Pub Date : 2025-11-04DOI: 10.1016/j.jpbao.2025.100095
Prajna Gupta , Saurav Sarkar , Sandip Karmakar , Sougata Jana , Gouranga Nandi , Sreejan Manna
The recent advancements in medical science and technology have enabled the diversified applications of existing drug delivery systems. Scaffolds are regarded as a relatively novel drug delivery system mostly employed in therapeutic and biomedical applications. In recent times, scaffolds are widely being investigated for sensory applications in in-vivo conditions. The mostly employed scaffold types for sensory applications are nanofibers, hydrogels, 3-D printed scaffolds and microparticulate scaffolds. Owing to its favorable physicochemical properties, scaffolds can also simultaneously function as a sensor in biological environment and also as delivery vectors. The surface charge, optical properties, porous nature, higher mechanical strength, and biodegradable behavior of polymeric scaffolds have encouraged pharmaceutical researchers to investigate upon it as biosensor. The ease of fabrication techniques, compatibility for customization and functionalization have made scaffolds a versatile system that is yet to be fully explored. The connection for integration of biosensor within scaffold has been described in this article. This review outlines the suitability of biomaterials-based scaffolds in sensory applications alongside the commonly employed fabrication techniques and biosensing applications.
{"title":"Biosensory implications of scaffolds: Designing, integration and biomedical applications","authors":"Prajna Gupta , Saurav Sarkar , Sandip Karmakar , Sougata Jana , Gouranga Nandi , Sreejan Manna","doi":"10.1016/j.jpbao.2025.100095","DOIUrl":"10.1016/j.jpbao.2025.100095","url":null,"abstract":"<div><div>The recent advancements in medical science and technology have enabled the diversified applications of existing drug delivery systems. Scaffolds are regarded as a relatively novel drug delivery system mostly employed in therapeutic and biomedical applications. In recent times, scaffolds are widely being investigated for sensory applications in in-vivo conditions. The mostly employed scaffold types for sensory applications are nanofibers, hydrogels, 3-D printed scaffolds and microparticulate scaffolds. Owing to its favorable physicochemical properties, scaffolds can also simultaneously function as a sensor in biological environment and also as delivery vectors. The surface charge, optical properties, porous nature, higher mechanical strength, and biodegradable behavior of polymeric scaffolds have encouraged pharmaceutical researchers to investigate upon it as biosensor. The ease of fabrication techniques, compatibility for customization and functionalization have made scaffolds a versatile system that is yet to be fully explored. The connection for integration of biosensor within scaffold has been described in this article. This review outlines the suitability of biomaterials-based scaffolds in sensory applications alongside the commonly employed fabrication techniques and biosensing applications.</div></div>","PeriodicalId":100822,"journal":{"name":"Journal of Pharmaceutical and Biomedical Analysis Open","volume":"6 ","pages":"Article 100095"},"PeriodicalIF":0.0,"publicationDate":"2025-11-04","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145473490","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Dietary supplements (DSs) or food supplements (FSs) are products widely consumed to support the diet. They could contain amino acids, peptides, proteins, vitamins, minerals, herbs, and compounds of botanical origin. Since they are considered food, they are not subjected to approval by government agencies. Therefore, they are popular because they can be bought without a prescription and are easily available on the internet. The addition of drugs to DSs/FSs is not allowed because it could cause serious damage to health. Therefore, there is a need for analytical methods capable of performing qualitative/quantitative analysis of the declared content and to verify the presence of adulterants. Among the analytical techniques employed, miniaturized techniques have been successfully applied to the analysis of such products. In this review, applications performed with capillary electrophoresis and nano-/capillary-liquid chromatography, and microchip electrophoresis published in the period 2018–2025 (July), are reported and discussed.
