Annales pharmaceutiques francaises最新文献

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IF 1.1
Annales pharmaceutiques francaises Pub Date : 2025-08-21 DOI: 10.1016/S0003-4509(25)00126-9
{"title":"Sommaire / Contents","authors":"","doi":"10.1016/S0003-4509(25)00126-9","DOIUrl":"10.1016/S0003-4509(25)00126-9","url":null,"abstract":"","PeriodicalId":8332,"journal":{"name":"Annales pharmaceutiques francaises","volume":"83 5","pages":"Pages v-vi"},"PeriodicalIF":1.1,"publicationDate":"2025-08-21","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144878269","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
Optimization of UV spectrophotometric techniques for tafamidis meglumine detection in pharmaceutical formulations and biological samples: A green chemistry perspective. 绿色化学视角下紫外分光光度法检测药物制剂和生物样品中三聚亚胺的优化研究
IF 1.1
Annales pharmaceutiques francaises Pub Date : 2025-08-16 DOI: 10.1016/j.pharma.2025.08.006
Md Mojeeb G Khan, Shubham R Raut, Md Rageeb Md Usman, Atul A Shirkhedkar, Md Shamsher Alam, Zamir G Khan
{"title":"Optimization of UV spectrophotometric techniques for tafamidis meglumine detection in pharmaceutical formulations and biological samples: A green chemistry perspective.","authors":"Md Mojeeb G Khan, Shubham R Raut, Md Rageeb Md Usman, Atul A Shirkhedkar, Md Shamsher Alam, Zamir G Khan","doi":"10.1016/j.pharma.2025.08.006","DOIUrl":"10.1016/j.pharma.2025.08.006","url":null,"abstract":"<p><strong>Objectives: </strong>The primary objective was to develop and validate four novel UV/visible spectrophotometric methods for the quantification of tafamidis meglumine in bulk drug, proprietary capsules, and spiked urine samples, ensuring accuracy, sensitivity, and environmental sustainability for pharmaceutical analysis.</p><p><strong>Methods: </strong>Four spectrophotometric approaches were established using absorbance and area under the curve (AUC) measurements, employing both zero-order and first-order derivative techniques. Method validation followed ICH guidelines, assessing linearity, accuracy, precision, sensitivity (LOD, LOQ), and greenness. Methanol was used as a green solvent, and eco-friendliness was evaluated using AGREE and ComplexGAPI metrics.</p><p><strong>Results: </strong>All methods exhibited excellent linearity (R<sup>2</sup>=0.9980-0.9995) over a 3-18μg/mL range. Accuracy was confirmed with recovery rates between 99.00% and 100.57%. Precision studies yielded %RSD values below 2%, indicating high reproducibility. Sensitivity was demonstrated with LOD and LOQ values from 0.27μg/mL to 2.3μg/mL. The use of methanol minimized environmental impact, and high AGREE and ComplexGAPI scores validated the methods' eco-friendly nature.</p><p><strong>Conclusion: </strong>The developed spectrophotometric methods are simple, rapid, sensitive, and environmentally sustainable for quantifying tafamidis meglumine in various matrices. These validated approaches set a new standard for green analytical chemistry in pharmaceutical quality control, ensuring both regulatory compliance and reduced environmental footprint.</p>","PeriodicalId":8332,"journal":{"name":"Annales pharmaceutiques francaises","volume":" ","pages":""},"PeriodicalIF":1.1,"publicationDate":"2025-08-16","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144871118","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
Computational genome engineering through AI-CRISPR-precision medicine integration in modern therapeutics. ai - crispr -精准医学在现代治疗中的整合
IF 1.1
Annales pharmaceutiques francaises Pub Date : 2025-08-07 DOI: 10.1016/j.pharma.2025.08.001
Oluwaseun E Agboola, Samuel S Agboola, Othuke B Odeghe, Oluranti E Olaiya, Zainab A Ayinla, Priscilla O Akinsanya, Olutosin S Ilesanmi, Tobi K Ibrahim, Theophilus A Adegbuyi, Oyebamiji Abel Kolawole, Idowu O Omotuyi, Babatunji E Oyinloye
