Annales pharmaceutiques francaises最新文献

{"title":"Cost analysis study comparing the impact of treatment with aprotinin versus tranexamic acid in cardiac surgery under cardiopulmonary bypass","authors":"Clémence Huynh , Isabelle Crubezy , Kilian Trin , Justine Perino , Nathalie Ong , Hanta Ramaroson , Maryse Puntous , Eloise Gallo , Alexandre Ouattara , Fabien Xuereb","doi":"10.1016/j.pharma.2024.07.005","DOIUrl":"10.1016/j.pharma.2024.07.005","url":null,"abstract":"<div><h3>Objectives</h3><div>An increased risk of mortality and postoperative side effects led to aprotinin (Trasylol®) withdrawal from the market in 2008, but since 2018 aprotinin has again been used in France. The French retrospective multicentre APACHE study (AProtinin versus tranexamic Acid in Cardiac surgery patients with High-risk for Excessive bleeding) compared the efficacy of tranexamic acid versus half-dose aprotinin. The aim of this study, ancillary to the APACHE study, is to carry out a medico-economic analysis of the use of these two antifibrinolytics on an APACHE subpopulation.</div></div><div><h3>Methods</h3><div>Economic data on reimbursement by the French health insurance system were extracted from the program for the data processing of medical information, and quantitative data on the cost of healthcare products were obtained from the hospital pharmacy software.</div></div><div><h3>Results</h3><div>The main analysis of costs for the population shows that the global valuation was not significantly different between the two treatment groups (<em>P</em> <!-->=<!--> <!-->0.60), but the costs of blood products included in the related hospital stay group (Groupe Homogène de séjour [GHS]) (whole blood, platelets and plasma) were higher for the tranexamic acid group (<em>P</em> <!-->=<!--> <!-->0.007). In a sub-analysis of patients alive at discharge, the costs of blood products in addition to GHS (blood-derived medicines) and the costs of blood products in the GHS were higher for the tranexamic acid group (<em>P</em> <!-->=<!--> <!-->0.04 and 0.001, respectively).</div></div><div><h3>Conclusions</h3><div>The additional cost of aprotinin at the time of purchase is offset by the additional costs of blood products in the tranexamic acid group.</div></div><div><h3>Objectifs</h3><div>Un risque accru de mortalité et d’effets indésirables postopératoires ont conduit au retrait du marché de l’aprotinine (Trasylol®) en 2008, mais depuis 2018, l’aprotinine est à nouveau utilisée en France. L’étude rétrospective multicentrique française APACHE (AProtinin versus tranexamic Acid in Cardiac surgery patients with High-risk for Excessive bleeding) a comparé l’efficacité de l’acide tranexamique par rapport à une demi-dose d’aprotinine. L’objectif de cette étude, ancillaire à l’étude APACHE, est de réaliser une analyse médicoéconomique de l’utilisation de ces deux antifibrinolytiques sur une sous-population APACHE.</div></div><div><h3>Méthodes</h3><div>Les données économiques de remboursement par l’assurance maladie française ont été extraites du programme de traitement de l’information médicale et les données quantitatives de coût des produits de santé ont été obtenues à partir du logiciel de la pharmacie hospitalière.</div></div><div><h3>Résultats</h3><div>L’analyse principale des coûts pour la population montre que la valorisation globale n’est pas significativement différente entre les deux groupes de traitement (<em>p</em> <!-->=<!--> <!-->0,60), m","PeriodicalId":8332,"journal":{"name":"Annales pharmaceutiques francaises","volume":"82 6","pages":"Pages 1118-1133"},"PeriodicalIF":1.0,"publicationDate":"2024-07-29","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"141858918","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":"Mise en place d’une antenne pharmaceutique de blocs opératoires dans un centre hospitalier universitaire","authors":"Caroline Figeac , Romane Chapuis , Cordélia Salomez-Ihl , Virginie Filisetti , Assia Daikh , Delphine Schmitt , Philippe Py , Pierrick Bedouch","doi":"10.1016/j.pharma.2024.07.006","DOIUrl":"10.1016/j.pharma.2024.07.006","url":null,"abstract":"<div><h3>Objectifs</h3><div>Une antenne pharmaceutique de blocs opératoires centralise les dispositifs médicaux et les médicaments de différentes spécialités chirurgicales. L’objectif de ce travail est de présenter la méthodologie employée dans notre établissement pour la mise en place de l’antenne pharmaceutique de blocs opératoires.