{"title":"Nano-liquid chromatography and electromigration techniques applied to the analysis of dietary supplements. A review","authors":"Chiara Fanali , Erica Cutè , Alessandra Gentili , Michele Pier Luca Guarino , Salvatore Fanali","doi":"10.1016/j.jpbao.2025.100093","DOIUrl":"10.1016/j.jpbao.2025.100093","url":null,"abstract":"<div><div>Dietary supplements (DSs) or food supplements (FSs) are products widely consumed to support the diet. They could contain amino acids, peptides, proteins, vitamins, minerals, herbs, and compounds of botanical origin. Since they are considered food, they are not subjected to approval by government agencies. Therefore, they are popular because they can be bought without a prescription and are easily available on the internet. The addition of drugs to DSs/FSs is not allowed because it could cause serious damage to health. Therefore, there is a need for analytical methods capable of performing qualitative/quantitative analysis of the declared content and to verify the presence of adulterants. Among the analytical techniques employed, miniaturized techniques have been successfully applied to the analysis of such products. In this review, applications performed with capillary electrophoresis and nano-/capillary-liquid chromatography, and microchip electrophoresis published in the period 2018–2025 (July), are reported and discussed.</div></div>","PeriodicalId":100822,"journal":{"name":"Journal of Pharmaceutical and Biomedical Analysis Open","volume":"6 ","pages":"Article 100093"},"PeriodicalIF":0.0,"publicationDate":"2025-10-25","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145473491","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2025-10-04DOI: 10.1016/j.jpbao.2025.100092
İnci Uludağ Anıl, Mustafa Kemal Sezgintürk
The emergence of anti-drug antibodies (ADAs) poses a significant challenge in biological therapeutics, undermining drug efficacy and patient safety. This review thoroughly assesses existing and novel analytical methods for ADA detection, highlighting their principles, strengths, and limitations. Conventional techniques like ELISA and ECL provide great sensitivity but may be inadequate for detecting low-affinity ADAs. On the other hand, surface plasmon resonance (SPR) offers advantages in detecting low-affinity anti-drug antibodies (ADAs) due to its real-time kinetic assessment. Recent advancements in label-free technologies, such as thin-film interferometry, electrolyte-gated organic field-effect transistors, and quartz crystal microbalance, show significant potential for rapid, sensitive, and real-time ADA monitoring. These advanced platforms enable accurate kinetic characterization and offer promise for point-of-care applications. Additionally, novel approaches address limitations of conventional immunoassays by simplifying workflows and reducing assay time. This review underscores the importance of ADA assessment for optimizing personalized therapeutic strategies and improving patient outcomes.
{"title":"Advances in anti-drug antibody detection: Miniaturized biosensor technologies and beyond","authors":"İnci Uludağ Anıl, Mustafa Kemal Sezgintürk","doi":"10.1016/j.jpbao.2025.100092","DOIUrl":"10.1016/j.jpbao.2025.100092","url":null,"abstract":"<div><div>The emergence of anti-drug antibodies (ADAs) poses a significant challenge in biological therapeutics, undermining drug efficacy and patient safety. This review thoroughly assesses existing and novel analytical methods for ADA detection, highlighting their principles, strengths, and limitations. Conventional techniques like ELISA and ECL provide great sensitivity but may be inadequate for detecting low-affinity ADAs. On the other hand, surface plasmon resonance (SPR) offers advantages in detecting low-affinity anti-drug antibodies (ADAs) due to its real-time kinetic assessment. Recent advancements in label-free technologies, such as thin-film interferometry, electrolyte-gated organic field-effect transistors, and quartz crystal microbalance, show significant potential for rapid, sensitive, and real-time ADA monitoring. These advanced platforms enable accurate kinetic characterization and offer promise for point-of-care applications. Additionally, novel approaches address limitations of conventional immunoassays by simplifying workflows and reducing assay time. This review underscores the importance of ADA assessment for optimizing personalized therapeutic strategies and improving patient outcomes.</div></div>","PeriodicalId":100822,"journal":{"name":"Journal of Pharmaceutical and Biomedical Analysis Open","volume":"6 ","pages":"Article 100092"},"PeriodicalIF":0.0,"publicationDate":"2025-10-04","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145265852","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2025-09-20DOI: 10.1016/j.jpbao.2025.100091
Abdullah Al Faysal, Beril S. Kaya, Hatice Elmacioglu, Ayşegül Gölcü
Turkey has historically been a prominent player in the trade of medicinal and aromatic plants, a status attributed to its advantageous geographical position, favorable climate, rich plant diversity, agricultural capabilities, and extensive land area. The country's flora is home to numerous species that are integral to established practices in herbal medicine, as well as the global manufacturing of plant-based chemicals, food additives, cosmetics, and perfumery. Recent research has particularly emphasized the role of antioxidant substances and phenolic compounds found in plants in promoting health. This review thoroughly evaluates the analytical techniques utilized in assessing antioxidant activity, drawing attention to the essential chemical reactions that underpin these measurements. Furthermore, the article compellingly highlights the significant role of antioxidants across various industries, demonstrating their crucial contributions to health, food preservation, and beyond. Furthermore, an in-depth analysis of the antioxidant properties of Turkish plant extracts is presented, detailing their constituent components, the solvents utilized for extraction, and the methodologies applied in antioxidant research.
