Irradiation of pharmaceuticals: A literature review

Jacobs, G.P.

doi:10.1016/j.radphyschem.2021.109795

Cited by 15 publications

(9 citation statements)

References 175 publications

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“…Discoloration of active pharmaceutical ingredients and degradation product formation are frequently observed as a result of gamma irradiation. − Furthermore, ISO 11137–1, the standard for sterilization of health care products via radiation put forward by the International Organization for Standardization, requires the product to meet its specified functional requirements throughout its defined lifetime after treatment with the maximum acceptable radiation dose . For APIs, this translates to identifying a radiation dose that achieves sterility but does not significantly impact processability or purity of the drug substance.…”

Section: Resultsmentioning

confidence: 99%

“…There has been a significant body of work completed within the pharmaceutical industry on how external stressors such as heat, moisture, and light affect the stability of APIs of different forms, as these studies are prerequisites for developing and filing new drug applications . Several studies have described the effects of gamma irradiation on APIs; however, little is reported on the impact API physical form has on degradation upon gamma irradiation. − …”

Section: Introductionmentioning

confidence: 99%

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Islatravir Dimer: Crystal Form Dependence of a Radiation-Induced Degradation Product

Topolski,

Confer,

et al. 2024

Mol. Pharmaceutics

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A rare example of crystal form-dependent, gamma radiation-induced degradation is presented. Islatravir is known to exist in several polymorphic forms, but only one of these forms shows the generation of a specific dimer degradation product under gamma irradiation. Extended gamma irradiation studies demonstrated that only one of the known crystalline forms shows an appreciable rate of dimer formation. Additionally, this dimer is not observed to form under other forced stress conditions. We present the structural elucidation of this dimer impurity and rationalize its form-dependent generation based on the analysis of the underlying crystal structure.

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Section: Resultsmentioning

confidence: 99%

Section: Introductionmentioning

confidence: 99%

Islatravir Dimer: Crystal Form Dependence of a Radiation-Induced Degradation Product

Topolski,

Confer,

et al. 2024

Mol. Pharmaceutics

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“…irradiation is a widely used method for the sterilization of medical products as well as for the sterilization of food. 18,19 Many heat-labile pharmaceuticals are sterilized by gamma irradiation. Since polymers such as PET are used in packaging, it is of great interest to investigate how polymers are altered by gamma irradiation and whether this has any impact on the packaged product.…”

Section: ■ Introductionmentioning

confidence: 99%

“…The duration of γ-irradiation can last from minutes to hours, depending on the thickness and volume of the product. , It offers several advantages over other methods, including the ability to penetrate deeply, ensure a high degree of sterility and operate independently of temperature and pressure conditions. Γ-irradiation is a widely used method for the sterilization of medical products as well as for the sterilization of food. , Many heat-labile pharmaceuticals are sterilized by gamma irradiation. Since polymers such as PET are used in packaging, it is of great interest to investigate how polymers are altered by gamma irradiation and whether this has any impact on the packaged product.…”

Section: Introductionmentioning

confidence: 99%

Effects of Gamma Irradiation on Polyethylene Terephthalate and Detection of Microplastic Particles Down to 1 μm

Mikac,

Csáki,

Zentai

et al. 2024

Langmuir

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In response to increasing concern about the impact of plastic degradation on the environment, this study investigates the degradation of virgin and recycled polyethylene terephthalate (PET) under γ-irradiation in aqueous solutions, with particular focus on the resulting formation of microplastic particles (MP). By exposing both virgin and recycled PET samples to different doses of γ-irradiation (10, 50, and 100 kGy), a comprehensive analysis using UV–vis spectroscopy, dynamic light scattering (DLS) and micro-Raman spectroscopy is presented. The results, highlighted by micro-Raman spectroscopy, show that γ-irradiation produces micrometer-sized plastic particles, with the recycled PET having a significantly higher MP content than its original counterpart. Careful examination reveals the presence of a stabilizer in samples of recycled PET juice bottles. This study not only contributes to our understanding of the effects of γ-irradiation on PET but also highlights the need for further research into the environmental impact of such processes. The insights gained shed light on the behavior of PET under γ-irradiation and the resulting impact on microplastic pollution and make an important contribution to our understanding of the broader environmental context.

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“…Gamma irradiation has received wide attention owing to its potential to decrease the toxicity of alkaloids, steroids, and avonoids and increase the biological capacities of these compounds 10,11 . Recently, the anti-depressant drug nomifensine (Merital®) was reported to effectively improve the anti-cancer properties in breast cancer cells after exposed to ionizing radiation 12 .…”

Section: Introductionmentioning

confidence: 99%

Novel aminopyridazine derivative of minaprine modified by radiolysis presents potent anti-inflammatory effects in LPS-stimulated RAW 264.7 and DH82 macrophage cells

Jeong

Lee

Woo

et al. 2023

Preprint

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Radiation molecularly transforms naturally occurring products by inducing the methoxylation, hydroxylation, and alkylation of parent compounds, thereby affecting the anti-inflammatory capacities of those compounds. Minaprine (1) modified by ionizing radiation generated the novel hydroxymethylated hydropyridazine minaprinol (2), and its chemical structure was determined based on NMR and HRESIMS spectra. Compared to the original minaprine, the novel generated product showed a highly enhanced anti-inflammatory capacity inhibited nitric oxide (NO) and prostaglandin E2 (PGE2) production in lipopolysaccharide (LPS)-stimulated RAW 264.7 and DH82 macrophage cells. In addition, minaprinol effectively inhibited cyclooxygenase-2 (COX-2) and inducible NO synthase (iNOS) at the protein level and pro-inflammatory cytokine (tumor necrosis factor-α (TNF-α), interleukin-6 (IL-6), and IL-10) production in macrophages.

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Irradiation of pharmaceuticals: A literature review

Cited by 15 publications

References 175 publications

Islatravir Dimer: Crystal Form Dependence of a Radiation-Induced Degradation Product

Islatravir Dimer: Crystal Form Dependence of a Radiation-Induced Degradation Product

Effects of Gamma Irradiation on Polyethylene Terephthalate and Detection of Microplastic Particles Down to 1 μm

Novel aminopyridazine derivative of minaprine modified by radiolysis presents potent anti-inflammatory effects in LPS-stimulated RAW 264.7 and DH82 macrophage cells

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