Annales pharmaceutiques francaises最新文献

{"title":"Sommaire / Contents","authors":"","doi":"10.1016/S0003-4509(25)00198-1","DOIUrl":"10.1016/S0003-4509(25)00198-1","url":null,"abstract":"","PeriodicalId":8332,"journal":{"name":"Annales pharmaceutiques francaises","volume":"84 1","pages":"Pages iii-iv"},"PeriodicalIF":1.1,"publicationDate":"2026-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145799787","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":"Rédaction d’un livret d’accueil du nouvel arrivant au bloc opératoire : circuit des dispositifs médicaux stériles et mise en place d’un questionnaire d’évaluation","authors":"Lola Kazek, Isabelle Denis, Marwane Azizi, Morgane Cessiecq, Aude Capelle","doi":"10.1016/j.pharma.2025.09.001","DOIUrl":"10.1016/j.pharma.2025.09.001","url":null,"abstract":"<div><h3>Objectifs</h3><div>L’objectif de ce travail est de proposer une formation complète sur le circuit des dispositifs médicaux stériles (DMS) au bloc opératoire (BO) à l’aide d’un livret exhaustif ainsi que par la mise en place d’une évaluation des connaissances à destination des infirmières de bloc opératoire et des préparateurs en pharmacie hospitalière.</div></div><div><h3>Méthodes</h3><div>La rédaction de chaque partie du livret s’est appuyée sur les documents internes de qualité relatifs au circuit des DMS de notre centre et a fait l’objet d’une validation institutionnelle. Un questionnaire à choix multiples basé sur ce livret a été réalisé.</div></div><div><h3>Résultats</h3><div>Le livret apporte une réponse claire et précise sur le rôle de chacun en cas d’interrogations ponctuelles. Le questionnaire de 62 items devait être réalisé avant et après lecture du livret. Sur les 21 participants, une diminution globale du nombre d’erreurs de 58,5 % après lecture du livret a été mise en évidence. Les soignants en poste depuis plus d’un an ont fait en moyenne 9,9 erreurs [1–17], et 14 erreurs [8–21] pour ceux présents depuis moins d’un an.</div></div><div><h3>Conclusions</h3><div>Le livret développé en équipe pluridisciplinaire a été apprécié par l’ensemble des corps de métiers intervenants au BO sur le circuit des DMS. Il a contribué à harmoniser et éclaircir le rôle de chacun dans les différents circuits propres aux DMS. La mise au point d’un questionnaire d’évaluation a permis de cibler les principales difficultés sur lesquelles une formation complémentaire sera organisée. Les résultats de ces questionnaires ont objectivé la pertinence de la lecture de cet ouvrage.</div></div><div><h3>Objectives</h3><div>The objective of this work is to provide comprehensive training on the workflow of sterile medical devices (SMDs) in the operating room (OR) with the help of an exhaustive booklet and the introduction of an evaluation to assess OR nurses and hospital pharmacy technicians knowledge.</div></div><div><h3>Methods</h3><div>Each section of the booklet was written based on internal quality documents related to the SMD workflow at our hospital and was institutionally validated. A multiple-choice questionnaire based on the booklet was developed.</div></div><div><h3>Results</h3><div>The booklet provides a clear and precise explanation of each person's role when specific questions arise. The 62-item questionnaire was to be completed before and after reading the booklet. Among the 21 participants, an overall reduction in errors of 58.5% after reading the booklet was observed. Staff who have been in their position for more than a year made an average of 9.9 errors [1–17], compared to 14 errors [8–21] for those with less than one year of experience.