{"title":"A comprehensive evaluation of contemporary techniques employed to measure the antioxidant activity of plant extracts from Turkey, both in vitro and in vivo","authors":"Abdullah Al Faysal, Beril S. Kaya, Hatice Elmacioglu, Ayşegül Gölcü","doi":"10.1016/j.jpbao.2025.100091","DOIUrl":"10.1016/j.jpbao.2025.100091","url":null,"abstract":"<div><div>Turkey has historically been a prominent player in the trade of medicinal and aromatic plants, a status attributed to its advantageous geographical position, favorable climate, rich plant diversity, agricultural capabilities, and extensive land area. The country's flora is home to numerous species that are integral to established practices in herbal medicine, as well as the global manufacturing of plant-based chemicals, food additives, cosmetics, and perfumery. Recent research has particularly emphasized the role of antioxidant substances and phenolic compounds found in plants in promoting health. This review thoroughly evaluates the analytical techniques utilized in assessing antioxidant activity, drawing attention to the essential chemical reactions that underpin these measurements. Furthermore, the article compellingly highlights the significant role of antioxidants across various industries, demonstrating their crucial contributions to health, food preservation, and beyond. Furthermore, an in-depth analysis of the antioxidant properties of Turkish plant extracts is presented, detailing their constituent components, the solvents utilized for extraction, and the methodologies applied in antioxidant research.</div></div>","PeriodicalId":100822,"journal":{"name":"Journal of Pharmaceutical and Biomedical Analysis Open","volume":"6 ","pages":"Article 100091"},"PeriodicalIF":0.0,"publicationDate":"2025-09-20","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145157521","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2025-09-16DOI: 10.1016/j.jpbao.2025.100089
Erika Maria Ricci , Miryam Perrucci , Marcello Locatelli , Imran Ali , Halil I. Ulusoy , Abuzar Kabir , Fotouh R. Mansour
Growing concerns over environmental pollution have led to increased emphasis on Green Chemistry and, more specifically, Green Analytical Chemistry (GAC). These frameworks advocate for the reduction of hazardous substances, minimization of waste, and consideration of the entire life cycle of analytical procedures—from production to disposal. Within this context, miniaturized analytical techniques have emerged as sustainable and efficient alternatives to conventional methods. Among these, capillary liquid chromatography (cLC), nano-liquid chromatography (nano-LC), and various modes of capillary electrophoresis (CE)—including micellar electrokinetic chromatography (MEKC), capillary isotachophoresis (CITP), capillary zone electrophoresis (CZE), capillary isoelectric focusing (CIEF), and capillary gel electrophoresis (CGE) have gained significant traction. Their advantages in terms of reduced solvent and sample consumption, enhanced resolution, and faster analysis times have made them particularly valuable in pharmaceutical and biomedical applications. One critical application area is the chiral separation of active pharmaceutical ingredients (APIs), which is increasingly vital in biotechnology, chemistry, agriculture, and especially the pharmaceutical industry. Electrokinetic chromatography (EKC) has proven to be an effective and versatile technique for this purpose, offering high resolution, flexibility, speed, and cost-efficiency. The growing availability of novel chiral selectors further enhances its appeal for the separation of enantiomeric drug compounds. This review provides an overview of recent advancements in miniaturized analytical techniques and highlights their applications in the biomedical and pharmaceutical sectors, with a particular focus on chiral separations using EKC.
