Annales pharmaceutiques francaises最新文献

{"title":"[Construction of a methodology for clinical evaluation of medical devices using simulation tools and illustration through three studies].","authors":"Cordélia Salomez-Ihl, Claire Chapuis, Pierre Albaladejo, Marielle Picard, Aline Baron, Paz Pardo Garcia, Jean-Noël Evain, Joris Giai, Maud Barbado, Alexandre Moreau-Gaudry, Jean-Luc Bosson, Julien Picard, Pierrick Bedouch","doi":"10.1016/j.pharma.2024.09.003","DOIUrl":"10.1016/j.pharma.2024.09.003","url":null,"abstract":"<p><strong>Introduction: </strong>European regulations have recently moved towards more stringent requirements for demonstrating the safety and performance of medical devices (MDs).</p><p><strong>Objective: </strong>To apply an innovative testing method using medical simulation to the evaluation of three medical devices at different stages of their life cycle.</p><p><strong>Method: </strong>The methodology for evaluating DMs using simulation is based on seven stages: definition of the context, training, construction of a scenario to test the DM, validation of the scenario, realization of the scenario, evaluation of the scenario by the players and validation and exploitation of the results.</p><p><strong>Results: </strong>Our evaluation methodology enabled us to assess three DMs at different stages of their development: a respiratory protection device at the initial stage (prototype definition), a respiratory protection mask (prototype optimization) and bottle adapters (post-marketing).</p><p><strong>Conclusion: </strong>Simulation is a valuable tool for evaluating DM. The proposed methodology enables it to be used and adapted to different contexts. It responds to the specificities of clinical evaluation of this class of products, and helps to better anticipate certain risks.</p>","PeriodicalId":8332,"journal":{"name":"Annales pharmaceutiques francaises","volume":" ","pages":""},"PeriodicalIF":1.0,"publicationDate":"2024-09-12","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142279838","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":"Enhancing antibiotic prescribing practices at the main military training hospital of Tunis: A study of pharmaceutical interventions.","authors":"Aloui Ghaith, Sana Bennour, Yousfi Mohamed Ali","doi":"10.1016/j.pharma.2024.09.006","DOIUrl":"https://doi.org/10.1016/j.pharma.2024.09.006","url":null,"abstract":"<p><strong>Background: </strong>Bacterial infections have historically posed significant challenges until the discovery of antibiotics, which revolutionized infectious disease treatment. However, bacterial adaptation mechanisms over time have led to increased antimicrobial resistance, necessitating judicious antibiotic use.</p><p><strong>Objectives: </strong>This study aims to comprehensively analyze pharmaceutical interventions related to antibiotic prescriptions governed by antibiotic order forms to identify and rectify medication errors, optimizing antibiotic prescribing practices.</p><p><strong>Material and methods: </strong>Approval for this research was obtained from the institutional review board of the Main Military Training Hospital of Tunis, Tunisia. A retrospective study was conducted at the main military training hospital of Tunis over 4 months. Pharmaceutical validation of antibiotic prescriptions through antibiotic order forms was conducted by a pharmacy resident. Pharmaceutical interventions were initiated upon detection of errors, and patient records were accessed through institutional software.</p><p><strong>Results: </strong>Out of 1100 prescription forms analyzed, 41 pharmaceutical interventions were conducted for 7 antibiotics. Twenty-four percent of all interventions were related to antibiotic order forms, with the intensive care unit accounting for the highest number of errors. Under-dosage and prescription errors were common.