</div></div><div><h3>Conclusions</h3><div>The booklet, developed by a multidisciplinary team, was well received by all professionals involved in the SMD workflow within the OR. It helped clarify and harmonize e","PeriodicalId":8332,"journal":{"name":"Annales pharmaceutiques francaises","volume":"84 1","pages":"Pages 141-146"},"PeriodicalIF":1.1,"publicationDate":"2026-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145008648","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":"Development and characterization of AXT@metal-organic framework: A biocompatible, pH-responsive nanocarrier for targeted axitinib delivery in MCF-7 cancer cells","authors":"Jayvadan K. Patel , Ujashkumar A. Shah , Pravin O. Patil , Jitendra H. Patil","doi":"10.1016/j.pharma.2025.08.004","DOIUrl":"10.1016/j.pharma.2025.08.004","url":null,"abstract":"<div><div>Cancer remains a major global health challenge, characterized by low survival rates and significant side effects from conventional treatments. The metal-organic frameworks (MOFs) offer distinctive features that make them highly suitable for medical innovations. This study presents the development of MOFs as nanocarriers for the anticancer drug axitinib (AXT) to address these issues. Specifically, the MOFs were composed of titanium isopropoxide as metal ions and terephthalic acid as ligands, synthesized via a hydrothermal approach. The pH-responsive Ti-MOF was designed to enhance targeted drug delivery and minimize AXT side effects. The Ti-MOF was analyzed through various techniques, including UV-Vis spectroscopy, Fourier Transform Infrared (FTIR) spectroscopy, Scanning Electron Microscopy coupled with Energy Dispersive X-ray (SEM-EDX), zeta potential analysis, particle size measurement, Raman spectroscopy, and thermo gravimetric analysis (TGA). In vitro drug release studies at 37<!--> <!-->°C demonstrated that these porous carriers significantly slowed the release of AXT under neutral conditions, with only 4.5% to 8.0% released, mimicking normal tissue environments. In contrast, under acidic conditions (i.e., at pH 5), which simulates the acidic conditions of cancerous tissues, the release of AXT increased substantially, reaching 76% to 78% after 12<!--> <!-->h, While staying low at 8.0% to 9.5% at pH 7.4, this pH-sensitive release pattern results from the increased dissolution of the MOF material in acidic environments. This characteristic makes it a promising approach for targeted cancer therapy. The design of these MOF-based nanocarriers underscores their potential to enhance the precision and effectiveness of anticancer treatments.</div></div><div><div>Depuis sa création, le cancer reste un défi de santé mondial majeur, caractérisé par de faibles taux de survie et des effets secondaires importants liés aux traitements conventionnels. Les structures métallo-organiques (MOF) offrent des caractéristiques distinctives qui les rendent parfaitement adaptées aux applications biomédicales. Dans cette étude, nous avons développé des MOF comme nanoporteurs pour le médicament anticancéreux axitinib (AXT) afin de résoudre ces problèmes. Plus précisément, les MOF étaient composés de tétrachlorure de zinc (ZnCl4) comme ions métalliques et de dioxyde de titane comme ligands, synthétisés via une approche hydrothermale. Le Ti-MOF sensible au pH a été conçu pour améliorer l’administration ciblée de médicaments et minimiser les effets secondaires de l’AXT. Le Ti-MOF a été caractérisé par spectroscopie UV-Vis, spectroscopie infrarouge à transformée de Fourier (FTIR), microscopie électronique à balayage-rayons X à dispersion d’énergie (SEM-EDX), analyse du potentiel zêta, mesure de la taille des particules, spectroscopie Raman et analyse thermogravimétrique. Des études in vitro sur la libération de médicaments à 37<!--> <!