{"title":"Miniaturization in action: High-resolution, low-cost analytical platforms for biomedical and pharmaceutical research","authors":"Erika Maria Ricci , Miryam Perrucci , Marcello Locatelli , Imran Ali , Halil I. Ulusoy , Abuzar Kabir , Fotouh R. Mansour","doi":"10.1016/j.jpbao.2025.100089","DOIUrl":"10.1016/j.jpbao.2025.100089","url":null,"abstract":"<div><div>Growing concerns over environmental pollution have led to increased emphasis on Green Chemistry and, more specifically, Green Analytical Chemistry (GAC). These frameworks advocate for the reduction of hazardous substances, minimization of waste, and consideration of the entire life cycle of analytical procedures—from production to disposal. Within this context, miniaturized analytical techniques have emerged as sustainable and efficient alternatives to conventional methods. Among these, capillary liquid chromatography (cLC), nano-liquid chromatography (nano-LC), and various modes of capillary electrophoresis (CE)—including micellar electrokinetic chromatography (MEKC), capillary isotachophoresis (CITP), capillary zone electrophoresis (CZE), capillary isoelectric focusing (CIEF), and capillary gel electrophoresis (CGE) have gained significant traction. Their advantages in terms of reduced solvent and sample consumption, enhanced resolution, and faster analysis times have made them particularly valuable in pharmaceutical and biomedical applications. One critical application area is the chiral separation of active pharmaceutical ingredients (APIs), which is increasingly vital in biotechnology, chemistry, agriculture, and especially the pharmaceutical industry. Electrokinetic chromatography (EKC) has proven to be an effective and versatile technique for this purpose, offering high resolution, flexibility, speed, and cost-efficiency. The growing availability of novel chiral selectors further enhances its appeal for the separation of enantiomeric drug compounds. This review provides an overview of recent advancements in miniaturized analytical techniques and highlights their applications in the biomedical and pharmaceutical sectors, with a particular focus on chiral separations using EKC.</div></div>","PeriodicalId":100822,"journal":{"name":"Journal of Pharmaceutical and Biomedical Analysis Open","volume":"6 ","pages":"Article 100089"},"PeriodicalIF":0.0,"publicationDate":"2025-09-16","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145104307","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2025-09-15DOI: 10.1016/j.jpbao.2025.100090
Wenning Zhu , Xinyu Liu , Yaping Zhao , Jingwei Wang , Xuwen Zhang , Chenxi Liu
Albendazole (ABZ) exists as two solid-state isomers: the amino form (Form I) and the imino form (Form II). While Form II significantly influences bioavailability, current analytical methods primarily focus on qualitative identification of polymorphs or quantify only Form I in raw materials. To address the lack of quantitative methods for both isomers in formulations, we developed a novel near-infrared (NIR) spectroscopy–based approach. This work established a validated quantitative model. ABZ Form II was prepared and characterized via X–ray diffraction, thermal analysis, and Raman imaging. Commercial albendazole tablets were simulated by spiking Form II into excipients at gradient concentrations (5–95 % w/w). The near-infrared (NIR) spectra were screened with preprocessing methods and wavenumber regions. A Factor was set that included the comprehensive determination coefficient (R2), root mean square error of cross validation (RMSECV), Bias and relative percentage deviation (RPD). Models with a Factor score < 0.5 or recovery rates outside 90–110 % were excluded. The method demonstrated high precision (RSD = 0.07 %), with LOD and LOQ values of 0.7840 ± 0.0028 % w/w and 3.0243 ± 0.0139 % w/w, respectively. In summary, this is the first reported NIR method for simultaneous quantification of ABZ Form I and Form II in tablets, providing a rapid, non–destructive tool for pharmaceutical quality control
{"title":"Quantitative analysis of Form II in albendazole formulations using near-infrared spectroscopy and partial least squares analysis","authors":"Wenning Zhu , Xinyu Liu , Yaping Zhao , Jingwei Wang , Xuwen Zhang , Chenxi Liu","doi":"10.1016/j.jpbao.2025.100090","DOIUrl":"10.1016/j.jpbao.2025.100090","url":null,"abstract":"<div><div>Albendazole (ABZ) exists as two solid-state isomers: the amino form (Form I) and the imino form (Form II). While Form II significantly influences bioavailability, current analytical methods primarily focus on qualitative identification of polymorphs or quantify only Form I in raw materials. To address the lack of quantitative methods for both isomers in formulations, we developed a novel near-infrared (NIR) spectroscopy–based approach. This work established a validated quantitative model. ABZ Form II was prepared and characterized via X–ray diffraction, thermal analysis, and Raman imaging. Commercial albendazole tablets were simulated by spiking Form II into excipients at