</p><p><strong>Conclusion: </strong>Our pharmaceutical interventions related to antibiotic order forms are crucial for optimizing antibiotic therapy. Feedback mechanisms to healthcare teams are essential for enhancing prescription quality and patient care outcomes. Ongoing surveillance and improvement efforts are necessary to address medication errors and enhance antimicrobial stewardship.</p>","PeriodicalId":8332,"journal":{"name":"Annales pharmaceutiques francaises","volume":" ","pages":""},"PeriodicalIF":1.0,"publicationDate":"2024-09-12","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142279852","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 palbociclib-loaded PLGA nanobubbles for targeted cancer therapy.","authors":"Boddu Kishore Kumar, Gubbiyappa Shiva Kumar","doi":"10.1016/j.pharma.2024.09.005","DOIUrl":"https://doi.org/10.1016/j.pharma.2024.09.005","url":null,"abstract":"<p><strong>Objective: </strong>The objective of this study was to develop and optimize palbociclib-loaded nanobubbles for targeted breast cancer therapy.</p><p><strong>Materials and methods: </strong>Biocompatible poly(DL-lactide-co-glycolide) was used to create nanobubbles loaded with palbociclib. The formulation process was meticulously crafted using a three-level Box-Behnken design and a double emulsion solvent evaporation method to precisely tailor the nanobubbles' properties.</p><p><strong>Results: </strong>The Derringer's desirability method optimized variables by transforming responses into a desirability scale, resulting in a global desirability value. Optimal settings, A: 526.97mg, B: 250mg,C: 2.0% w/v, D: 6101rpm, achieved a D value of 0.949. Palbociclib nanobubbles demonstrated a smaller particle size (31.78±2.12) than plain nanobubbles (38.56±3.56). PDI values indicated a uniform size distribution. The zeta potential remained consistent, with values of -31.34±3.36 for plain and -31.56±3.12 for drug-loaded nanobubbles. Encapsulation efficiency was 70.12%, highlighting effective drug encapsulation. Palbociclib release was significantly higher from nanobubbles in pH 7.4, especially with ultrasound, releasing almost 99.34% of the drug. Hemolytic activity assays confirmed safety for injection. Fluorescent intensity analysis revealed a two-fold increase in cellular uptake of palbociclib facilitated by ultrasound. The MTT assay demonstrated enhanced cytotoxicity of palbociclib-loaded nanobubbles, especially with ultrasound, emphasizing their potential for improved therapeutic efficacy. The IC₅₀ values for palbociclib, without ultrasound, and with ultrasound were 98.3μM, 72.34μM, and 61.34μM, respectively.</p><p><strong>Conclusion: </strong>The significant findings of this study emphasize the potential of palbociclib-loaded nanobubbles as a promising therapeutic system for improved breast cancer treatment.</p>","PeriodicalId":8332,"journal":{"name":"Annales pharmaceutiques francaises","volume":" ","pages":""},"PeriodicalIF":1.0,"publicationDate":"2024-09-11","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142279851","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 vivo pharmacokinetic study of carmustine in rats after giving single-dose of carmustine API solution, flexible liposomes, in situ nasal gel, optimized flexible liposomes embedded in situ nasal gel, and marketed formulation.","authors":"Audumbar Mali, Anil Bhanwase","doi":"10.1016/j.pharma.2024.09.002","DOIUrl":"10.1016/j.pharma.2024.09.002","url":null,"abstract":"<p><strong>Background: </strong>Carmustine is used in the treatment of glioblastoma (GBM). GBM is a well-known life-threatening type of cancerous tumor. GBM covers 60.00% among all primary brain tumors, with an occurrence of 74,000 cases across the globe. Management for GBM is still very difficult because most of the medicines are unable to cross the blood-brain barrier (BBB). The present work observed that flexible liposomes embedded in situ nasal gel of carmustine is the best brain-targeted medicine delivery system for the management of GBM through the nasal route.</p><p><strong>Aim: </strong>To evaluate in vivo pharmacokinetic parameters of carmustine formulations administered through nasal routes in Wistar rats.