</div></div><div><h3>Méthodes</h3><div>Cette démarche a impliqué la formation de groupes de travail pluri-professionnels. Les besoins des blocs opératoires ont été définis à partir d’une analyse des consommations et des inventaires de stock de produits de santé. Des fiches de matériel ont été définies pour chaque geste. Sur la base de simulations, les modalités de mise à disposition du matériel ont été choisies en précisant les flux de matériel, les équipements, les postes de travail et les systèmes d’informations.</div></div><div><h3>Résultats</h3><div>Plus de 3200 références de produits de santé ont été identifiées et 862 fiches de matériel ont été créées. Les stocks de proximité ont été limités aux chariots de salles. Des packs opératoires d’urgence ont été déployés pour les imprévus opératoires. Des armoires ont été dédiées au transport des dispositifs médicaux restérilisables et des chariots ont été achetés pour les packs opératoires programmés. La mise à disposition du matériel est réalisée par des agents logistiques et des préparateurs en pharmacie sous responsabilité pharmaceutique.</div></div><div><h3>Conclusions</h3><div>Cette approche innovante constitue un modèle pour les établissements souhaitant centraliser et sécuriser la logistique des produits de santé au bloc opératoire. Des ajustements continus seront requis pour répondre aux nouveaux besoins des blocs opératoires.</div></div><div><h3>Objectives</h3><div>An operating room pharmaceutical unit centralizes medical devices and drugs for various surgical specialities. The aim of this work is to present the methodology used in our establishment to set up the operating room pharmaceutical unit.</div></div><div><h3>Methods</h3><div>This approach involved the formation of multi-professional working groups. The needs of operating theatres were defined based on an analysis of healthcare product consumption and stock inventories. Material sheets were defined for each procedure. On the basis of simulations, material supply arrangements were selected, specifying material flows, equipment, workstations and information systems.</div></div><div><h3>Results</h3><div>Over 3200 healthcare product references were identified and 862 equipment files were created. Local stocks have been limited to medical trolleys for nursing staff. Emergency operating packs have been deployed for unforeseen operations. Cabinets have been dedicated to transporting re-sterilizable medical devices, and carts have been purchased for programmed operating packs. The equipment is made available by logistics agents and pharmacy assistants under pharmaceutical responsibility.</div></div><div><h3>","PeriodicalId":8332,"journal":{"name":"Annales pharmaceutiques francaises","volume":"82 6","pages":"Pages 1178-1185"},"PeriodicalIF":1.0,"publicationDate":"2024-07-24","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"141765056","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":"AQbD-guided development and validation of an innovative extraction procedure and stability-indicating RP-HPLC method for quantification of posaconazole in tablet formulation","authors":"Surajkumar Jadhav, Shailesh Wadher","doi":"10.1016/j.pharma.2024.07.003","DOIUrl":"10.1016/j.pharma.2024.07.003","url":null,"abstract":"<div><h3>Objective</h3><div>The objective of this work is to develop a stability-indicating HPLC method for the quantification of posaconazole (PCZ) in tablet formulation using an Analytical Quality by Design (AQbD) approach.</div></div><div><h3>Materials and methods</h3><div>The development process involved the Design of Experiments (DOE) utilizing distinctive constraints mixture design for mobile phase ratio optimization and a 2-level factorial design for selection of extraction diluent compositions. Key responses measured included % assay and system suitability parameters. Method operable design regions (MODR) were determined, and final optimum conditions were selected. Forced degradation studies were conducted to assess method stability.</div></div><div><h3>Results</h3><div>The optimized HPLC method employed a Zorbax C18 column with a mobile phase consisting of pH 3.5 10<!--> <!-->mM phosphate buffer, acetonitrile, and methanol in a ratio of 30:53:17% v/v/v. The method demonstrated stability-indicating capabilities, with PCZ degradation observed in acidic and oxidative environments, while remaining stable in alkali. Peak purity analysis from Empower software confirmed the absence of interaction with degradants. Validation according to ICH Q2 (R2) guidelines showed precision, linearity over the range of 0.25 to 376<!