-->°C ont démontré que ces supp","PeriodicalId":8332,"journal":{"name":"Annales pharmaceutiques francaises","volume":"84 1","pages":"Pages 101-113"},"PeriodicalIF":1.1,"publicationDate":"2026-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144803312","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":"From inhibition to degradation: Cutting-edge technology in COVID-19 drug discovery","authors":"Emmanuel Adediran , Martin Ikhoyameh , Ololade S. Gbadebo","doi":"10.1016/j.pharma.2025.08.002","DOIUrl":"10.1016/j.pharma.2025.08.002","url":null,"abstract":"<div><div>Proteolysis-targeting chimera (PROTAC) molecules are hetero-bifunctional chemical entities with three different units which include a ligand that binds to a protein of interest; a second ligand that binds to the E3 ubiquitin ligase; and a linker that conjugates the two ligands together. The technology utilizes the ubiquitin-proteasome system (UPS) to target a specific protein and induce its degradation in the cell. PROTAC has drawn the interest of researchers in anti-cancer drug discovery and has yielded a better outcome in degrading regulatory proteins, kinases, nuclear receptors, transcription factors, and enzymes. This paper discusses this technology and its application to COVID-19 drug discovery. In 2019, the Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2), an infectious agent emerged from Wuhan resulting in millions of deaths worldwide. The WHO declared it a global pandemic because of its fast transmissibility and infectivity across the continents. To curtail this menace, efforts were made to develop therapeutics and inhibitors very quickly. Vaccines and therapeutics discovery were fast-tracked, and already FDA-approved drug molecules were also repurposed – many of which were protein inhibitors. However, PROTAC technology potentially offers a more direct and sustainable contribution to anti-COVID drug discovery than protein inhibition-based therapeutics.</div></div><div><div>Les molécules <em>Proteolysis-Targeting Chimera</em> (PROTAC) sont des entités chimiques hétérobifonctionnelles composées de trois unités distinctes : un ligand qui se lie à une protéine d’intérêt ; un second ligand qui se lie à l’ubiquitine ligase E3 ; et un espaceur qui conjugue les deux ligands. Cette technologie utilise le système ubiquitine-protéasome (UPS) pour cibler une protéine spécifique et induire sa dégradation dans la cellule. PROTAC a suscité l’intérêt des chercheurs en recherche de médicaments anticancéreux et a permis d’obtenir de meilleurs résultats dans la dégradation des protéines régulatrices, des kinases, des récepteurs nucléaires, des facteurs de transcription et des enzymes. Cet article présente cette technologie et son application à la recherche de médicaments contre la Covid-19. En 2019, le coronavirus du syndrome respiratoire aigu sévère 2 (SARS-CoV-2), un agent infectieux apparu à Wuhan, a fait des millions de morts dans le monde. L’OMS l’a déclaré pandémie mondiale en raison de sa transmissibilité et de son infectiosité rapides sur tous les continents. Pour endiguer cette menace, des efforts ont été déployés pour développer très rapidement des thérapies et des inhibiteurs. La découverte de vaccins et de thérapies a été accélérée, et des molécules médicamenteuses déjà approuvées par la FDA ont également été réutilisées, dont beaucoup étaient des inhibiteurs de protéines. Cependant, la technologie PROTAC offre potentiellement une contribution plus directe et durable à la découverte de médicaments anti-Covid que les thérapi","PeriodicalId":8332,"journal":{"name":"Annales pharmaceutiques francaises","volume":"84 1","pages":"Pages 48-61"},"PeriodicalIF":1.1,"publicationDate":"2026-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144803313","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":"Acknowledging our reviewers","authors":"","doi":"10.1016/j.pharma.2025.12.006","DOIUrl":"10.1016/j.pharma.2025.12.006","url":null,"abstract":"","PeriodicalId":8332,"journal":{"name":"Annales pharmaceutiques francaises","volume":"84 1","pages":"Page 