Annales pharmaceutiques francaises最新文献

{"title":"In pursuit of software solutions for pharmaceutical regulatory affairs: Insights and trends","authors":"Shrushti Sharma , Dyandevi Mathure , Shreyas Dingankar , Vividha Dhapte-Pawar","doi":"10.1016/j.pharma.2025.05.005","DOIUrl":"10.1016/j.pharma.2025.05.005","url":null,"abstract":"<div><div>With rapid upsurge in technology and digital tools, the existing systems including the healthcare systems, especially the pharmaceutical sector is experiencing the revolution in the flow and management of data. Use of digital tools in pharmaceutical regulatory framework and compliance has led to development of a more harmonized system globally. This has facilitated growth in pharmaceutical sector internationally along with timely availability of healthcare facilities with assured safety and efficacy. Technological solutions have upgraded the workflow in industry with the assurance of data veracity. Clinical studies demand for a huge controlled study design and data which concerns patient safety; it includes statistical interpretations and analysis. This is mostly time dependent variable and smart use of software and tools accelerate this process. Automation of the work reduces time, efforts and also streamlines timely submissions. Advanced technologies with support of machine learning, artificial intelligence would assist industry and regulatory authorities to build transparency between the documentation and data. Many regulatory agencies have come up with regulations for validation of electronic tools and data integrity to ensure ethical use of these tools. US Federal law, 21CFR is recognized and have been widely accepted. However, most of the countries have their own regulatory agency that governs these regulations. Artificial Intelligence have come up with add-on features which would overcome the lag in the systems and simplify the operations and interpretations of various studies in pharmaceutical sector. Yet, with the advancing technologies there is need for more precise regulations to evaluate it through all parameters.</div></div><div><div>Avec la montée rapide de la technologie et des outils numériques, les systèmes existants, y compris les systèmes de santé et en particulier le secteur pharmaceutique, connaissent une révolution dans la gestion et le flux des données. L’utilisation des outils numériques dans le cadre réglementaire pharmaceutique et la conformité ont conduit au développement d’un système plus harmonisé à l’échelle mondiale. Cela a favorisé la croissance du secteur pharmaceutique à l’international et a permis la disponibilité rapide des soins de santé avec une sécurité et une efficacité garanties. Les solutions technologiques ont amélioré les flux de travail dans l’industrie en assurant la véracité des données. Les études cliniques nécessitent une conception d’étude contrôlée et une quantité importante de données concernant la sécurité des patients, incluant des analyses et interprétations statistiques. Ces études étant dépendantes du temps, l’utilisation intelligente des logiciels et outils accélère le processus. L’automatisation réduit le temps, les efforts et facilite les soumissions en temps voulu. Les technologies avancées, soutenues par l’apprentissage automatique et l’intelligence artificielle, aideraient l","PeriodicalId":8332,"journal":{"name":"Annales pharmaceutiques francaises","volume":"83 6","pages":"Pages 1053-1061"},"PeriodicalIF":1.1,"publicationDate":"2025-11-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144126477","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}