{"title":"Computational genome engineering through AI-CRISPR-precision medicine integration in modern therapeutics.","authors":"Oluwaseun E Agboola, Samuel S Agboola, Othuke B Odeghe, Oluranti E Olaiya, Zainab A Ayinla, Priscilla O Akinsanya, Olutosin S Ilesanmi, Tobi K Ibrahim, Theophilus A Adegbuyi, Oyebamiji Abel Kolawole, Idowu O Omotuyi, Babatunji E Oyinloye","doi":"10.1016/j.pharma.2025.08.001","DOIUrl":"10.1016/j.pharma.2025.08.001","url":null,"abstract":"<p><p>The convergence of precision medicine strategies, CRISPR gene editing technologies, and artificial intelligence (AI) is causing a revolutionary change in the pharmaceutical industry in recent times. Latest trends and future directions of these integrated technologies in pharmaceutical science and molecular biology are presented in the present exhaustive review. With more than 250 gene-editing clinical trials being tracked internationally as of February 2025, the recent clinical successes point toward the therapeutic potency of CRISPR-based therapeutics. In parallel, AI-based drug discovery platforms are recording fantastic hit rates; compared to conventional industry benchmarks, AI-emerging drugs reflect 80-90% Phase I trial success rates. Therapeutic development paradigms are being transformed by the intersection of machine learning algorithms, multi-omics technologies, and precision medicine paradigms. The review provides insights into the revolutionary potential of these converging approaches in addressing unmet medical requirements and optimizing therapeutic benefits through syntheses of existing evidence from clinical trials, regulatory matters, and technological innovations.</p>","PeriodicalId":8332,"journal":{"name":"Annales pharmaceutiques francaises","volume":" ","pages":""},"PeriodicalIF":1.1,"publicationDate":"2025-08-07","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144811659","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
Comparative evaluation of the anticancer effects of Echium amoenum and Valeriana officinalis on U87-MG glioblastoma cells. 紫锥菊和缬草对U87-MG胶质瘤细胞抗癌作用的比较研究。
IF 1.1
Annales pharmaceutiques francaises Pub Date : 2025-08-06 DOI: 10.1016/j.pharma.2025.08.003
Maryam Mohseni, Reza Masoomi Jahandizi, Ehsan Zayerzadeh
{"title":"Comparative evaluation of the anticancer effects of Echium amoenum and Valeriana officinalis on U87-MG glioblastoma cells.","authors":"Maryam Mohseni, Reza Masoomi Jahandizi, Ehsan Zayerzadeh","doi":"10.1016/j.pharma.2025.08.003","DOIUrl":"10.1016/j.pharma.2025.08.003","url":null,"abstract":"<p><strong>Objectives: </strong>Glioblastoma (GBM) is one of the most aggressive and treatment-resistant types of brain cancer, and conventional therapies such as surgery, chemotherapy, and radiotherapy have limited effectiveness in controlling it. In this context, the use of natural compounds with anticancer properties has been explored as a complementary strategy. The purpose of the current study was to assess the cytotoxic and pro-apoptotic potential of the plant extracts Echium amoenum and Valeriana officinalis in U87-MG glioblastoma cells.</p><p><strong>Materials and methods: </strong>The Maceration technique was used to prepare the plant extracts. U87-MG cells and L-929 cell lines were cultured and treated with various concentrations (31.25, 62.5, 125, 250, 500 and 1000μg/mL) of the extracts upon reaching optimal confluence. An MTT assay was performed to evaluate the cytotoxicity at 24, 48 and 72hours. To investigate the expression of apoptosis-related genes (Bax, Bcl-2 and Caspase-3, Caspase-9 and puma), RNA was extracted and converted to cDNA and then the expression of these genes was analyzed by real-time PCR.