147"},"PeriodicalIF":1.1,"publicationDate":"2026-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145799741","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":"Crystal structure, spectral characterization, photophysical properties, Hirshfeld surface analysis, and antimicrobial activity of homopiperazinium dichromate(VI)","authors":"Utkirjon Holikulov ,&nbsp;Sonia Trabelsi ,&nbsp;Houda Marouani ,&nbsp;Thierry Roisnel ,&nbsp;Omar M. Al-Dossary ,&nbsp;Abduvakhid Jumabaev ,&nbsp;Noureddine Issaoui","doi":"10.1016/j.pharma.2025.07.010","DOIUrl":"10.1016/j.pharma.2025.07.010","url":null,"abstract":"<div><div>This work presents a comprehensive study of the crystal structure, spectral properties (IR and UV-Vis), thermal behavior, and antimicrobial activity of homopiperazinium dichromate (C₅H1₄N₂)Cr₂O₇(VI). X-ray diffraction reveals that the compound crystallizes in the monoclinic space group <em>P</em>2₁/c, with unit cell dimensions a<!--> <!-->=<!--> <!-->8.7275(8)Å, b<!--> <!-->=<!--> <!-->10.5769(11)Å, and c<!--> <!-->=<!--> <!-->14.7467(10)<!--> <!-->Å and β<!--> <!-->=<!--> <!-->122.941(4)°. The crystal packing is stabilized by intermolecular N–H…O and C–H…O hydrogen bonds, with Hirshfeld surface analysis revealing dominant O…H/H…O interactions contributing 80.5% to the overall crystal cohesion. UV-Vis absorption bands are observed at 279, 354, and 446<!--> <!-->nm, with an estimated band gap energy of 3.019<!--> <!-->eV, indicating high stability and moderate optical activity. Thermal analysis shows an intense endothermic fusion peak followed by continuous decomposition, leading to chromium oxide formation. Antimicrobial tests demonstrate significant inhibition activity against tested pathogens, including notable antifungal effects against Candida albicans. These results highlight the potential of this hybrid material in antimicrobial development and photochemical applications.</div></div><div><div>Ce travail présente une étude approfondie de la structure cristalline, des propriétés spectrales (IR et UV-Vis), du comportement thermique et de l’activité antimicrobienne du dichromate d’homopipérazinium (C5H14N2)Cr2O7 (VI). La diffraction des rayons X révèle que le composé cristallise dans le groupe d’espace monoclinique P21/c, avec les dimensions de la maille unitaire a<!--> <!-->=<!--> <!-->8,7275(8)<!--> <!-->Å, b<!--> <!-->=<!--> <!-->10,5769(11)<!--> <!-->Å et c<!--> <!-->=<!--> <!-->14,7467(10)<!--> <!-->Å, et β<!--> <!-->=<!--> <!-->122,941(4)°. Le packing cristallin est stabilisé par des liaisons hydrogène intermoléculaires N–H…O et C–H…O, avec une analyse de surface de Hirshfeld révélant des interactions dominantes O…H/H…O contribuant à 80,5 % à la cohésion globale du cristal. Les bandes d’absorption UV-Vis sont observées à 279, 354 et 446<!--> <!-->nm, avec une énergie de bande interdite estimée à 3019<!--> <!-->eV, indiquant une stabilité élevée et une activité optique modérée. L’analyse thermique montre un pic endothermique intense de fusion suivi d’une décomposition continue, conduisant à la formation d’oxyde de chrome. Les tests antimicrobiens démontrent une activité d’inhibition significative contre les pathogènes testés, y compris des effets antifongiques notables contre Candida albicans. Ces résultats mettent en évidence le potentiel de ce matériau hybride dans le développement d’agents antimicrobiens et les applications photochimiques.