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.
{"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}
Pub Date : 2024-12-10DOI: 10.1016/j.pharma.2024.12.002
Tasleem Ahmed, Nithya Shanthi, Arun Kumar Mahato
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.
{"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}
Objectives: To review the literature and national practices concerning the handling and decontamination of live medications, in order to revise our local practices.
Methods: 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.
Results: 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.
Conclusions: 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.
{"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}
Context: 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.
Objective: To describe drug shortage episodes in Canada over a recent 4-year period.
Methods: 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.
Results: 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.
Conclusions: 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.
背景:药物短缺影响着所有国家的患者。据欧盟制药集团(Pharmaceutical Group of European Union)称,大多数欧洲国家报告称,2023年药品短缺将加剧。目的:描述近4年来加拿大药品短缺事件。方法:本研究重点关注2019年9月1日至2023年12月31日52个月期间的药品短缺事件。使用了两个数据来源:加拿大强制性报告网站(社区和医院设置)和医院批发商数据。仅进行描述性统计分析。结果:2019年9月1日至2023年12月31日,加拿大网站共报告了10975起药品短缺事件和1087起停药事件,而医院批发商报告了2562起药品短缺事件。根据加拿大网站数据的报告,发作的中位持续时间为51天,而根据批发商的数据为145天。加拿大网站的数据涉及184家制造商,而批发商的数据包括83家制造商。只有86集被评为三级。结论:这项研究突出了近年来加拿大的药品短缺问题,无论是在整体市场还是在医院市场。尽管全国范围内的平均发作时间有所减少,但涉及的制造商数量却有所增加。危险在于认为目前的情况是不可避免的、正常的和持续的。
{"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}
Pub Date : 2024-11-29DOI: 10.1016/j.pharma.2024.11.006
Pruthvi P Khamkar, Kalpeshkumar S Wagh, Sopan N Nangare, Sachin S Mali, Gaurav S Patil
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 (R2=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.
{"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}
Pub Date : 2024-11-27DOI: 10.1016/j.pharma.2024.11.005
Abigael Alik Samma, Christopher Kosasi Ko, Musyfira Sahra, Nurul Fitrayani, Felicia Virginia Thios, Andi Dian Permana
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.
{"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}
Pub Date : 2024-11-22DOI: 10.1016/j.pharma.2024.11.004
Ambreen Malik Uttra , Suhail Ahmad , Taseer Ahmad , Sumera Qasim , Hafiza Sara Afzal , Waqas Younis
<div><div>Cardiovascular diseases like hypertension require diuretics, but their effectiveness and side effects limit their use. Alternatives like <em>Ribes orientale</em> extract are being investigated for potential diuretic. In acute diuretic action, the extract and fractions of <em>Ribes orientale</em> were investigated in saline-loaded rats at doses of 12.5, 25, and 50<!--> <!-->mg/kg, p.o., while prolonged diuretic activity was also performed by administration of the most potent and significant dose of <em>Ribes orientale</em> butanol fraction (ROBF) for 7<!--> <!-->days. ROBF diuretic action was confirmed through parameters like urine volume, electrolyte concentration, pH and conductivity. The study found that 50<!--> <!-->mg/kg of ROBF had the most potent and significant diuretic activity, like furosemide (10<!--> <!-->mg/kg). It also produced significant natriuresis and insignificant kaliuresis in electrolyte excretion. ROBF increased diuretic activity significantly from the first and 7th days. In the mechanistic study, it has been evaluated that nitric oxide and prostaglandins pathways are not involved in the diuretic effect of ROBF, while cholinergic pathway might be responsible for the diuretic effect of ROBF. Hematological, renal function tests and histopathological studies confirmed the safety of <em>Ribes orientale</em> at 50<!--> <!-->mg/kg. Results showed slight changes in blood count parameters and no significant changes in creatinine and blood urea nitrogen levels compared to the negative control. Furthermore, downregulation of aldosterone by ROBF prolonged activity enhances the local bradykinin availability that results in marked diuretic and natriuretic activity. It is evident from the decreased level of malondialdehyde (MDA) that <em>Ribes orientale</em> reduces the oxidative stress while increased level of superoxide dismutase (SOD) depicts improving level of antioxidant activity. We conclude that the butanol fraction of <em>Ribes orientale</em> roots possesses a considerable diuretic effect. Therefore, more study is needed to identify the exact mechanism of action and the real efficacy of <em>Ribes orientale</em> as diuretic.</div></div><div><div>Les maladies cardiovasculaires comme l’hypertension nécessitent des diurétiques, mais leur efficacité et leurs effets secondaires limitent leur utilisation. Des alternatives comme l’extrait de Ribes orientale sont à l’étude pour leur potentiel diurétique. En ce qui concerne l’action diurétique aiguë, l’extrait et les fractions de Ribes orientale ont été étudiés chez des rats’ chargés en solution saline à des doses de 12,5, 25 et 50<!--> <!-->mg/kg, p.o., tandis qu’une activité diurétique prolongée a également été réalisée par l’administration de la dose la plus puissante et la plus significative de fraction butanol orientale Ribes (ROBF) pendant 7 jours. L’action diurétique du ROBF a été confirmée par des paramètres tels que le volume d’urine, la concentration d’électrolytes, le pH
