Annales pharmaceutiques francaises最新文献

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Laggera pterodonta: Traditional uses, phytochemistry and biological activities. 蕨菜:传统用途、植物化学和生物活性。
IF 1.1
Annales pharmaceutiques francaises Pub Date : 2025-07-19 DOI: 10.1016/j.pharma.2025.07.008
Pham Van Huyen, Nguyen Thi Thu Hien, Tran Thi Ngoc Hanh, Nguyen Huu Huong Duyen, Nguyen Huu Toan Phan, Nguyen Thi Dieu Thuan
{"title":"Laggera pterodonta: Traditional uses, phytochemistry and biological activities.","authors":"Pham Van Huyen, Nguyen Thi Thu Hien, Tran Thi Ngoc Hanh, Nguyen Huu Huong Duyen, Nguyen Huu Toan Phan, Nguyen Thi Dieu Thuan","doi":"10.1016/j.pharma.2025.07.008","DOIUrl":"10.1016/j.pharma.2025.07.008","url":null,"abstract":"<p><p>Laggera pterodonta is a promising medicinal plant with multiple therapeutic applications, supporting its traditional use and potential for modern drug development. With its diverse bioactive constituents such as flavonoids, terpenoids, phenolics, alkaloids, and lignans, along with antiviral activity, anti-inflammatory activity, insecticidal activity, antibacterial activity, and antifungal activity, L. pterodonta is gradually asserting its value in pharmaceutical applications. Studies have shown its effectiveness against influenza viruses, enteroviruses, and herpes simplex viruses by inhibiting viral replication and modulating immune responses. Additionally, its anti-inflammatory effects help reduce pro-inflammatory cytokines, while its antimicrobial and antifungal activities make it a promising candidate for combating drug-resistant pathogens. The plant's insecticidal properties suggest its potential use in eco-friendly pest control. The present review aims to provide an in-depth report on the traditional uses, phytochemistry, and biological activities of L. pterodonta. This knowledge provides scientists with a clear direction for effectively utilizing the plant in the search for potent and sustainable medicinal resources for public health care.</p>","PeriodicalId":8332,"journal":{"name":"Annales pharmaceutiques francaises","volume":" ","pages":""},"PeriodicalIF":1.1,"publicationDate":"2025-07-19","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144681911","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}
引用次数: 0
[Impact of therapeutic education on knowledge, adherence, asthma control, and respiratory function in asthmatic patients: A 6-month follow-up]. 治疗教育对哮喘患者知识、依从性、哮喘控制和呼吸功能的影响:一个6个月的随访。
IF 1
Annales pharmaceutiques francaises Pub Date : 2025-07-16 DOI: 10.1016/j.pharma.2025.07.007
Faiza Sebhi, Lydia Adjou, Rania Bazia, Djazia El Hadef, Merzak Gharnaout, Reda Djidjik
{"title":"[Impact of therapeutic education on knowledge, adherence, asthma control, and respiratory function in asthmatic patients: A 6-month follow-up].","authors":"Faiza Sebhi, Lydia Adjou, Rania Bazia, Djazia El Hadef, Merzak Gharnaout, Reda Djidjik","doi":"10.1016/j.pharma.2025.07.007","DOIUrl":"10.1016/j.pharma.2025.07.007","url":null,"abstract":"<p><strong>Introduction: </strong>Therapeutic patient education (TPE) is a key component in the management of asthma. This study aims to assess the impact of TPE on disease control, treatment adherence, lung function, and the frequency of hospitalizations and emergency visits.</p><p><strong>Methods: </strong>A pilot study followed by an interventional study was conducted on 47 asthmatic patients at CHU Issaad Hassani in Algiers. The participants attended TPE sessions and were evaluated at multiple time points: T0 (before TPE), T4 (4 weeks), T8 (8 weeks), T12 (12 weeks), and T24 (24 weeks).</p><p><strong>Results: </strong>The findings show a significant improvement in patients' knowledge, treatment adherence, and asthma control. A notable progression in inhaler technique (IT) was also observed. Additionally, the number of hospitalizations significantly decreased after TPE, while emergency visits showed no significant change. Regarding lung function, an improvement in the ratio of forced expiratory volume in one second to forced vital capacity (FEV1/FVC) was observed in the short term (T12) but not in the long term (T24).</p><p><strong>Conclusion: </strong>These results confirm the effectiveness of TPE in improving asthma patient management. Integrating TPE into care protocols, along with regular follow-up, is essential to optimize asthma control and enhance patients' quality of life.</p>","PeriodicalId":8332,"journal":{"name":"Annales pharmaceutiques francaises","volume":" ","pages":""},"PeriodicalIF":1.0,"publicationDate":"2025-07-16","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144666956","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}
