Journal of Pharmaceutical and Biomedical Analysis Open最新文献

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A novel microextraction method for further elemental impurity determination in oily pharmaceutical excipients by ICP-MS ICP-MS微萃取法进一步测定含油药用辅料中元素杂质
Journal of Pharmaceutical and Biomedical Analysis Open Pub Date : 2025-03-01 DOI: 10.1016/j.jpbao.2025.100063
Cristian Rafael Andriolli , Mariele Samuel Nascimento , Alessandra Schneider Henn , Eder Lisandro Moraes Flores , Erico Marlon Moraes Flores , Rochele Sogari Picoloto
{"title":"A novel microextraction method for further elemental impurity determination in oily pharmaceutical excipients by ICP-MS","authors":"Cristian Rafael Andriolli ,&nbsp;Mariele Samuel Nascimento ,&nbsp;Alessandra Schneider Henn ,&nbsp;Eder Lisandro Moraes Flores ,&nbsp;Erico Marlon Moraes Flores ,&nbsp;Rochele Sogari Picoloto","doi":"10.1016/j.jpbao.2025.100063","DOIUrl":"10.1016/j.jpbao.2025.100063","url":null,"abstract":"<div><div>In this study, a reversed-phase dispersive liquid-liquid microextraction (RP-DLLME) method was proposed for the subsequent determination of elemental impurities of class 1 (As, Cd, Hg, and Pb) and class 2 A (Co, Ni, and V) in oily pharmaceutical excipients, as recommended by the International Council for Harmonisation (ICH) guideline Q3D. Analyte determination was carried out by inductively coupled plasma mass spectrometry (ICP-MS). Operational parameters were evaluated, including dispersant and extractant solvents, total volume and proportion of the extraction solution, sample mass, temperature, heating time, centrifugation, and stirring. Suitable results were obtained using a high sample mass (5 g), 2 mL of 50:50 % (v/v) of <em>n</em>-propanol:HNO<sub>3</sub> (3 mol L<sup>−1</sup> HNO<sub>3</sub> for all analytes and 6 mol L<sup>−1</sup> HCl only for Hg), heating at 85 °C for 20 min, stirring for 1 min, and centrifugation for 10 min. Accuracy was assessed using certified reference materials (CRMs) of mineral oil, comparison with a reference method (microwave-assisted wet digestion), and analyte recovery experiments at three concentration levels, following ICH Q3D recommendations and the United States Pharmacopeia (USP) guidelines for injectable drugs. No statistical differences were observed in any of the accuracy assessments. The method achieved low quantification limits (LOQs) of 0.045, 0.006, 0.006, 0.009, 0.040, 0.020, and 0.102 µg g<sup>−1</sup> for As, Cd, Co, Hg, Ni, Pb, and V, respectively, all of which were below the maximum levels allowed by the ICH guideline. The proposed method presented several advantages for routine analysis, including simplicity, high throughput, the use of diluted solutions, and minimal laboratory waste generation.</div></div>","PeriodicalId":100822,"journal":{"name":"Journal of Pharmaceutical and Biomedical Analysis Open","volume":"5 ","pages":"Article 100063"},"PeriodicalIF":0.0,"publicationDate":"2025-03-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143576883","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
Turning diverse analytical data into actionable knowledge for enzymatically driven polysorbate degradation risk assessment and control in biotherapeutic protein formulations 将不同的分析数据转化为生物治疗蛋白制剂中酶驱动的聚山梨酸酯降解风险评估和控制的可操作知识
Journal of Pharmaceutical and Biomedical Analysis Open Pub Date : 2025-02-24 DOI: 10.1016/j.jpbao.2025.100068
Alex Dow , Divya Chandra , Ximeng Dow , Benjamin Adams , Morgan Ayres , Shannon Rivera , Rong-Sheng Yang , Anita P. Liu , Xuanwen Li , Tingting Jiang , Fengqiang Wang , Tony Pereira , Rosalind Ang , Chunyan Li , Lei Zhang , Jonathan Welch , Lloyd Breunig
