Annales pharmaceutiques francaises最新文献

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[Development of a cost-satisfaction indicator for monitoring implantable medical devices on loan and in permanent storage]. [为监测借用和永久储存的植入式医疗器械制定成本满意度指标]。
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Annales pharmaceutiques francaises Pub Date : 2024-12-15 DOI: 10.1016/j.pharma.2024.12.009
François Franceschi, Charlotte Debanne, Valérie Archer, Lionel Tortolano
{"title":"[Development of a cost-satisfaction indicator for monitoring implantable medical devices on loan and in permanent storage].","authors":"François Franceschi, Charlotte Debanne, Valérie Archer, Lionel Tortolano","doi":"10.1016/j.pharma.2024.12.009","DOIUrl":"10.1016/j.pharma.2024.12.009","url":null,"abstract":"<p><p>The implantable medical devices (IMDs) in the operating rooms of our hospital are managed through permanent deposits. Recently, a shift in supplier practices seems to limit the opening of permanent deposits in favor of iterative loans. Their increasing number appears to complicate the flow of IMDs. The aim of this study was to estimate the costs associated with these circuits while considering the satisfaction of the key stakeholders involved. The flows of deposits and loans in the orthopedic operating room were analyzed retrospectively over the course of a year. In parallel, a prospective assessment was made of the hours dedicated to managing both permanent and temporary deposits by the preparers and operating room managers. A satisfaction survey was conducted for all stakeholders: preparers, managers, pharmacists, surgeons, nurses, and suppliers. The cost per unit of IMD managed through permanent deposit is €1.89, compared to €2.66 for loans. The overall satisfaction for deposit management is 81%, compared to 55% for the same implant managed through loans (P<0.001). Furthermore, an implant in loan proves to be 68% more expensive for the hospital when the unit cost is weighted by satisfaction (€4.84 vs. €2.33). Managing IMDs through loans is thus more costly for the hospital. This difference becomes even more pronounced when professional satisfaction is factored into all the roles involved in the IMD flows. This study focuses specifically on aspects of IMD management on the ground (renewals, labeling, expired items, and returns). No similar studies were found in literature. The reliance on loans is increasingly burdensome for stakeholders, generating stress and sometimes demotivating work due to a lack of recognition.</p>","PeriodicalId":8332,"journal":{"name":"Annales pharmaceutiques francaises","volume":" ","pages":""},"PeriodicalIF":1.0,"publicationDate":"2024-12-15","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142833813","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
Metabolomic analysis of 18th-19th pipes from the kingdom of Dahomey (actual Benin) indicates smoking of caffeine-bearing plants. 来自达荷美王国(实际的贝宁)的18 -19支烟斗的代谢组学分析表明,吸食含咖啡因的植物。
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Annales pharmaceutiques francaises Pub Date : 2024-12-14 DOI: 10.1016/j.pharma.2024.12.008
Philippe Charlier, Mario Zimmermann, Anna Berim, Shannon Tushingham, David Gang, Samson Tokannou, Didier N'Dah
{"title":"Metabolomic analysis of 18th-19th pipes from the kingdom of Dahomey (actual Benin) indicates smoking of caffeine-bearing plants.","authors":"Philippe Charlier, Mario Zimmermann, Anna Berim, Shannon Tushingham, David Gang, Samson Tokannou, Didier N'Dah","doi":"10.1016/j.pharma.2024.12.008","DOIUrl":"10.1016/j.pharma.2024.12.008","url":null,"abstract":"<p><p>Increasingly, molecular chemistry and pharmacology are complementing classical studies in the field of archaeology. In this case, we present the results of the chemical study of pipe residues found in the context of an archaeological mission (AROMA mission: Archaeology of the Exercise of Royal and Magico-Religious Power) in the royal palaces of Abomey (Benin), dating from the 17th-19th century. The search for many products was carried out (mainly tobacco, cannabis) but surprisingly only highlighted the presence of caffeine residues. This result is discussed and compared with field notions and in particular with ethnological surveys where coffee was consumed in the old way, smoked in a pipe (peripheral part or shell, and not the bean itself or the leaves).</p>","PeriodicalId":8332,"journal":{"name":"Annales pharmaceutiques francaises","volume":" ","pages":""},"PeriodicalIF":1.0,"publicationDate":"2024-12-14","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142833814","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