gradient concentrations (5–95 % w/w). The near-infrared (NIR) spectra were screened with preprocessing methods and wavenumber regions. A Factor was set that included the comprehensive determination coefficient (R<sup>2</sup>), root mean square error of cross validation (RMSECV), Bias and relative percentage deviation (RPD). Models with a Factor score < 0.5 or recovery rates outside 90–110 % were excluded. The method demonstrated high precision (RSD = 0.07 %), with LOD and LOQ values of 0.7840 ± 0.0028 % w/w and 3.0243 ± 0.0139 % w/w, respectively. In summary, this is the first reported NIR method for simultaneous quantification of ABZ Form I and Form II in tablets, providing a rapid, non–destructive tool for pharmaceutical quality control</div></div>","PeriodicalId":100822,"journal":{"name":"Journal of Pharmaceutical and Biomedical Analysis Open","volume":"6 ","pages":"Article 100090"},"PeriodicalIF":0.0,"publicationDate":"2025-09-15","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145104304","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Biosensors utilising nanotechnology are advancing swiftly and are extensively employed across various domains, including biomedicine, environmental monitoring, and analytical chemistry, where they have attained significant roles. Novel nanomaterials are being extensively designed and produced for prospective biosensing and theranostic uses. This review provides a comprehensive analysis of relevant literature from the past ten years, focusing on the use of nanoparticles in this context. The amalgamation of diagnostic biosensors with drug delivery systems for the administration of therapeutic agents presents significant potential in next-generation theranostic platforms. The controllable, precise, and safe delivery of diagnostic biosensing devices and therapeutic drugs to target tissues, organs, or cells is a crucial factor in the development of improved nanobiosensor-based theranostic systems. Recently, the utilisation of natural biological carriers in drug delivery systems has become one of the most extensively studied research issues. Erythrocytes, or red blood cells, may serve as carriers for a diverse array of pharmaceuticals, encompassing anticancer, antibacterial, antiviral, and anti-inflammatory agents, as well as numerous proteins, peptides, enzymes, and other macromolecules. Red blood cell (RBC)-based nanocarrier systems, known as erythrocyte nanovesicles, exhibit remarkable characteristics including prolonged circulation times, evasion of the immune system, gradual drug release, protection of drugs and biosensors from endogenous factors, targeted delivery, and applications in both therapeutic and diagnostic domains within biomedical sciences. Erythrocytes, the most prevalent circulating blood cells, have been thoroughly studied for biomimetic coatings on artificial nanocarriers owing to their enhanced biocompatibility, biodegradability, non-immunogenicity, and prolonged circulation in the bloodstream. Consequently, erythrocyte nanovehicles (ENV) has many applications, including drug transport, imaging, phototherapy, immunomodulation, sensing, and detection, which indicate substantial promise for therapeutic and diagnostic uses in various disorders. This paper covers recent advancements in the biomedical uses of ENV in cancer, infections, cardiovascular issues, and several other associated ailments particularly for biosensing. This paper also presents the RBC-mediated transport of nanobiosensors for bio-imaging at the single-cell level, enhanced medical diagnostics, and the analytical detection of biomolecules and cellular activity.
{"title":"Erythrocyte-derived nanosystems for biosensing: A green approach for analysis","authors":"Shivam Rajput , Rishabha Malviya , Sathvik Belagodu Sridhar , Tarun Wadhwa , Javedh Shareef","doi":"10.1016/j.jpbao.2025.100088","DOIUrl":"10.1016/j.jpbao.2025.100088","url":null,"abstract":"<div><div>Biosensors utilising nanotechnology are advancing swiftly and are extensively employed across various domains, including biomedicine, environmental monitoring, and analytical chemistry, where they have attained significant roles. Novel nanomaterials are being extensively designed and produced for prospective biosensing and theranostic uses. This review provides a comprehensive analysis of relevant literature from the past ten years, focusing on the use of nanoparticles in this context. The amalgamation of diagnostic biosensors with drug delivery systems for the administration of therapeutic agents presents significant potential in next-generation theranostic platforms. The controllable, precise, and safe delivery of diagnostic biosensing devices and therapeutic drugs to target tissues, organs, or cells is a crucial factor in the development of improved nanobiosensor-based theranostic systems. Recently, the utilisation of natural biological carriers in drug delivery systems has become one of the most extensively studied research issues. Erythrocytes, or red blood cells, may serve as carriers for a diverse