{"title":"Turning diverse analytical data into actionable knowledge for enzymatically driven polysorbate degradation risk assessment and control in biotherapeutic protein formulations","authors":"Alex Dow ,&nbsp;Divya Chandra ,&nbsp;Ximeng Dow ,&nbsp;Benjamin Adams ,&nbsp;Morgan Ayres ,&nbsp;Shannon Rivera ,&nbsp;Rong-Sheng Yang ,&nbsp;Anita P. Liu ,&nbsp;Xuanwen Li ,&nbsp;Tingting Jiang ,&nbsp;Fengqiang Wang ,&nbsp;Tony Pereira ,&nbsp;Rosalind Ang ,&nbsp;Chunyan Li ,&nbsp;Lei Zhang ,&nbsp;Jonathan Welch ,&nbsp;Lloyd Breunig","doi":"10.1016/j.jpbao.2025.100068","DOIUrl":"10.1016/j.jpbao.2025.100068","url":null,"abstract":"<div><div>In recent years polysorbate (PS) degradation in biotherapeutic protein formulations has become one of the most challenging topics for residual host cell protein control. With such focus, various assays have been showcased to help inform on enzymatically driven PS degradation risk assessment and control. Access to multiple, orthogonal data sets can improve understanding but also increases complexity in data interpretation. To highlight how multiple assays can work together to provide an aligned enzymatically driven PS degradation risk assessment and control, three cases studies are discussed. The case studies are diverse in the driver for performing these experiments along with if they are proactively or reactively addressing PS degradation. From these three case studies it becomes apparent that assays are consistent in their use and alignment regarding enzymatically driven PS degradation risk assessment and control. In general, an assay will fall into one of three categories: risk informing, characterization, and extended characterization. With this information future work focused on enzymatically driven PS degradation risk assessment and control has a blueprint for what assays can be used and what the data informs on.</div></div>","PeriodicalId":100822,"journal":{"name":"Journal of Pharmaceutical and Biomedical Analysis Open","volume":"5 ","pages":"Article 100068"},"PeriodicalIF":0.0,"publicationDate":"2025-02-24","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143644374","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
Innovative QSRR modeling approach for the development of an ultra-sensitive LC-MS/MS method for trace analysis of N-nitrosamines 创新的QSRR建模方法用于开发n -亚硝胺痕量分析的超灵敏LC-MS/MS方法
Journal of Pharmaceutical and Biomedical Analysis Open Pub Date : 2025-02-19 DOI: 10.1016/j.jpbao.2025.100064
Yue Zhang, Sabah Houari, Thomas Van Laethem, Amandine Dispas, Eric Ziemons, Philippe Hubert, Cédric Hubert
{"title":"Innovative QSRR modeling approach for the development of an ultra-sensitive LC-MS/MS method for trace analysis of N-nitrosamines","authors":"Yue Zhang,&nbsp;Sabah Houari,&nbsp;Thomas Van Laethem,&nbsp;Amandine Dispas,&nbsp;Eric Ziemons,&nbsp;Philippe Hubert,&nbsp;Cédric Hubert","doi":"10.1016/j.jpbao.2025.100064","DOIUrl":"10.1016/j.jpbao.2025.100064","url":null,"abstract":"<div><div>To address regulatory concerns regarding N-nitrosamine contamination in pharmaceutical products, generic LC-MS/MS methods for determining N-nitrosamines were developed using an innovative <em>in silico</em> approach based on Quantitative Structure Retention Relationship modeling (QSRR). The development process included screening and optimization phases, offering flexibility in targeting N-nitrosamines and addressing the challenges related to the matrix effect. This methodology represents a significant advancement in method development. Among the developed methods, a highly sensitive and accurate LC-MS/MS method was successfully validated to simultaneously determine 5 small-molecule N-nitrosamine impurities in tablets, which was used in the present proof-of-concept study. The validation followed the ICH Q2 (R2) guidelines, employing a combined approach for accuracy and precision based on total error risk-based methodology. The method was validated to function as both an impurity limit test and a quantitative method. Validation results demonstrated adequate quantitative performance of the method, establishing a validated dosing range from 1 to 30 ng/mL for all N-nitrosamines. The estimated detection limit ranged from 0.75 pg/mL to 0.02 ng/mL. The detection and quantification limits for each N-nitrosamine met the EMA N-nitrosamine investigation approach requirements. Moreover, both are always below 10 % of their respective acceptable limit in the studied finished product formulation. This proposed method is suitable for investigating small-molecule N-nitrosamines in pharmaceutical products and also provides a starting point for further method development, particularly for the determination of newly identified small-molecule N-nitrosamines and drug-substance-related N-nitrosamines.</div></div>","PeriodicalId":100822,"journal":{"name":"Journal of Pharmaceutical and Biomedical Analysis Open","volume":"5 ","pages":"Article 100064"},"PeriodicalIF":0.0,"publicationDate":"2025-02-19","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143445617","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
