Search Results (1,423)

Background/Objectives: Semaglutide, a long-acting glucagon-like peptide-1 (GLP-1) analog for type 2 diabetes and obesity, requires sensitive and high-throughput bioanalytical methods to support pharmacokinetic studies. However, previously reported liquid chromatography–tandem mass spectrometry (LC–MS/MS) assays have been limited by lengthy run times (~18 min) and suboptimal sensitivity. This study aimed to develop and validate a rapid, sensitive LC–MS/MS method for quantifying semaglutide in plasma. Methods: Plasma samples (50 μL) were prepared by acetone-mediated protein precipitation followed by solid-phase extraction. Chromatographic separation was performed on a Cadenza CD-C18 MF column within 9 min, using positive electrospray ionization in multiple reaction monitoring mode with the transitions m/z 1029.4 → 110.1 for semaglutide and m/z 938.9 → 109.9 for liraglutide (internal standard). Validation followed the U.S. Food and Drug Administration (FDA) bioanalytical guidelines. Results: The assay showed a lower limit of quantification of 1 ng/mL with linearity across 1–500 ng/mL (R² = 0.9999), with sharp peak shape and no carryover. Intra- and inter-day accuracies were 95.69–103.76% and 94.93–100.08%, with precision ≤4.50% and ≤5.88%. Recovery (93.05–107.95%) and matrix effects (96.34–104.12%) were consistent across quality control levels, and the analyte was stable under all tested conditions. The method was successfully applied to a pharmacokinetic study in Sprague–Dawley rats following subcutaneous administration of 50 μg semaglutide. Conclusions: The validated method offers shorter analysis time, improved sensitivity, and reduced sample volume compared with previously reported assays, supporting its application in preclinical pharmacokinetic studies of semaglutide and related GLP-1 analogs. Full article

Doxorubicin (DOX) is a potent chemotherapeutic drug, whose clinical application is largely restricted by dose-dependent cardiotoxicity (DIC). Dracocephalum moldavica L. is a classic medicinal and edible plant with obvious cardiovascular protective effects; however, the role of its total flavonoids (TFDM) in DIC remains unclear. This study explored the cardioprotective effect of TFDM on DOX-induced myocardial injury and its mechanism related to mitochondrial quality control. We established in vivo and in vitro DIC models and adopted echocardiography, detection of cardiac injury and oxidative stress indicators, transmission electron microscopy, mitochondrial functional assessment and Western blotting, with AMPK knockdown performed for mechanism verification. Results showed that TFDM effectively improved cardiac function, reduced myocardial oxidative stress and apoptosis, and maintained mitochondrial ultrastructure and energy metabolism. TFDM activated the AMPK/PGC1α signaling axis to facilitate mitochondrial biogenesis, and AMPK silencing eliminated the protective effect of TFDM. In conclusion, AMPK/PGC-1α pathway is a primary key pathway involved in TFDM’s protective effects, which provides an experimental basis for the development of Dracocephalum moldavica L. as a functional food and adjuvant agent against DIC. Full article

Transferosomes are liposome-derived ultradeformable vesicles designed to improve drug delivery across restrictive biological barriers, particularly in non-invasive administration routes. Their structure is based on phospholipid bilayers modified with edge activators, usually surfactants or bile salts, which increase membrane flexibility while preserving vesicular organization. This balance between deformability and stability distinguishes transferosomes from conventional liposomes and has supported their use in dermal, transdermal, ocular, nasal, buccal, and other mucosal delivery systems. However, despite extensive experimental interest, the field remains limited by inconsistent terminology, heterogeneous formulation strategies, non-harmonized deformability assays, and incomplete translation from laboratory formulations to clinically relevant products. This review critically examines transferosomes from a formulation-development perspective, focusing on the relationship between lipid composition, edge-activator selection, vesicle properties, deformability, drug release, and biological performance. Particular attention is given to critical quality attributes, analytical characterization, mechanistic interpretations of barrier interaction, and the unresolved debate between intact vesicle penetration, drug-release-dominated delivery, and barrier perturbation. Transferosomes are also positioned in comparison with conventional liposomes, ethosomes, and transethosomes. Finally, the review identifies key unmet needs related to standardization, reproducibility, scalability, storage stability, and regulatory uncertainty. By integrating formulation design with mechanistic and translational analysis, this review aims to clarify when transferosomes offer a genuine delivery advantage and which parameters must be controlled to support their further pharmaceutical development. Full article