</div></div>","PeriodicalId":8332,"journal":{"name":"Annales pharmaceutiques francaises","volume":"84 1","pages":"Pages 78-89"},"PeriodicalIF":1.1,"publicationDate":"2026-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144774562","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":"Optimization of UV spectrophotometric techniques for tafamidis meglumine detection in pharmaceutical formulations and biological samples: A green chemistry perspective","authors":"Md. Mojeeb G. Khan ,&nbsp;Shubham R. Raut ,&nbsp;Md. Rageeb Md. Usman ,&nbsp;Atul A. Shirkhedkar ,&nbsp;Md. Shamsher Alam ,&nbsp;Zamir G. Khan","doi":"10.1016/j.pharma.2025.08.006","DOIUrl":"10.1016/j.pharma.2025.08.006","url":null,"abstract":"&lt;div&gt;&lt;h3&gt;Objectives&lt;/h3&gt;&lt;div&gt;The primary objective was to develop and validate four novel UV/visible spectrophotometric methods for the quantification of tafamidis meglumine in bulk drug, proprietary capsules, and spiked urine samples, ensuring accuracy, sensitivity, and environmental sustainability for pharmaceutical analysis.&lt;/div&gt;&lt;/div&gt;&lt;div&gt;&lt;h3&gt;Methods&lt;/h3&gt;&lt;div&gt;Four spectrophotometric approaches were established using absorbance and area under the curve (AUC) measurements, employing both zero-order and first-order derivative techniques. Method validation followed ICH guidelines, assessing linearity, accuracy, precision, sensitivity (LOD, LOQ), and greenness. Methanol was used as a green solvent, and eco-friendliness was evaluated using AGREE and ComplexGAPI metrics.&lt;/div&gt;&lt;/div&gt;&lt;div&gt;&lt;h3&gt;Results&lt;/h3&gt;&lt;div&gt;All methods exhibited excellent linearity (R&lt;sup&gt;2&lt;/sup&gt; &lt;!--&gt;=&lt;!--&gt; &lt;!--&gt;0.9980–0.9995) over a 3–18&lt;!--&gt; &lt;!--&gt;μg/mL range. Accuracy was confirmed with recovery rates between 99.00% and 100.57%. Precision studies yielded %RSD values below 2%, indicating high reproducibility. Sensitivity was demonstrated with LOD and LOQ values from 0.27&lt;!--&gt; &lt;!--&gt;μg/mL to 2.3&lt;!--&gt; &lt;!--&gt;μg/mL. The use of methanol minimized environmental impact, and high AGREE and ComplexGAPI scores validated the methods’ eco-friendly nature.&lt;/div&gt;&lt;/div&gt;&lt;div&gt;&lt;h3&gt;Conclusion&lt;/h3&gt;&lt;div&gt;The developed spectrophotometric methods are simple, rapid, sensitive, and environmentally sustainable for quantifying tafamidis meglumine in various matrices. These validated approaches set a new standard for green analytical chemistry in pharmaceutical quality control, ensuring both regulatory compliance and reduced environmental footprint.&lt;/div&gt;&lt;/div&gt;&lt;div&gt;&lt;h3&gt;Objectifs&lt;/h3&gt;&lt;div&gt;L’objectif principal était de développer et valider quatre nouvelles méthodes spectrophotométriques UV/Visible pour la quantification du méglumine de tafamidis dans la substance pure, les gélules commerciales et les échantillons d’urine dopés, en garantissant précision, sensibilité et durabilité environnementale pour l’analyse pharmaceutique.&lt;/div&gt;&lt;/div&gt;&lt;div&gt;&lt;h3&gt;Méthodes&lt;/h3&gt;&lt;div&gt;Quatre approches spectrophotométriques ont été établies en utilisant les mesures d’absorbance et de surface sous la courbe (AUC), avec des techniques dérivées d’ordre zéro et de premier ordre. La validation des méthodes a suivi les lignes directrices ICH, évaluant la linéarité, l’exactitude, la précision, la sensibilité (LOD, LOQ) et l’écocompatibilité. Le méthanol a été utilisé comme solvant vert, et l’impact environnemental a été évalué à l’aide des métriques AGREE et ComplexGAPI.&lt;/div&gt;&lt;/div&gt;&lt;div&gt;&lt;h3&gt;Résultats&lt;/h3&gt;&lt;div&gt;Toutes les méthodes ont montré une excellente linéarité (R&lt;sup&gt;2&lt;/sup&gt; &lt;!--&gt;=&lt;!--&gt; &lt;!--&gt;0,9980–0,9995) sur une plage de 3–18&lt;!--&gt; &lt;!