IrO2 nanoparticles-doped bacterial cellulose as a paper-based platform for optical detection of dopamine IrO2纳米颗粒掺杂细菌纤维素作为多巴胺光学检测的纸质平台
Journal of Pharmaceutical and Biomedical Analysis Open Pub Date : 2025-02-19 DOI: 10.1016/j.jpbao.2025.100065
Handenur Tomaşoğlu , Eda Gumus , Erhan Zor , Haluk Bingol
{"title":"IrO2 nanoparticles-doped bacterial cellulose as a paper-based platform for optical detection of dopamine","authors":"Handenur Tomaşoğlu ,&nbsp;Eda Gumus ,&nbsp;Erhan Zor ,&nbsp;Haluk Bingol","doi":"10.1016/j.jpbao.2025.100065","DOIUrl":"10.1016/j.jpbao.2025.100065","url":null,"abstract":"<div><div>Paper-based sensors including different indicators are attractive to many scientists because they can be used in many different fields. Due to their visual interpretability and ease of use, a large number of paper-based sensors have been created as competitors to traditional detection methods. In particular, the application of nanomaterials with different strategies to paper-based biosensors can provide an enhanced colorimetric readout for selective and sensitive detection. Among them, the numerous hydroxyl groups on IrO<sub>2</sub> nanoparticles (IrO<sub>2</sub>NPs) surface made it easier for organic molecules to be adsorbed, leading to optical change of IrO<sub>2</sub>NPs in the presence of biologically important molecules as analyte. In this study, a paper-based optical sensor platform was obtained using bacterial cellulose (BC) doped with IrO<sub>2</sub>NPs. The IrO<sub>2</sub>NPs-doped BC (IrO<sub>2</sub>NPs@BC) was cut into circular pieces (spot) for easily handling and used for dopamine detection. The dopamine sensor showed linear response in a concentration range of 0.30 µM to 10 µM in solution, while it revealed a linear range of 0.60 mM to 2.5 mM in paper-based platform. Limit of detection (LOD) and limit of quantification (LOQ) values were determined to be 0.107 µM and 0.325 µM in solution media, and to be 0.479 mM and 1.45 mM for the proposed paper-based optical sensor platform, respectively.</div></div>","PeriodicalId":100822,"journal":{"name":"Journal of Pharmaceutical and Biomedical Analysis Open","volume":"5 ","pages":"Article 100065"},"PeriodicalIF":0.0,"publicationDate":"2025-02-19","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143453735","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
Nanohybrids based on multi-walled carbon nanotubes and MOF-199: Advantages on the electrochemical reduction of hydrogen peroxide and sensing applications 基于多壁碳纳米管和MOF-199的纳米杂化材料:过氧化氢电化学还原及传感应用的优势
Journal of Pharmaceutical and Biomedical Analysis Open Pub Date : 2025-02-18 DOI: 10.1016/j.jpbao.2025.100066
Pablo A. Gallay , Virginia M. Vaschetti , Facundo Aghemo , Pablo R. Dalmasso , Gustavo A. Rivas
{"title":"Nanohybrids based on multi-walled carbon nanotubes and MOF-199: Advantages on the electrochemical reduction of hydrogen peroxide and sensing applications","authors":"Pablo A. Gallay ,&nbsp;Virginia M. Vaschetti ,&nbsp;Facundo Aghemo ,&nbsp;Pablo R. Dalmasso ,&nbsp;Gustavo A. Rivas","doi":"10.1016/j.jpbao.2025.100066","DOIUrl":"10.1016/j.jpbao.2025.100066","url":null,"abstract":"<div><div>We report the advantages of a nanohybrid obtained through the integration of multi-walled carbon nanotubes (MWCNTs) and MOF-199 by sono-synthesis. The resulting nanohybrid presents important synergic effects on the catalytic reduction of hydrogen peroxide due to the facilitated regeneration of the catalytic center in the presence of the interconnected carbon nanomaterial. Glassy carbon electrodes (GCE) modified with this hybrid nanomaterial dispersed in Nafion allowed the sensitive quantification of hydrogen peroxide: linear range between 5.0 × 10<sup>−6</sup> M and 7.5 × 10<sup>−5</sup> M (R<sup>2</sup> = 0.997), with a sensitivity of (128 ± 3) x 10<sup>2</sup> µA M<sup>−1</sup>, a detection limit of 2 µM, and a reproducibility of 8.0 % for the same nanohybrid and 5 different electrodes allowing the competitive electrochemical determination of hydrogen peroxide. The sensor was successfully used for the quantification of this important analyte in diverse commercial samples (milk, human serum, contact lens disinfecting solution, and mouthwash).