array of pharmaceuticals, encompassing anticancer, antibacterial, antiviral, and anti-inflammatory agents, as well as numerous proteins, peptides, enzymes, and other macromolecules. Red blood cell (RBC)-based nanocarrier systems, known as erythrocyte nanovesicles, exhibit remarkable characteristics including prolonged circulation times, evasion of the immune system, gradual drug release, protection of drugs and biosensors from endogenous factors, targeted delivery, and applications in both therapeutic and diagnostic domains within biomedical sciences. Erythrocytes, the most prevalent circulating blood cells, have been thoroughly studied for biomimetic coatings on artificial nanocarriers owing to their enhanced biocompatibility, biodegradability, non-immunogenicity, and prolonged circulation in the bloodstream. Consequently, erythrocyte nanovehicles (ENV) has many applications, including drug transport, imaging, phototherapy, immunomodulation, sensing, and detection, which indicate substantial promise for therapeutic and diagnostic uses in various disorders. This paper covers recent advancements in the biomedical uses of ENV in cancer, infections, cardiovascular issues, and several other associated ailments particularly for biosensing. This paper also presents the RBC-mediated transport of nanobiosensors for bio-imaging at the single-cell level, enhanced medical diagnostics, and the analytical detection of biomolecules and cellular activity.</div></div>","PeriodicalId":100822,"journal":{"name":"Journal of Pharmaceutical and Biomedical Analysis Open","volume":"6 ","pages":"Article 100088"},"PeriodicalIF":0.0,"publicationDate":"2025-08-14","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144841093","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
A robust and sensitive ultra-performance liquid chromatography (UPLC) method was developed and rigorously validated for the simultaneous quantification of rizatriptan, meloxicam, and their corresponding N-nitrosamine impurities in pharmaceutical dosage forms. Method development and optimization were conducted using a Box–Behnken Design to systematically investigate the effects of acetonitrile proportion, mobile phase flow rate, and pH on critical chromatographic responses, including retention time and tailing factor. Optimal separation was achieved with a mobile phase comprising 30 % v/v acetonitrile, a flow rate of 0.2 mL/min, and a pH of 2.5, resulting in well-resolved, symmetrical peaks. Validation performed in accordance with ICH guidelines confirmed excellent linearity (R² > 0.999) over the tested concentration ranges, low limits of detection (0.47–1.39 µg/mL), high precision (%RSD <2 %), and satisfactory accuracy (98–102 % recoveries). The method demonstrated robustness under deliberate minor variations of chromatographic parameters and maintained specificity by effectively resolving target analytes from degradation products during forced degradation studies. Sustainability and environmental impact were comprehensively assessed using ComplexGAPI, AGREE, AGREEprep, Analytical Eco-Scale, and Blue Applicability Grade Index metrics, all indicating high greenness and operational suitability. Application of the method to the commercial combination product Symbravo confirmed its capability for accurate quantification of active pharmaceutical ingredients and low-level nitrosamine impurities. Collectively, these findings underscore the method’s suitability for routine quality control, impurity profiling, and regulatory compliance in modern pharmaceutical analysis.
{"title":"A stability-indicating and environmentally sustainable UPLC method for simultaneous determination of rizatriptan, meloxicam, and related N-nitrosamine impurities","authors":"KiranKumar Chagarlamudi , Venkata Kanaka Srivani Maddala , Kumaraswamy Gandla","doi":"10.1016/j.jpbao.2025.100087","DOIUrl":"10.1016/j.jpbao.2025.100087","url":null,"abstract":"<div><div>A robust and sensitive ultra-performance liquid chromatography (UPLC) method was developed and rigorously validated for the simultaneous quantification of rizatriptan, meloxicam, and their corresponding N-nitrosamine impurities in pharmaceutical dosage forms. Method development and optimization were conducted using a Box–Behnken Design to systematically investigate the effects of acetonitrile proportion, mobile phase flow rate, and pH on critical chromatographic responses, including retention time and tailing factor. Optimal separation was achieved with a mobile phase comprising 30 % v/v acetonitrile, a flow rate of 0.2 mL/min, and a pH of 2.5, resulting in well-resolved, symmetrical peaks. Validation performed in accordance with ICH guidelines confirmed excellent linearity (R² > 0.999) over the tested concentration ranges, low limits of detection (0.47–1.39 µg/mL), high precision (%RSD <2 %), and satisfactory accuracy (98–102 % recoveries). The method demonstrated robustness under deliberate minor variations of chromatographic parameters and maintained specificity by effectively resolving target analytes from degradation products during forced degradation studies. Sustainability and environmental impact were comprehensively assessed using ComplexGAPI, AGREE, AGREEprep, Analytical Eco-Scale, and Blue Applicability Grade Index metrics, all indicating high greenness and operational suitability. Application of the method to the commercial combination product Symbravo confirmed its capability for accurate quantification of active pharmaceutical ingredients and low-level nitrosamine impurities. Collectively, these findings underscore the method’s suitability for routine quality control, impurity profiling, and regulatory compliance in modern pharmaceutical analysis.