Annales pharmaceutiques francaises最新文献

{"title":"Release of chlororotetracycline hydrochloride from novel hydrogels based on crosslinked chitosan and PVA","authors":"Mohammed Amine Zitouni ,&nbsp;Mustapha Chabane ,&nbsp;Chikh Melkaoui","doi":"10.1016/j.pharma.2025.05.001","DOIUrl":"10.1016/j.pharma.2025.05.001","url":null,"abstract":"<div><div>Hydrogels based on hydrochloride polyvinyl alcohol (PVA) containing chlortetracycline and crosslinked chitosan (CS) by glutaraldehyde (GLA) were prepared by the freeze-thawing method and then characterized. The swelling properties and gel fraction of these hydrogels were studied and characterized by FTIR spectroscopy, the thermal and mechanical properties were evaluated by DSC and rheology. Controlled release of chlortetracycline hydrochloride from these hydrogels was studied by UV–Visible spectroscopy. The gel fraction decreases with increase of crosslinked chitosan concentration in hydrogel but the swelling was more important due to the relaxation of the hydrogel, and the extension of macromolecular chains in the system. The crystallinity of these hydrogels increased with increasing PVA concentration. All these hydrogels exhibited a gel character with a high crosslinking degree and possessed a network structure. The release of chlortetracycline hydrochloride from these hydrogels was occurred by fickian diffusion, faster at 37<!--> <!-->°C than at 25<!--> <!-->°C because hydrogels were more swollen at 37<!--> <!-->°C and their network densities were decreased to perfect the release of drugs from hydrogels.</div></div><div><div>Des hydrogels à base de polyalcool vinylique (PVA) et de chitosane (CS) réticulé par le glutaraldéhyde (GLA) contenant de la chlortétracycline ont été préparés par la méthode de congélation-décongélation puis caractérisés. Les propriétés de gonflement et la fraction de gel de ces hydrogels ont été étudiées et caractérisées par spectroscopie FTIR. Les propriétés thermiques et mécaniques ont été évaluées par DSC et rhéologie. La libération contrôlée de l’hydrochlorure de chlortétracycline à partir de ces hydrogels a été étudiée par spectroscopie UV–Visible. La fraction de gel diminue avec l’augmentation de la concentration en chitosane réticulé dans l’hydrogel, mais le gonflement est plus important en raison de la relaxation de l’hydrogel et de l’extension des chaînes macromoléculaires dans le système. La cristallinité de ces hydrogels a augmenté avec l’augmentation de la concentration de PVA. Tous ces hydrogels présentent un caractère de gel avec un degré de réticulation élevé et possèdent une structure de réseau. La libération de l’hydrochlorure de chlortétracycline à partir de ces hydrogels s’est produite par diffusion fickienne, plus rapide à 37<!--> <!-->°C qu’à 25<!--> <!-->°C car les hydrogels étaient plus gonflés à 37<!--> <!-->°C et leurs densités de réseau étaient réduites, facilitant ainsi la libération des médicaments à partir des hydrogels.</div></div>","PeriodicalId":8332,"journal":{"name":"Annales pharmaceutiques francaises","volume":"83 5","pages":"Pages 954-967"},"PeriodicalIF":1.1,"publicationDate":"2025-09-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143960817","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":"Formulation and evaluation of a smart mucoadhesive nasal gel containing oregano, chamomile, and lavender for seizure control in PTZ-induced seizure model in rats","authors":"Samin Sheikholeslami ,&nbsp;Amir Baghaei ,&nbsp;Marziyeh Amiri-Andebili ,&nbsp;Faranak Salmannejad ,&nbsp;Mohammad Mahdi Ahmadian-Attari","doi":"10.1016/j.pharma.2025.03.004","DOIUrl":"10.1016/j.pharma.2025.03.004","url":null,"abstract":"&lt;div&gt;&lt;h3&gt;Background&lt;/h3&gt;&lt;div&gt;Epilepsy is a prevalent neurological disorder characterized by recurrent seizures, affecting approximately 1% of the global population. Despite the availability of antiepileptic drugs, a significant proportion of patients experience uncontrolled seizures, which necessitates the development of alternative therapeutic strategies. Herbal medicine has gained attention due to its potential anticonvulsant properties.&lt;/div&gt;&lt;/div&gt;&lt;div&gt;&lt;h3&gt;Objectives&lt;/h3&gt;&lt;div&gt;This study aimed to assess the anticonvulsant effects of hydroalcoholic extracts of oregano, chamomile, and lavender in rats’ pentylenetetrazol (PTZ)- induced seizure model. Furthermore, it sought to formulate and evaluate a mucoadhesive nasal hydrogel containing these extracts.