{"title":"Theobromine as a multi-target therapeutic agent: Analgesic, anti-inflammatory, and anti-arthritic potential with network pharmacology insights","authors":"Hafiza-Sara Afzal , Ambreen-Malik Uttra , Sumera Qasim , Abdul Malik , Aisha Mobashar","doi":"10.1016/j.pharma.2025.04.007","DOIUrl":"10.1016/j.pharma.2025.04.007","url":null,"abstract":"<div><h3>Objective</h3><div>Inflammatory disorders, including rheumatoid arthritis (RA) and osteoarthritis, contribute significantly to global health burdens. Theobromine, a xanthine alkaloid present in cocoa, has pharmacological properties with potential therapeutic benefits in inflammatory conditions. Nonetheless, its analgesic and anti-inflammatory attributes remained underexplored.</div></div><div><h3>Materials and methods</h3><div><span>Analgesic, anti-arthritic and anti-inflammatory efficacy of theobromine was evaluated via experimental models, alongside network pharmacology to understand its molecular mechanisms. Theobromine's effects were assessed in multiple models: acetic acid-induced writhing, tail immersion, and </span>formalin<span> tests to evaluate analgesia; carrageenan- and egg albumin-induced paw edema models for anti-inflammatory activity; and protein denaturation and human red blood cell (HRBC) membrane stabilization for anti-arthritic effects. Network pharmacology was utilized to identify molecular targets and pathways, including KEGG pathway enrichment analysis.</span></div></div><div><h3>Results</h3><div>Theobromine exhibited significant analgesic effects, reducing writhing behavior by 42.71% at 200<!--> <span><span>mg/kg, and increasing tail-flick latency. Theobromine significantly lowered pain during both early as well as late phase of formalin test. Inflammation was notably reduced in both egg albumin and </span>carrageenan inflammatory models. Theobromine also demonstrated anti-arthritic properties, inhibiting protein denaturation and stabilizing HRBC membranes. Network pharmacology revealed key targets such as COX-2, TNF-α, and NF-kB, implicated in inflammation and immune responses.</span></div></div><div><h3>Conclusion</h3><div>Theobromine exhibits significant analgesic, anti-inflammatory, and anti-arthritic effects. Network pharmacology provides insights into its molecular mechanisms, suggesting its promise as a therapeutic modality for inflammatory disorders.</div></div><div><h3>Objectif</h3><div>Les troubles inflammatoires, notamment la polyarthrite rhumatoïde (PR) et l’arthrose, contribuent de manière significative aux problèmes de santé mondiaux. La théobromine (THEOBROMINE), un alcaloïde xanthique présent dans le cacao, possède des propriétés pharmacologiques avec des avantages thérapeutiques potentiels dans les états inflammatoires. Néanmoins, ses attributs analgésiques et anti-inflammatoires restent sous-explorés.</div></div><div><h3>Matériels et méthodes</h3><div>L’efficacité analgésique, anti-arthritique et anti-inflammatoire de la théobromine a été évaluée via des modèles expérimentaux, ainsi que la pharmacologie en réseau pour comprendre ses mécanismes moléculaires. Les effets de la théobromine ont été évalués dans plusieurs modèles : contorsions induites par l’acide acétique, immersion de la queue et tests au formol pour évaluer l’analgésie ; modèles d’œdème de la patte induits par la carragénine et l’alb","PeriodicalId":8332,"journal":{"name":"Annales pharmaceutiques francaises","volume":"83 6","pages":"Pages 1114-1129"},"PeriodicalIF":1.1,"publicationDate":"2025-11-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143953200","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}

{"title":"Physicochemical stability of a bevacizumab biosimilar in vials and diluted preparations: Implications for hospital practice and inventory management","authors":"Victoire Vieillard , Lucile Foulley , Salim Benkhalifa , Muriel Paul","doi":"10.1016/j.pharma.2025.06.002","DOIUrl":"10.1016/j.pharma.2025.06.002","url":null,"abstract":"<div><div>Biosimilars like Vegzelma can significantly enhance access to biologic therapies and reduce healthcare costs, provided that comprehensive stability data is available. This study aimed to provide extended stability data, allowing hospitals and healthcare professionals to effectively manage drug preparation, minimize wastage, and optimize cost-efficiency. The stability assessments employed in this study included ion exchange chromatography, steric exclusion chromatography, dynamic light scattering, and measurements of pH, density, and osmolality. These assessments focused on the physicochemical stability of the bevacizumab biosimilar (Vegzelma) in vials and polyolefin infusion bags when diluted to concentrations of 1.4 and 16.5<!