{"title":"The therapeutic potential of Ribes orientale in hypertension: Improving electrolyte balance, enhancing antioxidant activity, and modulating the muscarinic pathway","authors":"Ambreen Malik Uttra , Suhail Ahmad , Taseer Ahmad , Sumera Qasim , Hafiza Sara Afzal , Waqas Younis","doi":"10.1016/j.pharma.2024.11.004","DOIUrl":"10.1016/j.pharma.2024.11.004","url":null,"abstract":"<div><div>Cardiovascular diseases like hypertension require diuretics, but their effectiveness and side effects limit their use. Alternatives like <em>Ribes orientale</em> extract are being investigated for potential diuretic. In acute diuretic action, the extract and fractions of <em>Ribes orientale</em> were investigated in saline-loaded rats at doses of 12.5, 25, and 50<!--> <!-->mg/kg, p.o., while prolonged diuretic activity was also performed by administration of the most potent and significant dose of <em>Ribes orientale</em> butanol fraction (ROBF) for 7<!--> <!-->days. ROBF diuretic action was confirmed through parameters like urine volume, electrolyte concentration, pH and conductivity. The study found that 50<!--> <!-->mg/kg of ROBF had the most potent and significant diuretic activity, like furosemide (10<!--> <!-->mg/kg). It also produced significant natriuresis and insignificant kaliuresis in electrolyte excretion. ROBF increased diuretic activity significantly from the first and 7th days. In the mechanistic study, it has been evaluated that nitric oxide and prostaglandins pathways are not involved in the diuretic effect of ROBF, while cholinergic pathway might be responsible for the diuretic effect of ROBF. Hematological, renal function tests and histopathological studies confirmed the safety of <em>Ribes orientale</em> at 50<!--> <!-->mg/kg. Results showed slight changes in blood count parameters and no significant changes in creatinine and blood urea nitrogen levels compared to the negative control. Furthermore, downregulation of aldosterone by ROBF prolonged activity enhances the local bradykinin availability that results in marked diuretic and natriuretic activity. It is evident from the decreased level of malondialdehyde (MDA) that <em>Ribes orientale</em> reduces the oxidative stress while increased level of superoxide dismutase (SOD) depicts improving level of antioxidant activity. We conclude that the butanol fraction of <em>Ribes orientale</em> roots possesses a considerable diuretic effect. Therefore, more study is needed to identify the exact mechanism of action and the real efficacy of <em>Ribes orientale</em> as diuretic.</div></div><div><div>Les maladies cardiovasculaires comme l’hypertension nécessitent des diurétiques, mais leur efficacité et leurs effets secondaires limitent leur utilisation. Des alternatives comme l’extrait de Ribes orientale sont à l’étude pour leur potentiel diurétique. En ce qui concerne l’action diurétique aiguë, l’extrait et les fractions de Ribes orientale ont été étudiés chez des rats’ chargés en solution saline à des doses de 12,5, 25 et 50<!--> <!-->mg/kg, p.o., tandis qu’une activité diurétique prolongée a également été réalisée par l’administration de la dose la plus puissante et la plus significative de fraction butanol orientale Ribes (ROBF) pendant 7 jours. L’action diurétique du ROBF a été confirmée par des paramètres tels que le volume d’urine, la concentration d’électrolytes, le pH","PeriodicalId":8332,"journal":{"name":"Annales pharmaceutiques francaises","volume":"83 2","pages":"Pages 389-400"},"PeriodicalIF":1.0,"publicationDate":"2024-11-22","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142709019","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}
Titanium dioxide, a naturally occurring compound, has been extensively utilized across various industries such as food, pharmaceuticals, and cosmetics. In the food sector, it was commonly employed as a color and opacity enhancer under the designation E171. However, due to safety concerns, the EU has prohibited its use as a food additive, effective August 2022, following a six-month transition period. The decision was based on scientific research highlighting risks associated with inhaling titanium dioxide nanoparticles and its potential genotoxic effects. This review also summarizes the implications of this ban on the pharmaceutical industry, where titanium dioxide is utilized in drug manufacturing. While the safety of titanium dioxide in tablets remains inconclusive, the EU's regulatory action has prompted a closer examination of alternative options. While alternatives exist, they may not provide the same benefits as TiO2, particularly in pharmaceuticals. Further research is needed to determine the safety and effectiveness of TiO2 and its alternatives in these applications.