&lt;/div&gt;&lt;/div&gt;&lt;div&gt;&lt;h3&gt;Methods&lt;/h3&gt;&lt;div&gt;The herbal extracts were prepared using ethanol (70%) through maceration and analyzed based on the Iranian Herbal Pharmacopeia standards. Total phenolic content (TPC) was quantified using the spectrophotometric method to standardize the extracts. Using various gelling agents, the nasal hydrogel formulation was optimized for mucoadhesion and gelation properties. The anticonvulsant activity was evaluated in vivo using seizure models induced by pentylenetetrazol (PTZ).&lt;/div&gt;&lt;/div&gt;&lt;div&gt;&lt;h3&gt;Results&lt;/h3&gt;&lt;div&gt;The herbal extracts met the pharmacopeial standards, and the nasal hydrogel formulation demonstrated favorable physicochemical properties, including optimal pH and mucoadhesive strength. In vivo studies showed that intranasal administration of the herbal extracts significantly delayed seizure onset and reduced seizure intensity at a dose of 34&lt;!--&gt; &lt;!--&gt;mg/kg, compared to the negative control group (&lt;em&gt;P&lt;/em&gt; &lt;!--&gt;&lt;&lt;!--&gt; &lt;!--&gt;0.001).&lt;/div&gt;&lt;/div&gt;&lt;div&gt;&lt;h3&gt;Conclusion&lt;/h3&gt;&lt;div&gt;The smart mucoadhesive nasal hydrogel containing oregano, chamomile, and lavender extracts exhibited promising anticonvulsant activity, suggesting its potential as a novel, non-invasive alternative for epilepsy management.&lt;/div&gt;&lt;/div&gt;&lt;div&gt;&lt;h3&gt;Contexte&lt;/h3&gt;&lt;div&gt;L’épilepsie est un trouble neurologique répandu caractérisé par des crises récurrentes, touchant environ 1 % de la population mondiale. Malgré la disponibilité des médicaments antiépileptiques, une proportion importante de patients souffrent de crises incontrôlées, ce qui nécessite le développement de stratégies thérapeutiques alternatives. La phytothérapie a attiré l’attention en raison de ses propriétés anticonvulsivantes potentielles.&lt;/div&gt;&lt;/div&gt;&lt;div&gt;&lt;h3&gt;Objectifs&lt;/h3&gt;&lt;div&gt;Cette étude visait à évaluer les effets anticonvulsivants des extraits hydroalcooliques d’origan, de camomille et de lavande dans le modèle de crise induite par le pentylènetétrazole (PTZ) chez le rat. De plus, elle visait à formuler et à évaluer un hydrogel nasal mucoadhésif contenant ces extraits.&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 préparés à l’éthanol (70 %) par macération et analysés selon les normes de la pharmacopée iranie","PeriodicalId":8332,"journal":{"name":"Annales pharmaceutiques francaises","volume":"83 5","pages":"Pages 852-861"},"PeriodicalIF":1.1,"publicationDate":"2025-09-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143673408","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":"Cheminformatic profiling of Azardirachta indica phytochemicals as dual SHP2/HSP90 oncogenic inhibitors: Identification of nimbocinol, nimbidinin, and margolone","authors":"Oluwaseun E. Agboola ,&nbsp;Zainab A. Ayinla ,&nbsp;Oladayo E. Apalowo ,&nbsp;Samuel S. Agboola ,&nbsp;Omotola M. Fajana ,&nbsp;Bidemi E. Ekundayo ,&nbsp;Babamotemi O. Itakorode ,&nbsp;Babatunji E. Oyinloye","doi":"10.1016/j.pharma.2025.04.001","DOIUrl":"10.1016/j.pharma.2025.04.001","url":null,"abstract":"<div><div>Cancer therapy faces challenges due to drug resistance and signaling pathway redundancy, allowing cancer cells to evade treatment. Dual inhibition of Src homology region 2 domain-containing phosphatase-2 (SHP2) and heat shock protein 90 (HSP90) offers a promising strategy to overcome these limitations. We evaluated neem-derived compounds against SHP2 (PDB ID: 5EHR) and HSP90 (PDB ID: 1YET) using molecular docking, hierarchical clustering, and structural similarity analyses. Drug-likeness was assessed using Lipinski's rule of five, and Tanimoto similarity coefficients were calculated. Nimbocinol, nimbidin, and margolone showed promising binding affinities to both targets. Nimbocinol demonstrated superior binding to SHP2 (−10.463<!--> <!-->kcal/mol) compared to SHP099 (−10.009<!--> <!