--> <!-->mg/mL in 0.9% NaCl and stored at temperatures between 2 to 8<!--> <!-->°C and at 25<!--> <!-->°C. Results from stability and sterility assays confirm that when diluted in 0.9% NaCl and stored in polyolefin IV bags, Vegzelma remains stable at the commonly used concentrations of 1.4 and 16.5<!--> <!-->mg/mL for a 96-hour thermal cycle. For opened vials, the study extends the stability period to 60 days at 2–8<!--> <!-->°C under light-protected conditions. Unopened vials can be safely stored at room temperature, protected from light, for up to 72<!--> <!-->hours without compromising the product's integrity. All analyses, particle sizing, ion exchange chromatography, spectral analysis, and thermal denaturation, indicated stable molecular and structural integrity of the bevacizumab, with no observed changes in aggregation, ionic distribution, tertiary structure, or thermodynamic properties. These findings demonstrate the biosimilar's resilience against a 72-hour temperature spike. Pharmacies could use this data for flexible treatment scheduling, advanced preparation for weekends, and holidays, resulting in cost-efficiencies with biosimilars.</div></div><div><div>Les biosimilaires de haute qualité comme Vegzelma peuvent significativement améliorer l’accès aux thérapies biologiques et réduire les coûts sur les systèmes de santé, à condition que des données de stabilité complètes soient disponibles. Cette étude vise à fournir des données de stabilité étendues, permettant aux hôpitaux et aux professionnels de la santé de gérer efficacement la préparation des médicaments, de minimiser le gaspillage et d’optimiser le rapport coût-efficacité. Les évaluations de la stabilité utilisées dans cette étude comprenaient la chromatographie d’échange d’ions, la chromatographie d’exclusion stérique, la diffusion dynamique de la lumière et les mesures du pH, de la densité et de l’osmolalité. Ces évaluations ont porté sur la stabilité physicochimique du biosimilaire du bevacizumab (Vegzelma) dans des flacons et des poches de perfusion en polyoléfine lorsqu’il est dilué à des concentrations de 1,4 et 16,5<!--> <!-->mg/mL dans du NaCl à 0,9 % et conservé à des températures comprises entre 2 et 8<!--> <!-->°C et à 25<!--> <!-->°C. ","PeriodicalId":8332,"journal":{"name":"Annales pharmaceutiques francaises","volume":"83 6","pages":"Pages 1150-1164"},"PeriodicalIF":1.1,"publicationDate":"2025-11-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144301022","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}

{"title":"Investigation of cytotoxic activity properties of etoxazole towards human cancer and healthy cell lines and molecular docking studies","authors":"İkbal Demet Nane","doi":"10.1016/j.pharma.2025.07.001","DOIUrl":"10.1016/j.pharma.2025.07.001","url":null,"abstract":"<div><div>The effect of etoxazole on cancer cells was evaluated <em>in vitro</em> using different cell lines. In this context, its cytotoxic activity on breast (MCF-7), liver (HepG2), colon (DLD-1) and lung (A549) cancer cell lines was investigated. The 3-(4,5-dimethylthiazol-2-yl)-2,5-diphenyl tetrazolium bromide (MTT) method was used to determine the effects on cell viability. Tests were also performed on a healthy human embryonic kidney cell line (HEK-293T) to evaluate the selectivity of the compound. The results revealed that etoxazole showed varying degrees of antiproliferative activity in cancer cell lines. In particular, it showed the most potent inhibition effect with an IC<sub>50</sub> value of 33.18<!--> <!-->μM in HepG2 cell line. In contrast, in the A549 cell line, the IC<sub>50</sub> value was measured as 91.38<!--> <!-->μM, indicating that the compound had a lower cytotoxic effect in lung cancer cells. Etoxazole, which exhibited a more pronounced effect against liver cancer cells, showed moderate cytotoxicity in other cell lines. Moreover, the IC<sub>50</sub> value in healthy HEK-293T cells was found to be 1628.0<!--> <!