</p><p><strong>Results: </strong>MTT assay results showed that both extracts inhibited cancer cell growth in a dose- and time-dependent manner. At 72hours and a concentration of 1000μg/mL, E. amoenum extract exhibited the highest inhibition rate (96%), while V. officinalis extract showed 95% inhibition under the same conditions. At the molecular level, E. amoenum extract significantly upregulated Caspase-3 expression by more than 20-fold (P<0.0001) indicating a strong activation of the apoptotic pathway, while V. officinalis extract did not cause a significant change in the expression of this gene. Additionally, Bcl-2 expression was significantly elevated in the E. amoenum-treated group (P<0.001). However, the upregulation of Bcl-2-a gene associated with cell survival-was considerably weaker compared to the robust induction of Caspase-3. Also, E. amoenum significantly upregulated Caspase-9 expression (P<0.0001), indicating activation of the intrinsic apoptotic pathway.</p><p><strong>Conclusion: </strong>The results demonstrated that extracts from V. officinalis and E. amoenum have anticancer effects on U87-MG cells, possibly through the induction of apoptosis. E. amoenum was more effective in raising Caspase-3 and initiating pathways leading to programmed cell death, whereas V. officinalis did not change the expression levels of apoptotic genes. Our finding suggests that this plant may exert its anticancer effects through non-apoptotic or alternative apoptotic mechanisms, rather than the classical intrinsic or mitochondrial pathway. These findings imply that more research should be done on the application of natural substances as a supplemental approach to GBM therapy.</p>","PeriodicalId":8332,"journal":{"name":"Annales pharmaceutiques francaises","volume":" ","pages":""},"PeriodicalIF":1.1,"publicationDate":"2025-08-06","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144803311","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
A multidisciplinary intervention to improve postoperative antithrombotic therapy after urgent coronary artery bypass-grafts. 多学科干预提高紧急冠状动脉旁路移植术后抗血栓治疗。
IF 1.1
Annales pharmaceutiques francaises Pub Date : 2025-08-06 DOI: 10.1016/j.pharma.2025.08.005
Alma Feka, Mario Verdugo-Marchese, Sarah Hugelshofer, Stéphane Guerrier, Nancy Perrottet, Matthias Kirsch, Farshid Sadeghipour, Ziyad Gunga
{"title":"A multidisciplinary intervention to improve postoperative antithrombotic therapy after urgent coronary artery bypass-grafts.","authors":"Alma Feka, Mario Verdugo-Marchese, Sarah Hugelshofer, Stéphane Guerrier, Nancy Perrottet, Matthias Kirsch, Farshid Sadeghipour, Ziyad Gunga","doi":"10.1016/j.pharma.2025.08.005","DOIUrl":"10.1016/j.pharma.2025.08.005","url":null,"abstract":"<p><strong>Objectives: </strong>The objective of this study was to assess whether implementing a protocol could improve adherence to European guidelines on postoperative antithrombotic therapy prescription in patients undergoing coronary artery bypass-grafts surgery (CABG) after acute coronary syndrome (ACS).</p><p><strong>Methods: </strong>We included patients who underwent cardiac surgery between January 2018 and December 2022. The population was divided in two groups, one before (group 1) and one after (group 2) the dissemination of a protocol on postoperative antithrombotic therapy issued by a multidisciplinary collaboration (January 2021) and its subsequent implementation during ward rounds. We analysed the protocol's impact on adherence to European guidelines in terms of antithrombotic therapy at discharge.</p><p><strong>Results: </strong>We included 259 patients, 83.8% were men and the median age was 67 [58; 74] years. At baseline, group 1 (n=152) and group 2 (n=107) had similar demographic characteristics except for smoking status and ACS events. Patients in group 2 had a higher rate of guideline adherence in terms of postoperative antithrombotic therapy (group 1=58.6% vs. group 2=82.2%, P<0.001). Using logistic regression accounting for demographic and temporal factors, the effect of the intervention was positive but not statistically significant. Adherence increased significantly over time, suggesting that the intervention contributed to an overall trend of improved adherence as apart of ongoing quality improvement efforts.