-->kcal/mol). Margolone formed specific interactions, including a salt bridge between its carboxylate group and His100 in HSP90. All compounds complied with Lipinski's rule, with margolone showing structural similarities to geldanamycin and SHP099. This study identifies neem-derived compounds as potential dual inhibitors of SHP2 and HSP90, presenting a paradigm shift in cancer therapeutic strategy. These findings provide a foundation for developing novel multi-targeted anticancer therapeutics.</div></div><div><div>Le traitement du cancer est confronté à des défis en raison de la résistance aux médicaments et de la redondance des voies de signalisation. La double inhibition de région d’homologie Src 2 contenant le domaine phosphate-2 (SHP2) et protéine de choc thermique 90 (HSP90) offre une stratégie prometteuse pour surmonter ces limitations. Nous avons évalué les composés dérivés du neem par rapport à SHP2 (PDB ID : 5EHR) et HSP90 (PDB ID : 1YET) en utilisant l’amarrage moléculaire, le clustering hiérarchique et les analyses de similarité structurelle. La similarité médicamenteuse a été évaluée à l’aide de la règle de Lipinski de cinq, et les coefficients de similarité de Tanimoto ont été calculés. Le nimbocinol, la nimbidine et la margolone ont montré des affinités de liaison prometteuses aux deux cibles. Le nimbocinol a démontré une liaison supérieure à SHP2 (−10,463<!--> <!-->kcal/mol) par rapport à SHP099 (−10,009<!--> <!-->kcal/mol). La margolone a formé des interactions spécifiques, notamment un pont salin entre son groupe carboxylate et His100 dans HSP90. Tous les composés étaient conformes à la règle de Lipinski, la margolone présentant des similitudes structurelles avec la geldanamycine et SHP099. Cette étude identifie les composés dérivés du neem comme des inhibiteurs doubles potentiels de SHP2 et HSP90, ce qui représente un changement de paradigme dans la stratégie thérapeutique contre le cancer. Ces résultats fournissent une base pour le développement de nouvelles thérapies anticancéreuses multi-cibles.</div></div>","PeriodicalId":8332,"journal":{"name":"Annales pharmaceutiques francaises","volume":"83 5","pages":"Pages 907-920"},"PeriodicalIF":1.1,"publicationDate":"2025-09-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143957758","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":"Drug deprescribing policy and incentives in France","authors":"Francis Megerlin ,&nbsp;Gilles Bouvenot ,&nbsp;Patrice Queneau","doi":"10.1016/j.pharma.2025.04.003","DOIUrl":"10.1016/j.pharma.2025.04.003","url":null,"abstract":"<div><div>Deprescribing inappropriate drug treatments is a public health issue particularly in countries with a high level of polymedication (polypharmacy). Despite the introduction of the term ‘deprescribing’ in France in 2002 and the clinical practice guidelines, progress in the outpatient sector has been limited. Our article describes the financial incentives adopted by national agreements between the Assurance Maladie (France's compulsory health insurer scheme) and unions of independent practitioners: pharmacists are encouraged to draw up and share medication reviews (since 2018, target population extended in 2022). As the outcomes have been modest, doctors have then been since 2024 also incentivised to offer medical consultations explicitly dedicated to deprescribing, and to prescribe medication reviews to be drawn up by pharmacists. This article describes the new legal framework for outpatient and inpatient services. It calls for the results expected from 2025 onwards to be measured and studied in national health databases, thanks to the coding associated with these new services.</div></div><div><div>La déprescription de médicaments (devenus) inappropriés est partout un enjeu de santé publique, notamment dans les pays de forte polymédication. Malgré l’introduction du terme « déprescription » en France dès 2002 et les recommandations de pratique clinique, ses progrès en secteur ambulatoire ont été limités. Notre article décrit les incitations financières adoptées par conventions nationales entre l’Assurance maladie (assureur santé obligatoire en France) et les syndicats de praticiens indépendants : les pharmaciens sont incités à établir et partager des bilans de médication (depuis 2018, population cible étendue en 2022). Mais les résultats ayant été modestes, les médecins sont depuis 2024 financièrement incités à proposer des consultations médicales dédiées à la déprescription, et à prescrire des bilans de médication par les pharmaciens. Cet article décrit le nouveau cadre en droit en secteur ambulatoire et hospitalier, et invite à en étudier les effets attendus dès 2025 sur les bases de données nationales grâce au codage pour le paiement de nouveaux services.