Pub Date : 2024-10-16DOI: 10.1016/j.pharma.2024.10.004
Imran Kazmi, Hemant K S Yadav, Fahad A Al-Abbasi, Muhammad Afzal, Muhammad Shahid Nadeem, Hisham N Altayb, Abhay Raizaday, Md Sadique Hussain, Haider Ali, Faisal Imam, Gaurav Gupta
The analysis aimed to prepare an in-situ implant (ISFI) formulation holding dimethyl fumarate as (a model drug) using cross-linked gellan gum by homogenization method. Cross-linking of gellan gum was done with L-cysteine to improve its gelation properties. Fourier transform infrared spectroscopy (FTIR) and (DSC) Differential scanning calorimetry were used to test the compatibility of the drug-polymer. The diverse formulations were prepared and tested using Design Expert® ver 8.0.1 software to optimize the experiment technique and employ the response surface. The tissue compatibility of the test verified the existence of non-irritants in the established formulation. All preparations contained the drug content from approximately 97.98 to 99.88%. Viscosities are ideal for injection in the optimized formulation (1,55 percent w/w in water). The optimized formula was monitored, and up to 156hours, it was found to be 95.7%. The result was that ISFI can effectively monitor and control the delivery of several powerful drug products.
{"title":"Design of in-situ implant for the brain-targeted drug delivery using cross-linked gellan gum polymer through response surface methodology.","authors":"Imran Kazmi, Hemant K S Yadav, Fahad A Al-Abbasi, Muhammad Afzal, Muhammad Shahid Nadeem, Hisham N Altayb, Abhay Raizaday, Md Sadique Hussain, Haider Ali, Faisal Imam, Gaurav Gupta","doi":"10.1016/j.pharma.2024.10.004","DOIUrl":"10.1016/j.pharma.2024.10.004","url":null,"abstract":"<p><p>The analysis aimed to prepare an in-situ implant (ISFI) formulation holding dimethyl fumarate as (a model drug) using cross-linked gellan gum by homogenization method. Cross-linking of gellan gum was done with L-cysteine to improve its gelation properties. Fourier transform infrared spectroscopy (FTIR) and (DSC) Differential scanning calorimetry were used to test the compatibility of the drug-polymer. The diverse formulations were prepared and tested using Design Expert® ver 8.0.1 software to optimize the experiment technique and employ the response surface. The tissue compatibility of the test verified the existence of non-irritants in the established formulation. All preparations contained the drug content from approximately 97.98 to 99.88%. Viscosities are ideal for injection in the optimized formulation (1,55 percent w/w in water). The optimized formula was monitored, and up to 156hours, it was found to be 95.7%. The result was that ISFI can effectively monitor and control the delivery of several powerful drug products.</p>","PeriodicalId":8332,"journal":{"name":"Annales pharmaceutiques francaises","volume":" ","pages":""},"PeriodicalIF":1.0,"publicationDate":"2024-10-16","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142456832","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 : 2024-10-15DOI: 10.1016/j.pharma.2024.10.002
Krishna Koradia, Arjun Dedakia, Hiral Koradia
Purpose: Conjunctivitis is a common eye disorder that causes swelling and inflammation of the conjunctiva. Topical dosage form containing antibiotics and non-steroidal anti-inflammatory drugs are prescribed for the treatment and in order to overcome problems of conventional dosage forms the present study aims to develop an ocular insert containing moxifloxacin HCl and ketorolac tromethamine.
Methods: Insert was prepared by a solvent casting method by taking different polymers PVA, PVP K-30, and a combination of both as film-forming polymer, and glycerol as a plasticizer and characterized by various parameters like thickness, folding endurance, pH, swelling index, drug content, mechanical properties, in vitro and in vivo release study.
Results: The formulation prepared by a combination of both polymers demonstrated significantly improved properties including % elongation, tensile strength, swelling index, drug content and drug release compared to the formulation made with single polymer. The in vitro release data indicated that the batch R8 exhibited sustain release of drug (85% release in 10 hr) and following the Higuchi model for release kinetics. In vivo, study in rabbit eyes revealed the sustained release of the drug up to 16 hr with a good correlation between in vitro and in vivo release data.