--> <!-->μg/mL, and accuracy demonstrated through recovery studies from 50 to 150%.</div></div><div><h3>Conclusion</h3><div>The developed HPLC method utilizing AQbD approach is specific, robust, precise, and accurate for the quantification of PCZ in tablet formulations, thus suitable for routine analysis.</div></div><div><h3>Objectif</h3><div>L’objectif de ce travail est de développer une méthode HPLC indicatrice de stabilité pour la quantification du posaconazole (PCZ) dans la formulation de comprimés en utilisant une approche de qualité analytique dès la conception (AQbD).</div></div><div><h3>Matériel et méthodes</h3><div>Le processus de développement a impliqué le plan d’expériences (DOE) utilisant des contraintes distinctes, une conception de mélange pour l’optimisation du rapport de phase mobile et un plan factoriel à 2 niveaux pour la sélection des compositions de diluants d’extraction. Les principales réponses mesurées comprenaient le pourcentage d’essai et les paramètres d’adéquation du système. Les régions de conception opérables par la méthode (MODR) ont été déterminées et les conditions optimales finales ont été sélectionnées. Des études de dégradation forcée ont été menées pour évaluer la stabilité de la méthode.</div></div><div><h3>Résultats</h3><div>La méthode HPLC optimisée utilisait une colonne Zorbax C18 avec une phase mobile composée d’un tampon phosphate pH 3,5 10<!--> <!-->mM, d’acétonitrile et de méthanol dans un rapport de 30:53:17 % v/v/v. La méthode a démontré des capacités d’indication de la stabilité, avec une dégradation du PCZ observée dans des environnements acides et oxydatifs, tout en restant stable d","PeriodicalId":8332,"journal":{"name":"Annales pharmaceutiques francaises","volume":"82 6","pages":"Pages 1088-1102"},"PeriodicalIF":1.0,"publicationDate":"2024-07-14","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"141603242","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":"Quality by design-based development and in vitro evaluation of dual release tablet of etoricoxib and thiocolchicoside: A novel chronotherapeutic approach for arthritis pain management","authors":"Anchal Sharma , Supriya Singh , Geetanjali Saini , Sanjay Sharma , Bhupendra Singh , Deepak Choudhary","doi":"10.1016/j.pharma.2024.07.004","DOIUrl":"10.1016/j.pharma.2024.07.004","url":null,"abstract":"<div><h3>Objective</h3><div>The traditional drug delivery system is not much effective when treating chronopathological diseases like arthritis. Consequently, there is a gap in the market for a delivery system that can provide an explicit treatment following the chronopharmacology of this disorder. The present study is based on the objective to develop Eudragit coated dual release bilayer tablet designed by the quality by design (QbD) and based on the chronotherapeutic approach. The dual release tablet contained an immediate release layer of etoricoxib and a sustained release layer of thiocolchicoside.</div></div><div><h3>Material and method</h3><div>The quality target product profile (QTTP) of the formulation was established along with critical quality attributes (CQA). The optimization of the dual release layer was done using a three-level, three-factor Box-Behnken design. A total of thirteen formulations of etoricoxib (ET1–ET13) and thiocolchicoside (TH1–TH13) were developed based on the design composition of etoricoxib, sodium starch glycolate and sodium bicarbonate for the immediate release (IR) layer and thiocolchicoside, HPMC E5 LV and magnesium stearate for the sustained release (SR) layer respectively. The developed dual release layers were compressed to form a bilayer tablet. The bilayer tablets were further coated with pH-dependent polymer Eudragit S-100 to avoid drug release in upper GIT. The initial characterization and drug-excipient interaction studies were performed initially using infra-red (IR) spectroscopy and X-ray diffraction studies (XRD). Formulations showing good micrometric properties, disintegration and drug release were selected for final compression of bilayer tablets.</div></div><div><h3>Result</h3><div>Formulation ET13 showed the fastest drug release (88%) at 15<!--> <!-->minutes and quick disintegration time (21<!--> <!