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Nitrosamines crisis in pharmaceuticals-Insights on toxicological implications,root causes and risk assessment:A systematic review

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Journal of Pharmaceutical Analysis 2024年第5期14卷 639-652页

作者： Hemanth P.R.Vikram Tegginamath Pramod Kumar Gunjan Kumar narasimha m.beeraka Rajashree Deka Sheik mohammed Suhail Sandeep Jat Namitha Bannimath Gayatiri Padmanabhan Ravandur S.Chandan Pramod Kumar Bannimath Gurupadayya Department of Pharmaceutical Chemistry JSS College of Pharmacy MysuruJSS Academy of Higher Education and Research(JSSAHER)Mysuru570015India Xenone Healthcare Pvt.Ltd. New Delhi110076India Department of Pharmaceutics JSS College of Pharmacy MysuruJSS Academy of Higher Education and Research(JSSAHER)Mysuru570015India Department of Human Anatomy I.M.Sechenov First Moscow State Medical University(Sechenov University)Moscow119991Russian Federation Department of Pharmacology Raghavendra Institute of Pharmaceutical Education and Research(RIPER)Ananthapuramu515721India Herman B.Wells Center for Pediatric Research Department of PediatricsIndiana University School of MedicineIndianapolisIN46202USA Animal Physiology and Biochemistry Laboratory Department of ZoologyGauhati UniversityGuwahati781014India Department of Pharmacology JSS College of Pharmacy MysuruJSS Academy of Higher Education and Research(JSSAHER)Mysuru570015India Department of Pharmaceutical Analysis National Institute of Pharmaceutical Education and Research(NIPER)-GuwahatiChangsari781101India Department of Pharmacology University of GalwayGalwayH91 TK33Ireland

The presence of N-nitroso compounds,particularly N-nitrosamines,in pharmaceutical products has raised global safety concerns due to their significant genotoxic and mutagenic *** systematic review investigates their toxicity in active pharmaceutical ingredients(APIs),drug products,and pharmaceutical excipients,along with novel analytical strategies for detection,root cause analysis,reformulation strategies,and regulatory guidelines for *** review emphasizes the molecular toxicity of N-nitroso compounds,focusing on genotoxic,mutagenic,carcinogenic,and other physiological ***,it addresses the ongoing nitrosamine crisis,the development of nitrosamine-free products,and the importance of sensitive detection methods and precise risk *** comprehensive overview will aid molecular biologists,analytical scientists,formulation scientists in research and development sector,and researchers involved in management of nitrosamine-induced toxicity and promoting safer pharmaceutical products.

关键词： Carcinogenicity Genotoxicity mutagenicity molecular toxicity Nitrosamine impurities Nitrosamine drug substance-related impurities

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Corrigendum to“Nitrosamines crisis in pharmaceuticals-Insights on toxicological implications,root causes and risk assessment:A systematic review”[***.14(2024)100919]

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Journal of Pharmaceutical Analysis 2024年第6期14卷 934-936页

Original statement in the Section 2:*** search Our primary screening of 180 articles yielded the relevant data for this *** selection A total of 180 articles spanning from 1960 to the present day,including original research,reviews,case reports and studies reporting nitrosamine impurities above the no-observed-adverse-effect levels(NOAEL)established by regulatory agencies,were initially *** the primary screening,we considered factors such as relevance,publication date,access to the full article text,and content.

关键词： statement initially spanning

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Numerical study on gas production via a horizontal well from hydrate reservoirs with different slope angles in the South China Sea

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Deep Underground Science and Engineering 2024年第2期3卷 171-181页

作者： Tingting Luo Jianlin Song Xiang Sun Fanbao Cheng madhusudhan Bangalore narasimha murthy Yulu Chen Yi Zhao Yongchen Song School of mechanics and Civil Engineering China University of Mining and TechnologyXuzhouChina Institute of Rock and Soil mechanics Chinese Academy of SciencesWuhanChina Key Laboratory of Ocean Energy Utilization and Energy Conservation of ministry of Education Dalian University of TechnologyDalianChina Faculty of Engineering and the Environment University of SouthamptonSouthamptonUK

