Radiation sterilization as safe and effective way to obtain sterile biapenem

Rosiak, Natalia; Kilińska, Karolina; Skibiński, Robert; Szymanowska, Daria; Miklaszewski, Andrzej; Lewandowska, Kornelia; Bednarski, Waldemar; Tykarska, Ewa; Zalewski, Przemysław

doi:10.1016/j.radphyschem.2021.109363

Cited by 2 publications

(1 citation statement)

References 29 publications

Supporting

Mentioning

Contrasting

Order By: Relevance

“…Ionizing radiation shows bactericidal properties but can also cause physicochemical changes in sterilized drugs, as discussed in many publications [ 16 , 17 , 18 , 19 ]. Moreover, it was demonstrated that ionizing radiation in the standard dose of 25 kGy did not reduce the antimicrobial activity of many tested antibiotics [ 20 , 21 , 22 ]. Our research aims to explain how DC and AC behave in a solid state when exposed to radiation in the form of an electron beam and to assess their radiation stability.…”

Section: Introductionmentioning

confidence: 99%

Electron Beam Radiation as a Safe Method for the Sterilization of Aceclofenac and Diclofenac—The Usefulness of EPR and 1H-NMR Methods in Determination of Molecular Structure and Dynamics

et al. 2022

View full text Add to dashboard Cite

Diclofenac (DC) [2-(2,6-Dichloroanilino)phenyl]acetic acid,) and aceclofenac (AC) 2-[2-[2-[(2,6-dichlorophenyl)amino]phenyl]acetyl]oxyacetic acid in substantia were subjected to ionizing radiation in the form of a beam of high-energy electrons from an accelerator in a standard sterilization dose of 25 kGy and higher radiation doses (50–400 kGy). We characterized non-irradiated and irradiated samples of DC and AC by using the following methods: organoleptic analysis (color, form), spectroscopic (IR, NMR, EPR), chromatographic (HPLC), and others (microscopic analysis, capillary melting point measurement, differential scanning calorimetry (DSC)). It was found that a absorbed dose of 50 kGy causes a change in the color of AC and DC from white to cream-like, which deepens with increasing radiation dose. No significant changes in the FT-IR spectra were observed, while no additional peaks were observed in the chromatograms, indicating emerging radio-degradation products (25 kGy). The melting point determined by the capillary method was 153.0 °C for AC and 291.0 °C for DC. After irradiation with the dose of 25 kGy for AC, it did not change, for DC it decreased by 0.5 °C, while for the dose of 400 kGy it was 151.0 °C and 286.0 °C for AC and DC, respectively. Both NSAIDs exhibit high radiation stability for typical sterilization doses of 25–50 kGy and are likely to be sterilized with radiation at a dose of 25 kGy. The influence of irradiation on changes in molecular dynamics and structure has been observed by 1H-NMR and EPR studies. This study aimed to determine the radiation stability of DC and AC by spectrophotometric, thermal and chromatographic methods. A standard dose of irradiation (25 kGy) was used to confirm the possibility of using this dose to obtain a sterile form of both NSAIDs. Higher doses of radiation (50–400 kGy) have been performed to explain the changes in DC and AC after sterilization.

show abstract