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Nanoparticle-based Drug Delivery · Journal article
Chemical Research in Toxicology · August 11, 2026
Early or partial results. Treat as a signal, not a conclusion.
This is a preclinical toxicity characterization of copper nitroprusside analogue nanoparticles (CuNPANP) in cell culture and BALB/c mice at therapeutic doses, reporting no significant toxicological changes in body weight, organ weight, haematology, biochemistry, or histopathology over 120 days. The study supports further preclinical development but does not constitute evidence of clinical safety or efficacy and lacks formal comparative control data and statistical analysis.
Uncontrolled in vitro and in vivo toxicity assessment. RAW 264.7 murine macrophage cells in vitro; BALB/c mice (male and female) in vivo.. Intervention: Copper nitroprusside analogue nanoparticles (CuNPANP) at therapeutic doses of 1 and 5 mg/kg body weight. Compared with: Untreated (UT) group.
In vitro assays in RAW 264.7 cells showed no significant cytotoxicity, alterations in cell cycle, or excessive apoptosis or reactive oxygen species In vivo BALB/c mice (male and female) at therapeutic doses 1 and 5 mg/kg body weight showed no significant changes in body weight, feed consumption, or relative organ weight over 30, 60, and 120 days No major alterations in blood haematology and serum biochemical measurements in treated versus untreated groups
Anticancer efficacy mentioned in introduction but not demonstrated or reported in this toxicity study In vitro assays in RAW 264.7 cells showed no significant cytotoxicity, alterations in cell cycle, or excessive apoptosis or reactive oxygen species
These findings provide preliminary safety data supporting continued development of CuNPANP for potential therapeutic use, but do not establish human safety or efficacy. Clinical translation requires formal toxicology studies, regulatory approval pathways, and human trials.
Uncontrolled in vitro and in vivo toxicity characterization study in animals with no comparator group, lacking clinical efficacy data and designed primarily to assess safety before translation.
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These findings provide preliminary safety data supporting continued development of CuNPANP for potential therapeutic use, but do not establish human safety or efficacy. Clinical translation requires formal toxicology studies, regulatory approval pathways, and human trials.
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Abstract Copper-based nanomedicines have broader applications in the biomedical sector because of their unique fundamental properties. Very recently, our group has designed and synthesized new copper nitroprusside analogue nanoparticles (CuNPANP in vitro and in vivo) anticancer therapy in both breast cancer and melanoma. The toxicity study of these therapeutically active nanomedicines in small and large animals is a prerequisite before their clinical translation. In the present manuscript, detailed toxicity studies of CuNPANP are demonstrated through various in vitro and in vivo studies. Initially, the biocompatible nature of the CuNPANP has been established through several in vitro assays (cell viability assay, cell cycle study, apoptosis analysis, and determination of reactive oxygen species using DCFDA) in RAW 264.7 cells. Further, the noninflammatory nature of the nanoparticles toward RAW 264.7 cells has been investigated through immunocytochemistry (COX-2 staining) and Western blot analysis. The in vivo toxicity studies of CuNPANP have been performed in a BALB/c mouse (male and female) model using therapeutic doses (1 and 5 mg kg–1 body weight (b.w) in a time-dependent manner (30, 60, and 120 days). There were no significant changes observed in different body parameters (body weight, feed consumption, and relative organ weight) of the mice and no major alterations were found in blood hematology and serum biochemical measurements, while we compare the CuNPANP-treated groups with the UT group. Furthermore, the histopathological examination of male mice group upon 30, 60, and 120 days exposure reveals the biocompatibility of CuNPANP. Further, the biodistribution study reveals the distribution of copper in vital organs. Altogether, the results demonstrate the nontoxicity and biocompatibility of the nanomaterials.
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