</p><p><strong>Methods: </strong>In this work, different pharmacokinetic parameters were determined for carmustine formulations viz. carmustine API (Active Pharmaceutical Ingredient) solution, flexible liposomes, in situ thermoreversible intranasal gel, optimized flexible liposomes embedded in situ thermoreversible intranasal gel via intranasal administration in rats, and compared with marketed intravenous injection of carmustine administered through intravenous route. Carmustine was estimated with the help of a validated high-performance liquid chromatography (HPLC) approach. Three to four-months-old normal Wistar rats of either sex, having a weight of 200-250 grams were used in this study.</p><p><strong>Results: </strong>Intranasal administration of optimized flexible liposomes embedded in situ nasal gel showed greater C_max (∼two-fold), AUC_0→t (∼three-fold), AUC_0→∞ (∼six-fold), and decreased T_max (1h) data in the brain, than commercial intravenous injection of carmustine. The plasma concentration of carmustine administered through nasal route was found to be comparatively lower than intravenous administration, indicating lower systemic exposure to carmustine via the nasal route.</p><p><strong>Conclusion: </strong>In vivo pharmacokinetics results revealed that the optimized flexible liposomes embedded in situ nasal gel of carmustine can effectively deliver carmustine to brain by nasal drug delivery system in Wistar rats.</p>","PeriodicalId":8332,"journal":{"name":"Annales pharmaceutiques francaises","volume":" ","pages":""},"PeriodicalIF":1.0,"publicationDate":"2024-09-11","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142279853","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":"[Training pharmacy students to conduct targeted interviews on oral anticoagulants: Development and evaluation of training using healthcare simulation].","authors":"Léa Jamart, Justine Clarenne, Florian Slimano, Dominique Hettler, Pauline Quillet","doi":"10.1016/j.pharma.2024.09.001","DOIUrl":"10.1016/j.pharma.2024.09.001","url":null,"abstract":"<p><strong>Objectives: </strong>Pharmaceutical care for patients receiving oral anticoagulants (OACs) should be performed by trained healthcare professionals to prevent adverse effects and improve patient adherence. Before meeting patients, all pharmacy students in our department (in a one-year hospital internship program) experienced a theoretical training for several years. It was decided to add a practical component based on simulation training. The study reports the simulation program conception and the assessment of the simulation-based training for pharmacy students involved in conducting interviews with patients receiving ACOs.</p><p><strong>Methods: </strong>Organization and content of the training course were defined by two hospital pharmacists and one pharmacy resident. Skills' assessment was measured in pharmacy students in 3 steps: (1) initial assessment by individual interview, (2) group training by simulation, (3) final assessment by individual interview. Student satisfaction was also assessed at the end of the training.</p><p><strong>Results: </strong>Four scenarios and one assessment form were developed and 16 pharmacy students experienced the training. An improvement in skills after the simulations courses was observed in all parts of the process: the pre-interview (mean +15%), the interview itself (+16%) and the post-interview (+18%). All students felt more comfortable and motivated to conduct interviews and recommended that this training be continued.</p><p><strong>Conclusions: </strong>The study underlines the impact of the simulation training on students' skills and their satisfaction with the overall training program. The simulation training is now fully added to the program. Further studies should explore the skills improvement in real life during the first patient interview.