</div></div>","PeriodicalId":100822,"journal":{"name":"Journal of Pharmaceutical and Biomedical Analysis Open","volume":"6 ","pages":"Article 100087"},"PeriodicalIF":0.0,"publicationDate":"2025-08-10","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144841092","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
This study presents a detailed forced degradation profiling of lumateperone under stress conditions to develop a stability-indicating method capable of separating degradation products (DP-1 to DP-11), followed by their identification and characterization using hyphenated analytical techniques. Significant degradation was observed under oxidative, acidic, alkaline, and photolytic conditions. Oxidative stress generated an intensely colored quinone derivative (DP-2) as a major degradation product along with DP-3, DP-4, and DP-6. Alkaline hydrolysis yielded N-dealkylated and hydroxylated species (DP-1, DP-4, DP-5) and also produced a volatile degradation product, DP-7. Photolytic stress resulted in DP-2 and DP-8, whereas neutral hydrolysis led to the formation of DP-1, DP-2, DP-4, and DP-7. Notably, acidic hydrolysis in hydrochloric acid triggered dimer degradation product (DP-9) and chlorinated positional isomers of lumateperone (DP-10 and DP-11). The chemical structures of DP-1 to DP-6 and DP-8 to DP-11 were proposed by liquid chromatography-high-resolution mass spectrometry (LC-HRMS). DP-7 was identified as 1-(4-Fluorophenyl)ethanol using gas chromatography-mass spectrometry (GC–MS). The major degradation product, DP-2, was isolated and further characterized by nuclear magnetic resonance (NMR). A few DPs shared structural features with previously reported metabolites, suggesting a resemblance between chemical degradation and metabolic processes. The developed method was validated in accordance with ICH Q2(R1), demonstrating excellent linearity (r² > 0.999), accuracy, precision, specificity, and robustness. In silico toxicity analysis using ADMET Predictor® flagged four DPs (DP-1, DP-2, DP-5, and DP-6) with mutagenic alerts and predicted additional hepatotoxic, cardiotoxic, and receptor-mediated risks.These findings support formulation and quality management of lumateperone.
{"title":"Identification and characterization of forced degradation products of lumateperone tosylate by LC-HRMS, GC-MS, NMR, and in silico toxicity prediction","authors":"Nehal Bhatt , Devendra Sonaje , Vijiaya Madhyanapu Golla , Rahul Khemchandani , Roshitha K. R , Arun Kumar Gupta , Gananadhamu Samanthula","doi":"10.1016/j.jpbao.2025.100085","DOIUrl":"10.1016/j.jpbao.2025.100085","url":null,"abstract":"<div><div>This study presents a detailed forced degradation profiling of lumateperone under stress conditions to develop a stability-indicating method capable of separating degradation products (DP-1 to DP-11), followed by their identification and characterization using hyphenated analytical techniques. Significant degradation was observed under oxidative, acidic, alkaline, and photolytic conditions. Oxidative stress generated an intensely colored quinone derivative (DP-2) as a major degradation product along with DP-3, DP-4, and DP-6. Alkaline hydrolysis yielded N-dealkylated and hydroxylated species (DP-1, DP-4, DP-5) and also produced a volatile degradation product, DP-7. Photolytic stress resulted in DP-2 and DP-8, whereas neutral hydrolysis led to the formation of DP-1, DP-2, DP-4, and DP-7. Notably, acidic hydrolysis in hydrochloric acid triggered dimer degradation product (DP-9) and chlorinated positional isomers of lumateperone (DP-10 and DP-11). The chemical structures of DP-1 to DP-6 and DP-8 to DP-11 were proposed by liquid chromatography-high-resolution mass spectrometry (LC-HRMS). DP-7 was identified as 1-(4-Fluorophenyl)ethanol using gas chromatography-mass spectrometry (GC–MS). The major degradation product, DP-2, was isolated and further characterized by nuclear magnetic resonance (NMR). A few DPs shared structural features with previously reported metabolites, suggesting a resemblance between chemical degradation and metabolic processes. The developed method was validated in accordance with ICH Q2(R1), demonstrating excellent linearity (r² > 0.999), accuracy, precision, specificity, and robustness. <em>In silico</em> toxicity analysis using ADMET Predictor® flagged four DPs (DP-1, DP-2, DP-5, and DP-6) with mutagenic alerts and predicted additional hepatotoxic, cardiotoxic, and receptor-mediated risks.These findings support formulation and quality management of lumateperone.</div></div>","PeriodicalId":100822,"journal":{"name":"Journal of Pharmaceutical and Biomedical Analysis Open","volume":"6 ","pages":"Article 100085"},"PeriodicalIF":0.0,"publicationDate":"2025-08-04","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144771384","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2025-07-22DOI: 10.1016/j.jpbao.2025.100081