</p><p><strong>Conclusion: </strong>Implementing the protocol was associated with a positive effect on guideline adherence for postoperative antithrombotic therapy in ACS patients undergoing CABG. Although the intervention's independent effect was not statistically significant after adjustment, the findings support its role in achieving sustained improvement in adherence over time.</p>","PeriodicalId":8332,"journal":{"name":"Annales pharmaceutiques francaises","volume":" ","pages":""},"PeriodicalIF":1.1,"publicationDate":"2025-08-06","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144803310","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
From inhibition to degradation: Cutting-edge technology in COVID-19 drug discovery. 从抑制到降解:COVID-19药物发现的前沿技术。
IF 1.1
Annales pharmaceutiques francaises Pub Date : 2025-08-06 DOI: 10.1016/j.pharma.2025.08.002
Emmanuel Adediran, Martin Ikhoyameh, Ololade S Gbadebo
{"title":"From inhibition to degradation: Cutting-edge technology in COVID-19 drug discovery.","authors":"Emmanuel Adediran, Martin Ikhoyameh, Ololade S Gbadebo","doi":"10.1016/j.pharma.2025.08.002","DOIUrl":"10.1016/j.pharma.2025.08.002","url":null,"abstract":"<p><p>Proteolysis-targeting chimera (PROTAC) molecules are hetero-bifunctional chemical entities with three different units which include a ligand that binds to a protein of interest; a second ligand that binds to the E3 ubiquitin ligase; and a linker that conjugates the two ligands together. The technology utilizes the ubiquitin-proteasome system (UPS) to target a specific protein and induce its degradation in the cell. PROTAC has drawn the interest of researchers in anti-cancer drug discovery and has yielded a better outcome in degrading regulatory proteins, kinases, nuclear receptors, transcription factors, and enzymes. This paper discusses this technology and its application to COVID-19 drug discovery. In 2019, the Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2), an infectious agent emerged from Wuhan resulting in millions of deaths worldwide. The WHO declared it a global pandemic because of its fast transmissibility and infectivity across the continents. To curtail this menace, efforts were made to develop therapeutics and inhibitors very quickly. Vaccines and therapeutics discovery were fast-tracked, and already FDA-approved drug molecules were also repurposed - many of which were protein inhibitors. However, PROTAC technology potentially offers a more direct and sustainable contribution to anti-COVID drug discovery than protein inhibition-based therapeutics.</p>","PeriodicalId":8332,"journal":{"name":"Annales pharmaceutiques francaises","volume":" ","pages":""},"PeriodicalIF":1.1,"publicationDate":"2025-08-06","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144803313","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
Development and characterization of AXT@metal-organic framework: A biocompatible, pH-responsive nanocarrier for targeted axitinib delivery in MCF-7 cancer cells. AXT@Metal-Organic框架的开发和表征:一种生物相容性,ph响应的纳米载体,用于靶向递送MCF-7癌细胞中的阿西替尼。
IF 1.1
Annales pharmaceutiques francaises Pub Date : 2025-08-06 DOI: 10.1016/j.pharma.2025.08.004
Jayvadan K Patel, Ujashkumar A Shah, Pravin O Patil, Jitendra H Patil
