Asymmetric Fe-N3C coordination in Fe single-atom sites boosts electrochemical activation of H2O2 for efficient •OH generation.

Adsorptive removal of pharmaceutical and personal care products by carbon nanotubes: Insights into the adsorbent pore size and adsorbate size

Navigating the complexities in characterization of NDSRIs using advanced analytical techniques.

Pelargonium sidoides - from ethnopharmacology to evidence-based medicine: a systematic review.

Tofacitinib citrate nanoemulgel induced repigmentation in vitiligo: Assessment of oxidative stress, protein, immunohistochemistry, and mRNA expressions.

AI-Driven nanofiber platforms for essential oil delivery in dry period cows: a sustainable strategy against mastitis and antimicrobial resistance.

Recent advances in toxicology, extraction, and analytical techniques for benzimidazole veterinary drug residues in food.

DPPH Rf-shift assay to overcome spectral interference: A rapid, portable TLC-based approach for semi-quantitative antioxidant evaluation.

Background: The safety, effectiveness, and quality of pharmaceutical products are guaranteed by Regulatory Affairs (RA). However, traditional regulatory systems have resource constraints, documentation burdens, and delays. Aim: Examine how RA functions can be re-engineered using artificial intelligence (AI), with an emphasis on education, innovation, and pharmaceutical ecosystem empowerment. Methods: Evaluation of AI-enabled tools for documentation, submissions, and pharmacovigilance, along with a qualitative and analytical study based on regulatory frameworks (FDA, EMA, CDSCO, ICH). Key Findings: Automation of regulatory documentation, predictive analysis, accelerated submissions, and improved compliance monitoring are all possible with AI. The Educate–Innovate–Empower model enhances datadriven decision-making, workflow redesign, and skill development. Conclusion: If AI is implemented with appropriate governance and competency training, it can greatly modernise international regulatory systems.

External Reference Pricing Policy of Pharmaceutical Products in Saudi Arabia: Policy Development and Methodological Considerations.

Whey protein isolate-based amphiphilic surfactin complexes: Structural, antioxidant, and interfacial properties, and molecular docking analysis.

Microbial fermentation is widely used in the production of food, pharmaceuticals, and bioenergy. Proper monitoring of the fermentation process is essential to ensure consistent product quality and yield. Although the indicators of fermentation progress vary among systems, they are generally evaluated by quantifying the major metabolites in the fermentation broth. However, these measurements rely on offline analyses involving time-consuming sampling and pretreatment, which hinder the real-time detection of process deviations. In this study, volatile organic compounds (VOCs) in the fermentation gas during beer fermentation were analyzed to develop a non-invasive method for the prediction of the current state of sugar, organic acid, and ethanol concentrations in the fermentation broth at each sampling point. VOCs emitted during fermentation serve as valuable indicators reflecting the metabolic state of the yeast. Beer brewing was adopted as a model system to validate VOC monitoring, because it involves sequential sugar consumption, organic acid and ethanol formation, and abundant VOC generation. We constructed multivariate regression models using the VOC profiles obtained from gas chromatography-mass spectrometry (GC-MS) analysis using Tenax TA. Parallel sampling of the fermentation gas and broth followed by orthogonal partial least squares (OPLS) regression yielded highly accurate models for predicting key fermentation indicators at corresponding time points. Furans and aldehydes abundant at early stages showed inverse correlations with higher alcohols and esters produced later, indicating distinct metabolic transitions. This study demonstrated the feasibility of applying VOC profiles for the quantitative prediction of the current fermentation progress and highlights the potential of this approach as a novel non-invasive monitoring method linking aroma chemistry and process control.

The development of rCHO cell lines that stably express therapeutic proteins is crucial for pharmaceutical protein industrial production. In this study, a systematic method was established to identify genomic hotspots for exogenous protein expression in CHO cells and construct stable recombinant CHO cell strains. Four stable monoclonal cell lines (1b7, 1d2, 2d9, and 2f7) were obtained by using the lentiviral random integration reporter gene. Chromosome mapping analysis found four stable integration sites: chr1_0 (7,30,83,299-7,32,45,508 bp) in 1b7, chr1_0 (17,69,68,187-17,69,68,191 bp) in 1d2, chr3 (4,08,81,262-4,08,99,858 bp) in 2d9, and chr5 (1,69,77,575-1,70,61,744 bp) in 2f7. Based on these sites, we developed recombinant CHO cells capable of long-term stable expression of foreign proteins through the combined application of CRISPR/Cas9 technology and Bxb1 recombinase-mediated cassette exchange. Utilizing "promoter capture technology", all screened LP cell monoclonal lines can express exogenous proteins, with the entire construction process completed in just 2∼3 weeks.