引用次数: 0
[Implementation and evaluation of the Objectives Structured Practical Examination (OSPE) in the French pharmacy curriculum: Feedback from a first experience at the Lille Faculty of Pharmacy]. 目标与结构药学考试(EPOS),药学评估的演变:里尔经验的反馈。
IF 1
Annales pharmaceutiques francaises Pub Date : 2025-07-11 DOI: 10.1016/j.pharma.2025.07.006
Cyrille Berlemont, Yanèle Poteaux, Anne Garat, Sébastien Zanetti, Patrick Wierre, Tony Sanctorum, Pierre Ravaux, Bertrand Décaudin, Annie Standaert
{"title":"[Implementation and evaluation of the Objectives Structured Practical Examination (OSPE) in the French pharmacy curriculum: Feedback from a first experience at the Lille Faculty of Pharmacy].","authors":"Cyrille Berlemont, Yanèle Poteaux, Anne Garat, Sébastien Zanetti, Patrick Wierre, Tony Sanctorum, Pierre Ravaux, Bertrand Décaudin, Annie Standaert","doi":"10.1016/j.pharma.2025.07.006","DOIUrl":"10.1016/j.pharma.2025.07.006","url":null,"abstract":"<p><strong>Objectives: </strong>The aim of this work is to evaluate the implementation of Objective Structured Practical Examinations (OSPE) at the Lille Faculty of Pharmacy as part of the skills assessment of 6th year pharmacy students.</p><p><strong>Method: </strong>The OSPE was designed and implemented in 2022 as a summative exam of the 1st semester of the 6th year. The stations were designed in accordance with our educational framework in the field of community pharmacy. Student performance scores were collected and analyzed using descriptive statistics. After the summative assessment, students completed an anonymous electronic survey concerning their opinion and perception on the suitability of the OSPE.</p><p><strong>Results: </strong>OSPE consisted of 8 stations, 6 of which involved standardized participants. The skills assessed included dispense medicines or health products, respond to a patient's request, patient-centered approach, interprofessional communication, apply legal practices, and administer vaccines. 105 students participated in the first edition in December 2022. The overall pass rate was 62.8%. Stations focusing on interprofessional communication and vaccine administration were more successful than those focusing on patient support (particularly in oncology). A total of 84.8% of the students found the method to be relevant, and 73.3% felt that it had enabled them to become more aware of their skills. However, 91% reported that OSPE was stressful. Students also reported that the stations on legislation and oncology patient care did not match they had seen during their training.</p><p><strong>Conclusions: </strong>The OSPE experience at the Lille Faculty of Pharmacy highlights the relevance of this tool to assess the skills of future community pharmacists. However, changes are needed to enhance the alignment between OSPE and training, and to better prepare students for this new assessment approach. This initiative is part of a broader reflection undertaken by the Faculty in anticipation of the forthcoming reform of pharmacy studies in France aimed at better addressing the evolving needs of the profession.</p>","PeriodicalId":8332,"journal":{"name":"Annales pharmaceutiques francaises","volume":" ","pages":""},"PeriodicalIF":1.0,"publicationDate":"2025-07-11","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144625218","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}
引用次数: 0
Investigation of cytotoxic activity properties of etoxazole towards human cancer and healthy cell lines and molecular docking studies. 乙恶唑对人肿瘤和健康细胞系的细胞毒活性及分子对接研究。