{"title":"The implications of the EU ban on titanium dioxide: A comprehensive review of safety concerns and alternatives.","authors":"Varsha Pokharkar, Sejal Chandak, Rutika Pawar, Akshay Khandke","doi":"10.1016/j.pharma.2024.11.002","DOIUrl":"10.1016/j.pharma.2024.11.002","url":null,"abstract":"<p><p>Titanium dioxide, a naturally occurring compound, has been extensively utilized across various industries such as food, pharmaceuticals, and cosmetics. In the food sector, it was commonly employed as a color and opacity enhancer under the designation E171. However, due to safety concerns, the EU has prohibited its use as a food additive, effective August 2022, following a six-month transition period. The decision was based on scientific research highlighting risks associated with inhaling titanium dioxide nanoparticles and its potential genotoxic effects. This review also summarizes the implications of this ban on the pharmaceutical industry, where titanium dioxide is utilized in drug manufacturing. While the safety of titanium dioxide in tablets remains inconclusive, the EU's regulatory action has prompted a closer examination of alternative options. While alternatives exist, they may not provide the same benefits as TiO<sub>2</sub>, particularly in pharmaceuticals. Further research is needed to determine the safety and effectiveness of TiO<sub>2</sub> and its alternatives in these applications.</p>","PeriodicalId":8332,"journal":{"name":"Annales pharmaceutiques francaises","volume":" ","pages":""},"PeriodicalIF":1.0,"publicationDate":"2024-11-15","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142643692","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}
<div><h3>Objectives</h3><div>Enterprise Resource Planning like SAP are software solutions integrating various functional aspects. The study investigates the utilization challenges after the adoption of SAP ERP within a pharmaceutical firm. It is driven by four interrelated objectives: comprehending the operation of the SAP, the motivations behind its implementation, identifying the utilization deficiencies, and examining the relation between deficiencies and implementation challenges.</div></div><div><h3>Materials and methods</h3><div>A triangulation approach was adopted. The methods employed are based on batch monitoring, data collection, semi-structured interviews, a literature review, an overview of the software package, a comparison of the SAP with the previous management system, and an in-depth implementation study.</div></div><div><h3>Results</h3><div>Thirty-eight challenges were found in the literature, in a causal relationship with 11 identified utilization deficiencies in the study field. This analysis emphasized the significance of the human dimension, particularly the training of users, as a critical element in SAP implementation.</div></div><div><h3>Conclusion</h3><div>The advantages gained from implementing an ERP primarily revolve around the users and the processes. Deployment in itself is not an improvement. By recognizing the importance of the human factor, organizations can focus on improving training programs and enhancing user proficiency to maximize the benefits of SAP implementation.</div></div><div><h3>Objectif</h3><div>Les progiciels de gestion intégrés tels que SAP sont des solutions logicielles qui intègrent divers aspects fonctionnels. L’étude examine les difficultés d’utilisation après l’adoption de SAP ERP au sein d’une entreprise pharmaceutique, et est motivée par quatre objectifs interdépendants: comprendre le fonctionnement de SAP, les motivations derrière sa mise en œuvre, identifier les lacunes d’utilisation, et examiner la relation entre les lacunes d’utilisation et les difficultés de mise en œuvre.</div></div><div><h3>Matériels et méthodes</h3><div>Une approche par triangulation méthodologique a été adoptée. Les méthodes employées sont basées sur le suivi des lots, la collecte de données, des entretiens semi-structurés et une revue de la littérature.</div></div><div><h3>Résultats</h3><div>Une liste de 38 défis a été trouvée dans la littérature, en relation causale avec 11 déficiences d’utilisation identifiées dans le domaine de l’étude. Cette analyse a mis en évidence l’importance de la dimension humaine, en particulier la formation des utilisateurs, en tant qu’élément critique de la mise en œuvre de SAP.</div></div><div><h3>Conclusion</h3><div>Les avantages d’un ERP concernent principalement les utilisateurs et les processus. Le déploiement en lui-même n’est pas une amélioration. En reconnaissant l’importance du facteur humain, les organisations peuvent se focaliser sur l’amélioration des programmes de formatio