{"title":"Development and characterization of AXT@metal-organic framework: A biocompatible, pH-responsive nanocarrier for targeted axitinib delivery in MCF-7 cancer cells.","authors":"Jayvadan K Patel, Ujashkumar A Shah, Pravin O Patil, Jitendra H Patil","doi":"10.1016/j.pharma.2025.08.004","DOIUrl":"10.1016/j.pharma.2025.08.004","url":null,"abstract":"<p><p>Cancer remains a major global health challenge, characterized by low survival rates and significant side effects from conventional treatments. The metal-organic frameworks (MOFs) offer distinctive features that make them highly suitable for medical innovations. This study presents the development of MOFs as nanocarriers for the anticancer drug axitinib (AXT) to address these issues. Specifically, the MOFs were composed of titanium isopropoxide as metal ions and terephthalic acid as ligands, synthesized via a hydrothermal approach. The pH-responsive Ti-MOF was designed to enhance targeted drug delivery and minimize AXT side effects. The Ti-MOF was analyzed through various techniques, including UV-Vis spectroscopy, Fourier Transform Infrared (FTIR) spectroscopy, Scanning Electron Microscopy coupled with Energy Dispersive X-ray (SEM-EDX), zeta potential analysis, particle size measurement, Raman spectroscopy, and thermo gravimetric analysis (TGA). In vitro drug release studies at 37°C demonstrated that these porous carriers significantly slowed the release of AXT under neutral conditions, with only 4.5% to 8.0% released, mimicking normal tissue environments. In contrast, under acidic conditions (i.e., at pH 5), which simulates the acidic conditions of cancerous tissues, the release of AXT increased substantially, reaching 76% to 78% after 12h, While staying low at 8.0% to 9.5% at pH 7.4, this pH-sensitive release pattern results from the increased dissolution of the MOF material in acidic environments. This characteristic makes it a promising approach for targeted cancer therapy. The design of these MOF-based nanocarriers underscores their potential to enhance the precision and effectiveness of anticancer treatments.</p>","PeriodicalId":8332,"journal":{"name":"Annales pharmaceutiques francaises","volume":" ","pages":""},"PeriodicalIF":1.1,"publicationDate":"2025-08-06","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144803312","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
Crystal structure, spectral characterization, photophysical properties, Hirshfeld surface analysis, and antimicrobial activity of homopiperazinium dichromate(VI). 重铬酸同哌嗪(VI)的晶体结构、光谱表征、光物理性质、Hirshfeld表面分析和抗菌活性。
IF 1.1
Annales pharmaceutiques francaises Pub Date : 2025-08-05 DOI: 10.1016/j.pharma.2025.07.010
Utkirjon Holikulov, Sonia Trabelsi, Houda Marouani, Thierry Roisnel, Omar M Al-Dossary, Abduvakhid Jumabaev, Noureddine Issaoui
{"title":"Crystal structure, spectral characterization, photophysical properties, Hirshfeld surface analysis, and antimicrobial activity of homopiperazinium dichromate(VI).","authors":"Utkirjon Holikulov, Sonia Trabelsi, Houda Marouani, Thierry Roisnel, Omar M Al-Dossary, Abduvakhid Jumabaev, Noureddine Issaoui","doi":"10.1016/j.pharma.2025.07.010","DOIUrl":"10.1016/j.pharma.2025.07.010","url":null,"abstract":"<p><p>This work presents a comprehensive study of the crystal structure, spectral properties (IR and UV-Vis), thermal behavior, and antimicrobial activity of homopiperazinium dichromate (C<sub>5</sub>H1<sub>4</sub>N<sub>2</sub>)Cr<sub>2</sub>O<sub>7</sub>(VI). X-ray diffraction reveals that the compound crystallizes in the monoclinic space group P2<sub>1</sub>/c, with unit cell dimensions a=8.7275(8)Å, b=10.5769(11)Å, and c=14.7467(10)Å and β=122.941(4)°. The crystal packing is stabilized by intermolecular N-H…O and C-H…O hydrogen bonds, with Hirshfeld surface analysis revealing dominant O…H/H…O interactions contributing 80.5% to the overall crystal cohesion. UV-Vis absorption bands are observed at 279, 354, and 446nm, with an estimated band gap energy of 3.019eV, indicating high stability and moderate optical activity. Thermal analysis shows an intense endothermic fusion peak followed by continuous decomposition, leading to chromium oxide formation. Antimicrobial tests demonstrate significant inhibition activity against tested pathogens, including notable antifungal effects against Candida albicans. These results highlight the potential of this hybrid material in antimicrobial development and photochemical applications.</p>","PeriodicalId":8332,"journal":{"name":"Annales pharmaceutiques francaises","volume":" ","pages":""},"PeriodicalIF":1.1,"publicationDate":"2025-08-05","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144774562","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