IF 1
Annales pharmaceutiques francaises Pub Date : 2025-07-10 DOI: 10.1016/j.pharma.2025.07.001
İkbal Demet Nane
{"title":"Investigation of cytotoxic activity properties of etoxazole towards human cancer and healthy cell lines and molecular docking studies.","authors":"İkbal Demet Nane","doi":"10.1016/j.pharma.2025.07.001","DOIUrl":"10.1016/j.pharma.2025.07.001","url":null,"abstract":"<p><p>The effect of etoxazole on cancer cells was evaluated in vitro using different cell lines. In this context, its cytotoxic activity on breast (MCF-7), liver (HepG2), colon (DLD-1) and lung (A549) cancer cell lines was investigated. The 3-(4,5-dimethylthiazol-2-yl)-2,5-diphenyl tetrazolium bromide (MTT) method was used to determine the effects on cell viability. Tests were also performed on a healthy human embryonic kidney cell line (HEK-293T) to evaluate the selectivity of the compound. The results revealed that etoxazole showed varying degrees of antiproliferative activity in cancer cell lines. In particular, it showed the most potent inhibition effect with an IC<sub>50</sub> value of 33.18μM in HepG2 cell line. In contrast, in the A549 cell line, the IC<sub>50</sub> value was measured as 91.38μM, indicating that the compound had a lower cytotoxic effect in lung cancer cells. Etoxazole, which exhibited a more pronounced effect against liver cancer cells, showed moderate cytotoxicity in other cell lines. Moreover, the IC<sub>50</sub> value in healthy HEK-293T cells was found to be 1628.0μM, which demonstrates that etoxazole has a high selectivity index and low toxicity towards normal cells. On the other hand, evaluations in the healthy HEK-293T cell line revealed that etoxazole has a selective effect. The IC<sub>50</sub> value in healthy cells was relatively high, suggesting that the compound may exhibit a specific cytotoxic activity against cancer cells. In general, etoxazole was found to have varying levels of cytotoxic activity in different cancer cell lines. The effect of the compound varied depending on the cell type and it was observed that it exhibited a more pronounced antiproliferative activity especially in liver cancer cells. These results indicate that etoxazole may be a promising candidate for hepatocellular carcinoma treatment. Furthermore, molecular docking simulations were conducted to evaluate the binding mode and affinity of the etoxazole ligand against the Kinase Insert Domain Receptor (PDB ID: 3WZE). The docking results indicated that etoxazole exhibited a binding energy of -8.6kcal/mol and formed stable interactions within the active site, suggesting a high inhibitory potential. In particular, key stabilizing interactions were identified, including hydrogen bonds with ASP183 and a halogen bond with GLU72, further supporting the molecular affinity. These findings suggest that etoxazole may be the subject of further research as a potential anticancer agent.</p>","PeriodicalId":8332,"journal":{"name":"Annales pharmaceutiques francaises","volume":" ","pages":""},"PeriodicalIF":1.0,"publicationDate":"2025-07-10","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144616098","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
Design, development and evaluation of curcumin (Curcuma longa) encapsulated phospholipid nanocarrier to enhance solubility and improve efficacy in MCF-7 cell line by Quality by Design. 姜黄素包封磷脂纳米载体在MCF-7细胞中增强溶解度和提高疗效的设计、开发与评价
IF 1.1
Annales pharmaceutiques francaises Pub Date : 2025-07-10 DOI: 10.1016/j.pharma.2025.07.004
Vaibhav Bhadange, Supriya Jogdand, Ankita Kawtikwar, Pravin Kawtikwar