</div></div>","PeriodicalId":100822,"journal":{"name":"Journal of Pharmaceutical and Biomedical Analysis Open","volume":"5 ","pages":"Article 100066"},"PeriodicalIF":0.0,"publicationDate":"2025-02-18","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143509241","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
Progress and future directions in determining drugs using spectroelectrochemical methods 光谱电化学测定药物的研究进展及未来发展方向
Journal of Pharmaceutical and Biomedical Analysis Open Pub Date : 2025-02-18 DOI: 10.1016/j.jpbao.2025.100067
Vildan Sanko , Ozge Surucu , Filiz Kuralay
{"title":"Progress and future directions in determining drugs using spectroelectrochemical methods","authors":"Vildan Sanko ,&nbsp;Ozge Surucu ,&nbsp;Filiz Kuralay","doi":"10.1016/j.jpbao.2025.100067","DOIUrl":"10.1016/j.jpbao.2025.100067","url":null,"abstract":"<div><div>The use of drugs is essential for the continuity of human health and the prevention of diseases for living creatures. A key factor in effective drug use is taking it at the correct dosage and timing. Otherwise, some adverse or side effects of these drugs may occur. For this reason, it is crucial to determine the drugs used. In some cases, drug analysis is also essential to understand the use of harmful active substances, such as in the class of prohibited ones. The simple definition of a drug (medication) is a chemical substance that produces a biological effect when adapted to an organism. There are many techniques to determine the drug amount, including spectrometric, chromatographic, electrochemical, colorimetric, or immunological. These analytical techniques have been successfully used to quantify drugs. To improve the effectiveness of the detection protocols, combined systems such as spectroelectrochemistry (SEC) provide significant advantages. This well-known technique unites the principles of spectroscopy and electrochemistry by creating a synergy to provide information on redox properties, mechanisms, and molecular structures. This review highlights the transformative potential of SEC in determining drug molecules, offering a detailed exploration of its principles, methodologies, and unique advantages. The main emphasis, however, is on the use of SEC in pharmaceutical analysis, where its accuracy and adaptability have driven significant progress. Recent studies are presented in detail, demonstrating SEC's effectiveness in detecting, quantifying, and characterizing drug molecules with high sensitivity and specificity.</div></div>","PeriodicalId":100822,"journal":{"name":"Journal of Pharmaceutical and Biomedical Analysis Open","volume":"5 ","pages":"Article 100067"},"PeriodicalIF":0.0,"publicationDate":"2025-02-18","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143474674","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
Developments toward analysis of pesticides at residue levels among High Chlorophyll Containing Edible Leafy Plants – Sampling, QuEChERS and LC-MS/MS based analysis 高叶绿素食用叶类植物农药残留分析研究进展——取样、QuEChERS和LC-MS/MS分析
Journal of Pharmaceutical and Biomedical Analysis Open Pub Date : 2025-02-12 DOI: 10.1016/j.jpbao.2025.100062
Vikrant Goel , Deepika Pandey , Sudeep Shukla