-->μM, which demonstrates that etoxazole has a high selectivity index and low toxicity towards normal cells. On the other hand, evaluations in the healthy HEK-293T cell line revealed that etoxazole has a selective effect. The IC<sub>50</sub> value in healthy cells was relatively high, suggesting that the compound may exhibit a specific cytotoxic activity against cancer cells. In general, etoxazole was found to have varying levels of cytotoxic activity in different cancer cell lines. The effect of the compound varied depending on the cell type and it was observed that it exhibited a more pronounced antiproliferative activity especially in liver cancer cells. These results indicate that etoxazole may be a promising candidate for hepatocellular carcinoma treatment. Furthermore, molecular docking simulations were conducted to evaluate the binding mode and affinity of the etoxazole ligand against the Kinase Insert Domain Receptor (PDB ID: 3WZE). The docking results indicated that etoxazole exhibited a binding energy of −8.6<!--> <!-->kcal/mol and formed stable interactions within the active site, suggesting a high inhibitory potential. In particular, key stabilizing interactions were identified, including hydrogen bonds with ASP183 and a halogen bond with GLU72, further supporting the molecular affinity. These findings suggest that etoxazole may be the subject of further research as a potential anticancer agent.</div></div><div><div>L’effet de l’étoxazole sur les cellules cancéreuses a été évalué in vitro en utilisant différentes lignées cellulaires. Dans ce contexte, son activité cytotoxique sur les lignées de cellules cancéreuses du sein (MCF-7), du foie (HepG2), du côlon (DLD-1) et du poumon (A549) a été étudiée. La méthode du bromure de 3-(4,5-diméthylthiazol-2-yl)-2,5-diphényl-tétrazolium (MTT) a été utilisée pour dé","PeriodicalId":8332,"journal":{"name":"Annales pharmaceutiques francaises","volume":"83 6","pages":"Pages 1165-1174"},"PeriodicalIF":1.1,"publicationDate":"2025-11-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144616098","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}

{"title":"Design, development and evaluation of curcumin (Curcuma longa) encapsulated phospholipid nanocarrier to enhance solubility and improve efficacy in MCF-7 cell line by Quality by Design","authors":"Vaibhav Bhadange , Supriya Jogdand , Ankita Kawtikwar , Pravin Kawtikwar","doi":"10.1016/j.pharma.2025.07.004","DOIUrl":"10.1016/j.pharma.2025.07.004","url":null,"abstract":"<div><div>Lipid-based excipients are increasingly used to enhance the stability of innovative drug delivery systems. Phospoholipid nanocarriers, a botanical formulation, are used to build lipophilic molecular complexes, improving stability, absorption, and bioavailability. Turmeric (<em>Curcuma longa</em>) contains curcumin, which has poor bioavailability due to its solubility and wettability. Hence, the study was designed to enhance the solubility of curcumin by phospholipid complexation. The curcumin-encapsulated phospholipid nanocarriers (Ccm-PNs) were developed by solvent evaporation method, and the formula was optimized using a Box-Behnekn design based on QbD. Physicochemical properties and functional characterization were done by accessing particle size, entrapment efficiency, <em>in vitro</em> drug release. The adenocarcinoma breast cell line (MCF-7) was used for cytotoxicity investigation of Ccm-PNs. It showed lower particle size and stable zeta potential values, and their compatibility with excipients was confirmed through DSC and FTIR studies. They also demonstrated higher entrapment and <em>in vitro</em> drug release over 48<!--> <!-->hours. The cytotoxicity study showed improved efficacy than pure curcumin solution. In conclusion, overall results show that phospholipid nanocarriers have the ability to enhance therapeutic efficacy and bioavailability.