</p>","PeriodicalId":8332,"journal":{"name":"Annales pharmaceutiques francaises","volume":" ","pages":""},"PeriodicalIF":1.0,"publicationDate":"2024-09-11","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142279850","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":"[Role of cranioplasty in the management of decompressive craniectomies: Study of the Adolphe de Rothschild Foundation Hospital cohort over 7 years].","authors":"Zohra Gachouch, Georges Nicolaos, Claire Judel, Chloé Dupont, Caroline Le Guerinel","doi":"10.1016/j.pharma.2024.09.004","DOIUrl":"https://doi.org/10.1016/j.pharma.2024.09.004","url":null,"abstract":"<p><strong>Objectives: </strong>The objective of our study is to take stock of the cranioplasty implants used within our establishment.</p><p><strong>Materials and method: </strong>We analyzed the patients files who underwent craniectomy followed by cranioplasty between 2017 and 2023, with at least 1 year of follow-up after cranioplasty (n=75). The data were extracted from the computerized patient file (DxCare®, Dédalus) and the pharmaceutical management tool for drugs and sterile medical devices (Pharma®, Computer Engineering). The sex ratio, indication for craniectomy, operating time, time between craniectomy and cranioplasty, complications and aesthetic result were statistically analyzed.</p><p><strong>Results: </strong>The main indications are stroke (n=59; 78.5%) and aneurysms (n=7; 9.5%). Among the 75 patients, 52 benefited from the placement of a custom implant (PolyEtherEtherCetone/PEEK or Hydroxyapatite) and 23 from cementoplasty. The operating time was significantly shorter (P<0.05) for custom cranioplasty (1.93±0.61h vs. 1.62±0.53). Only 4 patients (5.3%) were not satisfied with the aesthetic result following the placement of a custom implant. A greater risk of infection was found in the context of cementoplasty (43% for cementoplasties vs. 25% for the custom implant, so χ² (P=0.1095), this difference not being statistically significant.</p><p><strong>Conclusion: </strong>This collaborative work between the pharmacy and the adult neurosurgery department served to establish an initial register for monitoring patients who have undergone cranioplasty for whom the ideal implant remains to be determined.</p>","PeriodicalId":8332,"journal":{"name":"Annales pharmaceutiques francaises","volume":" ","pages":""},"PeriodicalIF":1.0,"publicationDate":"2024-09-11","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142279849","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":"[Lipoprotein-associated phospholipase A₂ (Lp-PLA₂): Relevant biomarker and therapeutic target?]","authors":"Dominique Bonnefont-Rousselot","doi":"10.1016/j.pharma.2024.08.011","DOIUrl":"10.1016/j.pharma.2024.08.011","url":null,"abstract":"<p><p>Over the last fifteen years, numerous studies have sought to decipher the role of lipoprotein-associated phospholipase A₂ (Lp-PLA₂) in vascular inflammation-related diseases, notably atherosclerosis. Despite the disappointing results of clinical trials using the Lp-PLA₂ inhibitor darapladib, new pathophysiological, epidemiological and genetic data have enabled the development of new inhibitors. Recent studies also show that Lp-PLA₂ is involved in vascular inflammation-related diseases other than atherosclerosis (ischemic stroke, Alzheimer's disease and vascular dementia, diabetes, cancers…), and inhibition of Lp-PLA₂ could have beneficial therapeutic in these diseases. This review aims to present new data on Lp-PLA₂ and to evaluate its current interest as a biomarker but also as a therapeutic target.</p>","PeriodicalId":8332,"journal":{"name":"Annales pharmaceutiques francaises","volume":" ","pages":""},"PeriodicalIF":1.0,"publicationDate":"2024-09-04","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142144928","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, optimization and validation of an analytical method for the determination of voriconazole in plasma by high-performance liquid chromatography-ultraviolet detection: Application for comprehensive study","authors":"","doi":"10.1016/j.pharma.2024.05.002","DOIUrl":"10.1016/j.pharma.2024.05.002","url":null,"abstract":"&lt;div&gt;&lt;h3&gt;Objectives&lt;/h3&gt;&lt;p&gt;Voriconazole is a widely used antifungal agent in clinical settings. However, its use has been associated with neurological side effects in some patients. For this reason, it is crucial to monitor its plasma levels to ensure that they are within the therapeutic range. Thus, in this study, we aimed to develop a simple, fast, and efficient method for the determination of voriconazole in plasma using reversed-phase HPLC-UV. We also aimed to validate the method for its application to routine analysis of immunocompromised patients.