It is important to study the effect of hydrate production on the physical and mechanical properties of low-permeability clayey–silty reservoirs for the largescale exploitation of hydrate reservoirs in the South China *** this study,a multiphysical-field coupling model,combined with actual exploration drilling data and the mechanical experimental data of hydrate cores in the laboratory,was established to investigate the physical and mechanical properties of low-permeability reservoirs with different slope angles during 5-year hydrate production by the depressurization method via a horizontal *** result shows that the permeability of reservoirs severely affects gas production rate,and the maximum gas production amount of a 20-m-long horizontal well can reach186.8 m3/day during the 5-year hydrate *** with smaller slope angles show higher gas production *** depressurization propagation and hydrate dissociation mainly develop along the direction parallel to the ***,the mean effective stress of reservoirs is concentrated in the near-wellbore area with the on-going hydrate production,and gradually decreases with the increase of the slope *** from the effective stress distribution law,the total reservoir settlement amount first decreases and then increases with the increase of the slope *** maximum settlement of reservoirs with a 0°slope angle is up to 3.4 m,and the displacement in the near-wellbore area is as high as2.2 m after 5 years of hydrate *** is concluded that the pore pressure drop region of low-permeability reservoirs in the South China Sea is limited,and various slope angles further lead to differences in effective stress and strain of reservoirs during hydrate production,resulting in severe uneven settlement of reservoirs.

关键词： effective stress low‐permeability reservoirs natural gas hydrate production numerical simulation settlement slope angle the South China

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An improved analytical model of 4H-SiC mESFET incorporating bulk and interface trapping effects

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Journal of Semiconductors 2015年第1期36卷 64-75页

作者： m.Hema Lata Rao N.V.L.narasimha murty School of Electrical Sciences IIT BhubaneswarBhubaneswar 751013India

An improved analytical model for the current–voltage（I–V） characteristics of the 4H-SiC metal semiconductor field effect transistor（mESFET） on a high purity semi-insulating（HPSI） substrate with trapping and thermal effects is presented. The 4H-SiC mESFET structure includes a stack of HPSI substrates and a uniformly doped channel layer. The trapping effects include both the effect of multiple deep-level traps in the substrate and surface traps between the gate to source/drain. The self-heating effects are also incorporated to obtain the accurate and realistic nature of the analytical model. The importance of the proposed model is emphasised through the inclusion of the recent and exact nature of the traps in the 4H-SiC HPSI substrate responsible for substrate *** analytical model is used to exhibit DC I–V characteristics of the device with and without trapping and thermal effects. From the results, the current degradation is observed due to the surface and substrate trapping effects and the negative conductance introduced by the self-heating effect at a high drain voltage. The calculated results are compared with reported experimental and two-dimensional simulations（Silvaco -TCAD）. The proposed model also illustrates the effectiveness of the gate–source distance scaling effect compared to the gate–drain scaling effect in optimizing 4H-SiC mESFET performance. Results demonstrate that the proposed I–V model of 4H-SiC mESFET is suitable for realizing SiC based monolithic circuits（mmICs） on HPSI substrates.

关键词： SiC mESFET HPSI substrate deep-level traps mmICs

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Intracellular biosynthesis of Au and Ag nanoparticles using ethanolic extract of Brassica oleracea L. and studies on their physicochemical and biological properties

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Journal of Environmental Sciences 2015年第3期27卷 151-157页

作者： Palaniselvam Kuppusamy Solachuddin J.A.Ichwan narasimha Reddy Parine mashitah m.Yusoff Gaanty Pragas maniam Natanamurugaraj Govindan Biomaterial and Biosensor Laboratory Faculty of Industrial Sciences and Technology Universiti Malaysia Pahang Kulliyyah of Dentistry International Islamic University Malaysia Genome Research Chair Department of Biochemistry College of Science King Saud University

In this present study, we reported broccoli （Brassica oleracea L.） as a potential candidate for the synthesis of gold and silver nanoparticles （NPs） in green chemistry method. The synthesized metal nanoparticles are evaluated their antimicrobial efficacy against different human pathogenic organisms. The physico-chemical properties of gold nanoparticles were analyzed using different analytical techniques such as a UV-Vis spectrophotometer, Field Emission Scanning Electron microscopy, energy dispersive X-ray spectroscopy, X-ray diffraction and a Fourier Transform Infrared spectrophotometer. In addition, gold and silver NP antimicrobial efficacy was checked by disc diffusion assay. UV-Vis color intensity of the nanoparticles was shown at 540 and 450 nm for gold and silver nanoparticles respectively. Higher magnification of the Field Emission Scanning Electron microscopy image shows the variable morphology of the gold nanoparticles such as spherical, rod and triangular shapes and silver nanoparticles were seen in spherical shapes. The average spherical size of the particles was observed in 24- 38 nm for gold and 30-45 nm for silver NPs. X-ray diffraction pattern confirmed the presence of gold nanopartides and silver nanoparticles which were crystalline in nature. Additionally, the functional metabolites were identified by the Fourier Transform Infrared spectroscopy. IR spectra revealed phenols, alcohols, aldehydes （sugar moieties）, vitamins and proteins are present in the broccoli extract which are accountable to synthesize the nanoparticles. The synthesized gold and silver NPs inhibited the growth of the tested bacterial and fungal pathogens at the concentration of 50 μg/mL respectively. In addition, broccoli mediated gold and silver nanoparticles have shown potent antimicrobial activity against human pathogens.