</div></div>","PeriodicalId":8332,"journal":{"name":"Annales pharmaceutiques francaises","volume":"83 5","pages":"Pages 933-940"},"PeriodicalIF":1.1,"publicationDate":"2025-09-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143959757","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":"PLAROsomes as a modified liposomes delivery system for Mimosa pudica L. extract: Augmenting anticancer potential against prostate and skin cancer cell lines","authors":"Vaishali K. Gaikwad ,&nbsp;Ravindra B. Laware ,&nbsp;Nitin Mohire ,&nbsp;Somnath Devidas Bhinge","doi":"10.1016/j.pharma.2025.04.004","DOIUrl":"10.1016/j.pharma.2025.04.004","url":null,"abstract":"&lt;div&gt;&lt;h3&gt;Objective&lt;/h3&gt;&lt;div&gt;PLAROsomes, a modified liposomal drug carrier system, were developed to overcome the major drawback of drug leakage in conventional liposomes. This study aimed to encapsulate Mimosa pudica L. extract (MIPA) within PLAROsomes to enhance anticancer efficacy against prostate (PC-3) and skin (B16F10) cancer cell lines.&lt;/div&gt;&lt;/div&gt;&lt;div&gt;&lt;h3&gt;Method&lt;/h3&gt;&lt;div&gt;PLAROsomes were formulated using the thin-film hydration technique and characterized through infrared (IR) and ultraviolet (UV) spectroscopy, thermal analysis (TGA and DSC), particle size distribution, zeta potential measurement, and morphological assessment via SEM and TEM. Key formulation parameters, including encapsulation efficiency (%EE), drug loading capacity (%DLC), and drug release (%DR), were optimized for stability and efficacy. Cytotoxicity was evaluated using the MTT assay. Additionally, MIPA-loaded PLAROsomes were prepared without 2-methyl-resorcinol to assess its role in preventing drug leakage.&lt;/div&gt;&lt;/div&gt;&lt;div&gt;&lt;h3&gt;Results&lt;/h3&gt;&lt;div&gt;The optimized MIPA-loaded PLAROsomes had a particle size of 193.2&lt;!--&gt; &lt;!--&gt;±&lt;!--&gt; &lt;!--&gt;41.6&lt;!--&gt; &lt;!--&gt;nm, confirmed by TEM at 139&lt;!--&gt; &lt;!--&gt;±&lt;!--&gt; &lt;!--&gt;15&lt;!--&gt; &lt;!--&gt;nm. They exhibited higher encapsulation efficiency (83.45&lt;!--&gt; &lt;!--&gt;±&lt;!--&gt; &lt;!--&gt;0.45%) and drug loading (9.85%) compared to formulations without 2-methyl-resorcinol (74.56&lt;!--&gt; &lt;!--&gt;±&lt;!--&gt; &lt;!--&gt;0.65% EE and 8.80% DLC), indicating its stabilizing effect. Drug release followed the Korsmeyer-Peppas model, demonstrating a sustained profile. At 100&lt;!--&gt; &lt;!--&gt;μg/mL, MIPA-loaded PLAROsomes significantly reduced cell viability (52.22&lt;!--&gt; &lt;!--&gt;±&lt;!--&gt; &lt;!--&gt;1.54% in B16F10 and 45.57&lt;!--&gt; &lt;!--&gt;±&lt;!--&gt; &lt;!--&gt;0.80% in PC-3), outperforming the free extract.&lt;/div&gt;&lt;/div&gt;&lt;div&gt;&lt;h3&gt;Conclusion&lt;/h3&gt;&lt;div&gt;MIPA-loaded PLAROsomes exhibit enhanced anticancer potential and could serve as an effective targeted therapy, warranting further clinical investigation.&lt;/div&gt;&lt;/div&gt;&lt;div&gt;&lt;h3&gt;Objectif&lt;/h3&gt;&lt;div&gt;Les PLAROsomes, un système de transport de médicament liposomal modifié, ont été développés pour surmonter l’inconvénient majeur de la fuite de médicament dans les liposomes conventionnels. Cette étude visait à encapsuler l’extrait de Mimosa pudica L. (MIPA) dans les PLAROsomes pour améliorer l’efficacité anticancéreuse contre les lignées cellulaires cancéreuses de la prostate (PC-3) et de la peau (B16F10).