{"title":"Developments toward analysis of pesticides at residue levels among High Chlorophyll Containing Edible Leafy Plants – Sampling, QuEChERS and LC-MS/MS based analysis","authors":"Vikrant Goel ,&nbsp;Deepika Pandey ,&nbsp;Sudeep Shukla","doi":"10.1016/j.jpbao.2025.100062","DOIUrl":"10.1016/j.jpbao.2025.100062","url":null,"abstract":"<div><div>The usage of pesticides is crucial in maintaining the long-term health of plantations and boosting crop productivity. Nonetheless, their uncontrolled application has led to contamination of the environment, primarily affecting crops, soil, and water resources. Leafy plants rich in chlorophyll, classified as superfoods, have enhanced the quality of human life, however, they are prone to contamination with foreign contamination compounds known as xenobiotics, which pose a challenge for routine laboratory analysis. This paper reviews advancements among various sample preparation techniques evolving towards modern QuEChERS methodology and the features of the liquid chromatography mass spectroscopy technique that are useful for the assessment of pesticides from multiple classes at residue levels in such highly nutritious substances from High Chlorophyll Containing Edible Leafy Plants.</div></div>","PeriodicalId":100822,"journal":{"name":"Journal of Pharmaceutical and Biomedical Analysis Open","volume":"5 ","pages":"Article 100062"},"PeriodicalIF":0.0,"publicationDate":"2025-02-12","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143453734","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
Highly selective and sensitive detection of atorvastatin from using a MIP-based electrochemical sensor 基于mip的电化学传感器对阿托伐他汀的高选择性和高灵敏度检测
Journal of Pharmaceutical and Biomedical Analysis Open Pub Date : 2025-02-03 DOI: 10.1016/j.jpbao.2025.100061
Ensar Piskin , Fatih Ahmet Korkut , Ahmet Cetinkaya , Sibel A. Ozkan
{"title":"Highly selective and sensitive detection of atorvastatin from using a MIP-based electrochemical sensor","authors":"Ensar Piskin ,&nbsp;Fatih Ahmet Korkut ,&nbsp;Ahmet Cetinkaya ,&nbsp;Sibel A. Ozkan","doi":"10.1016/j.jpbao.2025.100061","DOIUrl":"10.1016/j.jpbao.2025.100061","url":null,"abstract":"<div><div>Atorvastatin (ATR) is one of the statins that are widely used all around the world. This study presents a molecularly imprinted polymer (MIP) based electrochemical sensor for the sensitive and selective detection of ATR in binary mixtures and commercial serum samples. The designed sensor was fabricated using a photopolymerization (PP) approach on a glassy carbon electrode (GCE) using ATR as the template and acrylamide (ACR) as the functional monomer. The developed ATR/ACR@MIP-GCE sensor was evaluated electrochemically and morphologically using electrochemical impedance spectroscopy (EIS), cyclic voltammetry (CV), and scanning electron microscopy (SEM). The indirect measuring method was used with a 5.0 mM [Fe(CN)<sub>6</sub>]<sup>3–/4–</sup> solution to determine the ATR in the linear range of 1.0–10.0 pM. Moreover, the sensor demonstrated excellent linearity and extremely sensitive quantification (LOQ) limit of detection (LOD) values in both biological media and standard solutions. It also performed well in terms of specificity by effectively differentiating ATR from compounds with similar structures. Excellent repeatability and reproducibility results have confirmed the reliability of the sensor. The selectivity of the ATR/ACR@MIP-GCE sensor for ATR was proven by interference studies on ezetimibe and their binary mixtures.</div></div>","PeriodicalId":100822,"journal":{"name":"Journal of Pharmaceutical and Biomedical Analysis Open","volume":"5 ","pages":"Article 100061"},"PeriodicalIF":0.0,"publicationDate":"2025-02-03","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143143655","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
Assessment of the serum and salivary free light chain levels in patients with proteinuria post cardiac surgery 心脏手术后蛋白尿患者血清和唾液游离轻链水平的评估
Journal of Pharmaceutical and Biomedical Analysis Open Pub Date : 2025-02-01 DOI: 10.1016/j.jpbao.2025.100058
Moazaz Rashad Saed , Thikra Hasan Mathkor
