Annales pharmaceutiques francaises最新文献

{"title":"The paradigm shift from Stringent Regulatory Authorities to WHO-Listed Authorities.","authors":"Valérie Faillat","doi":"10.1016/j.pharma.2025.03.006","DOIUrl":"https://doi.org/10.1016/j.pharma.2025.03.006","url":null,"abstract":"<p><p>Regulatory systems play a key role in assuring the quality, safety, and efficacy of health products. After more than 20 years of efforts on regulatory capacity improvement of the less-equipped National Regulatory Authorities, the transition from the concept of Stringent Regulatory Authorities (SRAs) to WHO-Listed Authorities (WLAs) represents a significant paradigm shift in global health ecosystem. This review aims to provide a better understanding of this evolution and to clarify the WLA concept, as a component for the long-term success of this framework.</p>","PeriodicalId":8332,"journal":{"name":"Annales pharmaceutiques francaises","volume":" ","pages":""},"PeriodicalIF":1.0,"publicationDate":"2025-04-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143778728","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Development and Validation of a Novel Reverse-Phase High-Performance Liquid Chromatography (RP-HPLC) Method for the Quantification of Related Substances of Vasopressin Injection: A Characterization and Comparative Analysis of Vasopressin Formulation Samples against Vasostrict (RLD) in Various Diluents.","authors":"Sivaji Maganti, Suryakala Duvvuri, Prudhvi Raju Pericharla, Ravi Kumar Bellam, Ameer Khan Shaik","doi":"10.1016/j.pharma.2025.03.007","DOIUrl":"https://doi.org/10.1016/j.pharma.2025.03.007","url":null,"abstract":"<p><p>In the present study, we developed and validated a sensitive, accurate, robust and simple RP-HPLC method for quantification of related substances of Vasopressin (VPS) injection. The development phase prioritized the optimization of wavelength, mobile phase composition and column selection to enhance separation and sensitivity for the analytical evaluation of VPS injection. By considering peak symmetry, resolution and retention time, chromatographic conditions of VPS injection were established. The YMC PACK ODS AM (100 ×4.6) mm, 3µm was employed in the study. Mobile phase A was prepared with 0.113 M NaH₂PO₄.H₂O (pH 3.0), while mobile phase B was a 50:50 (v/v) ratio of acetonitrile and water, pumped through a flow rate of 1.0 mL/min. VPS injection was exposed to thermal, photolytic, acid, base and peroxide degradation conditions and these were analysed by the current method. The method was validated following the guidelines set by the International Council for Harmonization guideline (ICH). The linearity studies demonstrating that a correlation coefficient value is more than 0.999 for VPS and its related substances. The detection and quantification limits for all related substances were found to be 0.01% and 0.05%, respectively. All the impurities exhibited consistent recoveries ranging from 85 to 105%. The unknown impurities were eluting at RRT 1.23 and RRT 1.25 in the RS methodology (HPLC-UV) of VPS injection are identified and assessed the impurity levels. Furthermore, aggregate profiles and secondary structure analysis studies were carried out using FTIR and LC-HRMS, comparing the VPS formulation samples with the Reference Listed Drug (RLD) (Vasostrict) samples across various diluents.</p>","PeriodicalId":8332,"journal":{"name":"Annales pharmaceutiques francaises","volume":" ","pages":""},"PeriodicalIF":1.0,"publicationDate":"2025-04-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143778725","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Formulation of repurposed celecoxib-loaded nanostructured lipid carriers using Box Behnken design, its characterization, and anticancer evaluation.","authors":"Ashwini Bhavar, Kaustubh Ajit Kolekar, Tejashree Yadav, Kapil Kole, Durgacharan Bhagwat, Sachin Kumar Singh, Popat S Kumbhar, John Disouza","doi":"10.1016/j.pharma.2025.03.005","DOIUrl":"https://doi.org/10.1016/j.pharma.2025.03.005","url":null,"abstract":"<p><strong>Objectives: </strong>The key objective of present research is to effectively treat lung cancer with repurposed celecoxib while overcoming challenges such as solubility, bioavailability, non-selectivity, and negative effects by delivering celecoxib through nanostructured lipid carriers via the parenteral route.</p><p><strong>Methods: </strong>Celecoxib-laden nanostructured lipid carriers were manufactured by melt-emulsification ultrasonication approach and optimized through Box-Behnken Design. The celecoxib nanostructured lipid carriers were examined for particle size, % entrapment efficiency, zeta potential, in vitro release, cytotoxicity, stability, etc. Results: The optimized celecoxib nanostructured lipid carriers displayed a % entrapment efficiency of 91.69±4.9% and particle size of 132.1±6.8 nm with a polydispersity index of 0.41±0.06, and a zeta potential of -39.1 ± 3.0 mV. Notably, celecoxib nanostructured lipid carriers exhibited better and controlled celecoxib release at phosphate buffer solution pH 6.8 than pH 7.4, revealing the tumor-targeting potential of nanostructured lipid carriers. Also, the release of celecoxib from nanostructured lipid carriers was controlled for 48 h, indicating reduced chances of systemic toxicity. The in vitro cytotoxicity against A549 cells of celecoxib nanostructured lipid carriers was 1.5-fold greater than that of pure celecoxib, confirming significant anti-lung cancer effectiveness. Further, the celecoxib-loaded nanostructured lipid carriers remained stable for twelve weeks at cold and ambient temperatures.