Pharmaceuticals and personal care products (PPCPs) are emerging as the major contaminants of great concern in the world water matrices due to their high numbers, distribution, and bioaccumulation possibilities. The review has examined around 80+ peer-reviewed articles (2014-2026) in the Web of Science, Scopus, and Google Scholar databases, based on the AOP-NBS synergy to pharmaceutical remediation. Systematic searches were done by using cluster of keywords such as advanced oxidation, nature-based solutions, emerging contaminants, and mineralization efficiency as the performance and sustainability of current hybrid treatments. The present review article, the existing and possible remediation techniques of the pharmaceutical waste water have been discussed. The study concludes that the conventional wastewater treatment plants (WWTPs) are far from efficient in eliminating complex active pharmaceutical ingredients (APIs). Consequently, the integration of advanced oxidation process (AOPs) and nature-based solution is a most essential requirement to attain superior removal efficiencies. An example is hybrid treatment wetlands that used local zeolite that has shown almost 100 percent (93.6-99.9) removal of various antibiotics such as ciprofloxacin and ofloxacin. On the other hand, some of the non-biodegradable compounds such as carbamazepine and diclofenac are observed to be resistant to most treatment regimens with their presence in some systems only clearing 1.1%. The research emphasizes the importance of the hybrid technologies- the combination of biological technologies with AOPs to enhance the biodegradability and the nearly total mineralization. Moreover, the shift to a so-called circular economy based on recovery of resources (up to 80 percent regarding certain materials) and application of the principles of Industry is determined as the important direction of the future. This article offers a strategic guideline in selecting treatment units depending on the nature of wastewater with the aim to reduce the adverse impact of PPCPs on aquatic organisms and human health.

Innovation in medical devices is essential for advancing patient care but has been undermined by inadequate evaluation and regulation. The UK vaginal mesh scandal exposed systemic flaws in medical device evaluation, where insufficient pre-market testing and ineffective post-market surveillance caused harm to countless women. Unlike pharmaceutical products, medical devices often enter clinical practice without robust evidence or long-term safety data. However, evaluation of devices can present methodological challenges, particularly when they are used during invasive procedures, given their multifaceted nature and contextual variables. Using the ASSIST study and the OdonAssist™ inflatable device for assisted vaginal birth as a case study, we wish to highlight these challenges and present a model for conducting feasibility studies of complex interventions. Early feasibility studies of the OdonAssist device demonstrated that although women accepted the innovation, the success rate of assisted vaginal birth was lower than anticipated. An embedded qualitative evaluation provided critical insights, revealing key factors influencing device use, design, and operator technique. The use of qualitative case study methodology allowed for systematic observation, stakeholder feedback, and iterative device refinement. For example, issues such as accidental activation of the deflation button were identified, leading to real-time design modifications in conjunction with industry partners. Stakeholder engagement-including patients, clinicians (doctors and midwives), ethics committees, and industry partners-was integral to optimising study design, device functionality, and training programmes. This collaborative, data-driven approach expedited the identification of modifications to device use, necessitating design changes and thereby ensuring device safety and usability. The evaluation of innovative devices like the OdonAssist requires a holistic approach that incorporates qualitative methodologies, stakeholder collaboration, and iterative feedback. Embedding case study research within feasibility trials ensures rapid identification of challenges, supports timely modifications, and fosters safer device implementation. Future research should explore video-recorded observations and enhanced patient feedback to refine device technique and training further.