Inter-relational dynamics of factors affecting the emergence of orphan drugs. 影响孤儿药出现因素的相互关系动态。
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Annales pharmaceutiques francaises Pub Date : 2024-12-14 DOI: 10.1016/j.pharma.2024.12.005
Rinchen Gensapa, Vivek Pandey, Saibal Kumar Saha, Samrat Kumar Mukherjee, Ajeya Jha
{"title":"Inter-relational dynamics of factors affecting the emergence of orphan drugs.","authors":"Rinchen Gensapa, Vivek Pandey, Saibal Kumar Saha, Samrat Kumar Mukherjee, Ajeya Jha","doi":"10.1016/j.pharma.2024.12.005","DOIUrl":"10.1016/j.pharma.2024.12.005","url":null,"abstract":"<p><p>Orphan drugs are medications that are produced for the treatment of rare diseases. As there is less number of patients, the drug manufacturing companies are not keen in producing these drugs. Due to high costs of research and development and low profitability, companies do not want to invest in manufacturing of orphan drugs. Several laws have been passed by Governments of different nations to encourage the development of orphan drugs and make it available to patients. This study explores the interrelation dynamics of factors that has resulted in the greater availability of orphan drugs in recent times. Ten factors: internet technology, legislation, online patient support groups, government subsidiary, biotechnological advancements, corporate social responsibility, awareness and diagnosis of rare diseases and exclusive budgeting by pharmaceutical industries for orphan drugs related research and development and production were taken for the study. With a sample size of 38 experts, the technique of decision-making trial and evaluation laboratory (DEMATEL) was used for the study. It was found that information technology, legislation, support groups, and budget were the causes and the factors awareness, diagnosis, medicine availability, subsidiary, CSR and biotechnology emerged to be the effect.</p>","PeriodicalId":8332,"journal":{"name":"Annales pharmaceutiques francaises","volume":" ","pages":""},"PeriodicalIF":1.0,"publicationDate":"2024-12-14","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142827266","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
Polysaccharide-based implant drug delivery systems for precise therapy: Recent developments, and future trends. 用于精确治疗的基于多糖的植入药物输送系统:最近的发展和未来的趋势。
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Annales pharmaceutiques francaises Pub Date : 2024-12-13 DOI: 10.1016/j.pharma.2024.12.004
Suraj Kumar, Rishabha Malviya, Sathvik Belagodu Sridhar, Tarun Wadhwa, Javedh Shareef, Dhanalekshmi Unnikrishnan Meenakshi
{"title":"Polysaccharide-based implant drug delivery systems for precise therapy: Recent developments, and future trends.","authors":"Suraj Kumar, Rishabha Malviya, Sathvik Belagodu Sridhar, Tarun Wadhwa, Javedh Shareef, Dhanalekshmi Unnikrishnan Meenakshi","doi":"10.1016/j.pharma.2024.12.004","DOIUrl":"10.1016/j.pharma.2024.12.004","url":null,"abstract":"<p><p>Implantable drug delivery systems offer numerous benefits, including effective drug administration at lower concentrations, fewer side effects, and improved patient compliance. Various polymers are used for fabricating implants, with biopolymers, particularly polysaccharides, being notable for their ability to modulate drug delivery characteristics. The review aims to describe the strategies employed in the development of polysaccharide-based implants and provide a comprehensive understanding of various polysaccharides such as starch, cellulose, alginate, chitosan, pullulan, carrageenan, dextran, hyaluronic acid, agar, pectin, and gellan gum in the fabrication of implant for targeted therapy. The review explores the biomedical applications of polysaccharide-based implantable devices, highlighting recent advancements in the development of these systems. Detailed discussions cover implants used in the oral cavity, nasal cavity, bone, ocular applications, and antiviral therapy. Additionally, regulatory considerations concerning implantable drug delivery are emphasized. The findings of the study show that polysaccharides can be used for the development of implants for drug delivery applications.</p>","PeriodicalId":8332,"journal":{"name":"Annales pharmaceutiques francaises","volume":" ","pages":""},"PeriodicalIF":1.0,"publicationDate":"2024-12-13","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142827267","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
[Emergence of antifungal resistance: A creeping environmental threat?] 抗真菌耐药性的出现:一种逐渐蔓延的环境威胁?]
