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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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Elaboration of a Road Material Based on Clayey Soil and Crushed Sand

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Fluid Dynamics & Materials Processing 2022年第6期18卷 1595-1605页

作者： H.G.R.Sekloka C.P.Yabi R.Cloots M.Gibigaye Group of research in Energy and Environment from Materials(GREENMAT) LiègeBelgium Laboratory of Energetics and Applied Mechanics(LEMA) CotonouBenin Laboratory of Tests and Studies in Civil Engineering(L2EGC) AbomeyBenin

To contribute to the enhancement of unconventional local materials used for road construction,this study characterizes a crushed sand 0/5,a clayey soil and the litho-stabilized material without and with hydraulic binder and determines their use in accordance with some reference specifications(CEBTP 1984).It is shown that the different components are not usable alone in pavement ***,the plasticity index obtained for the clayey soil is 21%,a value higher than the imposed *** addition,the grading of the 0/5 crushed sand does not fit into the range proposed by CEBTP.A combination of these two(02)components is therefore considered to obtain a suitable material usable for the *** new material does not enter any class of the CEBTP lateritic *** order to be used in base layer,a treatment with hydraulic binder is carried out with the intention to improve its mechanical *** optimal dosage of hydraulic binder to achieve the desired mechanical performance is obtained by studying the evolution of the mechanical characteristics of the *** this treatment,the Bearing Ratio index of the mix increases from 37 to 223 for the optimal dosage and the dry compaction density decreases from 2.11 to 2.06 g/cm3 while the optimal water content increases from 9%to 10.1%.

关键词： Clayey sand crushed sand hydraulic binder road base

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Drug utilization evaluation of medications used in the management of neurological disorders

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Global Health Journal 2023年第3期7卷 153-156页

作者： Meghana Upadhya Nivya Jimmy Jesslyn Maria Jaison Shahal Sidheque Harsha Sundaramurthy Nemichandra S c Shasthara Paneyala Madhan Ramesh Jehath Syed Nikita Pal Sri Harsha Chalasani Department of Pharmacy Practice JSS College of PharmacyJSS Academy of Higher Education&ResearchMysuruKarnataka 570015India Department of Neurology JSS Medical College and HospitalJSS Academyof Higher Education&ResearchMysuruKarnataka570015India

Background and object:The burden of neurological disorders in India is expected to increase due to the rapid demographic and epidemiological transition,with irrational drug use,which is also a global ***,drug utilization evaluation is designed to ensure appropriate medicine use within the healthcare *** aim of the study was to assess the rate and pattern of drug utilization in the management of neurological *** and methods:A hospital-based cross-sectional drug utilization evaluation study on neurological drugs was carried out at the Department of Neurology over a span of six *** legible prescriptions consisting neurological medications irrespective of patient's gender,aged≥18 years were included for the *** World Health Organization(WHO)core drug use indicators were used to assess the drug prescribing and utilization ***:A total of 310 prescriptions were reviewed,where male predominance was found to be 56.45%.Out of 310 prescriptions,drugs belonging to 26 neurological classes were prescribed for the management of various neurological *** majority of patients were diagnosed with epilepsy and the most prescribed drugs per patient were phenytoin(14.8%)and valproic acid(6.45%).By following the WHO core drug prescribing indicators,65.47%of drugs prescribed from the India National List of Essential Medicines,2022,followed by 29.83%of drugs prescribed in generic name and 10.86%of prescriptions including ***:The study findings showed that the prescribing pattern in the Department of Neurology was in accordance with the WHO core prescribing ***,the extent of polypharmacy prescriptions was very ***,interventions are very necessary to promote rational drug prescribing patterns and thus clinical pharmacists can contribute to assess and review the drug utilization pattern to optimize the drug therapy and improvement in patient safety.

关键词： Drug utilization evaluation Neurological disorders Essential medication list Drug-related problems Patient safety

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Effects of L-arginine on preeclampsia risks and maternal and neonatal outcomes:A systematic review and meta-analysis

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Asian pacific Journal of Reproduction 2021年第6期10卷 241-251页

作者： Shonitha Sagadevan Oorvashree Sri Hari Mohamed Jahangir Sirajudeen Gopi Ramalingam Roopa Satyanarayan Basutkar Department of Pharmacy Practice JSS College of PharmacyJSS Academy of Higher Education&ResearchOotyThe NilgirisTamil NaduIndia

Objective:To summarize whether the supplementation of L-arginine in pregnant women helps in management of preeclampsia and its impact on maternal and neonatal ***:Studies conducted from the past 17 years(1999 to 2016).were referred from database like Cochrane Central Registry of Controlled Trials(CENTRAL),Scopus,Google Scholar and *** of 134 studies,7 studies were included.L-arginine versus placebo was considered for quantitative *** Cochrane data extraction form was used to collect the *** risk of bias was assessed using Cochrane’s risk of bias assessment tool in RevMan 5.4 and the summary of findings was determined using GradePro ***:L-arginine showed a significant reduction of preeclampsia[odds ratio(OR)0.38;95%confidence interval(CI)0.25,0.58)].There was a significant reduction in systolic blood pressure[mean difference(MD)-2.47;95%CI-4.53,-0.42]and diastolic blood pressure(MD-0.97;95%CI-3.83,1.89).The effects of L-arginine on secondary outcomes like maternal gestational age,latency,neonatal weight,and appearance,pulse,grimace,activity,respiration(APGAR)score at 1st and 5th minute were not statistically ***:L-arginine supplementation is effective in lowering systolic and diastolic blood pressure of preeclamptic ***,it has no noticeable effects on maternal and neonatal outcomes.

关键词： L-arginine Amino acid supplementation Preeclampsia Pregnancy Arginine supplementation

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