{"title":"Design, development and evaluation of curcumin (Curcuma longa) encapsulated phospholipid nanocarrier to enhance solubility and improve efficacy in MCF-7 cell line by Quality by Design.","authors":"Vaibhav Bhadange, Supriya Jogdand, Ankita Kawtikwar, Pravin Kawtikwar","doi":"10.1016/j.pharma.2025.07.004","DOIUrl":"10.1016/j.pharma.2025.07.004","url":null,"abstract":"<p><p>Lipid-based excipients are increasingly used to enhance the stability of innovative drug delivery systems. Phospoholipid nanocarriers, a botanical formulation, are used to build lipophilic molecular complexes, improving stability, absorption, and bioavailability. Turmeric (Curcuma longa) contains curcumin, which has poor bioavailability due to its solubility and wettability. Hence, the study was designed to enhance the solubility of curcumin by phospholipid complexation. The curcumin-encapsulated phospholipid nanocarriers (Ccm-PNs) were developed by solvent evaporation method, and the formula was optimized using a Box-Behnekn design based on QbD. Physicochemical properties and functional characterization were done by accessing particle size, entrapment efficiency, in vitro drug release. The adenocarcinoma breast cell line (MCF-7) was used for cytotoxicity investigation of Ccm-PNs. It showed lower particle size and stable zeta potential values, and their compatibility with excipients was confirmed through DSC and FTIR studies. They also demonstrated higher entrapment and in vitro drug release over 48hours. The cytotoxicity study showed improved efficacy than pure curcumin solution. In conclusion, overall results show that phospholipid nanocarriers have the ability to enhance therapeutic efficacy and bioavailability.</p>","PeriodicalId":8332,"journal":{"name":"Annales pharmaceutiques francaises","volume":" ","pages":""},"PeriodicalIF":1.1,"publicationDate":"2025-07-10","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144616096","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
[Incompatibility of injectable drugs in neonatal intensive care: From assessment to implementation of a preventive tool]. [新生儿重症监护中注射药物不配伍:从评估到预防工具的实施]。
IF 1
Annales pharmaceutiques francaises Pub Date : 2025-07-10 DOI: 10.1016/j.pharma.2025.07.002
Marie Guedon, Catherine Mennesson, Baptiste Fulbert, Elise D'huart, Laura Menvielle, Elodie Tisserand, Dominique Hettler
{"title":"[Incompatibility of injectable drugs in neonatal intensive care: From assessment to implementation of a preventive tool].","authors":"Marie Guedon, Catherine Mennesson, Baptiste Fulbert, Elise D'huart, Laura Menvielle, Elodie Tisserand, Dominique Hettler","doi":"10.1016/j.pharma.2025.07.002","DOIUrl":"10.1016/j.pharma.2025.07.002","url":null,"abstract":"<p><strong>Introduction: </strong>Complex administration patterns in neonatal intensive care lead to the mixing of several active ingredients on the same route. The aim of this study was to assess the frequency of these concomitant administrations and their physico-chemical compatibility, and then to establish a specific compatibility table.</p><p><strong>Material and methods: </strong>A prospective, observational, single-center study was carried out in a neonatal intensive care unit between February 15 and April 2, 2024. Data (patients, approaches, parenteral nutrition, injectable drugs [dose, dilution, administration methods]) were collected from computerized prescriptions and observation of connections at the patient's bed. Compatibilities were assessed using Stabilis® and the Handbook of Injectable Drugs®.</p><p><strong>Results: </strong>Forty-nine prescriptions containing 385 Y combinations were included: 36% were compatible, 3% incompatible and 46% not studied. A compatibility table was created, including 24 of the most commonly prescribed molecules (anti-infectives and nervous system drugs specifically).</p><p><strong>Discussion and conclusion: </strong>Y-combinations appear inevitable in patient management. Although few incompatible associations have been observed, the absence of data for many molecules should lead to increased vigilance. The creation of a specific compatibility table would appear to be a tool that would reduce the risk of incompatibility. An evaluation of this tool should be envisaged, as well as an extension of the project to the establishment's various pediatric departments.</p>","PeriodicalId":8332,"journal":{"name":"Annales pharmaceutiques francaises","volume":" ","pages":""},"PeriodicalIF":1.0,"publicationDate":"2025-07-10","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144616095","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