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Annales pharmaceutiques francaises Pub Date : 2024-12-13 DOI: 10.1016/j.pharma.2024.12.010
Guillaume Decocq, Jean-Noël Colin, Anne-Lise Bienvenu
{"title":"[Emergence of antifungal resistance: A creeping environmental threat?]","authors":"Guillaume Decocq, Jean-Noël Colin, Anne-Lise Bienvenu","doi":"10.1016/j.pharma.2024.12.010","DOIUrl":"10.1016/j.pharma.2024.12.010","url":null,"abstract":"<p><p>Antifungal resistance in humans is a clinical reality of increasing incidence that raises problems for patient care. In this current event, we discuss the link that can be made between the presence of antifungals in the environment and the development of resistance in humans, as well as the ecotoxicology of antifungals. The presence of antifungals in the environment has a health, but also an ecological impact. A \"One Health\" approach will help to address this environmental health challenge.</p>","PeriodicalId":8332,"journal":{"name":"Annales pharmaceutiques francaises","volume":" ","pages":""},"PeriodicalIF":1.0,"publicationDate":"2024-12-13","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142827265","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
Amorolfine hydrochloride loaded solid lipid nanoparticles: Preparation, characterization and ex vivo nail permeation study to treat onychomycosis. 盐酸阿莫罗芬载固体脂质纳米颗粒:制备、表征及体外甲渗透治疗甲癣的研究。
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Annales pharmaceutiques francaises Pub Date : 2024-12-10 DOI: 10.1016/j.pharma.2024.12.002
Tasleem Ahmed, Nithya Shanthi, Arun Kumar Mahato
{"title":"Amorolfine hydrochloride loaded solid lipid nanoparticles: Preparation, characterization and ex vivo nail permeation study to treat onychomycosis.","authors":"Tasleem Ahmed, Nithya Shanthi, Arun Kumar Mahato","doi":"10.1016/j.pharma.2024.12.002","DOIUrl":"10.1016/j.pharma.2024.12.002","url":null,"abstract":"<p><p>Onychomycosis is a disease of the nail plate caused by fungi, leading to the progressive defacing of the nail. The infection requires a longer period of treatment orally and topically. The treatment with the topical route is difficult due to the low availability of drugs across the infected nail. This failure in topical treatment is the drawback of the conventional drug delivery system (DDS), particularly drug penetration issues across the nail plate. The solid lipid nanoparticle (SLN) approach was used to overcome such issues. The drug amorolfine hydrochloride (AOF) was incorporated into SLN by using the micro-emulsion cold dilution method. Monostrearin and stearic acid were used as solid lipids in the formulation of drug-loaded SLNs. The nanoparticle formulation was optimized by varying the type of solid lipids and bile salts. Sodium taurocholate (STC) and sodium tauroglycholate (STG) are the bile salts used as biosurfactants in the formulation. The SLNs prepared with stearic acid and STG demonstrated higher drug encapsulation efficiency (71.73%) and drug loading efficiency (13.03%) than monostearin. Bile salts have affected the particle size range and STG was found to produce smaller size particles with stearic acid (406nm) than STC. Process parameter homogenization speed was also optimized and 403 relative centrifugal force (RCF) was optimal to produce smaller-size particles (406nm). The drug permeation through the nail plate and anti-fungal studies were also performed for AOF-SLNs loaded cream and marketed cream (Amfocin). The SLNs have improved the permeation (1.63-fold) and anti-fungal activity (2.50-fold) of AOF. Transmission electron microscopy (TEM) images revealed a spherical shape of SLNs with no aggregation. The physical stability was performed and SLNs have higher stability at refrigeration storage. The SLNs were incorporated in cream for the final application for onychomycosis. The analytical method of high-performance liquid chromatography (HPLC) was used for the quantification of AOF in the formulations.</p>","PeriodicalId":8332,"journal":{"name":"Annales pharmaceutiques francaises","volume":" ","pages":""},"PeriodicalIF":1.0,"publicationDate":"2024-12-10","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142817089","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
Handling and decontamination of live medications: What challenges for hospital pharmacies in France? 活药的处理和消毒:法国医院药房面临的挑战是什么?