-->s). The sustained release thiocolchicoside tablet layer (TH1–TH13) had a hardness that varied from 4.01 to 4.45<!--> <!-->kg/cm<sup>2</sup>. Formulation TH12 had the highest hardness, whereas TH6 showed the lowest hardness. The sustained release layer showing 97.63% of drug release after 8<!--> <!-->hours was selected for the compression to bilayer tablet. The developed dual layer tablets were investigated for quality parameters like hardness, percentage friability, weight variation, disintegration and dissolution.</div></div><div><h3>Conclusion</h3><div>A high level of patient compliance is ensured through the current design as the patient does not need to get out of bed at night to take the medication.</div></div><div><h3>Objectif</h3><div>Le système traditionnel d’administration de médicaments n’est pas très efficace dans le traitement de maladies chronopathologiques comme l’arthrite. Par conséquent, il existe une lacune sur le marché pour un système d’administration capable de fournir un traitement explicite suivant la chronopharmacologie de ce trouble. La présente étude est basée sur l’objecti","PeriodicalId":8332,"journal":{"name":"Annales pharmaceutiques francaises","volume":"82 6","pages":"Pages 1103-1117"},"PeriodicalIF":1.0,"publicationDate":"2024-07-11","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"141603243","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":"L’impact environnemental peut-il être considéré comme une dimension du bon usage des médicaments ? Retour sur le 5e Forum de l’Association Bon Usage du Médicament","authors":"","doi":"10.1016/j.pharma.2024.07.001","DOIUrl":"10.1016/j.pharma.2024.07.001","url":null,"abstract":"<div><div>Par son empreinte tout au long de son cycle de vie, de la production à son utilisation, le médicament a un impact négatif sur l’environnement. La réduction de cet impact est rarement envisagée sous l’angle des choix que les professionnels de santé pourraient être amenés à opérer dans leur pratique de prescription ou de dispensation. Faut-il faire de l’impact environnemental, à côté de l’efficacité et la tolérance, une des dimensions du bon usage des médicaments ? Le 5^e Forum de l’Association pour le Bon Usage des Médicaments a rappelé les principales dimensions de l’impact environnemental des médicaments : l’empreinte carbone et toutes les formes de pollution liées aux déchets produits à toutes les étapes de la chaîne de valeur du médicament, de sa conception à son usage par les patients. L’outil d’évaluation suédois « Hazard Score », qui permet de classer les molécules en fonction de leur pouvoir polluant dans le milieu aquatique, a été présenté comme outil d’orientation des choix de prescription. Les échanges entre les différents acteurs (pouvoirs publics, médecins, pharmaciens, industriels, patients) intervenus dans le cadre du forum ont permis d’émettre des préconisations dans l’attente de recommandations scientifiques et éthiques souhaitables.</div></div><div><div>Through their footprint throughout their life cycle, from production to use, medicines have a significant impact on the environment. Reducing this impact is rarely considered from the perspective of the choices that healthcare professionals might have to make when prescribing or dispensing medicines. Should we consider environmental impact, alongside effectiveness and tolerance, one of the dimensions of the proper use of medicines? To address this question, the 5th Forum of the Association for the Proper Use of Medicines highlighted the main sources of pharmaceutical pollution: the carbon footprint linked to production, greenhouse gas emissions, the impact of residues on water and waste from packaging. While the eco-design of medicines should make it possible to limit their environmental impact upstream, there are still few initiatives aimed at their use. The Swedish “Hazard Score” assessment tool, which classifies compounds according to their potential to pollute the aquatic environment, was presented as a tool for guiding prescription choices. Through the exchanges between the various stakeholders (public authorities, doctors, pharmacists, manufacturers, patients) during this forum, recommendations were drawn up both on scientific and ethical grounds.