</p><p><strong>Conclusion: </strong>Thus, the given research concludes that parenteral administration of nanostructured lipid carriers could be a harmless, efficient, and novel choice to treat lung cancer using repurposed celecoxib.</p>","PeriodicalId":8332,"journal":{"name":"Annales pharmaceutiques francaises","volume":" ","pages":""},"PeriodicalIF":1.0,"publicationDate":"2025-03-26","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143741904","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Formulation and evaluation of a smart mucoadhesive nasal gel containing oregano, chamomile, and lavender for seizure control in PTZ-induced seizure model in rats.","authors":"Samin Sheikholeslami, Amir Baghaei, Marziyeh Amiri-Andebili, Faranak Salmannejad, Mohammad Mahdi Ahmadian-Attari","doi":"10.1016/j.pharma.2025.03.004","DOIUrl":"10.1016/j.pharma.2025.03.004","url":null,"abstract":"<p><strong>Background: </strong>Epilepsy is a prevalent neurological disorder characterized by recurrent seizures, affecting approximately 1% of the global population. Despite the availability of antiepileptic drugs, a significant proportion of patients experience uncontrolled seizures, which necessitates the development of alternative therapeutic strategies. Herbal medicine has gained attention due to its potential anticonvulsant properties.</p><p><strong>Objectives: </strong>This study aimed to assess the anticonvulsant effects of hydroalcoholic extracts of oregano, chamomile, and lavender in rats' pentylenetetrazol (PTZ)- induced seizure model. Furthermore, it sought to formulate and evaluate a mucoadhesive nasal hydrogel containing these extracts.</p><p><strong>Methods: </strong>The herbal extracts were prepared using ethanol (70%) through maceration and analyzed based on the Iranian Herbal Pharmacopeia standards. Total phenolic content (TPC) was quantified using the spectrophotometric method to standardize the extracts. Using various gelling agents, the nasal hydrogel formulation was optimized for mucoadhesion and gelation properties. The anticonvulsant activity was evaluated in vivo using seizure models induced by pentylenetetrazol (PTZ).</p><p><strong>Results: </strong>The herbal extracts met the pharmacopeial standards, and the nasal hydrogel formulation demonstrated favorable physicochemical properties, including optimal pH and mucoadhesive strength. In vivo studies showed that intranasal administration of the herbal extracts significantly delayed seizure onset and reduced seizure intensity at a dose of 34mg/kg, compared to the negative control group (P<0.001).</p><p><strong>Conclusion: </strong>The smart mucoadhesive nasal hydrogel containing oregano, chamomile, and lavender extracts exhibited promising anticonvulsant activity, suggesting its potential as a novel, non-invasive alternative for epilepsy management.</p>","PeriodicalId":8332,"journal":{"name":"Annales pharmaceutiques francaises","volume":" ","pages":""},"PeriodicalIF":1.0,"publicationDate":"2025-03-19","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143673408","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"[The medical biologist \"under the microscope\": Analysis of digital images depicting laboratory medicine].","authors":"Bertrand Lefrère, Lionel Barrand, Jean-Louis Beaudeux","doi":"10.1016/j.pharma.2025.03.003","DOIUrl":"10.1016/j.pharma.2025.03.003","url":null,"abstract":"<p><p>In France, the practice of laboratory medicine has, over the past ten years or so, met with a certain amount of disenchantment from medical students. Despite its intricacy and importance to healthcare, the world of the clinical laboratory lacks visibility in medical studies. While other phenomena can explain this disenchantment, our belief in the importance of promoting greater visibility of laboratory medicine in medical studies led us to examine for this article the images and symbols associated with the profession, based on a semiotic analysis. We created a collection of digital images published over the last ten years and found that these images, aside from a few outliers, offer a fairly reasonable representation of the analytical dimension of laboratory medicine. However, we found that this collection of images does not reflect the wealth of specialities, technological complexity and other important aspects of the practice of laboratory medicine especially regarding the clinical staff. Furthermore, we found that clinical interactions (i.e., interactions with patients or doctors) remain, with a few exceptions, absent from most of the images, raising questions about the impact of the images on medical students' perceptions of the profession.