Abstract Background and aims Ibogaine, one of the oldest psychedelic alkaloids introduced to Western society and medicine, has a largely overlooked history prior to Howard Lotsof's accidental identification of its anti-addictive properties in the 1960s. This manuscript explores some previously hidden aspects of ibogaine, with a focus on the entangled cultural, colonial, and scientific histories related to its early development from plant and ritual remedy to commercialized pharmaceutical before the 1960s. Methods The article is primarily based on a non-systematic literature review of various discoveries found in historical sources. In structuring the findings, we outline three main and somewhat overlapping phases of ibogaine's historical trajectory before the 1960s: i) the colonial appropriation and classification of ibogaine-containing plants from the Congo Basin during French colonial rule, ii) the isolation of ibogaine from the Tabernanthe iboga plant in 1900 and the early pharmaceutical research on its effects and uses, mainly in the French scientific community, and iii) the commodification of ibogaine in several pharmaceutical products and their international diffusion throughout the 20th century. Drawing on a historiographical approach rooted in postcolonial perspectives on colonial botany, biopiracy, and the intellectual property system, our analysis foregrounds the power-relations that have structured each of these three phases of ibogaine's early development, use, and commercialization as a pharmaceutical. Results Throughout this historical investigation, we present evidence that ibogaine was commercialized in several retail medicines beyond the well-known Lambarène . These included Dragées Nyrdahl, Grains des Anémiques, Syséros, Viris Lucet , Ibobiose , and Iperton . We further present discounted records documenting local uses of iboga in the Congo Basin, alongside early scientific publications on ibogaine, both of which served to guide and contextualize the medical research conducted during the early and mid-20th century. These findings complicate simplified narratives of the drug discovery of ibogaine, underscoring the critical role of indigenous medicinal knowledge in contributing to and shaping subsequent scientific understanding. Moreover, we identify evidence that ibogaine was first used in Mexico in 1913 for the treatment of a substance use disorder – a finding that challenges established historiographies and compels a revision of the dominant account of the ‘discovery’ of ibogaine's anti-addictive potential. Conclusions The article uncovers a range of previously overlooked historical sources that broadens the understanding of ibogaine's international trajectory and its embeddedness in various cultural, colonial, and scientific contexts. By illuminating ibogaine's multifaceted past, we seek to deepen the understanding of its contemporary framing and contextualize its potential future use in Western medicine. This historical inquiry contributes to a more nuanced and comprehensive account of ibogaine's past and its evolving place at the intersection of pharmacological and cultural histories and changing power dynamics. Among other things, we complicate unilinear accounts of who ‘discovered’ the anti-addictive effects of ibogaine, and we provide historical grounds for recognizing the people of the Congo Basin as both knowledge and resource providers of ibogaine's early development and commercialization as a pharmaceutical.

The distribution of low-quality medications poses a serious risk to public health, especially in underdeveloped nations like Ethiopia. Ineffective use of Current Good Manufacturing Practices (cGMP) increases these dangers, which include cross-contamination, mix-ups, and incorrect labeling. To ensure consistent product quality and adherence to set standards, a Pharmaceutical Quality System (PQS) that effectively integrate cGMP is essential. Assessing cGMP compliance is essential for the reliable production of safe pharmaceuticals. This study aims to assess cGMP compliance in Ethiopian pharmaceutical manufacturers. A cross-sectional descriptive design was employed for this study. The data collection process involved a checklist for field observations and, interview-based questions. The checklist, developed based on WHO GMP requirements, was filled through direct site observations, document reviews, and discussions with key persons in the appropriate departments. The study included six companies located in Addis Ababa and its surrounding areas. The qualitative data were transformed into quantitative data through coding and categorization for easier analysis. The data were then analyzed using descriptive statistics, cross-tabulation, and other statistical tests with SPSS software version 28. The results were displayed using data visualization tools like tables and graphs. The study revealed overall cGMP compliance rates of 62.8%, 85.84%, 84.95%, 86.72%, 84.95%, and 84.1% for companies 1-6, respectively. All companies had some degree of GMP non-conformity; however, only Company 1 had critical deviations. The GMP standards were well-maintained by the remaining five companies. Company 1 has to make improvements in several areas, most notably its QA systems. Additionally, Companies 1, 5, and 6 must improve their QRM systems. Company 5 needs to improve its production process, while Companies 1, 2, and 3 should focus on better managing their equipment and materials. This study evaluated GMP compliance levels across six pharmaceutical manufacturers in Ethiopia. Most of the assessed companies showed a satisfactory degree of GMP compliance. To improve compliance, minimize risks, and ensure product quality, safety, and operational efficiency, the study suggested strengthening risk mitigation measures such as raising employees' knowledge and training.