</div></div>","PeriodicalId":8332,"journal":{"name":"Annales pharmaceutiques francaises","volume":"82 6","pages":"Pages 1008-1012"},"PeriodicalIF":1.0,"publicationDate":"2024-07-09","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"141589456","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":"Feedback on a socio-aesthetic program for the benefit of young patients with self-endangerment","authors":"","doi":"10.1016/j.pharma.2024.07.002","DOIUrl":"10.1016/j.pharma.2024.07.002","url":null,"abstract":"<div><h3>Objectives</h3><div>Socio-aesthetics is a practice born in psychiatric departments but has since developed particularly in the field of oncology. For our part, since January 2018, we have initiated an experiment of this type at the Espace Unit of the CHU in Nantes, a unit that takes care of young patients who find themselves in a situation of crisis and endangerment of themselves.</div></div><div><h3>Methods</h3><div>The qualitative evaluation of the interest of a socio-aesthetic mediation (relaxation modelling, facial care, make-up) with young patients was carried out by a collection of their feelings.</div></div><div><h3>Results</h3><div>Youth who expressed an overall judgment of socio-esthetic mediation appreciated it in 61% of cases. They express their satisfaction with words such as “I liked”, “I loved”, “I’m happy”, “it was too good”, “super good” or “great”.</div></div><div><h3>Conclusion</h3><div>This successful socio-aesthetic therapy practice experiment will continue with a quantitative analysis to demonstrate the relevance of this type of service to psychiatric patients.</div></div><div><h3>Objectifs</h3><div>La socio-esthétique est une pratique née dans des services psychiatrie mais s’est depuis particulièrement développée dans le domaine de l’oncologie. Pour notre part, nous avons initié, depuis janvier 2018, une expérience de ce type à l’unité espace du CHU de Nantes, unité qui prend en charge des jeunes patients qui se trouvent dans une situation de crise et de mise en danger de soi. Il s’agissait, pour nous, d’en évaluer la pertinence, d’une manière qualitative.</div></div><div><h3>Méthodes</h3><div>L’intérêt d’une médiation socio-esthétique (modelages de détente, soin du visage, maquillage) auprès des jeunes patients a été évaluée sur un plan qualitatif par un recueil de leur ressenti.</div></div><div><h3>Résultats</h3><div>Les jeunes qui ont exprimé un jugement global de la médiation socio-esthétique l’ont appréciée dans 61 % des cas. Ils manifestent leur satisfaction par des mots ou expressions comme « j’ai aimé », « j’ai adoré », « je suis content(e) », « c’était trop bien », « hyper bien » ou encore « génial ».</div></div><div><h3>Conclusion</h3><div>Cette expérimentation réussie de pratique socio-esthétique se poursuit par une analyse quantitative pour faire la preuve de la pertinence de ce type d’offre proposée aux patients en psychiatrie.</div></div>","PeriodicalId":8332,"journal":{"name":"Annales pharmaceutiques francaises","volume":"82 6","pages":"Pages 1082-1087"},"PeriodicalIF":1.0,"publicationDate":"2024-07-09","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"141589457","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":"Stability-indicating HPLC for remogliflozin, vildagliptin, and metformin: Method development, validation, and greenness","authors":"","doi":"10.1016/j.pharma.2024.06.006","DOIUrl":"10.1016/j.pharma.2024.06.006","url":null,"abstract":"&lt;div&gt;&lt;h3&gt;Objective&lt;/h3&gt;&lt;div&gt;The present work represents a reverse-phase high-performance liquid chromatography method in addition to stability studies for sequential estimation of remogliflozin etabonate, vildagliptin, and metformin HCl in tablet formulation.&lt;/div&gt;&lt;/div&gt;&lt;div&gt;&lt;h3&gt;Method&lt;/h3&gt;&lt;div&gt;The mentioned method utilizes a Phenomenex Luna C18 column (250&lt;!--&gt; &lt;!--&gt;×&lt;!--&gt; &lt;!--&gt;4.6&lt;!--&gt; &lt;!--&gt;mm, 5&lt;!--&gt; &lt;!--&gt;μm). It consists of a column oven's temperature of 35&lt;!--&gt; &lt;!--&gt;°C. Mobile phase includes a mixture of 50% phosphate buffer (pH – 6.8) and 50% acetonitrile along with a flow rate of 0.8&lt;!--&gt; &lt;!--&gt;mL/min and 20&lt;!--&gt; &lt;!--&gt;minutes of run time. The injection volume was 20&lt;!--&gt; &lt;!--&gt;μL; 217&lt;!--&gt; &lt;!--&gt;nm is a detection wavelength, and a PDA detector is used for detection.