</p>","PeriodicalId":8332,"journal":{"name":"Annales pharmaceutiques francaises","volume":" ","pages":""},"PeriodicalIF":1.0,"publicationDate":"2025-03-14","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143639491","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Pharmacological and herbal approach to diabetes mellitus type 2 management: A comparative analysis of conventional therapy and alternative remedy.","authors":"Zahra Shareef, Afsana Murtaza, Ghousia Fatima, Amjad Islam Aqib, Zahid Manzoor, Muhammad Sibghat Ullah Malik, Hafiz Iftikhar Hussain","doi":"10.1016/j.pharma.2025.03.002","DOIUrl":"10.1016/j.pharma.2025.03.002","url":null,"abstract":"<p><p>Diabetes mellitus is a heterogeneous metabolic disorder that affects the metabolism of protein, fats, and carbohydrates due to the destruction of beta-cells resulting disruptions in insulin action/insulin secretion. According to International Diabetes Federation (IDF) prevalence of 90% people with diabetes has type 2 diabetes is driven by socio-economic, demographic, environmental, and genetic factors. DM type 2 sparks myriad of debilitating disease needs management to cure it. Management needs multifactorial authentication including diet, lifestyle and pharmacotherapy. Literature reveals, metformin is the first line of medication used to cure diabetes Mellitus type 2, also associated with contraindications and adverse effects which spark the interest in alternative herbal remedies. This review will compare pharmacological therapy (metformin) with alternative herbal remedies (Moringa oleifera) in the management of diabetes mellitus type 2 including in mechanism, dosing relationship consequential effect. According to various guidelines and recommendations, Moringa oleifera is herbal remedy to exhibit anti-diabetic properties by enhancing insulin sensitivity and glucose regulation, reducing oxidation stress and inhibiting free radicals. Significant outcomes suggest that moringa leaf extract is a valuable adjoining therapy with safety high profiling with fewer or no side effects as compared to metformin. There is a need for alternative approaches to diabetes management due to side effects of pharmacological therapies. This review paper will also demonstrate the potential of alternative remedy (Moringa oleifera) in the management of DM type 2 and to what extent its dosing is related to efficacy and safety as compared to the pharmacological approach (Metformin).</p>","PeriodicalId":8332,"journal":{"name":"Annales pharmaceutiques francaises","volume":" ","pages":""},"PeriodicalIF":1.0,"publicationDate":"2025-03-12","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143630121","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":"Regulatory frameworks and filing discrepancies in generic drug approvals: A cross-regional study with analysis of FDA ANDA deficiencies.","authors":"Jyoti Pawar, Namita Hegde, Sanjay Sharma","doi":"10.1016/j.pharma.2025.03.001","DOIUrl":"10.1016/j.pharma.2025.03.001","url":null,"abstract":"<p><strong>Objectives: </strong>This research aims to analyse the regulatory frameworks for generic drug applications in the U.S., EU, India, Japan, and China comparing their filing requirements to identify gaps and areas for harmonization. Additionally, it focuses on examining common deficiencies in ANDA from FDA submissions in 2014-2023 to address issues, facilitating more efficient approvals and minimizing delays.</p><p><strong>Material and methods: </strong>The research involved analysing regulatory documents available on official websites, including the FDA, EMA, CDSCO, PMDA, and NMPA to achieve first objective. For second objective, a recurring common deficiency across key review disciplines such as bioequivalence, labelling and chemistry was identified through a detailed analysis of deficiency letters available on the FDA website. A targeted analysis was conducted on ANDA submissions filed between 2014 and 2024.</p><p><strong>Results: </strong>A total of 172 deficiencies were identified, with bioequivalence (35%), chemistry (34%), and labelling (31%). Method validation had the most deficiencies, especially non-compliance with FDA guidelines. In the labelling discipline, the most common deficiency was non-compliance with reference listed drug (RLD) labelling. Comparisons with EMA and WHOPQTm revealed similarities in common deficiencies.</p><p><strong>Conclusion: </strong>This descriptive study highlights regulatory frameworks for generics share significant differences in practical requirements. A harmonized approach could enhance efficiency and standardized submissions. Bioequivalence issues were the most prevalent, with chemistry-related deficiencies, while labelling issues were the least common seen in ANDA applications. This offer concerns to manufacturers for dossier compilation, aiming to accelerate generic drug registration.