--&gt;μg/mL. L’exactitude a été confirmée avec des taux de récupération entre 99,00 % et 100,57 %. Les études de précision ont donné des valeurs de %RSD inférieures à 2 %, indiquant une reproductibilité élev","PeriodicalId":8332,"journal":{"name":"Annales pharmaceutiques francaises","volume":"84 1","pages":"Pages 124-140"},"PeriodicalIF":1.1,"publicationDate":"2026-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144871118","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":"Trends in FDA drug approvals: 2021–2024 insights & innovations","authors":"Geet Raut,&nbsp;Sanjay Sharma","doi":"10.1016/j.pharma.2025.06.004","DOIUrl":"10.1016/j.pharma.2025.06.004","url":null,"abstract":"<div><div>From 2021–2024, the U.S. Food and Drug Administration (FDA) approved novel drugs, advancing treatments in neurology, oncology, infectious diseases and rare disorders. This review analyzes approval trends, highlighting the targeted diseases and biologics, the rise of expedited pathways and focus on unmet medical needs. These examines key therapeutic areas the approval trends of different categories. The analysis draws on data from the FDA's Center for Drug Evaluation and Research (CDER) to provide insights into novel drug indication, regulatory innovations and their implications to healthcare. The review analyzes trends in drug approvals.</div></div><div><div>Entre 2021 et 2024, la <em>Food and Drug Administration</em> (FDA) américaine a approuvé de nouveaux médicaments, faisant progresser les traitements en neurologie, en oncologie, dans les maladies infectieuses et les maladies rares. Cette revue met en lumière les tendances d’approbation, en mettant l’accent sur les maladies et les produits biologiques ciblés, l’essor des procédures accélérées et l’accent sur les besoins médicaux non satisfaits. Ces domaines thérapeutiques importants sont examinés parallèlement aux tendances d’approbation des différentes catégories. L’analyse s’appuie sur les données du Centre d’évaluation et de recherche des médicaments (CDER) de la FDA pour fournir un aperçu des indications des nouveaux médicaments, des innovations réglementaires et de leurs implications pour les soins de santé. La revue analyse les tendances en matière d’approbation des médicaments.</div></div>","PeriodicalId":8332,"journal":{"name":"Annales pharmaceutiques francaises","volume":"83 6","pages":"Pages 1062-1072"},"PeriodicalIF":1.1,"publicationDate":"2025-11-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144526267","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":"In pursuit of software solutions for pharmaceutical regulatory affairs: Insights and trends","authors":"Shrushti Sharma ,&nbsp;Dyandevi Mathure ,&nbsp;Shreyas Dingankar ,&nbsp;Vividha Dhapte-Pawar","doi":"10.1016/j.pharma.2025.05.005","DOIUrl":"10.1016/j.pharma.2025.05.005","url":null,"abstract":"&lt;div&gt;&lt;div&gt;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.&lt;/div&gt;&lt;/div&gt;&lt;div&gt;&lt;div&gt;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 ,&nbsp;Ambreen-Malik Uttra ,&nbsp;Sumera Qasim ,&nbsp;Abdul Malik ,&nbsp;Aisha Mobashar","doi":"10.1016/j.pharma.2025.04.007","DOIUrl":"10.1016/j.pharma.2025.04.007","url":null,"abstract":"&lt;div&gt;&lt;h3&gt;Objective&lt;/h3&gt;&lt;div&gt;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.&lt;/div&gt;&lt;/div&gt;&lt;div&gt;&lt;h3&gt;Materials and methods&lt;/h3&gt;&lt;div&gt;&lt;span&gt;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 &lt;/span&gt;formalin&lt;span&gt; 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.&lt;/span&gt;&lt;/div&gt;&lt;/div&gt;&lt;div&gt;&lt;h3&gt;Results&lt;/h3&gt;&lt;div&gt;Theobromine exhibited significant analgesic effects, reducing writhing behavior by 42.71% at 200&lt;!--&gt; &lt;span&gt;&lt;span&gt;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 &lt;/span&gt;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.&lt;/span&gt;&lt;/div&gt;&lt;/div&gt;&lt;div&gt;&lt;h3&gt;Conclusion&lt;/h3&gt;&lt;div&gt;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.&lt;/div&gt;&lt;/div&gt;&lt;div&gt;&lt;h3&gt;Objectif&lt;/h3&gt;&lt;div&gt;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.&lt;/div&gt;&lt;/div&gt;&lt;div&gt;&lt;h3&gt;Matériels et méthodes&lt;/h3&gt;&lt;div&gt;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}