Search Results (105)

Sewage sludge (SS) is commonly applied as a soil amendment. This practice has raised concern about the dissemination of emerging pollutants (EPs). EPs include compounds such as flame retardants, plasticizers, pharmaceuticals, and personal care products, among others, which may pose risks to human health and ecosystems. The complexity of the SS matrix, combined to the absence of an international legislation framework, makes it necessary to evaluate the techniques available for detecting these contaminants. Detection is typically performed using sensitive analytical techniques; however, the extraction strategy selected remains a crucial step. This review aims to compile different methodologies for the determination of EPs in SS, focusing on extraction strategies reported between 2010 and 2025. Ultrasound-assisted extraction (UAE), pressurized liquid extraction (PLE), and microwave-assisted extraction (MAE) are the most widely used strategies for EPs. UAE is considered the most preferable option, as it enables the extraction of a wide range of compounds without the need for expensive equipment. Among novel techniques, the quick, easy, cheap, effective, rugged, and safe (QuEChERS) method is especially promising, as it is applicable to multiple target compounds. This review provides up-to-date information that can support the development of routine and standardized methodologies for the characterization of EPs in SS. Full article

Background/Objectives: In many parts of the world, pharmacists hold the primary responsibility for providing safe and effective pharmacotherapy. A key aspect is the availability of appropriate medicines for each individual patient. When industrially manufactured medicines are unsuitable or unavailable, pharmacists can prepare tailor-made medicines. While this principle applies globally, practices vary between countries. In the Netherlands, the preparation of medicines in pharmacies is well-established and integrated into routine healthcare. This narrative review explores the role and significance of extemporaneous compounding, pharmacy preparations and related product care in the Netherlands. Methods: Pharmacists involved in pharmacy preparations across various professional sectors, including community and hospital pharmacies, central compounding facilities, academia, and the professional pharmacists’ organisation, provided detailed and expert insights based on the literature and policy documents while also sharing their critical perspectives. Results: We present arguments supporting the need for pharmacy preparations and examine their position and role in community and hospital pharmacies in the Netherlands. Additional topics are discussed, including the regulatory and legal framework, outsourcing, quality assurance, standardisation, education, and international context. Specific pharmacy preparation topics, often with a research component and a strong focus on product care, are highlighted, including paediatric dosage forms, swallowing difficulties and feeding tubes, hospital-at-home care, reconstitution of oncolytic drugs and biologicals, total parenteral nutrition (TPN), advanced therapy medicinal products (ATMPs), radiopharmaceuticals and optical tracers, clinical trial medication, robotisation in reconstitution, and patient-centric solid oral dosage forms. Conclusions: The widespread acceptance of pharmacy preparations in the Netherlands is the result of a unique combination of strict adherence to tailored regulations that ensure quality and safety, and patient-oriented flexibility in design, formulation, and production. This approach is further reinforced by the standardisation of a broad range of formulations and procedures across primary, secondary and tertiary care, as well as by continuous research-driven innovation to develop new medicines, formulations, and production methods. Full article

Potential interactions of haloperidol with food ingredients such as flavonoids may be of great importance both for understanding the pharmacokinetic interactions of xenobiotics with human serum albumin and for clinical practice itself. In this study, the effect of the flavonoids quercetin, catechin, and diosmin on the interaction of haloperidol and human serum albumin was examined. These flavonoids are very common in foods of plant origin. Haloperidol is a typical antipsychotic that has a pronounced binding affinity for human serum albumin. Fluorescence spectroscopy, molecular docking analysis, and molecular dynamics simulations were used for these tests. Previous studies have shown that all test substances bind to the same binding site on human serum albumin (Sudlow site I, Subdomain IIA). Fluorescence spectroscopy revealed that the tested flavonoids reduce the value of the haloperidol binding constant to human serum albumin (from 4.45 × 10³ in the binary system to 3.75 × 10², 5.40 × 10² and 6.24 × 10² in the ternary systems, respectively), due to competition for the same binding site. Experimental results were confirmed by molecular docking analysis and molecular dynamics simulations. Full article

Humanity faces the great challenges arising from pollution and climate change which evidently lead to the irreversible effects observed on the planet. It is now more important than ever to monitor and safeguard the ecosystem as it has been highlighted by governments and scientists. Conventional approaches for water pollution rely on the detection of chemicals in the environment. However, these descriptive observations when compared against water quality standards used as metrics for pollution are unable to predict pollution early or capture the extent of its impact. This weakness is reflected in the legislation and the thresholds for emerging pollutants such as pharmaceuticals and nanomaterials. To bridge the gap and to understand the underlying mechanisms for toxicity, research in the field of molecular ecotoxicology shifts more and more towards the integration of model systems, in silico approaches and molecular information as endpoints. Focusing on the freshwater ecosystem, daphnids are key species employed in risk assessment which are characterised as highly responsive to pollutants and physical stressors. The translation of molecular information describing the physiology of these organisms provides novel and sensitive metrics for pollution assessment. Full article