&lt;/div&gt;&lt;/div&gt;&lt;div&gt;&lt;h3&gt;Méthode&lt;/h3&gt;&lt;div&gt;Les PLAROsomes ont été formulés en utilisant la technique d’hydratation en couche mince et caractérisés par spectroscopie infrarouge (IR) et ultraviolette (UV), analyse thermique (TGA et DSC), distribution granulométrique, mesure du potentiel zêta et évaluation morphologique via SEM et TEM. Les principaux paramètres de formulation, notamment l’efficacité d’encapsulation (%EE), la capacité de chargement du médicament (%DLC) et la libération du médicament (%DR), ont été optimisés pour la stabilité et l’efficacité. La cytotoxicité a été évaluée à l’aide du test MTT. D","PeriodicalId":8332,"journal":{"name":"Annales pharmaceutiques francaises","volume":"83 5","pages":"Pages 968-980"},"PeriodicalIF":1.1,"publicationDate":"2025-09-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143974879","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":"Formulation of repurposed celecoxib-loaded nanostructured lipid carriers using Box-Behnken design, its characterization, and anticancer evaluation","authors":"Ashwini Bhavar ,&nbsp;Kaustubh Ajit Kolekar ,&nbsp;Tejashree Yadav ,&nbsp;Kapil Kole ,&nbsp;Durgacharan Bhagwat ,&nbsp;Sachin Kumar Singh ,&nbsp;Popat S. Kumbhar ,&nbsp;John Disouza","doi":"10.1016/j.pharma.2025.03.005","DOIUrl":"10.1016/j.pharma.2025.03.005","url":null,"abstract":"&lt;div&gt;&lt;h3&gt;Objectives&lt;/h3&gt;&lt;div&gt;The key objective of present research is to effectively treat lung cancer with repurposed celecoxib while overcoming challenges such as solubility, bioavailability, non-selectivity, and negative effects by delivering celecoxib through nanostructured lipid carriers via the parenteral route.&lt;/div&gt;&lt;/div&gt;&lt;div&gt;&lt;h3&gt;Methods&lt;/h3&gt;&lt;div&gt;Celecoxib-laden nanostructured lipid carriers were manufactured by melt-emulsification ultrasonication approach and optimized through Box-Behnken design. The celecoxib nanostructured lipid carriers were examined for particle size, % entrapment efficiency, zeta potential, in vitro release, cytotoxicity, stability, etc.&lt;/div&gt;&lt;/div&gt;&lt;div&gt;&lt;h3&gt;Results&lt;/h3&gt;&lt;div&gt;The optimized celecoxib nanostructured lipid carriers displayed a % entrapment efficiency of 91.69&lt;!--&gt; &lt;!--&gt;±&lt;!--&gt; &lt;!--&gt;4.9% and particle size of 132.1&lt;!--&gt; &lt;!--&gt;±&lt;!--&gt; &lt;!--&gt;6.8&lt;!--&gt; &lt;!--&gt;nm with a polydispersity index of 0.41&lt;!--&gt; &lt;!--&gt;±&lt;!--&gt; &lt;!--&gt;0.06, and a zeta potential of −39.1&lt;!--&gt; &lt;!--&gt;±&lt;!--&gt; &lt;!--&gt;3.0&lt;!--&gt; &lt;!--&gt;mV. Notably, celecoxib nanostructured lipid carriers exhibited better and controlled celecoxib release at phosphate buffer solution pH 6.8 than pH 7.4, revealing the tumor-targeting potential of nanostructured lipid carriers. Also, the release of celecoxib from nanostructured lipid carriers was controlled for 48&lt;!--&gt; &lt;!--&gt;h, indicating reduced chances of systemic toxicity. The in vitro cytotoxicity against A549 cells of celecoxib nanostructured lipid carriers was 1.5-fold greater than that of pure celecoxib, confirming significant anti-lung cancer effectiveness. Further, the celecoxib-loaded nanostructured lipid carriers remained stable for twelve weeks at cold and ambient temperatures.&lt;/div&gt;&lt;/div&gt;&lt;div&gt;&lt;h3&gt;Conclusion&lt;/h3&gt;&lt;div&gt;Thus, the given research concludes that parenteral administration of nanostructured lipid carriers could be a harmless, efficient, and novel choice to treat lung cancer using repurposed celecoxib.&lt;/div&gt;&lt;/div&gt;&lt;div&gt;&lt;h3&gt;Objectifs&lt;/h3&gt;&lt;div&gt;L’objectif principal de la recherche actuelle est de traiter efficacement le cancer du poumon avec du célécoxib réutilisé tout en surmontant les défis tels que la solubilité, la biodisponibilité, la non-sélectivité et les effets négatifs en administrant du célécoxib via des transporteurs lipidiques nanostructurés par voie parentérale.&lt;/div&gt;&lt;/div&gt;&lt;div&gt;&lt;h3&gt;Méthodes&lt;/h3&gt;&lt;div&gt;Les transporteurs lipidiques nanostructurés chargés de célécoxib ont été fabriqués par une approche d’émulsification par fusion par ultrasons et optimisés par la conception Box-Behnken. Les transporteurs lipidiques nanostructurés de célécoxib ont été examinés pour la taille des particules, le pourcentage d’efficacité de piégeage, le potentiel zêta, la libération in vitro, la cytotoxicité, la stabilité, etc.&lt;/div&gt;&lt;/div&gt;&lt;div&gt;&lt;h3&gt;Résultats&lt;/h3&gt;&lt;div&gt;Les transporteurs lipidiques nanostructurés de célécoxib optimisés ont affiché une efficacité de piégeage de 91,69&lt;!--&gt; &lt;!--&gt;±&lt;!--&gt; &lt;!