</div></div><div><div>Les excipients à base de lipides sont de plus en plus utilisés pour améliorer la stabilité des systèmes innovants d’administration de médicaments. Les nanotransporteurs de phospoholipides, une formulation botanique, sont utilisés pour construire des complexes moléculaires lipophiles, améliorant ainsi la stabilité, l’absorption et la biodisponibilité. Le curcuma (<em>Curcuma longa</em>) contient de la curcumine, qui a une faible biodisponibilité en raison de sa solubilité et de sa mouillabilité. Par conséquent, l’étude a été conçue pour améliorer la solubilité de la curcumine par complexation des phospholipides. Les nanotransporteurs de phospholipides encapsulés dans la curcumine (Ccm-PN) ont été développés par la méthode d’évaporation du solvant, et la formule a été optimisée à l’aide d’un plan Box-Behnekn basé sur la QbD. Les propriétés physicochimiques et la caractérisation fonctionnelle ont été effectuées en accédant à la taille des particules, à l’efficacité du piégeage, et à la libération in vitro du médicament. La lignée cellulaire mammaire d’adénocarcinome (MCF-7) a été utilisée pour l’étude de la cytotoxicité des Ccm-PN. Il a montré une taille de particule plus faible et des valeurs de potentiel zêta stables, et leur compatibilité avec les excipients a été confirmée par des études DSC et FTIR. Ils ont également démontré un piégeage plus élevé et une libération in vitro du médicament sur 48<!--> <!-->heures. L’étude de cytotoxicité a montré une efficacité supérieure à celle d’une solution de curcumine pure. En conclusion, les résultats globaux montrent que les ","PeriodicalId":8332,"journal":{"name":"Annales pharmaceutiques francaises","volume":"83 6","pages":"Pages 1175-1188"},"PeriodicalIF":1.1,"publicationDate":"2025-11-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144616096","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}

{"title":"Sommaire / Contents","authors":"","doi":"10.1016/S0003-4509(25)00155-5","DOIUrl":"10.1016/S0003-4509(25)00155-5","url":null,"abstract":"","PeriodicalId":8332,"journal":{"name":"Annales pharmaceutiques francaises","volume":"83 6","pages":"Pages v-vi"},"PeriodicalIF":1.1,"publicationDate":"2025-11-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145335029","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}

{"title":"Incompatibilité des médicaments injectables en réanimation néonatale : de l’évaluation à la mise en place d’un outil préventif","authors":"Marie Guedon , Catherine Mennesson , Baptiste Fulbert , Elise D’huart , Laura Menvielle , Elodie Tisserand , Dominique Hettler","doi":"10.1016/j.pharma.2025.07.002","DOIUrl":"10.1016/j.pharma.2025.07.002","url":null,"abstract":"<div><h3>Introduction</h3><div>Les schémas d’administrations complexes en réanimation néonatale conduisent au mélange de plusieurs principes actifs sur une même voie. L’objectif de cette étude est d’évaluer la fréquence de ces administrations concomitantes et leur compatibilité physico-chimique, puis d’établir un tableau de compatibilité spécifique.</div></div><div><h3>Matériel et méthodes</h3><div>Une étude prospective, observationnelle, monocentrique a été réalisée dans un service de réanimation néonatale entre le 15 février et le 2 avril 2024. Les données (patients, voies d’abord, nutrition parentérale, médicaments injectables [dose, dilution, modalités d’administration]) ont été recueillies à partir de la prescription informatisée et d’une observation des branchements au lit du patient. Les compatibilités ont été évaluées à l’aide de Stabilis® et du <em>Handbook of Injectable Drugs</em>®.</div></div><div><h3>Résultats</h3><div>Quarante-neuf prescriptions, contenant 385 associations en Y ont été incluses : 36 % étaient compatibles, 3 % incompatibles et 46 % non étudiées. Un tableau de compatibilité, incluant 24 molécules parmi les plus prescrites (anti-infectieux et médicaments du système nerveux spécifiquement) a été créé.</div></div><div><h3>Discussion et conclusion</h3><div>Les associations en Y apparaissent comme inévitables lors de la prise en charge des patients. Bien que peu d’associations incompatibles aient été observées, l’absence de données pour de nombreuses molécules doit entraîner une vigilance accrue. La création d’un tableau de compatibilité spécifique apparaît comme un outil réduisant le risque de survenue d’une incompatibilité. Une évaluation de cet outil doit être envisagée ainsi qu’une extension du projet aux différents services de pédiatrie de l’établissement.