Almir Custodio Batista Junior, Yuri Arrates Rocha, Andrea Rodrigues Chaves
N-Nitrosamines (NAs) are classified as potent mutagenic impurities, raising substantial concerns due to their presence in various consumer products, including pharmaceuticals products. The detection of NAs in valsartan-containing medicines in 2018 led regulatory agencies to establish strict guidelines for permissible levels in drug formulations. The standard-gold analytical techniques for NAs determination have been chromatographic techniques (liquid and gas chromatography) coupled with mass spectrometry system, which present higher sensibility and accuracy for target NAs. However, accurate determination of NAs in medicines remains challenging due to their trace-level concentrations and susceptibility to matrix effects, carryover, and contamination of the analytical instrumentation, emphasizing the need for robust sample preparation strategies. Traditional sample preparation methods, although effective, often involve high consumption of solvents, samples, and extraction phases, along with substantial waste generation. In response, miniaturized sample preparation techniques have emerged as sustainable alternatives, offering reduced solvent usage, minimal sample requirements, and lower energy consumption, all while maintaining analytical performance. These green approaches not only align with sustainable analytical practices but also enhance efficiency and environmental compliance in pharmaceutical analysis. This review provides a comprehensive overview of recent advancements in miniaturized sample preparation strategies for the determination of NAs in pharmaceutical products, highlighting their analytical merits and potential for regulatory adoption.
n -亚硝胺（na）被归类为强致突变杂质，由于其存在于各种消费品中，包括药品，引起了极大的关注。2018年在含有缬沙坦的药物中检测到NAs，导致监管机构制定了严格的药物配方允许含量指导方针。测定NAs的标准金分析技术是色谱技术（液相和气相色谱）与质谱联用技术，对目标NAs具有较高的灵敏度和准确性。然而，药物中NAs的准确测定仍然具有挑战性，因为它们的痕量浓度和对基质效应、携带和分析仪器污染的敏感性，强调需要可靠的样品制备策略。传统的样品制备方法虽然有效，但往往涉及高溶剂，样品和提取相的消耗，以及大量的废物产生。因此，小型化样品制备技术已经成为可持续的替代方案，提供了更少的溶剂使用，最小的样品要求，更低的能源消耗，同时保持分析性能。这些绿色方法不仅与可持续分析实践相一致，而且还提高了药物分析的效率和环境合规性。本文综述了用于测定药品中NAs的小型化样品制备策略的最新进展，强调了它们的分析优点和监管采用的潜力。
{"title":"Miniaturized sample preparation strategies for the determination of N-nitrosamines in pharmaceutical products: A comprehensive review","authors":"Almir Custodio Batista Junior, Yuri Arrates Rocha, Andrea Rodrigues Chaves","doi":"10.1016/j.jpbao.2025.100081","DOIUrl":"10.1016/j.jpbao.2025.100081","url":null,"abstract":"<div><div>N-Nitrosamines (NAs) are classified as potent mutagenic impurities, raising substantial concerns due to their presence in various consumer products, including pharmaceuticals products. The detection of NAs in valsartan-containing medicines in 2018 led regulatory agencies to establish strict guidelines for permissible levels in drug formulations. The standard-gold analytical techniques for NAs determination have been chromatographic techniques (liquid and gas chromatography) coupled with mass spectrometry system, which present higher sensibility and accuracy for target NAs. However, accurate determination of NAs in medicines remains challenging due to their trace-level concentrations and susceptibility to matrix effects, carryover, and contamination of the analytical instrumentation, emphasizing the need for robust sample preparation strategies. Traditional sample preparation methods, although effective, often involve high consumption of solvents, samples, and extraction phases, along with substantial waste generation. In response, miniaturized sample preparation techniques have emerged as sustainable alternatives, offering reduced solvent usage, minimal sample requirements, and lower energy consumption, all while maintaining analytical performance. These green approaches not only align with sustainable analytical practices but also enhance efficiency and environmental compliance in pharmaceutical analysis. This review provides a comprehensive overview of recent advancements in miniaturized sample preparation strategies for the determination of NAs in pharmaceutical products, highlighting their analytical merits and potential for regulatory adoption.</div></div>","PeriodicalId":100822,"journal":{"name":"Journal of Pharmaceutical and Biomedical Analysis Open","volume":"6 ","pages":"Article 100081"},"PeriodicalIF":0.0,"publicationDate":"2025-07-22","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144704536","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
扫码关注我们
求助内容：
应助结果提醒方式：
京公网安备 11010802042870号