目标:SAP 等企业资源规划系统是集成了各种功能的软件解决方案。本研究调查了一家制药公司在采用 SAP ERP 后在使用方面遇到的挑战。本研究由四个相互关联的目标驱动:理解 SAP 的运作、实施 SAP 背后的动机、确定使用方面的不足以及研究不足与实施挑战之间的关系:采用三角测量法。采用的方法包括批量监测、数据收集、半结构式访谈、文献综述、软件包概述、SAP 与之前管理系统的比较以及深入的实施研究:结果:在文献中发现了 38 项挑战,与研究领域中发现的 11 项使用缺陷存在因果关系。这项分析强调了人的因素的重要性,尤其是对用户的培训,这是 SAP 实施的关键因素:实施企业资源规划系统的优势主要围绕用户和流程。部署本身并不是一种改进。通过认识到人的因素的重要性,企业可以集中精力改进培训计划,提高用户的熟练程度,从而最大限度地提高 SAP 实施的效益。
{"title":"Identification of utilization deficiencies post SAP enterprise resource planning implementation in the Algerian Pharmaceutical Sector","authors":"Mariah Khaldi , Redouane Amine Cherif , Houssem Belmekki","doi":"10.1016/j.pharma.2024.11.003","DOIUrl":"10.1016/j.pharma.2024.11.003","url":null,"abstract":"<div><h3>Objectives</h3><div>Enterprise Resource Planning like SAP are software solutions integrating various functional aspects. The study investigates the utilization challenges after the adoption of SAP ERP within a pharmaceutical firm. It is driven by four interrelated objectives: comprehending the operation of the SAP, the motivations behind its implementation, identifying the utilization deficiencies, and examining the relation between deficiencies and implementation challenges.</div></div><div><h3>Materials and methods</h3><div>A triangulation approach was adopted. The methods employed are based on batch monitoring, data collection, semi-structured interviews, a literature review, an overview of the software package, a comparison of the SAP with the previous management system, and an in-depth implementation study.</div></div><div><h3>Results</h3><div>Thirty-eight challenges were found in the literature, in a causal relationship with 11 identified utilization deficiencies in the study field. This analysis emphasized the significance of the human dimension, particularly the training of users, as a critical element in SAP implementation.</div></div><div><h3>Conclusion</h3><div>The advantages gained from implementing an ERP primarily revolve around the users and the processes. Deployment in itself is not an improvement. By recognizing the importance of the human factor, organizations can focus on improving training programs and enhancing user proficiency to maximize the benefits of SAP implementation.</div></div><div><h3>Objectif</h3><div>Les progiciels de gestion intégrés tels que SAP sont des solutions logicielles qui intègrent divers aspects fonctionnels. L’étude examine les difficultés d’utilisation après l’adoption de SAP ERP au sein d’une entreprise pharmaceutique, et est motivée par quatre objectifs interdépendants: comprendre le fonctionnement de SAP, les motivations derrière sa mise en œuvre, identifier les lacunes d’utilisation, et examiner la relation entre les lacunes d’utilisation et les difficultés de mise en œuvre.</div></div><div><h3>Matériels et méthodes</h3><div>Une approche par triangulation méthodologique a été adoptée. Les méthodes employées sont basées sur le suivi des lots, la collecte de données, des entretiens semi-structurés et une revue de la littérature.</div></div><div><h3>Résultats</h3><div>Une liste de 38 défis a été trouvée dans la littérature, en relation causale avec 11 déficiences d’utilisation identifiées dans le domaine de l’étude. Cette analyse a mis en évidence l’importance de la dimension humaine, en particulier la formation des utilisateurs, en tant qu’élément critique de la mise en œuvre de SAP.</div></div><div><h3>Conclusion</h3><div>Les avantages d’un ERP concernent principalement les utilisateurs et les processus. Le déploiement en lui-même n’est pas une amélioration. En reconnaissant l’importance du facteur humain, les organisations peuvent se focaliser sur l’amélioration des programmes de formatio","PeriodicalId":8332,"journal":{"name":"Annales pharmaceutiques francaises","volume":"83 2","pages":"Pages 378-388"},"PeriodicalIF":1.0,"publicationDate":"2024-11-14","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142643691","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}