Antimicrobial resistance and biofilm-associated contamination continue to pose critical challenges in food safety and biomedical applications, necessitating the development of advanced antimicrobial materials with enhanced efficacy, safety, and functional adaptability. Antimicrobial nanomaterials offer versatile solutions due to their tunable physicochemical properties, surface engineering capabilities, and controlled release behaviors, enabling improved antimicrobial and antibiofilm performance across diverse systems. This review highlights the main advancements in AI-assisted design of antimicrobial nanomaterials, demonstrating how data-driven approaches are increasingly used to predict antimicrobial activity, optimize synthesis parameters, model nanotoxicity, integrate multimodal datasets, and improve interpretability through explainable AI frameworks. Key findings indicate that machine learning-guided strategies and autonomous experimental platforms significantly accelerate material optimization while reducing reliance on traditional trial-and-error methods. The review further summarizes the performance and mechanisms of major antimicrobial nanomaterial systems, including metal and metal oxide nanoparticles, metal–organic frameworks, polymeric nanocarriers, nanoemulsions, and hybrid nanostructures, with emphasis on their translational applications in food preservation, antimicrobial coatings, wound healing, implant protection, and drug delivery. Despite these advances, challenges remain in data quality, model generalizability, toxicity prediction, reproducibility, and regulatory translation. AI-enabled and data-driven frameworks provide a powerful pathway for accelerating the rational design and practical implementation of next-generation antimicrobial nanomaterials. Full article

Polyhydroxyalkanoates (PHAs) are bio-based, biodegradable polyesters increasingly explored as sustainable biomaterials for regenerative medicine. This review summarizes recent advances in PHA-based bone substitute materials, highlighting their properties, fabrication methods, and biological performance. PHAs combine biocompatibility, tunable mechanical behavior, and degradation into non-toxic metabolites, while copolymerization and monomer selection modulate the stiffness, crystallinity, and resorption rate. Processing techniques such as solvent casting, electrospinning, and additive manufacturing allow the production of porous architectures that mimic bone extracellular matrix. Electrospinning is particularly suitable for nanoscale fibrous matrices, whereas 3D printing enables patient-specific scaffolds with controlled geometry and interconnected porosity. Scaffold performance can be further improved through the incorporation of osteoconductive fillers, including hydroxyapatite, β-tricalcium phosphate, bioactive glasses, graphene oxide, and carbon nanotubes, as well as through drug-delivery and pro-angiogenic functionalization. In vitro and in vivo studies consistently report favorable cytocompatibility, enhanced osteogenic differentiation, vascularization, and effective repair of bone defects in animal models. However, clinical translation remains limited by production costs, variability in polymer quality, thermal processing constraints, and regulatory challenges. Future progress will rely on more efficient biosynthesis, medical-grade purification, multifunctional scaffold design, and stronger collaboration between academia, industry, and clinicians to unlock the full potential of PHAs in regenerative bone therapies. Full article