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Annales pharmaceutiques francaises Pub Date : 2024-12-09 DOI: 10.1016/j.pharma.2024.12.003
Adélie Riazi, Élodie Allouis, Céline Sakr, Muriel Paul, Morgane Renault-Mahieux, Muriel Carvalho
{"title":"Handling and decontamination of live medications: What challenges for hospital pharmacies in France?","authors":"Adélie Riazi, Élodie Allouis, Céline Sakr, Muriel Paul, Morgane Renault-Mahieux, Muriel Carvalho","doi":"10.1016/j.pharma.2024.12.003","DOIUrl":"10.1016/j.pharma.2024.12.003","url":null,"abstract":"<p><strong>Objectives: </strong>To review the literature and national practices concerning the handling and decontamination of live medications, in order to revise our local practices.</p><p><strong>Methods: </strong>Literature searches and questionnaire sent to establishments handling live medications on several themes, including: preparation activity, circuits, preparation equipment, decontamination techniques and agents, personal protective equipment, viruses and genetically modified organisms.</p><p><strong>Results: </strong>Twenty establishments responded to the questionnaire (response rate: 66%) with 16 responses usable. The main live medications handled were viral vector (n=16) or cell-based gene therapies (n=14). The majority of respondents handled at least three types of live medication. The most popular and the most used preparation equipment was the biosafety cabinet (13/16). Handling was carried out in 9/16 establishments on a single piece of equipment, and in 7/16 on several. All the establishments decontaminated between two preparations of different types of live medication, and 15/16 between two preparations of the same type. None used ultraviolet decontamination. Although recommended in the literature, only five respondents distinguished between naked and enveloped viruses for decontamination. Seven out of 16 establishments had specific decontamination procedures for genetically modified organisms. There were few or no guidelines from French competent authorities or learned societies.</p><p><strong>Conclusions: </strong>The diversification of live medications is not accompanied by guidelines or scientific publications, which makes risk assessment difficult for hospital pharmacists. Nevertheless, this work has enabled us to take stock of current practices and revise our protocols, even if the decisions we take are still based on free will.</p>","PeriodicalId":8332,"journal":{"name":"Annales pharmaceutiques francaises","volume":" ","pages":""},"PeriodicalIF":1.0,"publicationDate":"2024-12-09","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142799286","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
Drug shortages in Canada, 2019-2023: A descriptive study. 2019-2023年加拿大药品短缺:一项描述性研究
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Annales pharmaceutiques francaises Pub Date : 2024-12-05 DOI: 10.1016/j.pharma.2024.12.001
Ilona Béatrix, Elsa Bonnabry, Suzanne Atkinson, Denis Lebel, Jean-François Bussières
{"title":"Drug shortages in Canada, 2019-2023: A descriptive study.","authors":"Ilona Béatrix, Elsa Bonnabry, Suzanne Atkinson, Denis Lebel, Jean-François Bussières","doi":"10.1016/j.pharma.2024.12.001","DOIUrl":"10.1016/j.pharma.2024.12.001","url":null,"abstract":"<p><strong>Context: </strong>Drug shortages impact patients from all countries. According to the Pharmaceutical Group of the European Union, most Europe countries reported a worsening of shortages in 2023.</p><p><strong>Objective: </strong>To describe drug shortage episodes in Canada over a recent 4-year period.