Vie de l’Académie – 1er semestre 2025 学院生活—2025年第一学期
IF 1.1
Annales pharmaceutiques francaises Pub Date : 2025-08-05 DOI: 10.1016/j.pharma.2025.07.003
{"title":"Vie de l’Académie – 1er semestre 2025","authors":"","doi":"10.1016/j.pharma.2025.07.003","DOIUrl":"10.1016/j.pharma.2025.07.003","url":null,"abstract":"","PeriodicalId":8332,"journal":{"name":"Annales pharmaceutiques francaises","volume":"83 5","pages":"Pages 1011-1018"},"PeriodicalIF":1.1,"publicationDate":"2025-08-05","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144878267","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
Synthesizing safety data on novel intravaginal formulations: A comprehensive scoping review of in vivo and in vitro research. “综合新型阴道内制剂的安全性数据:体内和体外研究的全面范围综述”。
IF 1.1
Annales pharmaceutiques francaises Pub Date : 2025-07-23 DOI: 10.1016/j.pharma.2025.07.009
Athul Tp, Anjani Seth, Vanshika Sharma, Meenakshi Pandey, R Galib, Sanjay Jachak, Tanuja Nesari, Meena S Deogade
{"title":"Synthesizing safety data on novel intravaginal formulations: A comprehensive scoping review of in vivo and in vitro research.","authors":"Athul Tp, Anjani Seth, Vanshika Sharma, Meenakshi Pandey, R Galib, Sanjay Jachak, Tanuja Nesari, Meena S Deogade","doi":"10.1016/j.pharma.2025.07.009","DOIUrl":"10.1016/j.pharma.2025.07.009","url":null,"abstract":"<p><strong>Background and objectives: </strong>Intravaginal drug delivery systems are gaining attention for their potential to treat local and systemic gynaecological conditions, offering advantages such as bypassing hepatic first-pass metabolism and improved bioavailability. However, the safety evaluation of these novel formulations remains inconsistent, with limited regulatory guidance. This scoping review aims to consolidate data from in vivo and in vitro safety studies to support the design of standardized safety protocols for future intravaginal formulations.</p><p><strong>Materials and methods: </strong>A systematic data search was conducted using PubMed and Scopus (2009-2024) data base following PRISMA-ScR guidelines. Eligible studies were included after data screening by individual reviewers. Study selection, data extraction, and charting were performed using a pre-defined protocol registered on the Open Science Framework.</p><p><strong>Results: </strong>A total of 77 studies were included, comprising 64 in vivo and 13 in vitro studies. Rabbit was the frequently used animal model, while HeLa and normal vaginal epithelial cells were predominant in cell-based assays. Key safety endpoints evaluated included vaginal irritation, systemic toxicity, cytotoxicity, and cytokine expression. A wide range of formulations was assessed, including gels, rings, suppositories, and hydrogels.</p><p><strong>Conclusions: </strong>This review highlights the need for harmonized safety assessment protocols for intravaginal formulations. By mapping current practices and models used in preclinical research, this work offers a foundation for researchers and regulators to develop more robust and standardized safety evaluation frameworks.</p>","PeriodicalId":8332,"journal":{"name":"Annales pharmaceutiques francaises","volume":" ","pages":""},"PeriodicalIF":1.1,"publicationDate":"2025-07-23","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144717278","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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