiology, Poznan University of Life Sciences, Wojska Polskiego 48, 60-627 Poznań, Poland
4
Institute of Material Science and Engineering, Poznan University of Technology, Jana Pawła II 24, 60-965 Poznań, Poland
5
Institute of Molecular Physics, Polish Academy of Sciences, Smoluchowskiego 17, 60-179 Poznań, Poland
6
Department of Chemical Technology of Drugs, Poznan University of Medical Sciences, Grunwaldzka 6, 60-780 Poznan, Poland
*
Author to whom correspondence should be addressed.
Academic Editor: Fernando Albericio
Molecules 2019, 24(16), 2944; https://doi.org/10.3390/molecules24162944
Received: 22 July 2019 / Revised: 10 August 2019 / Accepted: 11 August 2019 / Published: 14 August 2019
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PDF [2446 KB, uploaded 14 August 2019]
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Abstract

For the first time, the influence of ionising radiation on the physicochemical properties of ertapenem in solid state was studied. During our studies, we evaluated the possibility of applying radiosterilization to obtain sterile ertapenem. Spectroscopic (Fourier Transform Infrared (FT-IR)), thermal (differential scanning calorimetry (DSC), chromatography (High-Performance Liquid Chromatography (HPLC) and HPLC-MS), and X-ray powder diffraction (XRPD) studies shown that irradiation of ertapenem with the 25 kGy, the dose required to achieve sterility, does not change the physicochemical properties of the studied compound. The antimicrobial activity of ertapenem irradiated with the dose of 25 kGy was only reduced for one species. Based on the received results, we can conclude that radiostelization is a promising alternative method of obtaining sterile ertapenem. In our studies, ertapenem was also exposed to e-beam radiation with a dose of 400 kGy. It was determined that two novel degradation products that are structurally differently to degradants formed during hydrolysis and thermolysis. View Full-Text
Keywords: ertapenem; radiation sterilization; Q-TOF; microbiological activity; FT-IR; HPLC; EPR; XRPD; Raman ertapenem; radiation sterilization; Q-TOF; microbiological activity; FT-IR; HPLC; EPR; XRPD; Raman
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This is an open access article distributed under the Creative Commons Attribution License which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited (CC BY 4.0).
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Kilińska, K.; Cielecka-Piontek, J.; Skibiński, R.; Szymanowska, D.; Miklaszewski, A.; Lewandowska, K.; Bednarski, W.; Mizera, M.; Tykarska, E.; Zalewski, P. The Radiation Sterilization of Ertapenem Sodium in the Solid State. Molecules 2019, 24, 2944.

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