关键词： Biosynthesis Broccoli extract Gold Silver nanoparticles Antimicrobial

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Identification of a three-gene prognostic signature for radioresistant esophageal squamous cell carcinoma

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World Journal of Clinical Oncology 2023年第1期14卷 13-26页

作者： Xiao-Yan Wang narasimha m.beeraka Nan-Nan Xue Hui-ming Yu Ya Yang mao-Xing Liu Vladimir N Nikolenko Jun-Qi Liu Di Zhao Department of Endocrinology The First Affiliated Hospital of Zhengzhou UniversityZhengzhou 450052Henan ProvinceChina Department of Radiation Oncology The First Affiliated Hospital of Zhengzhou UniversityZhengzhou 450052Henan ProvinceChina Department of Human Anatomy I.M.Sechenov First Moscow State Medical UniversityMoscow 119991Russia Department of Pharmaceutical Chemistry JSS College of PharmacyMysuru 570015India Department of Radiation Oncology Peking University Cancer Hospital&InstituteBeijing 065005China Key Laboratory of Carcinogenesis and Translational Research(ministry of Education) Department of Gastrointestinal Surgery ⅣPeking University Cancer Hospital&InstituteBeijingChina m.V.Lomonosov moscow State University Moscow 119991Russia

BACKGROUND Esophageal squamous cell carcinoma(ESCC)is causing a high mortality rate due to the lack of efficient early prognosis markers and suitable therapeutic *** prognostic role of genes responsible for the acquisition of radioresistance in ESCC has not been fully *** To establish a prognostic model by studying gene expression patterns pertinent to radioresistance in ESCC *** Datasets were obtained from the Gene Expression Omnibus and The Cancer Genome Atlas *** edgeR,a Bioconductor package,was used to analyze mRNA expression between different *** screened genes specifically responsible for radioresistance to estimate overall *** correlation analysis was performed to confirm whether the expression of those genes correlated with each *** contributing to radioresistance and overall survival were assessed by the multivariate Cox regression model through the calculation ofβi and risk score using the following formula:∑^(n)_(i=1)βi×*** We identified three prognostic mRNAs(cathepsin S[CTSS],cluster of differentiation 180[CD180],and SLP adapter and CSK-interacting membrane protein[SCImP])indicative of *** expression of the three identified mRNAs was related to each other(r>0.70 and Pme-dependent receiver operating characteristic curve of the signature consisting of the three mRNAs was 0.716 and 0.841,*** stratifying patients based on the risk score derived from the signature,the high-risk group exhibited a higher death risk and shorter survival time than the low-risk group(PmO for ESCC,which may facilitate the prediction of early prognosis of this malignancy.

关键词： Esophageal squamous cell carcinoma CTSS CD180 SCImP Radioresistance TNm stage Prognosis

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Effect of laminate thickness on moisture diffusion of polymer matrix composites in artificial seawater ageing

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Frontiers of materials Science 2012年第3期6卷 225-235页

作者： Ratna PAL H.N.narasimha mURTHY m.SREEJlTHz,K.R.VISHNU mAHESH m.KRISHNA IS.C.SHARmA Department of mechanical Engineering R.V.College of EngineeringBangalore-560059KarnatakaIndia Department of P.G.Studies and Research in Industrial Chemistry Kuvempu UniversityShankaraghattaShimoga-577451KarnatakaIndia Tumkur University Tumkur-572103KarnatakaIndia

The influence of laminate thickness of polymer matrix composites on moisture diffusion in seawater immersion, as well as the resulting mechanical property degradation for composites of glass/isopolyester （G/IPE）, carbon/isopolyester （C/IPE）, glass/vinylester （G/VE） and carbon/vinylester （CNE）, was investigated in this paper. Laminates 3 and 10 mm in thickness, fabricated using the wet hand lay-up technique, were characterized for moisture absorption in artificial seawater medium, and their flexural strength and interlaminar shear strength （ILSS） degradations were studied. moisture diffusion was observed to be anamolous to the Fick＇s law for both 3 and 10 mm thick samples in the later stage of diffusion. moisture permeability of 10 mm thick samples was two to three order greater than that of 3 mm thick ones, while the time to moisture saturation remained unchanged. With the increase of laminate thickness, moisture saturation increased by 1.4% for CNE and 7% for GriPE. The residual flexural strength and ILSS were greater in case of 10 mm thick specimens after 200 days of exposure. SEm examination of the fractured specimens showed greater levels of fibre/matrix debonding in 10 mm thick specimens.