--&gt;4,9 % et une taille de particu","PeriodicalId":8332,"journal":{"name":"Annales pharmaceutiques francaises","volume":"83 5","pages":"Pages 862-875"},"PeriodicalIF":1.1,"publicationDate":"2025-09-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143741904","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":"Le biologiste médical sous la loupe sémiotique","authors":"Bertrand Lefrère ,&nbsp;Lionel Barrand ,&nbsp;Jean-Louis Beaudeux","doi":"10.1016/j.pharma.2025.03.003","DOIUrl":"10.1016/j.pharma.2025.03.003","url":null,"abstract":"<div><div>En France, l’exercice de la biologie médicale suscite, depuis une dizaine d’année, un certain désamour des étudiants en médecine. Malgré son intrication et son importance dans le parcours de soin, l’univers du laboratoire clinique manque de visibilité pratique dans les études médicales. Si la désaffection ne peut être directement imputée à ce phénomène structurel, au regard de phénomènes plus récents, l’accès et la qualité de l’information pour l’orientation vers les études conduisant à la biologie médicale apparaissent essentiels. Ceci nous a conduit à interroger l’image, au sens iconographique du terme, associée au métier, via une analyse sémiotique. En dépit de quelques fantaisies, le corpus iconographique obtenu, composé d’images numériques éditées depuis dix ans, offre une vision consensuelle, assez raisonnable, centrée sur la phase analytique ; cet aperçu tronqué du métier reflète de manière très imparfaite la richesse d’exercices, de spécialités, la complexité technologique de l’analyse biologique et la relation avec les patients et l’équipe soignante. À ce titre, l’interaction clinique, avec le patient ou le clinicien, demeure, sauf exception, absente, interrogeant l’impact sur la perception du métier suscitée chez les étudiants.</div></div><div><div>In France, the practice of laboratory medicine has, over the past ten years or so, met with a certain amount of disenchantment from medical students. Despite its intricacy and importance to healthcare, the world of the clinical laboratory lacks visibility in medical studies. While other phenomena can explain this disenchantment, our belief in the importance of promoting greater visibility of laboratory medicine in medical studies led us to examine for this article the images and symbols associated with the profession, based on a semiotic analysis. We created a collection of digital images published over the last ten years and found that these images, aside from a few outliers, offer a fairly reasonable representation of the analytical dimension of laboratory medicine. However, we found that this collection of images does not reflect the wealth of specialities, technological complexity and other important aspects of the practice of laboratory medicine especially regarding the clinical staff. Furthermore, we found that clinical interactions (i.e., interactions with patients or doctors) remain, with a few exceptions, absent from most of the images, raising questions about the impact of the images on medical students’ perceptions of the profession.</div></div>","PeriodicalId":8332,"journal":{"name":"Annales pharmaceutiques francaises","volume":"83 5","pages":"Pages 819-824"},"PeriodicalIF":1.1,"publicationDate":"2025-09-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143639491","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":"Ethyl cellulose-based in-situ film of itraconazole for enhanced treatment of fungal infections","authors":"Lutfi Chabib ,&nbsp;Yulianto ,&nbsp;Putri Wulandari Resky Ananda ,&nbsp;Rifka Nurul Utami ,&nbsp;Maria Mir ,&nbsp;Diany Elim ,&nbsp;Andi Maqhfirah Nurul Fitri ,&nbsp;Hilman Syamami Zaman ,&nbsp;Anugerah Yaumil Ramadhani Aziz ,&nbsp;Nurul Fauziah ,&nbsp;Latifah Rahman ,&nbsp;M. Pandoman Febrian ,&nbsp;Andi Dian Permana","doi":"10.1016/j.pharma.2025.04.002","DOIUrl":"10.1016/j.pharma.2025.04.002","url":null,"abstract":"&lt;div&gt;&lt;h3&gt;Objectives&lt;/h3&gt;&lt;div&gt;Fungal infections represent a significant global health challenge, requiring effective treatments to prevent complications and improve patient outcomes. This study aimed to develop an in-situ film-forming system (IFFS) for transcutaneous delivery of itraconazole (ITZ) as an alternative to oral administration, addressing issues such as low bioavailability, reduced efficacy, and potential side effects.