</div></div><div><h3>Introduction</h3><div>Complex administration patterns in neonatal intensive care lead to the mixing of several active ingredients on the same route. The aim of this study was to assess the frequency of these concomitant administrations and their physico-chemical compatibility, and then to establish a specific compatibility table.</div></div><div><h3>Material and methods</h3><div>A prospective, observational, single-center study was carried out in a neonatal intensive care unit between February 15 and April 2, 2024. Data (patients, approaches, parenteral nutrition, injectable drugs [dose, dilution, administration methods]) were collected from computerized prescriptions and observation of connections at the patient's bed. Compatibilities <em>were assessed using Stabilis® and the Handbook of Injectable Drugs®.</em></div></div><div><h3>Results</h3><div>Forty-nine prescriptions containing 385 Y combinations were included: 36% were compatible, 3% incompatible and 46% not studied. A compatibility table was created, including 24 of the most commonly prescribed molecules (anti-infectives and nervous system drugs specifically).</div></div><div><h3>Discussio","PeriodicalId":8332,"journal":{"name":"Annales pharmaceutiques francaises","volume":"83 6","pages":"Pages 1189-1197"},"PeriodicalIF":1.1,"publicationDate":"2025-11-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144616095","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}

{"title":"Oncology pharmacy practice: Key insights, challenges, and perspectives – A position paper from the French Society for Oncology Pharmacy (SFPO)","authors":"Florence Ranchon ,&nbsp;Florian Slimano ,&nbsp;Isabelle Borget ,&nbsp;Mathieu Boulin ,&nbsp;Christophe Bardin ,&nbsp;Pierre Coliat ,&nbsp;Nicolas Cormier ,&nbsp;Catherine Devys ,&nbsp;Raphaelle Fanciullino ,&nbsp;Muriel Paul ,&nbsp;Florent Puisset ,&nbsp;Catherine Rioufol ,&nbsp;Lionel Tortolano ,&nbsp;Jean-François Tournamille ,&nbsp;Jean Vigneron ,&nbsp;Régine Chevrier ,&nbsp;Bertrand Pourroy ,&nbsp;Jean-Louis Cazin","doi":"10.1016/j.pharma.2025.07.005","DOIUrl":"10.1016/j.pharma.2025.07.005","url":null,"abstract":"<div><div>The role of hospital oncology pharmacists (HOP) in the care of cancer patients has evolved considerably. This evidence led the experts of the French Society for Oncology Pharmacy (SFPO) to write a position paper. The first part presents the key insights of oncology pharmacy services (technology aspects of anticancer drug preparation and clinical pharmacy services), training of HOPs and research activities (clinical trials, research in oncology pharmacy). The second part of this position paper refers to the challenges and perspectives of E-health and artificial intelligence, precision medicine, access to innovation, and environmental issues.</div></div><div><div>Le rôle des pharmaciens hospitaliers dans la prise en charge du patient atteint de cancer a considérablement évolué. Cette évidence a amené les experts de la Société Française de Pharmacie Oncologique (SFPO) à rédiger un document de position. La première partie détaille les points clés de l’exercice actuel en soins (aspects pharmacotechniques de la préparation des médicaments anticancéreux, pharmacie clinique), formation et recherche (études cliniques, recherche en pharmacie oncologique). La seconde partie présente les défis et perspectives identifiés : e-santé et intelligence artificielle, médecine de précision, accès à l’innovation, questions environnementales.</div></div>","PeriodicalId":8332,"journal":{"name":"Annales pharmaceutiques francaises","volume":"83 6","pages":"Pages 1040-1052"},"PeriodicalIF":1.1,"publicationDate":"2025-11-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144616099","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}