Background: Conventional drug delivery systems often lead to fluctuating plasma concentrations (“Peak and Trough” phenomenon), causing toxicity or inefficacy. Microfluidics has emerged as a revolutionary tool to overcome, among other applications, the limitations of conventional bulk encapsulation methods, such as polydispersity and poor reproducibility. Methods: A systematic review of the literature published between 2020 and 2025 was conducted to evaluate the application of microfluidics in the synthesis of advanced nanomedicines. The review focused on Lipid Nanoparticles (LNPs), Polymeric Nanoparticles (PNPs), and Hydrogel Microspheres. Results: Microfluidics enables the production of monodisperse particles with precise control over geometry and drug loading stoichiometry. Key therapeutic applications include oncology (passive and active targeting), gene therapy (mRNA vaccines), and regenerative medicine (diabetic wound healing). Conclusions: While microfluidics offers superior quality control compared to bulk methods, industrial scalability remains the primary challenge, currently addressed through parallelization and continuous flow strategies. Full article

Background. Newborn ruminants are born agammaglobulinemic, and colostrum quality (IgG concentration) is often insufficient, especially in heifers, leading to high morbidity and mortality from diarrheal infections. Objective. To develop and evaluate colostrum enrichment with specific egg yolk immunoglobulins (IgY) for the prevention of diarrhea in newborn calves. Methods. Hens were hyperimmunized with an inactivated vaccine against rotavirus, coronavirus, and E. coli. Yolk melange was prepared. Total and specific IgY were measured by chromatography and ELISA. Trials were conducted in three farms with high diarrhea incidence: experimental calves (n = 25) received 100 mL of melange (5 yolks) with the first two colostrum feedings; controls (n = 25) received native colostrum. Results. One yolk contained up to 100 mg of polyclonal IgY, with 8% specific antibodies. Diarrhea occurred in 12% of experimental calves (mild, no drugs) vs. 76% in controls (24% required antibiotics/rehydration). Testing in two other farms (n = 42, n = 38) reduced incidence 5.2–6.8-fold compared to the previous period. Conclusions. Enriching colostrum with specific IgY from hyperimmunized hens is highly effective and affordable for preventing diarrheal infections in newborn calves, especially in herds with poor colostrum quality in heifers. Full article

Quantitative ¹H NMR (qNMR) is a versatile analytical tool that provides simultaneous structural and quantitative information without the need for analyte-specific standards. This review summarizes its key methodological fundamentals and broad applications in both pharmaceutical and biomedical analysis. In drug analysis, qNMR enables content determination and purity assessment of small molecules, polysaccharides and glycoconjugates, synthetic polymers, and complex herbal medicines. In biomedical analysis, it serves as a powerful platform for metabolomics profiling, real-time monitoring of cellular processes, and absolute quantification of metabolites in biofluids and tissues. Recent and emerging technological advancements, including hyperpolarization, quantum mechanical spectral analysis, artificial intelligence, and deep learning, hold great promise for further enhancing sensitivity, resolving power, and automation. With ongoing integration into pharmacopoeial standards and regulatory frameworks, qNMR is poised to expand its role in both routine quality control and cutting-edge biomedical research. Full article

Phase-inversion in situ implants (PIISIs) represent a versatile polymer platform in which the rational choice of matrix former and solvent system directly governs the macroscopic properties of the resulting depot. This study applied a Quality by Design (QbD) approach to rationalize a bleached shellac–based PIISI, with particular focus on the physicochemical interactions between the polymer and the injection vehicle. Bleached shellac—a natural, low-cost, biodegradable oligomeric resin bearing –COOH, –OH, and ester functional groups—was selected as the matrix former and screened in seven neat solvents and five 1:1 binary combinations at 25% (m/m). Twelve formulations were evaluated against a predefined set of critical quality attributes, including injectability, phase-inversion kinetics, solvent diffusion volume, and implant structure (n = 5 per formulation; mean ± standard deviation (SD); one-way analysis of variance (ANOVA) with Tukey’s post hoc test, p < 0.05). Three lead solvent systems—propylene glycol/N-methylpyrrolidone (PG+NMP), PG/dimethyl sulfoxide (PG+DMSO), and DMSO/benzyl alcohol (DMSO+BA)—were identified as those providing an optimal balance between hydrogen-bond donor/acceptor solvation and controlled solvent extraction. In the second stage, shellac concentration (20–35%) was optimized, with 30% shellac in PG+NMP yielding the fastest phase inversion (~50 s), a structurally uniform matrix, and the lowest swelling (22%). A working mechanistic framework consistent with all observed critical quality attribute (CQA) trends in which solvent hydrogen-bond donor/acceptor balance and water miscibility govern implant architecture is proposed, and it is intended as a hypothesis-generating basis for the rational design of PIISI formulations; direct validation by spectroscopic, thermal-analytical, and biological methods is identified as the next step. The developed formulations are presented as a preliminary physicochemical platform; biological validation (in vitro cytocompatibility and inflammatory response assessment) is required before the system can be considered a validated formulation for dental drug delivery. Full article