The whey protein (WP) fraction represents 18–20% of the total milk nitrogen content. It was originally considered a dairy industry waste, but upon its chemical characterization, it was found to be a precious source of bioactive components, growing in popularity as nutritional and functional food ingredients. This has generated a remarkable increase in interest in applications in the different sectors of nutrition, food industry, and pharmaceutics. WPs comprise immunoglobulins and proteins rich in branched and essential amino acids, and peptides endowed with several biological activities (antimicrobial, antihypertensive, antithrombotic, anticancer, antioxidant, opioid, immunomodulatory, and gut microbiota regulation) and technological properties (gelling, water binding, emulsification, and foaming ability). Currently, various process technologies and biotechnological methods are available to recover WPs and convert them into BioActive Peptides (BAPs) for commercial use. Additionally, in silico approaches could have a significant impact on the development of novel foods and/or ingredients and therapeutic agents. This review provides an overview of current and emerging methods for the production, selection, and application of whey peptides, offering insights into bioactivity profiling and potential therapeutic targets. Recent updates in legislation related to commercialized WPs-based products are also presented. Full article

Artificial intelligence (AI) is a subfield of computer science focused on developing systems that can execute tasks traditionally associated with human intelligence. AI systems work through algorithms based on rules or instructions that enable the machine to make decisions. With the advancement of science, more sophisticated AI techniques, such as machine learning and deep learning, have been developed, allowing machines to learn from large amounts of data and improve their performance over time. The pharmaceutical industry has greatly benefited from the development of this technology. AI has revolutionized drug discovery and development by enabling rapid and effective analysis of vast volumes of biological and chemical data during the identification of new therapeutic compounds. The algorithms developed can predict the efficacy, toxicity, and possible adverse effects of new drugs, optimize the steps involved in clinical trials, reduce associated time and costs, and facilitate the implementation of innovative drugs in the market, making it easier to develop precise therapies tailored to the individual genetic profile of patients. Despite significant advancements, there are still gaps in the application of AI, particularly due to the lack of comprehensive regulation. The constant evolution of this technology requires ongoing and in-depth legislative oversight to ensure its use remains safe, ethical, and free from bias. This review explores the role of AI in drug development, assessing its potential to enhance formulation, accelerate discovery, and repurpose existing medications. It highlights AI’s impact across all stages, from initial research to clinical trials, emphasizing its ability to optimize processes, drive innovation, and improve therapeutic outcomes. Full article

Food waste is a pressing global problem with significant environmental, economic and social impacts. This review examines the state of food waste management in Serbia and contextualizes the challenges and opportunities in a global and EU framework. In the Republic of Serbia, an estimated 247,000 tons of food is wasted annually, indicating critical gaps in waste management infrastructure, consumer awareness and missing legislation. While existing policies address general waste management, there is a lack of targeted measures for food waste prevention and resource recovery. The overview recommends aligning Serbian policy with an EU legislative frame, introducing extended producer responsibility and promoting public–private cooperation to improve food donation and recycling. This is the first comprehensive study specifically addressing food waste management in Serbia and assessing its compliance with European and global best practices. By comparing Serbia’s current status with established international models, this paper identifies critical gaps and proposes actionable strategies to improve the efficiency and sustainability of the food waste management system in Serbia. These include investment in infrastructure, public awareness campaigns and the use of innovative digital tools to reduce waste and support a circular economy. Full article

Background: China’s pharmaceutical regulatory framework is undergoing a pivotal shift from a traditional “command-control” model to a “lifecycle regulation” approach, aiming to balance drug safety, innovation, and accessibility. This study systematically examines the evolution, achievements, and challenges of China’s regulatory reforms, offering insights for global pharmaceutical governance. Methods: Using a mixed-methods approach integrating historical analysis, policy text mining, and case studies, we reviewed the pharmaceutical laws and regulations enacted since 1949, supplemented by case studies (e.g., COVID-19 vaccine emergency approvals) and a comparative analysis with international models (e.g., U.S. FDA and EU EMA frameworks). The data were sourced from authoritative platforms such as the PKULAW database, criminal law amendments, and international regulatory texts. Results: China’s regulatory evolution is categorized into four phases: Emergence (1949–1984), Foundational (1985–2000), Deepening Reform (2001–2018), and Lifecycle Regulation (2019–present). The revised Drug Administration Law (2019) institutionalized risk management, dynamic GMP inspections, and post-market surveillance, marking a transition to holistic lifecycle oversight. Key milestones include the introduction of the Vaccine Management Law (2019) and stricter penalties under the Criminal Law Amendment (XI) (2020). Conclusions: China’s lifecycle regulation model demonstrates potential to harmonize safety and innovation, evidenced by improved API export compliance (e.g., 15% increase in international certifications by 2023) and accelerated approvals for breakthrough therapies (e.g., domestically developed PD-1 inhibitors). However, challenges persist, including uneven enforcement capacities, tensions between conditional approvals and risk mitigation, and reliance on global supply chains. These findings provide critical lessons for developing countries navigating similar regulatory dilemmas. Full article