{"title":"Assessment of the serum and salivary free light chain levels in patients with proteinuria post cardiac surgery","authors":"Moazaz Rashad Saed ,&nbsp;Thikra Hasan Mathkor","doi":"10.1016/j.jpbao.2025.100058","DOIUrl":"10.1016/j.jpbao.2025.100058","url":null,"abstract":"<div><div>Acute kidney injury (AKI) is a prevalent complication following cardiac surgery, affecting both short- and long-term survival rates. Proteinuria serves as an indicator of structural kidney damage and is increasingly recognized as a crucial marker for kidney disease and a risk factor for AKI. Free light chains (FLCs) are being investigated as potential markers for assessing the risk of kidney damage. This study aimed to validate the early detection of AKI by examining FLCs (kappa, lambda, and the kappa/lambda ratio) in serum and saliva samples. Clinical data were collected from 149 patients who underwent cardiac surgery in Baghdad, with 90 providing both saliva and serum samples for FLC evaluation. Patients were categorized based on the severity of proteinuria. Results showed that serum kappa levels were significantly elevated in patients with severe proteinuria compared to those with mild or no proteinuria. Conversely, salivary kappa levels were higher in patients with mild proteinuria than in those with severe or no proteinuria, while salivary lambda levels decreased as proteinuria severity increased. The rise in serum kappa may be attributed to immune system activation and kidney impairment. Both serum and salivary kappa demonstrated strong predictive capabilities for post-surgery AKI prognosis, outperforming lambda and the kappa/lambda ratio based on ROC analysis. The findings suggest that FLCs, particularly kappa, could be valuable in the early detection of AKI following cardiac surgery, highlighting their potential to enhance patient outcomes through proactive monitoring and intervention.</div></div>","PeriodicalId":100822,"journal":{"name":"Journal of Pharmaceutical and Biomedical Analysis Open","volume":"5 ","pages":"Article 100058"},"PeriodicalIF":0.0,"publicationDate":"2025-02-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143280733","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
A compendium of noncoding RNAs as biomarkers in Type 2 Diabetes Mellitus 非编码rna作为2型糖尿病生物标志物的综述
Journal of Pharmaceutical and Biomedical Analysis Open Pub Date : 2025-01-30 DOI: 10.1016/j.jpbao.2025.100057
Manjusha Sita Akella, Angel Mendonca, Thanikes Manikandan, Dhananjay Sateesh, Akshitha Rajesh Swaminathan, Disha Parameshwaran, Manishika Gupta, Sujatha Sundaresan
{"title":"A compendium of noncoding RNAs as biomarkers in Type 2 Diabetes Mellitus","authors":"Manjusha Sita Akella,&nbsp;Angel Mendonca,&nbsp;Thanikes Manikandan,&nbsp;Dhananjay Sateesh,&nbsp;Akshitha Rajesh Swaminathan,&nbsp;Disha Parameshwaran,&nbsp;Manishika Gupta,&nbsp;Sujatha Sundaresan","doi":"10.1016/j.jpbao.2025.100057","DOIUrl":"10.1016/j.jpbao.2025.100057","url":null,"abstract":"<div><div>Diabetes Mellitus (DM) is among the most widespread multifactorial disorders worldwide, defined by increased plasma glucose levels. Type 2 Diabetes Mellitus (T2DM) is the most prevalent and common form of diabetes mellitus. T2DM is a metabolic condition characterized by abnormal blood glucose levels, insulin resistance in target tissues, and a reduced mass and function of islet β cells. Highlighting the significance of investigating new biomarkers, particularly during the initial stages of development, noncoding RNAs (ncRNAs) have been identified as valuable resources for T2DM. NcRNAs are a class of RNAs found in humans that play significant roles in epigenetics and in regulating post-transcriptional gene expression. Since they function as regulatory molecules, upon base pairing with the mRNA, they exhibit post-transcriptional alterations in the signaling cascade within the cells by regulating the expression of multiple targets simultaneously. Small non-coding RNAs (sncRNAs) and long non-coding RNAs (lncRNAs) are the two primary categories of non-coding RNAs. Several studies have shown that sncRNAs and lncRNAs have evolved as potential biomarkers in T2DM. This review focuses on non-coding RNAs as biomarkers for T2DM and their role in preventing chronic complications.</div></div>","PeriodicalId":100822,"journal":{"name":"Journal of Pharmaceutical and Biomedical Analysis Open","volume":"5 ","pages":"Article 100057"},"PeriodicalIF":0.0,"publicationDate":"2025-01-30","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143280732","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
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