{"title":"Synergistic anticonvulsant activity of oregano, chamomile, and lavender via intranasal administration: A dose-response modeling approach","authors":"Samin Sheikholeslami ,&nbsp;Marziyeh Amiri-Andebili ,&nbsp;Amir Baghaei ,&nbsp;Mohammad Mahdi Ahmadian-Attari","doi":"10.1016/j.pharma.2025.05.004","DOIUrl":"10.1016/j.pharma.2025.05.004","url":null,"abstract":"&lt;div&gt;&lt;h3&gt;Background&lt;/h3&gt;&lt;div&gt;This short communication presents an analytical approach to evaluate the synergistic anticonvulsant effects of an herbal combination containing hydroalcoholic extracts of &lt;em&gt;Origanum vulgare&lt;/em&gt; (oregano), &lt;em&gt;Matricaria chamomilla&lt;/em&gt; (chamomile), and &lt;em&gt;Lavandula angustifolia&lt;/em&gt; (lavender).&lt;/div&gt;&lt;/div&gt;&lt;div&gt;&lt;h3&gt;Objective&lt;/h3&gt;&lt;div&gt;The study aimed to apply linear dose-response modeling to seizure score data to predict the expected outcomes of combination therapy and quantify synergy by comparing predicted and observed effects.&lt;/div&gt;&lt;/div&gt;&lt;div&gt;&lt;h3&gt;Methods&lt;/h3&gt;&lt;div&gt;The herbal extracts were obtained through maceration with 70% ethanol. The animal study was performed using 2 different doses of each herb, involving 36 rats in 6 groups. Building on previous in vivo findings, the study utilized linear dose-response modeling to analyze the effects of the combination therapy on seizure scores and to determine the synergistic performance at combination doses of 17&lt;!--&gt; &lt;!--&gt;mg/kg, 34&lt;!--&gt; &lt;!--&gt;mg/kg, and 68&lt;!--&gt; &lt;!--&gt;mg/kg.&lt;/div&gt;&lt;/div&gt;&lt;div&gt;&lt;h3&gt;Results&lt;/h3&gt;&lt;div&gt;The results highlighted the synergistic performance of the herbal combination, particularly at the dose of 34&lt;!--&gt; &lt;!--&gt;mg/kg, demonstrating the pharmacodynamic advantages of combination therapy and confirming the enhanced antiseizure effect of the herbal combination.&lt;/div&gt;&lt;/div&gt;&lt;div&gt;&lt;h3&gt;Conclusions&lt;/h3&gt;&lt;div&gt;This study confirms the synergistic anticonvulsant effects of the herbal combination and demonstrates its potential as a new supplementary treatment for seizures via a non-invasive intranasal administration method.&lt;/div&gt;&lt;/div&gt;&lt;div&gt;&lt;h3&gt;Contexte&lt;/h3&gt;&lt;div&gt;Cette brève communication présente une approche analytique visant à évaluer les effets anticonvulsivants synergiques d’une association de plantes contenant des extraits hydroalcooliques d’&lt;em&gt;Origanum vulgare&lt;/em&gt; (origan), de &lt;em&gt;Matricaria chamomilla&lt;/em&gt; (camomille) et de &lt;em&gt;Lavandula angustifolia&lt;/em&gt; (lavande).&lt;/div&gt;&lt;/div&gt;&lt;div&gt;&lt;h3&gt;Objectif&lt;/h3&gt;&lt;div&gt;L’étude visait à appliquer une modélisation dose-réponse linéaire aux données de scores épileptiques afin de prédire les résultats attendus d’une polythérapie et de quantifier la synergie en comparant les effets prédits et observés.&lt;/div&gt;&lt;/div&gt;&lt;div&gt;&lt;h3&gt;Méthodes&lt;/h3&gt;&lt;div&gt;Les extraits de plantes ont été obtenus par macération dans de l’éthanol à 70 %. L’étude animale a été réalisée avec deux doses différentes de chaque plante, impliquant 36 rats répartis en six groupes. S’appuyant sur des résultats in vivo antérieurs, l’étude a utilisé une modélisation dose-réponse linéaire pour analyser les effets de la polythérapie sur les scores épileptiques et déterminer la performance synergétique aux doses combinées de 17&lt;!--&gt; &lt;!--&gt;mg/kg, 34&lt;!--&gt; &lt;!--&gt;mg/kg et 68&lt;!--&gt; &lt;!--&gt;mg/kg.&lt;/div&gt;&lt;/div&gt;&lt;div&gt;&lt;h3&gt;Résultats&lt;/h3&gt;&lt;div&gt;Les résultats ont mis en évidence l’efficacité synergétique de l’association de plantes, notamment à la dose de 34&lt;!--&gt; &lt;!--&gt;mg/kg, démontrant à la fois les avant","PeriodicalId":8332,"journal":{"name":"Annales pharmaceutiques francaises","volume":"83 6","pages":"Pages 1086-1091"},"PeriodicalIF":1.1,"publicationDate":"2025-11-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144085697","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}