&lt;/div&gt;&lt;/div&gt;&lt;div&gt;&lt;h3&gt;Materials and methods&lt;/h3&gt;&lt;div&gt;The IFFS was formulated using ethyl cellulose as the primary polymer, PEG 400 as a plasticizer, and a eutectic mixture of menthol and camphor as penetration enhancers. The system was characterized for viscosity, pH, drying time, water vapor permeability, bioadhesion, and physicochemical interactions (DSC and FTIR). Ex vivo skin permeation and retention studies were conducted using Franz diffusion cells, and antifungal efficacy was tested on an ex vivo &lt;em&gt;Candida albicans&lt;/em&gt; infection model. Skin integrity and hemolysis tests were performed to evaluate safety.&lt;/div&gt;&lt;/div&gt;&lt;div&gt;&lt;h3&gt;Results&lt;/h3&gt;&lt;div&gt;The IFFS exhibited desirable physicochemical properties, with increased polymer concentrations enhancing skin retention and bioadhesive strength while reducing permeation rates. Ex vivo studies showed sustained ITZ release and enhanced skin retention. The antifungal activity test demonstrated complete eradication of &lt;em&gt;Candida albicans&lt;/em&gt; within 48&lt;!--&gt; &lt;!--&gt;hours. Safety assessments confirmed no skin irritation or toxicity.&lt;/div&gt;&lt;/div&gt;&lt;div&gt;&lt;h3&gt;Conclusion&lt;/h3&gt;&lt;div&gt;The developed IFFS provides a safe and effective transcutaneous delivery system for ITZ. This innovative approach enhances antifungal efficacy, improves skin retention, and offers a promising alternative to oral administration, minimizing systemic side effects.&lt;/div&gt;&lt;/div&gt;&lt;div&gt;&lt;h3&gt;Objectifs&lt;/h3&gt;&lt;div&gt;Les infections fongiques constituent un défi majeur pour la santé mondiale, nécessitant des traitements efficaces pour prévenir les complications et améliorer les résultats cliniques. Cette étude visait à développer un système de film formant in-situ (IFFS) pour l’administration transcutanée de l’itraconazole (ITZ) en tant qu’alternative à l’administration orale, afin de résoudre des problèmes tels qu’une faible biodisponibilité, une efficacité réduite et des effets secondaires potentiels.&lt;/div&gt;&lt;/div&gt;&lt;div&gt;&lt;h3&gt;Matériels et méthodes&lt;/h3&gt;&lt;div&gt;L’IFFS a été formulé en utilisant l’éthylcellulose comme polymère principal, le PEG 400 comme plastifiant et un mélange eutectique de menthol et de camphre comme agents de pénétration. Le système a été caractérisé en termes de viscosité, pH, temps de séchage, perméabilité à la vapeur d’eau, bioadhésion et interactions physicochimiques (DSC et FTIR). Des études ex vivo sur la perméation et la rétention cutanées ont été menées avec des cellules de diffusion de Franz, et l’efficacité antifongique a été testée sur un modèle d’infection ex vivo par &lt;em&gt;Candida albicans&lt;/em&gt;. Des tests d’in","PeriodicalId":8332,"journal":{"name":"Annales pharmaceutiques francaises","volume":"83 5","pages":"Pages 921-932"},"PeriodicalIF":1.1,"publicationDate":"2025-09-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143968500","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":"The paradigm shift from Stringent Regulatory Authorities to WHO-Listed Authorities","authors":"Valérie Faillat","doi":"10.1016/j.pharma.2025.03.006","DOIUrl":"10.1016/j.pharma.2025.03.006","url":null,"abstract":"<div><div>Regulatory systems play a key role in assuring the quality, safety, and efficacy of health products. After more than 20 years of efforts on regulatory capacity improvement of the less-equipped National Regulatory Authorities, the transition from the concept of Stringent Regulatory Authorities (SRAs) to WHO-Listed Authorities (WLAs) represents a significant paradigm shift in global health ecosystem. This review aims to provide a better understanding of this evolution and to clarify the WLA concept, as a component for the long-term success of this framework.</div></div><div><div>Les systèmes de réglementation jouent un rôle clé dans l’assurance de la qualité, de la sécurité et de l’efficacité des produits de santé. Après plus de 20 ans d’efforts pour renforcer les capacités réglementaires des Autorités nationales de réglementation les moins équipées, la transition du concept de <em>Stringent Regulatory Authorities</em> (SRAs – autorités réglementaires strictes) vers celui de <em>WHO-Listed Authorities</em> (WLAs – autorités réglementaires listées par l’Organisation Mondiale de la Santé) représente un changement de paradigme significatif dans l’écosystème de la santé mondiale. Cette revue vise à mieux comprendre cette évolution et à clarifier le concept de WLA, en tant qu’élément essentiel pour le succès à long terme de ce cadre réglementaire.