&lt;/p&gt;&lt;/div&gt;&lt;div&gt;&lt;h3&gt;Material and methods&lt;/h3&gt;&lt;p&gt;Plasma samples from immunocompromised patients were subjected to deproteinization with acetonitrile followed by centrifugation. Chromatographic separation was carried out on a C18 column with UV detection at 254&lt;!--&gt; &lt;!--&gt;nm in isocratic mode. The concentrations were calculated by comparing peak areas to those of the internal standard, ketoconazole. The method was validated using the accuracy profile, which uses a calibration curve established for the therapeutic range of 1 to 5.5&lt;!--&gt; &lt;!--&gt;μg/mL.&lt;/p&gt;&lt;/div&gt;&lt;div&gt;&lt;h3&gt;Results&lt;/h3&gt;&lt;p&gt;The developed method was proved to be rapid by giving a short analysis time for voriconazole at around 5.5&lt;!--&gt; &lt;!--&gt;min. Additionally, no interference with the biological matrix was detected. The obtained recoveries were higher than 90%. The accuracy profile showed that the method was accurate and precise for the determination of voriconazole in plasma.&lt;/p&gt;&lt;/div&gt;&lt;div&gt;&lt;h3&gt;Conclusion&lt;/h3&gt;&lt;p&gt;The developed method was proved to be simple, efficient, that requires minimal sample preparation. Thus, it can be routinely applied for the therapeutic monitoring of voriconazole.&lt;/p&gt;&lt;/div&gt;&lt;div&gt;&lt;h3&gt;But/Objectif&lt;/h3&gt;&lt;p&gt;Le voriconazole est un antifongique largement utilisé en milieu clinique. Cependant, son utilisation est associée à des effets secondaires neurologiques chez certains patients. Il est donc essentiel de surveiller les concentrations plasmatiques pour s’assurer qu’elles se situent dans la fourchette thérapeutique. Dans cette étude, nous avons cherché à développer une méthode simple, rapide et efficace pour la détermination du voriconazole dans le plasma en utilisant la CLHP-UV en phase inversée. Nous avons également cherché à valider la méthode et à l’appliquer aux patients immunodéprimés.&lt;/p&gt;&lt;/div&gt;&lt;div&gt;&lt;h3&gt;Matériel et méthodes&lt;/h3&gt;&lt;p&gt;Les échantillons de plasma de patients immunodéprimés ont été soumis à une déprotéinisation avec de l’acétonitrile suivie d’une centrifugation. La séparation chromatographique a été effectuée sur une colonne C18 avec détection UV à 254&lt;!--&gt; &lt;!--&gt;nm en mode isocratique. Les concentrations ont été calculées en comparant les surfaces des pics à celles de l’étalon interne, le kétoconazole. La méthode a été validée à l’aide du profil d’exactitude, qui utilise une courbe d’étalonnage établie pour la gamme thérapeutique de 1 à 5,5&lt;!--&gt; &lt;!--&gt;μg/mL.&lt;/p&gt;&lt;/div&gt;&lt;div&gt;&lt;h3&gt;Résultats&lt;/h3&gt;&lt;p&gt;La méthode développée n","PeriodicalId":8332,"journal":{"name":"Annales pharmaceutiques francaises","volume":"82 5","pages":"Pages 886-897"},"PeriodicalIF":1.0,"publicationDate":"2024-09-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"140904036","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":"A UPLC method development and validation study of Upadacitinib and its impurities in extended – release oral tablet dosage forms","authors":"","doi":"10.1016/j.pharma.2024.03.007","DOIUrl":"10.1016/j.pharma.2024.03.007","url":null,"abstract":"&lt;div&gt;&lt;h3&gt;Objective&lt;/h3&gt;&lt;p&gt;The primary objective was to develop a concomitant isocratic ultra-performance liquid chromatographic photo-diode array detection method to estimate Upadacitinib and its process-related impurities: impurity-1 and impurity-2. Further validation was conducted and studied for possible degradants under stress environments.