Polymorphism is a relatively common phenomenon among pharmaceutical compounds, and one of the main aspects to be considered in the production and development of medications. The investigation of polymorphism associated with oxicams, a group belonging to the class of non-steroidal anti-inflammatory drugs (NSAIDs) has increased in recent years and, in the case of tenoxicam, the existence of four polymorphic forms is reported in the literature. The objective of this study was to characterize the presence of different polymorphic forms of tenoxicam in active pharmaceutical ingredient and oral pharmaceutical formulations, as well as to evaluate the influence on in vitro dissolution. The characterization of the three samples of pharmaceutical ingredient of tenoxicam from different suppliers by X-Ray Diffraction (XRD), Infrared (IR) and dissolution profile indicated the presence of a form III crystalline structure, without presenting significant differences between the in vitro dissolution profiles analyzed, and a Dissolution Efficiency (DE%) of 60.30%, 60.70% and 72.34%, respectively. When the four pharmaceutical specialties of tenoxicam were submitted to XRD analysis, they also presented form III crystalline structures. Despite this, the formulations presented different dissolution profiles and a DE% of 75.23%, 83.69%, 78.19% and 90.63%, respectively, without compromising their quality. However, often polymorphism affects physico-chemical properties of drugs, showing the importance of studying this phenomenon, by correlating the presence of crystalline structures to alterations in the quality of active ingredients and pharmaceutical products.

ABSTRACT Avatrombopag maleate (AOG), a thrombopoietin receptor agonist, is a generic drug for which a viable route of synthesis has been identified, in which three nitrosamine drug substance–related impurities (NDSRIs) have been identified. In silico toxicity assessment has been carried out. Being product specific NDSRIs, the specification limit has been defined based on Carcinogenic Potency Categorization Approach (CPCA) approach and selective and sensitive LC‐MS/MS–based analytical method developed and validated for their trace level with predefined parameters with results outcome, which are specificity, linearity with r 2 between 0.9905 and 0.9999, the LOD as 0.34 ppm, and LOQ as 0.67 ppm for all impurities; the obtained recovery was in the range of 94.0%–105.6% with a SD range between 0.6 and 2.8. The overall mean between the method precision and intermediate precision studies was in the range of 6.43–6.81 ppm, and the overall % RSD for the 12 determinations was between 1.3 and 2.4. The method robustness has also been demonstrated with deliberate variations. The solution stability was studied for about 24 h to assess the nature of the solutions prepared. Further, to assess the fate of each NDSRIs, the sample was inflicted to acid, base, oxidative, thermal, and photolytic stress conditions. This intensive stress study concluded that the identified NDSRIs are carried from the starting material of secondary amine scaffolds in the reaction conditions and not a degradation product. Thus, in this current research work, we revealed three new potential NDSRIs for the AOG drug substance, their toxicity assessment, and CPCA scoring to arrive at the specification limit (Category 3 → AI 400 ng/day → 6.6 ppm as target level). The source of the NDSRI formation has also been demonstrated; finally, their selective, sensitive, and stability indicating LC‐MS/MS–based analytical method has been implemented. This wholistic lifecycle approach eliminates the risk‐assessment gaps and ratifies the regulatory requirements, thereby endures the product quality and patients safety.

The residues of veterinary drugs in the food chain are a global concern for food safety, including questions about the origin of these residues, exposure pathways, health impacts, methods for their dissolution, and accurate monitoring methods. In recent years, numerous professional studies have addressed the above concerns from various perspectives. However, these studies are relatively scattered and cannot provide a systematic and comprehensive understanding of recent developments. In this systematic review, we aim to provide a comprehensive synthesis of the current state of knowledge concerning the residues of veterinary drugs in the food chain through critical examination of their origins, exposure pathways, and associated health/environmental hazards. Investigating creative mitigation techniques to lower such residues in food products is given special attention. In summary, this research proposes a paradigm that balances the development of animal production with strict food safety governance to address productivity, consumer health, and international standards.