</div></div>","PeriodicalId":8332,"journal":{"name":"Annales pharmaceutiques francaises","volume":"83 5","pages":"Pages 810-818"},"PeriodicalIF":1.1,"publicationDate":"2025-09-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143778728","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":"ICH-Q3D based elemental impurities study in an oral drug product: Risk assessment according to the component approach (option 2b) confirmed by the finished product analysis (option 3)","authors":"Ayoub Hamidallah,&nbsp;Mohamed Yafout,&nbsp;Ibrahim Sbai El Otmani","doi":"10.1016/j.pharma.2025.05.002","DOIUrl":"10.1016/j.pharma.2025.05.002","url":null,"abstract":"&lt;div&gt;&lt;h3&gt;Background&lt;/h3&gt;&lt;div&gt;Elemental impurities (EIs) in pharmaceutical products pose potential health risks, requiring strict regulatory control. The ICH Q3D guideline outlines two approaches for assessing EIs: the component approach, which estimates impurity levels based on supplier data, and the finished product approach, which directly quantifies EIs in the final drug product. This study compares both methods to evaluate their reliability in ensuring compliance with safety limits.&lt;/div&gt;&lt;/div&gt;&lt;div&gt;&lt;h3&gt;Methods&lt;/h3&gt;&lt;div&gt;A risk assessment of EIs in an oral effervescent drug product was performed using the component approach (ICH Q3D option 2b) by compiling impurity data from raw materials and packaging components. The estimated daily exposure levels were compared to permitted daily exposure (PDE) limits. To validate these findings, ICP-MS analysis (ICH Q3D option 3) was conducted on three batches of the finished product, quantifying 24 elemental impurities following USP &lt;233&gt; guidelines.&lt;/div&gt;&lt;/div&gt;&lt;div&gt;&lt;h3&gt;Results&lt;/h3&gt;&lt;div&gt;The component approach have indicated that all estimated EI levels were well below 30% of PDE, suggesting no need for additional controls. ICP-MS analysis of the finished product confirmed these findings, with actual EI concentrations consistently lower than those predicted by the component approach.&lt;/div&gt;&lt;/div&gt;&lt;div&gt;&lt;h3&gt;Conclusion&lt;/h3&gt;&lt;div&gt;Both the component and finished product approaches demonstrated compliance with ICH Q3D limits, confirming that no specific control strategy was required. While the finished product approach provides precise impurity quantification, the component approach offers a cost-efficient and predictive alternative, provided that data quality and supplier collaboration are ensured. This study underscores the importance of a risk-based assessment in elemental impurity control, balancing regulatory compliance with practical implementation in pharmaceutical manufacturing.&lt;/div&gt;&lt;/div&gt;&lt;div&gt;&lt;h3&gt;Contexte&lt;/h3&gt;&lt;div&gt;Les impuretés élémentaires (IE) dans les produits pharmaceutiques présentent des risques potentiels pour la santé, nécessitant un contrôle réglementaire strict. La directive ICH Q3D décrit deux approches pour évaluer les IE : l’approche par composants, qui estime les niveaux d’impuretés en fonction des données des fournisseurs, et l’approche produit fini, qui quantifie directement les IE dans le produit pharmaceutique final. Cette étude compare les deux méthodes pour évaluer leur fiabilité à garantir le respect des limites de sécurité.&lt;/div&gt;&lt;/div&gt;&lt;div&gt;&lt;h3&gt;Méthode&lt;/h3&gt;&lt;div&gt;Une évaluation des risques des IE dans un médicament effervescent oral a été réalisée à l’aide de l’approche par composants (ICH Q3D option 2b) en compilant les données sur les impuretés des matières premières et des composants de l’emballage. Les niveaux d’exposition journalière estimés ont été comparés aux limites d’exposition journalière autorisée (PDE). Pour valider ces résultats, une analyse ICP-MS (ICH Q3D option 3) a","PeriodicalId":8332,"journal":{"name":"Annales pharmaceutiques francaises","volume":"83 5","pages":"Pages 941-953"},"PeriodicalIF":1.1,"publicationDate":"2025-09-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144085696","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}