</p>","PeriodicalId":8332,"journal":{"name":"Annales pharmaceutiques francaises","volume":" ","pages":""},"PeriodicalIF":1.0,"publicationDate":"2025-03-10","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143613233","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":"[European pharmacovigilance of advanced therapy medicinal products].","authors":"Nadine Petitpain, Viktoryia Prontskus, Mélanie Gauthier, Lena Loutterbach, Cécile Pochon, Jean Hugues Dalle, Danièle Bensoussan","doi":"10.1016/j.pharma.2025.02.011","DOIUrl":"10.1016/j.pharma.2025.02.011","url":null,"abstract":"<p><p>Advanced therapy medicinal products (ATMPs) are playing an increasingly important role in therapeutics, and sometimes represent the only hope of improving or even curing some pathologies. Because of their biological origin, composition, mode of action, and their frequent technical complexity, ATMPs are potentially generating new risks. Moreover, clinical trial data generally concern only a very small number of patients. The pharmacovigilance of ATMPs must adapt to these constraints and to these new identified or potential risks to be authorized according to an European centralized procedure. The conception and the assessment of the Risk Management Plan are essential to complete routine pharmacovigilance with post-authorization studies and additional risk minimisation measures adapted to the identified safety concerns. This article provides an overview of existing ATMPs and their specific regulatory pharmacovigilance requirements, involving the role of the European committees. It aims to describe the essential elements of the risk management plan of ATMPS, with a focus on delayed adverse reactions. The particular case of ATMPs prepared in the context of « hospital exemption », is also addressed, with the example of ATMPs for adoptive immunotherapy.</p>","PeriodicalId":8332,"journal":{"name":"Annales pharmaceutiques francaises","volume":" ","pages":""},"PeriodicalIF":1.0,"publicationDate":"2025-02-27","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143536558","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":"Solubility and thermodynamic properties of amlodipine besylate in two binary mixtures of n-methyl pyrrolidone+1-propanol/2-propanol at different temperatures.","authors":"Seyedmahdi Naghavi Kalajahi, Elaheh Rahimpour, Abolghasem Jouyban","doi":"10.1016/j.pharma.2025.02.009","DOIUrl":"10.1016/j.pharma.2025.02.009","url":null,"abstract":"<p><p>In this study, the solubility of amlodipine besylate in N-methyl-pyrrolidone/1-propanol and N-methyl-pyrrolidone/2-propanol binary mixture systems were measured using a common shake-flask method followed by spectroscopy analysis at temperature ranges from 298.2K to 313.2K. The generated data were fitted to some models, van't Hoff, Jouyban-Acree, Jouyban-Acree-van't Hoff, mixture response surface, and modified Wilson, to mathematical representation the solubility data. Finally, the apparent thermodynamics properties for the saturated mixtures were computed using van't Hoff and Gibbs equations.</p>","PeriodicalId":8332,"journal":{"name":"Annales pharmaceutiques francaises","volume":" ","pages":""},"PeriodicalIF":1.0,"publicationDate":"2025-02-26","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143530957","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":"Biosensors in wearable medical devices: Regulatory framework and compliance across US, EU, and Indian markets.","authors":"Vaishnavi Pawnikar, Mital Patel","doi":"10.1016/j.pharma.2025.02.007","DOIUrl":"10.1016/j.pharma.2025.02.007","url":null,"abstract":"<p><p>Biosensors play a crucial role in the diagnosis and monitoring of diseases as therapeutic applications that come with ease through incorporation and collaboration with wearable medical devices. Various regulatory markets are implementing development and management strategies for this emerging medical device field. This paper provides regulatory navigation of biosensors in wearable diagnostic devices across the US, EU, and Indian markets. The regulatory structure of all three countries differs from their origination and management which is discussed in this article along with the regulatory requirements applicable to such devices. The study also focuses on areas such as Good Manufacturing Practices (GMP), risk-based device classification, validation, and post-market surveillance. Key highlights include understanding regulatory authorities, guidelines, rules, regulations, and standards; comparison of regulatory perspectives between the three markets; application of biosensors in medical devices; prospects and market size. The study identifies approval pathways, regulatory challenges, and harmonization efforts across the globe. The paper explores recent advancements in biosensors for health interventions, such as personalized medicine, collaboration with the IoT, biomedical applications, and their accessibility.</p>","PeriodicalId":8332,"journal":{"name":"Annales pharmaceutiques francaises","volume":" ","pages":""},"PeriodicalIF":1.0,"publicationDate":"2025-02-26","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143530952","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}