</p><p><strong>Methods: </strong>This study focused on drug shortage episodes over the 52-month period from September 1, 2019, to December 31, 2023. Two data sources were used: the Canadian mandatory reporting website (both community and hospital settings) and hospital wholesaler data. Only descriptive statistical analyses were performed.</p><p><strong>Results: </strong>From September 1, 2019, to December 31, 2023, a total of 10,975 drug shortage episodes and 1087 discontinuations were reported on the Canadian website, whereas 2562 drug shortage episodes were reported by the hospital wholesaler. The median duration of episodes was 51days according to reports at the Canadian website data versus 145days according to the wholesaler's data. The Canadian website data referred to a total of 184 manufacturers, whereas wholesaler data encompassed 83 manufacturers. Only 86 episodes were rated as Tier 3.</p><p><strong>Conclusions: </strong>This study highlights the high number of drug shortages in Canada in recent years, both in the overall market and in the hospital market. Although the median duration of episodes has decreased across the country, the number of manufacturers involved has increased. The danger lies in considering the current situation as inevitable, normal and persistent.</p>","PeriodicalId":8332,"journal":{"name":"Annales pharmaceutiques francaises","volume":" ","pages":""},"PeriodicalIF":1.0,"publicationDate":"2024-12-05","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142791001","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 of mesalamine loaded-fenugreek gum decorated pectin microspheres for colonic drug delivery: Ex-vivo and in-vitro characterizations. 美沙拉胺负载胡芦巴胶装饰果胶微球结肠给药的发展:离体和体外表征。
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Annales pharmaceutiques francaises Pub Date : 2024-11-29 DOI: 10.1016/j.pharma.2024.11.006
Pruthvi P Khamkar, Kalpeshkumar S Wagh, Sopan N Nangare, Sachin S Mali, Gaurav S Patil
{"title":"Development of mesalamine loaded-fenugreek gum decorated pectin microspheres for colonic drug delivery: Ex-vivo and in-vitro characterizations.","authors":"Pruthvi P Khamkar, Kalpeshkumar S Wagh, Sopan N Nangare, Sachin S Mali, Gaurav S Patil","doi":"10.1016/j.pharma.2024.11.006","DOIUrl":"10.1016/j.pharma.2024.11.006","url":null,"abstract":"<p><p>Mesalamine (MES) is a preferred therapeutic agent for managing various colon disorders, including inflammatory bowel diseases (IBD). However, conventional oral dosage forms of MES face significant limitations, which reduce their effectiveness in managing these conditions. To overcome these challenges, advanced dosage forms of MES are essential. Fenugreek gum (FG), a natural polysaccharide with non-toxicity, ease of synthesis, biodegradability, and biocompatibility, was selected as a key component for developing a novel delivery system. Calcium ion crosslinked MES-incorporated FG-decorated pectin microspheres (FG@MES/PM) were successfully designed for colon-specific drug delivery using an ionotropic gelation technique. The microspheres exhibited favorable physicochemical characteristics, including a particle size of 586nm, a polydispersity index of 0.348, an entrapment efficiency of 85.20±1.02%, and a drug content of 98.52±0.96%. Ex vivo mucoadhesion tests demonstrated strong mucoadhesive properties, highlighting the potential of FG@MES/PM to adhere effectively to the colonic mucosa. In vitro drug release studies showed a modified release profile, with 99.02±1.80% MES released over 24h. Release kinetics analysis confirmed that FG@MES/PM followed the Higuchi matrix model (R<sup>2</sup>=0.9867), indicating diffusion-controlled release. The drug release mechanism was characterized as anomalous (non-Fickian) transport, with a release exponent (n) of 0.563. Overall, FG@MES/PM demonstrated promising potential for colon-specific drug delivery, offering sustained release and enhanced mucoadhesion. This study underscores the utility of FG for developing advanced drug delivery systems targeting the colon. Future research should explore the broader application of FG and similar natural polysaccharides in designing efficient and biocompatible colon-targeted formulations to improve therapeutic outcomes for IBD and related conditions.