&lt;/div&gt;&lt;/div&gt;&lt;div&gt;&lt;h3&gt;Results&lt;/h3&gt;&lt;div&gt;The suggested technique was proven and validated per the ICH Q2 (R1) guideline. The combination was put under stress conditions that included acid, base, thermal, photolytic, and oxidative degradation. The combination was considerably degraded under oxidative, acidic, and basic circumstances for deterioration, and the degradation results were accurately identified from the observed peaks, demonstrating the method's effectiveness in detecting stability.&lt;/div&gt;&lt;/div&gt;&lt;div&gt;&lt;h3&gt;Conclusion&lt;/h3&gt;&lt;div&gt;The technique was quick, precise, sensitive, and accurate; as a result, it may be used in quality control laboratories and the pharmaceutical industry for routine quality monitoring of tablets containing all three medications.&lt;/div&gt;&lt;/div&gt;&lt;div&gt;&lt;h3&gt;Objectif&lt;/h3&gt;&lt;div&gt;Le présent travail représente une méthode de chromatographie liquide haute performance en phase inverse en plus des études de stabilité pour l’estimation séquentielle de l’étabonate de rémogliflozine, de la vildagliptine et de la metformine HCl dans la formulation de comprimés.&lt;/div&gt;&lt;/div&gt;&lt;div&gt;&lt;h3&gt;Méthode&lt;/h3&gt;&lt;div&gt;La méthode mentionnée utilise une colonne Phenomenex Luna C18 (250&lt;!--&gt; &lt;!--&gt;×&lt;!--&gt; &lt;!--&gt;4,6&lt;!--&gt; &lt;!--&gt;mm, 5&lt;!--&gt; &lt;!--&gt;μm). Il se compose d’une température de four à colonne de 35&lt;!--&gt; &lt;!--&gt;°C. La phase mobile comprend un mélange de 50 % de tampon phosphate (pH – 6,8) et 50 % d’acétonitrile avec un débit de 0,8&lt;!--&gt; &lt;!--&gt;mL/min et 20&lt;!--&gt; &lt;!--&gt;minutes d’exécution. Le volume d’injection était de 20&lt;!--&gt; &lt;!--&gt;μL ; 217&lt;!--&gt; &lt;!--&gt;nm est une longueur d’onde de détection et un détecteur PDA est utilisé pour la détection.&lt;/div&gt;&lt;/div&gt;&lt;div&gt;&lt;h3&gt;Résultats&lt;/h3&gt;&lt;div&gt;La technique suggérée a été éprouvée et validée conformément à la directive ICH Q2 (R1). La combinaison a été soumise à des conditions de stress comprenant une dégradation acide, basique, thermique, photolytique et oxydative. La combinaison a été considérablement dégradée dans des circonstances de détérioration oxydatives, acides et basiques, et les résultats de la dégradation ont été identifiés avec précision à partir des pics observés, démontrant l’efficacité de la méthode pour détecter la stabilité.&lt;/div&gt;&lt;/div&gt;&lt;div&gt;&lt;h3&gt;Conclusion&lt;/h3&gt;&lt;","PeriodicalId":8332,"journal":{"name":"Annales pharmaceutiques francaises","volume":"82 6","pages":"Pages 1071-1081"},"PeriodicalIF":1.0,"publicationDate":"2024-06-28","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"141465828","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":"Nanosuspensions: Enhancing drug bioavailability through nanonization.","authors":"Rohit Chavhan","doi":"10.1016/j.pharma.2024.06.003","DOIUrl":"10.1016/j.pharma.2024.06.003","url":null,"abstract":"<p><strong>Introduction: </strong>Nanosuspensions have emerged as a promising avenue in pharmaceutical innovation, particularly for enhancing the bioavailability of poorly soluble medications. This article explores the transformative potential of nanosuspensions, emphasizing the critical role of particle size reduction through nanonization techniques. With conventional approaches often falling short in addressing the bioavailability challenges of hydrophobic drugs, nanosuspensions offer multifaceted applications and distinctive advantages in drug delivery.</p><p><strong>Methods: </strong>The study delves into various nanosuspension preparation techniques, including high-pressure homogenization, media milling, emulsification-solvent evaporation, precipitation, and supercritical fluid processes. Each method brings unique advantages and limitations, contributing to the expanding repertoire of nanosuspension formulation methods. The article emphasizes the necessity for meticulous planning, evaluation, and ongoing research across different drugs to optimize their use effectively.</p><p><strong>Results: </strong>Nanosuspensions exhibit versatility in administration routes, spanning parenteral, peroral, ocular, and pulmonary pathways, making them applicable across diverse dosage forms. Current efforts are directed towards furthering their application in site-specific medication administration, indicating their potential in tailored therapeutic strategies. Nanosuspensions offer a promising solution for enhancing drug solubility and bioavailability, addressing the persistent challenge of poor solubility in pharmaceutical compounds.