Pub Date : 2024-11-06DOI: 10.1016/j.pharma.2024.11.001
Sagar Fatale, Javesh K Patil, Chandrakantsing V Pardeshi, Vishal V Pande, Mangesh A Bhutkar, Komal Parashar, Raju O Sonawane
Montmorillonite (MMT) clay is composed of naturally layered silicate. The clays were more popular in the pharmaceutical and other various fields due to their beneficial physicochemical properties viz. non-toxicity, high surface area, efficient adsorption capability, high swellability, high dispersibility, thixotropic behaviour, and cation exchange capacity. Chemically modified clay provides significant opportunities in variety of applications. MMT finds very crucial place in pharmaceutical field owing to its medicinal properties, which may be used to delay the drug release in chronic physiological conditions and the targeted drug release as well. It is also used to improve the dissolution rate of certain drug molecules, which increased the attention of the researchers to explore the MMT for drug delivery applications. MMT clay has been used as pharmaceutical aids viz. suspending agent, lubricant, anticaking agent, diluent, emulsifier, nanocomposites-forming material, and sometimes filler. MMT clay have been investigated in the fabrication of different pharmaceutical formulations viz. hydrogel, films, nanocomposites, and matrix-based systems. MMT has obtained industrial importance due to its adsorption property and also finds use in wastewater treatment. Other than this, MMT also finds applications in cosmetic industry, food industry, and paper industry. Considering the wide applicability of MMT, it is need of an hour to explore the MMT for further commercial exploitation.
{"title":"Montmorillonite: An advanced material with diverse pharmaceutical and medicinal applications.","authors":"Sagar Fatale, Javesh K Patil, Chandrakantsing V Pardeshi, Vishal V Pande, Mangesh A Bhutkar, Komal Parashar, Raju O Sonawane","doi":"10.1016/j.pharma.2024.11.001","DOIUrl":"10.1016/j.pharma.2024.11.001","url":null,"abstract":"<p><p>Montmorillonite (MMT) clay is composed of naturally layered silicate. The clays were more popular in the pharmaceutical and other various fields due to their beneficial physicochemical properties viz. non-toxicity, high surface area, efficient adsorption capability, high swellability, high dispersibility, thixotropic behaviour, and cation exchange capacity. Chemically modified clay provides significant opportunities in variety of applications. MMT finds very crucial place in pharmaceutical field owing to its medicinal properties, which may be used to delay the drug release in chronic physiological conditions and the targeted drug release as well. It is also used to improve the dissolution rate of certain drug molecules, which increased the attention of the researchers to explore the MMT for drug delivery applications. MMT clay has been used as pharmaceutical aids viz. suspending agent, lubricant, anticaking agent, diluent, emulsifier, nanocomposites-forming material, and sometimes filler. MMT clay have been investigated in the fabrication of different pharmaceutical formulations viz. hydrogel, films, nanocomposites, and matrix-based systems. MMT has obtained industrial importance due to its adsorption property and also finds use in wastewater treatment. Other than this, MMT also finds applications in cosmetic industry, food industry, and paper industry. Considering the wide applicability of MMT, it is need of an hour to explore the MMT for further commercial exploitation.</p>","PeriodicalId":8332,"journal":{"name":"Annales pharmaceutiques francaises","volume":" ","pages":""},"PeriodicalIF":1.0,"publicationDate":"2024-11-06","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142613678","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}