Green coffee beans and their derivatives are employed in dietary supplements, pharmaceuticals, and cosmetic formulations owing to their antioxidant properties and secondary metabolites, which may play a role in preventing metabolic syndrome. Mycotoxins, particularly ochratoxin A (OTA), present a considerable contamination risk and are regulated under strict guidelines established by the European Union and various food safety authorities. This study validates a reverse-phase HPLC method with a fluorimetric detector for quantifying OTA in green coffee beans, following the ISO 17025:2018 standard. The OTA recovery rate (≥70%) met European Union (EU) Regulation No. 2023/2782. The calibration curve showed perfect linearity (r-value = 1). As EU legislation requires, the application field detected OTA levels between 3 µg/kg and 5 µg/kg. Precision (sr = 0.0073) and accuracy (±0.76 µg/kg) were statistically acceptable, with a 95% confidence level indicating reliable results. Full article

The increasing consumption of pharmaceuticals, including antibiotics, and their improper disposal have resulted in both pharmaceuticals and their metabolites being released into the environment, where they pose a risk to both ecosystems and human health. One of the most serious threats to public health associated with the presence of antibiotics in the environment is antimicrobial resistance (AMR). In order to combat AMR, the legal aspect of water protection becomes a critical area of action. This article analyzes the current challenges and legislative developments in the European Union (EU) aimed at mitigating pharmaceutical contamination in aquatic environments, particularly with regard to AMR. It traces the evolution of EU water protection policies from the initial surface and groundwater directives to the recent updates of the Water Framework Directive, Groundwater Directive and Environmental Quality Standards Directive, focusing on the integration of pharmaceutical contaminants into the regulatory framework. In addition, these changes include the update of the Watch List system for monitoring emerging contaminants, the adoption of effects-based methods (EBMs) in the assessment of water status and the streamlining of the legislative process to respond more quickly to emerging threats in the aquatic environment. The EU’s strategic approach to pharmaceuticals in the environment is emphasized as a key framework for harmonizing the environmental standards and addressing the problem of AMR through more sustainable pharmaceutical practices. This study advocates for a proactive, integrated approach to water policy that aligns regulatory actions with scientific advancements to protect public health and ecosystem integrity. Full article

It is well established that marine organisms consist of a great variety of active compounds that appear exclusively in the marine environment while having the ability to be vastly reproduced, irrespective of the existing conditions. As a result, marine organisms can be used in many scientific fields, including the ones of pharmaceutics, nutrition, and cosmetic science. As for the latter, marine ingredients have been successfully included in cosmetic formulations for many decades, providing numerous benefits for the skin. In the present review, the contribution of marine compounds in wound healing is thoroughly discussed, focusing on their role both as active ingredients in suitable formulations, designed to contribute to different stages of skin regeneration and restoration and also, indirectly, as a tool for facilitating wound closure as part of a wound dressing. Additionally, the advantages of these marine ingredients are presented, as well as ways of incorporating them effectively in formulations, so as to enhance their performance. Numerous studies have been referenced, showcasing their efficacy in wound healing. Finally, important data in regard to their stability, limitations, and challenges to their use, safety issues, and the existing legislative framework are extensively reviewed. Full article

Incorporating sewage sludge (SS) into soils presents a cost-effective and environmentally friendly option compared to conventional farming practices. However, SS could be perceived as a double-edged sword, as it may contain a broad spectrum of contaminants, such as heavy metals (HMs), microplastics (MPs), Pharmaceuticals in the Environment (PIE), and personal care products (PSPs), raising concerns for soil health, water resources, food safety, and human health. Council Directive 86/278/EEC, which regulates SS application in agriculture, specifies limits for six HMs but has not undergone substantive revisions since its inception in 1986, until the release of the updated working document SWD-2023-{final 158}. This study critically examines the legislative landscape across the European Union (EU) Member States (MSs), identifying heterogeneity in implementation, regulatory gaps, and the absence of thresholds for emerging contaminants. The results reveal significant disparities in the permissible concentrations of HMs across MSs and in comparison to international guidelines established by the Food and Agriculture Organization (FAO) and the World Health Organization (WHO). Furthermore, the absence of regulatory measures for MPs, PIE, and other common soil pollutants underscores critical deficiencies in the current framework. These inconsistencies contribute to varying levels of soil health across the EU and highlight the need for a harmonized approach. The findings of this study highlight the imperative for a comprehensive overhaul of the EU legislative framework governing SS application. As evidenced, the establishment of harmonized contaminant thresholds, rigorous monitoring protocols, and regulatory provisions for emergent pollutants is essential for addressing the identified regulatory gaps, enhancing legislative coherence, and promoting sustainable agricultural practices aligned with the EU’s environmental and public health objectives. Full article