</p><p><strong>Discussion: </strong>The significance of careful formulation and stabilization using polymers and surfactants is underscored, ensuring the efficacy and safety of nanosuspensions. By discussing the benefits, drawbacks, and nuances of each preparation technique, the article aims to simplify future research endeavors in the field of nanosuspensions. Additionally, a comprehensive overview of nanosuspensions, including their preparation methods, benefits, characterization, patents, marketed products, and intended uses, sheds light on this evolving domain in pharmaceutical sciences.</p><p><strong>Conclusion: </strong>Nanosuspensions represent a promising approach for overcoming bioavailability challenges associated with poorly soluble medications. The article highlights their transformative potential in pharmaceutical innovation, emphasizing the importance of continued research and optimization to harness their benefits effectively. Nanosuspensions offer a viable solution for enhancing drug solubility and bioavailability, with implications for improving therapeutic outcomes in various medical conditions.</p>","PeriodicalId":8332,"journal":{"name":"Annales pharmaceutiques francaises","volume":" ","pages":""},"PeriodicalIF":1.0,"publicationDate":"2024-06-28","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"141465868","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":"Mise à jour par consensus de l’outil POPI","authors":"","doi":"10.1016/j.pharma.2024.06.004","DOIUrl":"10.1016/j.pharma.2024.06.004","url":null,"abstract":"&lt;div&gt;&lt;div&gt;L’erreur médicamenteuse est une des causes d’iatrogénie médicamenteuse chez les enfants. L’outil POPI de détection des prescriptions médicamenteuses inappropriées et des omissions de prescription en pédiatrie est le premier outil à avoir été publié dans ce domaine en 2014. Notre objectif était de mettre à jour l’outil POPI pour une utilisation française à partir des recommandations et pratiques actuelles. Les critères ont été retirés, mis à jour ou ajoutés à partir des recommandations des sociétés savantes et instances nationales. La méthode Delphi à deux tours a été utilisée afin d’arriver à un consensus d’experts. Le niveau d’accord des propositions des professionnels de santé a été noté sur une échelle de Likert à 9 points. Au premier tour, seules les propositions avec une médiane d’accord de 7 à 9 et un accord de plus de 65 % ont été conservées. Au second tour, seules celles avec une médiane d’accord de 7 à 9 et un accord de plus de 75 % ont été retenues. L’outil POPI comprend désormais huit catégories (divers, infectiologie, gastro-entérologie, pneumonologie, dermatologie, neurologie/pédopsychiatrie, hématologie et excipients). Tous les critères ont été argumentés par des références bibliographiques en regard. Ils ont été soumis à 20 professionnels de santé français : 9 pharmaciens et 11 médecins (17 hospitaliers et 3 libéraux). Après deux tours de Delphi, 166 critères ont été retenus et validés (111 prescriptions inappropriées et 55 omissions). En conclusion, cette étude a permis de mettre à jour l’outil POPI qui reste toujours disponible pour une évaluation des prescriptions pédiatriques.&lt;/div&gt;&lt;/div&gt;&lt;div&gt;&lt;div&gt;Medication errors are one of the causes of iatrogenic medication use in children. The POPI tool for detecting inappropriate drug prescriptions and prescription omissions in paediatrics was the first tool to be published in this field in 2014. Our aim was to update the POPI tool for French use based on current recommendations and practice. Criteria were removed, updated or added based on recommendations from learned societies and national bodies. The two-round Delphi method was used to reach a consensus of experts. The level of agreement of the healthcare professionals’ proposals was rated on a 9-point Likert scale. In the first round, only proposals with a median agreement of 7 to 9 and an agreement of more than 65% were retained. In the second round, only those with a median agreement of 7 to 9 and over 75% agreement were retained. The POPI tool now includes eight categories (various, infectiology, gastroenterology, pneumonology, dermatology, neurology/pedopsychiatry, haematology and excipients). All the criteria were supported by bibliographical references. They were submitted to 20 French healthcare professionals: 9 pharmacists and 11 doctors (17 