</p>","PeriodicalId":8332,"journal":{"name":"Annales pharmaceutiques francaises","volume":" ","pages":""},"PeriodicalIF":1.0,"publicationDate":"2024-11-29","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142765842","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
Validation of spectrophotometric and colorimetric method for the specific quantification of sofosbuvir From luminar capsule microneedle in liver tissue through ex vivo and in vivo applications. 光度法和比色法在离体和体内应用于肝组织中荧光胶囊微针索非布韦特异性定量的验证。
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Annales pharmaceutiques francaises Pub Date : 2024-11-27 DOI: 10.1016/j.pharma.2024.11.005
Abigael Alik Samma, Christopher Kosasi Ko, Musyfira Sahra, Nurul Fitrayani, Felicia Virginia Thios, Andi Dian Permana
{"title":"Validation of spectrophotometric and colorimetric method for the specific quantification of sofosbuvir From luminar capsule microneedle in liver tissue through ex vivo and in vivo applications.","authors":"Abigael Alik Samma, Christopher Kosasi Ko, Musyfira Sahra, Nurul Fitrayani, Felicia Virginia Thios, Andi Dian Permana","doi":"10.1016/j.pharma.2024.11.005","DOIUrl":"10.1016/j.pharma.2024.11.005","url":null,"abstract":"<p><p>An antiviral prodrug that has received regulatory approval and primarily employed in the treatment of hepatitis C is sofosbuvir (SOF). It is therefore imperative to develop advanced delivery methods for SOF in order to address existing absor ption issue and maximize the efficacy. In this study, we developed microneedle-integrated SOF (MN-SOF) which were elongated with branches and coated capsules to form luminar capsule microneedles (LUCAMs). To facilitate the formulation of LUCAMs, analytical methods for SOF in ethanol, artificial intestinal fluid (AIF), and artificial gastric fluid (AGF) were developed using a UV-vis spectrophotometer and colorimetric techniques in liver tissue. These methods were validated by combi ning the samples with ammonium metavanadate reagent. The validation process was conducted in order to ensure the accuracy, precision, linearity, specificity, and sensitivity of the methods. These methods exhibited a correlation coefficient of 0.9999, with a coefficient of variation below 25%. The methods demonstrate high accuracy and precision, with relative standard deviation (RSD) values ranging from 0.67% to 9.42% across different medium. The limit of detection (LOD) and limit of quantification (LOQ) values of SOF on each calibration curve of ethanol, artificial gastric fluid (AGF), artificial intestinal fluid (AIF), and rabbit liver tissue are 0.54μg/mL and 1.65μg/mL; 0.54μg/mL and 1.64μg/mL; 0.39μg/mL and 1.21μg/mL; 0.27μg/mL and 0.83μg/mL. As a significant outcome, the analytical method was validated and demonstrated suitability for determining the amount of SOF in the LUCAMs formulation through in vitro solubility, ex vivo permeation profiles, and in vivo drug delivery studies.</p>","PeriodicalId":8332,"journal":{"name":"Annales pharmaceutiques francaises","volume":" ","pages":""},"PeriodicalIF":1.0,"publicationDate":"2024-11-27","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142754508","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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