关键词： polymer matrix composite diffusion coefficient Fick's law degradation

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Deep Learned Singular Residual Network for Super Resolution Reconstruction

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Computers, materials & Continua 2023年第1期74卷 1123-1137页

作者： Gunnam Suryanarayana D.Bhavana P.E.S.N.Krishna Prasad m.m.K.narasimha Reddy md Zia Ur Rahman Department of Electronics and Communications V R Siddhartha Engineering CollegeVijayawada520007India Department of Electronics and Communication Engineering Koneru Lakshmaiah Education FoundationVaddeswaramGuntur522502India Department of CSE Anil Neerukonda Institute of Technology&SciencesSangivalasaVisakhapatnam531162India

Single image super resolution(SISR)techniques produce images of high resolution(HR)as output from input images of low resolution(LR).motivated by the effectiveness of deep learning methods,we provide a framework based on deep learning to achieve super resolution(SR)by utilizing deep singular-residual neural network(DSRNN)in training *** are obtained from the difference between HR and LR images to generate LR-residual example *** value decomposition(SVD)is applied to each LR-residual image pair to decompose into subbands of low and high frequency ***,DSRNN is trained on these subbands through input and output channels by optimizing the weights and biases of the *** fewer layers in DSRNN,the influence of exploding gradients is *** speeds up the learning process and also improves accuracy by using skip *** trained DSRNN parameters yield residuals to recover the HR subbands in the testing *** analysis shows that the proposed method results in superior performance to existingmethods in terms of subjective *** testing results on popular benchmark datasets such as set5,set14,and urban100 for a scaling factor of 4 show the effectiveness of the proposed method across different qualitative evaluation metrics.

关键词： Deep learning image reconstruction residual network singular values super resolution

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Optical and structural properties of highly porous shell structured Fe doped TiO_2 thin films

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Rare metals 2014年第5期33卷 578-582页

作者： C.S.Naveen P.Raghu H.m.mahesh K.narasimha Rao R.Rakesh Kumar A.R.Phani Department of Electronic Science Bangalore UniversityJnanabharathi Department of Instrumentation and Applied Physics Indian Institute of Science Nano-Research for Advanced materials and Technologies (Nano-RAM Technologies)

TiO2thin films with 0.2 wt%, 0.4 wt%, 0.6wt%, and 0.8 wt% Fe were prepared on glass and silicon substrates using sol–gel spin coating technique. The optical cut-off points are increasingly red-shifted and the absorption edge is shifted over the higher wavelength region with Fe content increasing. As Fe content increases, the optical band gap decreases from 3.03 to 2.48 eV whereas the tail width increases from 0.26 to 1.43 eV. The X-ray diffraction（XRD） patterns for doped films at 0.2 wt% and0.8 wt% Fe reveal no characteristic peaks, indicating that the film is amorphous whereas undoped TiO2exhibits（101） orientation with anatase phase. Thin films of higher Fe content exhibit a homogeneous, uniform, and nanostructured highly porous shell morphology.

关键词： Fe TiO2 Porous shell Sol–gel

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Formulation of unidirectional release buccal patches of carbamazepine and study of permeation through porcine buccal mucosa

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Asian Pacific Journal of Tropical Biomedicine 2013年第12期3卷 995-1002页

作者： Parthasarathy Govindasamy Bhaskar Reddy Kesavan Jayaveera Korlakunta narasimha R.R College of Pharmacy Sri Venkateswara College of Pharmacy JNTUA

Objective:To achieve transbuccal release of carbamazepine by loading in unidirectional release mucoadhesive buccal ***:Buccal patches of carbamazepine with unidirectional drug release were prepared using hydroxypropyl methyl cellulose,polyvinyl alcohol,polyvinyl pyrrolidone and ethyl cellulose by solvent casting *** impermeable backing layer(Pidilite?Biaxially-oriented polypropylene film)of patches provided unidirectional drug *** were evaluated for thickness,mass uniformity,surface pH and folding *** formulations FA2,FA8,FA10,FBI,FB14 and FB16(folding endurance above 250)were evaluated further for swelling studies,ex vivo mucoadhesive strength,ex vivo mucoadhesion time,in vitro drug release,ex vivo permeation,accelerated stability studies and FTIR and XRD spectral ***:The ex vivo mucoadhesion time of patches ranged between 109 min(FA10)to 126 min(FB14).The ex vivo mucoadhesive force was in the range of 0.278 lo 0.479 kg/m/*** in vitro drug release studies revealed that formulation FA8 released 84%and FB16 released 99.01%of drug in140 ***:The prepared unidirectional buccal patches of carbamazepine provided a maximum drug release within specified mucoadhesion period and it indicates a potential alternative drug delivery system for systemic denvery of carbamazepine.

关键词： Buccal patches Carbamazepine mucoadhesion Biaxially-oriented polypropylene films Porcine buccal mucosa

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