Oncology pharmacy practice: Key insights, challenges, and perspectives - A position paper from the French Society for Oncology Pharmacy (SFPO). 肿瘤药学实践:关键见解,挑战和观点-法国肿瘤药学学会(SFPO)的立场文件。
IF 1.1
Annales pharmaceutiques francaises Pub Date : 2025-07-10 DOI: 10.1016/j.pharma.2025.07.005
Florence Ranchon, Florian Slimano, Isabelle Borget, Mathieu Boulin, Christophe Bardin, Pierre Coliat, Nicolas Cormier, Catherine Devys, Raphaelle Fanciullino, Muriel Paul, Florent Puisset, Catherine Rioufol, Lionel Tortolano, Jean-François Tournamille, Jean Vigneron, Régine Chevrier, Bertrand Pourroy, Jean-Louis Cazin
{"title":"Oncology pharmacy practice: Key insights, challenges, and perspectives - A position paper from the French Society for Oncology Pharmacy (SFPO).","authors":"Florence Ranchon, Florian Slimano, Isabelle Borget, Mathieu Boulin, Christophe Bardin, Pierre Coliat, Nicolas Cormier, Catherine Devys, Raphaelle Fanciullino, Muriel Paul, Florent Puisset, Catherine Rioufol, Lionel Tortolano, Jean-François Tournamille, Jean Vigneron, Régine Chevrier, Bertrand Pourroy, Jean-Louis Cazin","doi":"10.1016/j.pharma.2025.07.005","DOIUrl":"10.1016/j.pharma.2025.07.005","url":null,"abstract":"<p><p>The role of hospital oncology pharmacists (HOP) in the care of cancer patients has evolved considerably. This evidence led the experts of the French Society for Oncology Pharmacy (SFPO) to write a position paper. The first part presents the key insights of oncology pharmacy services (technology aspects of anticancer drug preparation and clinical pharmacy services), training of HOPs and research activities (clinical trials, research in oncology pharmacy). The second part of this position paper refers to the challenges and perspectives of E-health and artificial intelligence, precision medicine, access to innovation, and environmental issues.</p>","PeriodicalId":8332,"journal":{"name":"Annales pharmaceutiques francaises","volume":" ","pages":""},"PeriodicalIF":1.1,"publicationDate":"2025-07-10","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144616099","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
Trends in FDA drug approvals: 2021-2024 insights & innovations. FDA药品审批趋势:2021-2024洞察与创新。
IF 1
Annales pharmaceutiques francaises Pub Date : 2025-06-27 DOI: 10.1016/j.pharma.2025.06.004
Geet Raut, Sanjay Sharma
{"title":"Trends in FDA drug approvals: 2021-2024 insights & innovations.","authors":"Geet Raut, Sanjay Sharma","doi":"10.1016/j.pharma.2025.06.004","DOIUrl":"10.1016/j.pharma.2025.06.004","url":null,"abstract":"<p><p>From 2021-2024, the U.S. Food and Drug Administration (FDA) approved novel drugs, advancing treatments in neurology, oncology, infectious diseases and rare disorders. This review analyzes approval trends, highlighting the targeted diseases and biologics, the rise of expedited pathways and focus on unmet medical needs. These examines key therapeutic areas the approval trends of different categories. The analysis draws on data from the FDA's Center for Drug Evaluation and Research (CDER) to provide insights into novel drug indication, regulatory innovations and their implications to healthcare. The review analyzes trends in drug approvals.</p>","PeriodicalId":8332,"journal":{"name":"Annales pharmaceutiques francaises","volume":" ","pages":""},"PeriodicalIF":1.0,"publicationDate":"2025-06-27","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144526267","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
Polymeric nanocomposites: Recent advances, challenges, techniques, and biomedical applications. 高分子纳米复合材料:最新进展、挑战、技术和生物医学应用。
IF 1
Annales pharmaceutiques francaises Pub Date : 2025-06-21 DOI: 10.1016/j.pharma.2025.06.003
Shivangi Sharma, Madhav Mishra, Harshit Sharma, Aman Singh Chauhan, Biswajit Das, Devyani Rajput, Vikas Pandey, Ram Babu Tripathi, Rajeev Sharma