Edible insects have emerged as a promising alternative to conventional livestock as the global demand for sustainable protein sources rises. Ensuring the safety of insect-based foods is crucial for consumer acceptance and regulatory approval. This review provides a comprehensive overview of the primary chemical and microbiological contaminants associated with edible insects, including heavy metals, pesticides, veterinary drugs, persistent organic pollutants (POPs), mycotoxins, microbiological hazards, and allergenic risks. Current evidence indicates that, when insects are farmed and processed under controlled conditions and in compliance with existing European Union regulations, contaminant levels are generally low and within the range of those found in traditional animal-derived foods. Most studies report that current risks are primarily linked to substrate quality and storage practices. Allergenic risks, particularly cross-reactivity with crustacean and mite allergens, remain a crucial consideration for individuals with sensitivities. Despite these reassuring findings, knowledge gaps persist regarding insect-specific contaminant limits, the metabolic fate of toxins, and the long-term safety of consuming novel insect-derived products. Continued research, targeted monitoring, and regulatory adaptation will be essential to ensure the safe and sustainable integration of insect-based foods into the human diet. Full article

The first six contributions considered in this Editorial provide a coherent view of the modern laboratory as an integrated system of safety governance, digital education, measurement confidence, diagnostic implementation, and clinical quality assurance. The papers considered here address occupational hygiene and health monitoring in university laboratories, the predictive modeling of chemical exposure risks among cleaning staff, the design of an immersive virtual reality laboratory for multidisciplinary student experiences, the evolving concept of measurement uncertainty in accredited laboratories, the field implementation of a near point-of-care HIV drug-resistance assay in Kenya, and the optimization of embryo culture conditions in IVF laboratories. Although these studies span different fields, they converge on a common message: laboratory excellence depends not only on instruments and protocols but also on human factors, training, exposure control, usability, uncertainty management, and translation into real-world decisions. This Editorial synthesizes these contributions and identifies future priorities for Laboratories as a forum for interdisciplinary laboratory science and practice. Full article

We present the use of iOrganoAssay (images of Organoid Assay) to connect microscopy images with organoid assessment assays such as live–dead, immunocytochemistry, and drug treatment assays. The iOrganoAssay consists of an R script-based application (App) interface and datasets encompassing (1) microscopy images, (2) segmentation results, (3) morphometric data, (4) a metadata file, and (5) a validation dataset. The microscopy image collection includes 234 large-area images of intestinal organoids cultured in Matrigel dome region (~3 mm), acquired using an automated stage-equipped microscopy system. Upon treatment with dextran sulfate sodium (DSS), microscopy images of morphological changes in intestinal organoids were captured and quantified. Image segmentation was performed to extract organoid morphological data, including area, perimeter, and circularity. These metrics were plotted to visualize daily variations, enabling systematic tracking of drug-induced morphological changes over time. Statistical comparisons were also provided using violin plots. To evaluate segmentation quality, we established a validation dataset of 28 manually annotated organoids (14 control, 14 DSS-treated) and calculated Dice scores, accuracy (Acc), segmentation error (SegErr), and centroid error (CenErr). This integrated dataset—covering organoid images, segmentation outputs, morphometric data, and validation metrics—provides a resource for organoid image-based studies in morphological monitoring and segmentation validation. Full article