Clinical pharmacy education varies widely between European countries, and several major changes have taken place in France. This review aims to describe the current state of pharmacy education in France, focusing on clinical pharmacy. Research into legislative texts on pharmacy education in France was conducted based on the national database “legifrance”. A complementary search on clinical pharmacy teaching methods used in France was carried out on the Medline, Embase, Pascal and Francis database for articles published from 2008 to 30 April 2021. Pharmacy studies are taught in universities and last from six to ten years, depending on the student’s chosen options. The scientific curriculum is defined at the national level. Students choose their professional path after the fourth year with specialized courses. Whatever the direction chosen, all students have several internships, including a half-time one-year hospital internship, with patient-centered hospital functions within medical and pharmaceutical teams. The status of clinical pharmacy has been enhanced under French law and regulations, improving clinical pharmacy education, which is now skill-based, in a progressive, active, and dynamic process, with community or hospital pharmacists as university teachers and closer to real-life clinical pharmacy. Teaching is increasingly innovative, and this needs to be shared and reported in the literature. Several important reforms have modernized French pharmacy studies in recent years, conferring a pivotal place for clinical pharmacy. Full article

With the rapid development of the pharmaceutical industry and constant growth of drug usage, ecopharmacovigilance (EPV) has emerged as a way of coping with and minimizing the effects that drugs have on the environment. EPV concerns and describes unwanted effects that the use of a specific drug could have on the environment. The US, EU and Cananda are the improving position of EPV, both in legislation and practice. EPV requires further development as previous studies have shown that neither the general population nor healthcare professionals have enough knowledge about the subject. Improving awareness and knowledge about this topic is a key task for the future of EPV. The main objective was to determine students’ level of knowledge about ecopharmacovigilance and to examine ways of storing and disposing of unused and expired drugs. Students’ knowledge and habits were examined by a previously published survey. The survey contains twenty questions divided into three parts and the possibility of writing an additional note. There was no difference in the level of knowledge between the students of different studies. Also, students who had a family member working as healthcare professional did not show a higher level of knowledge compared to the others. Pharmacy students had a greater intention to educate their environment about EPV when compared to students of the other studies. This is in the line with a previous study which showed that the general public expects that pharmacists and physicians educate them about EPV. Medicine and dental medicine students will become prescribers after finishing their studies, and as such, they should be informed about eco-directed sustainable prescribing (EDSP) as part of an EPV strategy. More than half of the participants reported good adherence to prescribers’ instruction, which decreased the amount of unused drugs. Most of the students found that the drug expiration date was legible, but they did not check it often. In comparison with similar studies, Croatian students had more knowledge and better practices concerning EPV and drug disposal. Structured learning strategies and curriculum implementation for EPV are much needed for further raising awareness about the subject among healthcare professionals and the public. Full article

A novel high-performance liquid chromatography (HPLC) method with 4-N,N-dimethylaminobenzaldehyde as an internal standard was developed for the determination of Camphor with the main goal of facilitating the analysis of different cosmetic and pharmaceutical products that contain Camphor in analytical laboratories. The method can be applied to cosmetic and pharmaceutical samples such as gels, ointments, and creams containing Camphor. Chromatographic separation was carried out on the Symmetry^® C18, 5 μm column (Waters), 250 × 4.6 equipped with guard column E, InertSustain C18, 5 µm, while using the flow of 1.4 mL/min, with a column temperature of 25 °C. The mobile phase consisted of 600 mL of acetonitrile, 400 mL of purified water, and 6 mL of glacial acetic acid. The method was evaluated in accordance with ICH Q2 (R2) guidelines for validation parameters: selectivity, linearity (range 0.10–3.00 mg/mL), the limit of detection (LOD = 0.028 mg/mL), the limit of quantification (LOQ = 0.085 mg/mL), accuracy (confidence intervals < 0.05%), repeatability (peak area ratio = 0.39–1.97), and intermediate precision (peak area ratio = 0.40–1.98). The method is applicable for detecting and quantifying Camphor in a variety of cosmetic and pharmaceutical products from different parts of the world, thus covering the concentrations required by different law legislations. Full article