{"title":"Polymeric nanocomposites: Recent advances, challenges, techniques, and biomedical applications.","authors":"Shivangi Sharma, Madhav Mishra, Harshit Sharma, Aman Singh Chauhan, Biswajit Das, Devyani Rajput, Vikas Pandey, Ram Babu Tripathi, Rajeev Sharma","doi":"10.1016/j.pharma.2025.06.003","DOIUrl":"10.1016/j.pharma.2025.06.003","url":null,"abstract":"<p><p>Incredible advances in material technology have fueled the adoption of a variety of new materials, hybrids, and composites across a wide range of applications. Among these developing prospects, polymer nanocomposites stand out for their potential to revolutionize the future due to their diverse characteristics and accompanying benefits. These nanocomposites have a wide range of applications, including drug delivery, gene therapy, tissue engineering, bioimaging, and biosensors. The primary objective of this article is to provide a comprehensive overview of polymer nanocomposites, focusing on recent advancements, existing challenges, and various synthesis methods. Additionally, it explores the different types of polymer nanocomposites, and their biomedical applications.</p>","PeriodicalId":8332,"journal":{"name":"Annales pharmaceutiques francaises","volume":" ","pages":""},"PeriodicalIF":1.0,"publicationDate":"2025-06-21","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144473937","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}
引用次数: 0
Physicochemical stability of a bevacizumab biosimilar in vials and diluted preparations: Implications for hospital practice and inventory management. 贝伐单抗生物类似药在小瓶和稀释制剂中的物理化学稳定性:对医院实践和库存管理的影响。
IF 1
Annales pharmaceutiques francaises Pub Date : 2025-06-13 DOI: 10.1016/j.pharma.2025.06.002
Victoire Vieillard, Lucile Foulley, Salim Benkhalifa, Muriel Paul
{"title":"Physicochemical stability of a bevacizumab biosimilar in vials and diluted preparations: Implications for hospital practice and inventory management.","authors":"Victoire Vieillard, Lucile Foulley, Salim Benkhalifa, Muriel Paul","doi":"10.1016/j.pharma.2025.06.002","DOIUrl":"10.1016/j.pharma.2025.06.002","url":null,"abstract":"<p><p>Biosimilars like Vegzelma can significantly enhance access to biologic therapies and reduce healthcare costs, provided that comprehensive stability data is available. This study aimed to provide extended stability data, allowing hospitals and healthcare professionals to effectively manage drug preparation, minimize wastage, and optimize cost-efficiency. The stability assessments employed in this study included ion exchange chromatography, steric exclusion chromatography, dynamic light scattering, and measurements of pH, density, and osmolality. These assessments focused on the physicochemical stability of the bevacizumab biosimilar (Vegzelma) in vials and polyolefin infusion bags when diluted to concentrations of 1.4 and 16.5mg/mL in 0.9% NaCl and stored at temperatures between 2 to 8°C and at 25°C. Results from stability and sterility assays confirm that when diluted in 0.9% NaCl and stored in polyolefin IV bags, Vegzelma remains stable at the commonly used concentrations of 1.4 and 16.5mg/mL for a 96-hour thermal cycle. For opened vials, the study extends the stability period to 60 days at 2-8°C under light-protected conditions. Unopened vials can be safely stored at room temperature, protected from light, for up to 72hours without compromising the product's integrity. All analyses, particle sizing, ion exchange chromatography, spectral analysis, and thermal denaturation, indicated stable molecular and structural integrity of the bevacizumab, with no observed changes in aggregation, ionic distribution, tertiary structure, or thermodynamic properties. These findings demonstrate the biosimilar's resilience against a 72-hour temperature spike. Pharmacies could use this data for flexible treatment scheduling, advanced preparation for weekends, and holidays, resulting in cost-efficiencies with biosimilars.</p>","PeriodicalId":8332,"journal":{"name":"Annales pharmaceutiques francaises","volume":" ","pages":""},"PeriodicalIF":1.0,"publicationDate":"2025-06-13","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144301022","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
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