Long-acting injectables (LAIs) are widely used for chronic conditions such as schizophrenia, opioid use disorder, and HIV. Their prolonged efficacy improves adherence and reduces dosing frequency. Among these systems, poly(lactide-co-glycolide) (PLGA)-based formulations are commonly used to deliver drugs ranging from small molecules to peptides and proteins. In vitro release (IVR) tests play a critical role in evaluating drug product performance for both immediate- and prolonged-release dosage forms. However, there is a lack of standardized compendial IVR methods for the assessment of LAIs. This lack impedes the development of new drug products in this area and also complicates their regulatory approval process. Considering the complexity of drug release mechanisms and the diversity of various formulation design approaches, it is not possible to devise a universal IVR method that is applicable to all LAI products. The in vitro release test applied for quality control should be simple, robust, reproducible, and discriminatory. On the other hand, more complex biorelevant media and methods are often used during development to better reflect physiological conditions. This article provides a comprehensive review of compendial and non-compendial methods used for in vitro release testing of PLGA-based LAIs (microspheres and in situ forming implants), with the goal of aiding the development and standardization of future methodologies. Full article

Background/Objectives: Sedation is a fundamental component of gastrointestinal endoscopy, improving patient comfort, procedural quality, and overall satisfaction. However, traditional drug-centered sedation models are increasingly challenged by rising procedural volumes, aging populations, and limited anesthesiology resources. The aim of this narrative review is to provide an integrated overview of evolving pharmacological agents, monitoring strategies, organizational models, and future directions toward personalized, technology-supported sedation pathways. Methods: A structured literature search was conducted across PubMed/MEDLINE, Scopus, and Web of Science for studies published between January 2010 and December 2025. Relevant guidelines, randomized controlled trials, meta-analyses, and large observational studies were included. Evidence was synthesized qualitatively, emphasizing clinical applicability and real-world relevance. Results: Propofol remains the most widely used sedative agent due to its rapid onset and recovery profile, although its narrow therapeutic window and lack of antagonist limit its safety in high-risk patients. Emerging agents such as remimazolam and ciprofol demonstrate comparable efficacy with improved respiratory and hemodynamic safety profiles, particularly in elderly populations. Adjunctive strategies, including procedure-specific approaches such as spinal anesthesia, may further optimize sedation. Advanced monitoring tools, such as capnography, bispectral index, and high-flow nasal cannula, show potential in enhancing safety, especially in selected high-risk groups. Structured training programs and standardized discharge criteria are essential for ensuring quality and safety. Conclusions: Sedation in gastrointestinal endoscopy is transitioning from a standardized, drug-centered approach to a personalized, risk-adapted, and technology-supported model. Integration of novel pharmacological agents, advanced monitoring, and structured training will be key to improving patient safety, procedural efficiency, and healthcare sustainability. Full article

Antibody–drug conjugates (ADCs) are a pivotal technology for precision cancer therapy, harnessing the synergistic effects of antibody targeting and toxin delivery. However, traditional ADCs encounter limitations in efficacy that stem from tumor resistance, heterogeneity, and intense target competition. Dual-payload ADCs (DP-ADCs) represent a promising solution to these challenges, as they leverage dual mechanisms of action that mitigate acquired drug resistance and enhance adaptability to tumor heterogeneity. The complex structure of DP-ADCs presents substantial quality control hurdles. In this manuscript, we review the current payload selection and conjugation strategies of DP-ADCs and examine recent advances in quality control research. Specifically, we analyze the analytical challenges related to the quantification of free toxins, the determination of the total antibody content, and the characterization of the drug-to-antibody ratio and its distribution. Ultimately, the aim of this work is to provide valuable guidance for future DP-ADC quality control analyses to facilitate their clinical translation and application. Full article