&lt;/p&gt;&lt;/div&gt;&lt;div&gt;&lt;h3&gt;Materials and methods&lt;/h3&gt;&lt;p&gt;All the chemicals and reagents used were of HPLC (acetonitrile, methanol) and analytical grade (trifluoro acetic acid). The ultra-performance liquid chromatography (Agilent 1290 Infinity II LC system) consists of a quaternary pump, a BEH C18 (50&lt;!--&gt; &lt;!--&gt;×&lt;!--&gt; &lt;!--&gt;2.1&lt;!--&gt; &lt;!--&gt;mm, 1.7&lt;!--&gt; &lt;!--&gt;μ) column, and photo-diode array detector. The method was developed with acetonitrile: methanol: 0.1% v/v trifluoro acetic acid (50:20:30 v/v/v) mobile phase at 0.2&lt;!--&gt; &lt;!--&gt;mL/min flow rate within a run time of 5.5&lt;!--&gt; &lt;!--&gt;min The detection was carried at 231.2&lt;!--&gt; &lt;!--&gt;nm.&lt;/p&gt;&lt;/div&gt;&lt;div&gt;&lt;h3&gt;Results&lt;/h3&gt;&lt;p&gt;The respective retention times achieved were 2.289&lt;!--&gt; &lt;!--&gt;min (Upadacitinib), 0.972&lt;!--&gt; &lt;!--&gt;min (Upadacitinib impurity-1), and 3.508&lt;!--&gt; &lt;!--&gt;min (Upadacitinib impurity-2). The optimized method was validated further, and the linearity range was best fit at 15.0–180.0&lt;!--&gt; &lt;!--&gt;μg/mL for Upadacitinib and 1.0–12.0&lt;!--&gt; &lt;!--&gt;μg/mL for both Upadacitinib impurity-1 and 2 respectively. The detection and quantification limits were 4.50&lt;!--&gt; &lt;!--&gt;μg/mL, 15.00&lt;!--&gt; &lt;!--&gt;μg/mL (Upadacitinib) and 0.30&lt;!--&gt; &lt;!--&gt;μg/mL, 1.0&lt;!--&gt; &lt;!--&gt;μg/mL (Upadacitinib impurity-1 and 2).&lt;/p&gt;&lt;/div&gt;&lt;div&gt;&lt;h3&gt;Conclusion&lt;/h3&gt;&lt;p&gt;A fast, isocratic, specific, and reproducible ultra-performance liquid chromatographic method was developed and validated for various parameters according to the ICH Q2 (R1) guidelines studies. Stress studies were conducted exposing the sample dilution to various treatments (acid, alkali, peroxide, HPLC water, heat, and UV light). The degradants were well-separated apart from the peaks of the active substance. The stability indicating nature was observed during the degradation. The optimized method can be applied for the separation and estimation of Upadacitinib and its process-related impurities in pharma sector in tablet dosage forms.&lt;/p&gt;&lt;/div&gt;&lt;div&gt;&lt;h3&gt;Objectif&lt;/h3&gt;&lt;p&gt;L’objectif principal était de développer une méthode de détection concomitante par chromatographie liquide ultra-performante par réseau de photodiodes isocratiques pour estimer l’Upadacitinib et ses impuretés liées au processus: impureté-1 et impureté-2. Une validation plus approfondie a été menée et étudiée pour d’éventuels dégradants dans des conditions de stress.&lt;/p&gt;&lt;/div&gt;&lt;div&gt;&lt;h3&gt;Matériels et méthodes&lt;/h3&gt;&lt;p&gt;Tous les produits chimiques et réactifs utilisés étaient de qualité HPLC (acétonitrile, méthanol) et analytique (acide trifluoroacétique). La chromatographie liquide ultra-performante (système LC Agilent 1290 Infinity II) se compose d’une pompe quaternaire, d’une colonne BEH C18 (50&lt;!--&gt; &lt;","PeriodicalId":8332,"journal":{"name":"Annales pharmaceutiques francaises","volume":"82 5","pages":"Pages 780-791"},"PeriodicalIF":1.0,"publicationDate":"2024-09-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"140329586","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Sommaire / Contents","authors":"","doi":"10.1016/S0003-4509(24)00119-6","DOIUrl":"10.1016/S0003-4509(24)00119-6","url":null,"abstract":"","PeriodicalId":8332,"journal":{"name":"Annales pharmaceutiques francaises","volume":"82 5","pages":"Pages v-vi"},"PeriodicalIF":1.0,"publicationDate":"2024-09-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.sciencedirect.com/science/article/pii/S0003450924001196/pdfft?md5=45772e68f90fff82ada25f1c6a19a5fd&pid=1-s2.0-S0003450924001196-main.pdf","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142099341","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}