hospital-based and 3 self-employed). After two rounds of Delphi testing, 166 criteria were retained and validated (111 inappropriate prescriptions and 55 omissions). In conclusio","PeriodicalId":8332,"journal":{"name":"Annales pharmaceutiques francaises","volume":"82 6","pages":"Pages 1163-1177"},"PeriodicalIF":1.0,"publicationDate":"2024-06-27","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"141465866","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":"Effect of food on oral pharmacokinetics of edaravone coamorphous dispersion containing bile salts as coformers – Part II","authors":"","doi":"10.1016/j.pharma.2024.06.005","DOIUrl":"10.1016/j.pharma.2024.06.005","url":null,"abstract":"&lt;div&gt;&lt;h3&gt;Objectives&lt;/h3&gt;&lt;div&gt;Edaravone (EDR) is an effective neuroprotective agent in various neurological diseases; however, its use is restricted due to poor oral absorption. Bile salts are known for improving solubility and inhibiting drug crystallization in supersaturated conditions of the gastrointestinal tract (GIT). In our previous work, we prepared coamorphous dispersion (COAM) of EDR with sodium taurocholate (NaTC) using spray drying. The optimized EDR COAM exhibited superior &lt;em&gt;in vitro&lt;/em&gt; performance compared to plain EDR. EDR is well absorbed in fasted-over-fed conditions.&lt;/div&gt;&lt;/div&gt;&lt;div&gt;&lt;h3&gt;Methods&lt;/h3&gt;&lt;div&gt;The present work, we conducted a pharmacokinetic study for EDR and EDR COAM in fasted and fed conditions to check effect of food on its oral absorption. The LC–MS/MS-based method was developed and validated to determine the amount of EDR in plasma.&lt;/div&gt;&lt;/div&gt;&lt;div&gt;&lt;h3&gt;Results&lt;/h3&gt;&lt;div&gt;The results suggested that EDR COAM did not show a significant difference in C&lt;sub&gt;max&lt;/sub&gt; (&lt;em&gt;P&lt;/em&gt; &lt;!--&gt;=&lt;!--&gt; &lt;!--&gt;0.3544) and AUC (&lt;em&gt;P&lt;/em&gt; &lt;!--&gt;=&lt;!--&gt; &lt;!--&gt;0.1696) of fasted and fed states. On the other hand, plain EDR showed 2-fold and 3-fold reduced C&lt;sub&gt;max&lt;/sub&gt; (&lt;em&gt;P&lt;/em&gt; &lt;!--&gt;&lt;&lt;!--&gt; &lt;!--&gt;0.0001) and AUC (&lt;em&gt;P&lt;/em&gt; &lt;!--&gt;=&lt;!--&gt; &lt;!--&gt;0.0094) in the fed condition, respectively. The C&lt;sub&gt;max&lt;/sub&gt; and AUC of EDR COAM were improved in fasted (AUC: 2.56-fold) and fed states (AUC: 5.74-fold) than plain EDR, suggesting better oral absorption of COAM than crystalline EDR without having the effect of food.&lt;/div&gt;&lt;/div&gt;&lt;div&gt;&lt;h3&gt;Conclusions&lt;/h3&gt;&lt;div&gt;The unique structural attributes of NaTC had the potential to inhibit the recrystallization of EDR in GIT, while concurrently reducing the impact of food on the oral absorption of EDR.&lt;/div&gt;&lt;/div&gt;&lt;div&gt;&lt;h3&gt;Objectifs&lt;/h3&gt;&lt;div&gt;L’édaravone (EDR) est un agent neuroprotecteur efficace dans diverses maladies neurologiques ; cependant, son utilisation est limitée en raison d’une mauvaise absorption orale. Les sels biliaires sont connus pour améliorer la solubilité et inhiber la cristallisation des médicaments dans des conditions sursaturées du tractus gastro-intestinal (GIT). Dans nos travaux précédents, nous avons préparé une dispersion coamorphe (COAM) d’EDR avec du taurocholate de sodium (NaTC) par séchage par pulvérisation. L’EDR COAM optimisé a présenté des performances in vitro supérieures à celles de l’EDR ordinaire. L’EDR est bien absorbé dans des conditions de jeûne et de suralimentation.&lt;/div&gt;&lt;/div&gt;&lt;div&gt;&lt;h3&gt;Méthodes&lt;/h3&gt;&lt;div&gt;Dans le présent travail, nous avons mené une étude pharmacocinétique de l’EDR et de l’EDR COAM à jeun et nourris pour vérifier l’effet des aliments sur leur absorption orale. La méthode basée sur LC–MS/MS a été développée et validée pour déterminer la quantité d’EDR dans le plasma.&lt;/div&gt;&lt;/div&gt;&lt;div&gt;&lt;h3&gt;Résultats&lt;/h3&gt;&lt;div&gt;Les résultats suggèrent que l’EDR COAM n’a pas montré de différence significative dans la Cmax (&lt;em&gt;p&lt;/em&gt; &lt;!--&gt;=&lt;!--&gt; &lt;!--&gt;0,3544) et l’AUC (&lt;em&gt;p&lt;/em","PeriodicalId":8332,"journal":{"name":"Annales pharmaceutiques francaises","volume":"82 6","pages":"Pages 1062-1070"},"PeriodicalIF":1.0,"publicationDate":"2024-06-26","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"141465867","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}