{"title":"Unspecified degradation impurities identification and characterization in bilastine and montelukast tablet formulations by using UPLC and LCMS/MS: Robustness by design expert and green assessment","authors":"Raj Kumar Kodishala ,&nbsp;Kousrali Sayyad ,&nbsp;Leela Prasad Kowtharapu ,&nbsp;Naresh Konduru ,&nbsp;Tanmoy Mondal ,&nbsp;Mohan Varkolu ,&nbsp;Sreedhar Gundekari","doi":"10.1016/j.pharma.2025.04.006","DOIUrl":"10.1016/j.pharma.2025.04.006","url":null,"abstract":"&lt;div&gt;&lt;h3&gt;Objectives&lt;/h3&gt;&lt;div&gt;This study introduces a novel ultra-performance liquid chromatography (UPLC) method for the rapid, simple, and accurate detection of contaminants in bilastine (BLS) and montelukast (MTK) tablet formulations.&lt;/div&gt;&lt;/div&gt;&lt;div&gt;&lt;h3&gt;Material and methods&lt;/h3&gt;&lt;div&gt;The separation of BLS impurity-A, BLS impurity-B, BLS, MTK impurity-A, MTK, and MTK impurity-B was achieved using an Acquity BEH C18 column (50&lt;!--&gt; &lt;!--&gt;×&lt;!--&gt; &lt;!--&gt;2.1&lt;!--&gt; &lt;!--&gt;mm, 1.7&lt;!--&gt; &lt;!--&gt;μm) under gradient eluent conditions. The mobile phases consisted of 0.1% triethylamine in water with the pH adjusted to 2.5 using orthophosphoric acid (mobile phase A) and acetonitrile (mobile phase B). The ratio of mobile phase A to B was 70:30 (v/v). The column flow rate was set at 0.2&lt;!--&gt; &lt;!--&gt;mL/min, and the photodiode array detector (PDA) was used to quantify the analytes. The detection wavelength was set to 224&lt;!--&gt; &lt;!--&gt;nm.&lt;/div&gt;&lt;/div&gt;&lt;div&gt;&lt;h3&gt;Results&lt;/h3&gt;&lt;div&gt;In a runtime of just 20&lt;!--&gt; &lt;!--&gt;minutes, 13 analytes were successfully separated. The retention times for the target compounds and impurities were as follows: BLS impurity-A: 1509&lt;!--&gt; &lt;!--&gt;min, BLS impurity-B: 3435&lt;!--&gt; &lt;!--&gt;min, BLS: 5668&lt;!--&gt; &lt;!--&gt;min, MTK impurity-A: 8137&lt;!--&gt; &lt;!--&gt;min, MTK: 9784&lt;!--&gt; &lt;!--&gt;min, MTK impurity-B: 11,853&lt;!--&gt; &lt;!--&gt;min. The unspecified impurities in the degradation samples were detected at retention times of 2174, 2657, 3368, 4143, 8239, 11,722, and 12,436&lt;!--&gt; &lt;!--&gt;minutes, and were characterized using liquid chromatography-mass spectrometry (LC-MS).&lt;/div&gt;&lt;/div&gt;&lt;div&gt;&lt;h3&gt;Conclusion&lt;/h3&gt;&lt;div&gt;The UPLC-based analytical method demonstrated in this study is an effective and efficient technique for the quantification of BLS, MTK, and their associated impurities in tablet formulations. This method has been validated in accordance with ICH Q2(R2) and USP &lt;1225&gt; guidelines.&lt;/div&gt;&lt;/div&gt;&lt;div&gt;&lt;h3&gt;Objectifs&lt;/h3&gt;&lt;div&gt;Cette étude présente une nouvelle méthode de chromatographie liquide ultra-performante (UPLC) pour la détection rapide, simple et précise des contaminants dans les formulations de comprimés de bilastine (BLS) et de montélukast (MTK).&lt;/div&gt;&lt;/div&gt;&lt;div&gt;&lt;h3&gt;Matériel et méthodes&lt;/h3&gt;&lt;div&gt;La séparation des impuretés BLS A, BLS BLS, BLS, MTK A, MTK et MTK B a été réalisée à l’aide d’une colonne Acquity BEH C18 (50&lt;!--&gt; &lt;!--&gt;×&lt;!--&gt; &lt;!--&gt;2,1&lt;!--&gt; &lt;!--&gt;mm, 1,7&lt;!--&gt; &lt;!--&gt;μm) dans des conditions d’éluant à gradient. Les phases mobiles étaient constituées de 0,1 % de triéthylamine dans l’eau avec un pH ajusté à 2,5 à l’aide d’acide orthophosphorique (phase mobile A) et d’acétonitrile (phase mobile B). Le rapport entre les phases mobiles A et B était de 70:30 (v/v). Le débit de la colonne a été fixé à 0,2&lt;!--&gt; &lt;!--&gt;mL/min et le détecteur à barrette de photodiodes (PDA) a été utilisé pour quantifier les analytes. La longueur d’onde de détection a été fixée à 224&lt;!--&gt; &lt;!--&gt;nm.&lt;/div&gt;&lt;/div&gt;&lt;div&gt;&lt;h3&gt;Résultats&lt;/h3&gt;&lt;div&gt;En seulement 20 minutes, 13 analytes ont été séparés avec succès. Le","PeriodicalId":8332,"journal":{"name":"Annales pharmaceutiques francaises","volume":"83 6","pages":"Pages 1092-1113"},"PeriodicalIF":1.1,"publicationDate":"2025-11-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143953248","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}