Conclusion: From the study, it can be concluded that the developed ocular insert can be a promising formulation for rational therapy of conjunctivitis.
{"title":"Development and in vitro-in vivo evaluation of ocular insert containing ketorolac tromethamine and moxifloxacin hydrochloride.","authors":"Krishna Koradia, Arjun Dedakia, Hiral Koradia","doi":"10.1016/j.pharma.2024.10.002","DOIUrl":"10.1016/j.pharma.2024.10.002","url":null,"abstract":"<p><strong>Purpose: </strong>Conjunctivitis is a common eye disorder that causes swelling and inflammation of the conjunctiva. Topical dosage form containing antibiotics and non-steroidal anti-inflammatory drugs are prescribed for the treatment and in order to overcome problems of conventional dosage forms the present study aims to develop an ocular insert containing moxifloxacin HCl and ketorolac tromethamine.</p><p><strong>Methods: </strong>Insert was prepared by a solvent casting method by taking different polymers PVA, PVP K-30, and a combination of both as film-forming polymer, and glycerol as a plasticizer and characterized by various parameters like thickness, folding endurance, pH, swelling index, drug content, mechanical properties, in vitro and in vivo release study.</p><p><strong>Results: </strong>The formulation prepared by a combination of both polymers demonstrated significantly improved properties including % elongation, tensile strength, swelling index, drug content and drug release compared to the formulation made with single polymer. The in vitro release data indicated that the batch R8 exhibited sustain release of drug (85% release in 10 hr) and following the Higuchi model for release kinetics. In vivo, study in rabbit eyes revealed the sustained release of the drug up to 16 hr with a good correlation between in vitro and in vivo release data.</p><p><strong>Conclusion: </strong>From the study, it can be concluded that the developed ocular insert can be a promising formulation for rational therapy of conjunctivitis.</p>","PeriodicalId":8332,"journal":{"name":"Annales pharmaceutiques francaises","volume":" ","pages":""},"PeriodicalIF":1.0,"publicationDate":"2024-10-15","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142456833","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 : 2024-10-15DOI: 10.1016/j.pharma.2024.10.001
Vinod Ambalal Chaure, Atul Arun Shirkhedkar
Hypertension is often asymptomatic and can substantially elevate the risk of cardiovascular complications. Olmesartan medoxomil works by competitively blocking the angiotensin II receptors, preventing angiotensin II from constructing the blood vessels and releasing aldosterone. This discussion is focused on the critical analytical methods used to analyze olmesartan medoxomil in pharmaceutical and biological samples. A variety of analytical methods have been employed to both qualitatively and quantitatively determine the analyte, including high-performance thin-layer chromatography (HPTLC), high-performance liquid chromatography (HPLC), voltammetry, capillary zone electrophoresis, UV/Vis spectrophotometry, and 96-microwell assays. The review also includes official methods published in the Indian Pharmacopoeia. Based on existing literature, simple spectrophotometry and liquid chromatography are commonly used to analyze olmesartan medoxomil. These findings provide a solid foundation for future olmesartan medoxomil drug analysis research.
高血压通常没有症状,但会大大增加心血管并发症的风险。奥美沙坦酯氨丁三醇通过竞争性阻断血管紧张素 II 受体,阻止血管紧张素 II 构建血管和释放醛固酮而发挥作用。本讨论的重点是用于分析药物和生物样本中奥美沙坦酯甲珂米的关键分析方法。采用了多种分析方法来定性和定量测定该分析物,包括高效薄层色谱法(HPTLC)、高效液相色谱法(HPLC)、伏安法、毛细管区带电泳法、紫外/可见分光光度法和 96 微孔测定法。综述还包括印度药典中公布的官方方法。根据现有文献,简单的分光光度法和液相色谱法常用于分析奥美沙坦酯。这些发现为今后的奥美沙坦酯药物分析研究奠定了坚实的基础。
{"title":"An investigative review for pharmaceutical analysis of angiotensin receptor blockers: Olmesartan medoxomil.","authors":"Vinod Ambalal Chaure, Atul Arun Shirkhedkar","doi":"10.1016/j.pharma.2024.10.001","DOIUrl":"10.1016/j.pharma.2024.10.001","url":null,"abstract":"<p><p>Hypertension is often asymptomatic and can substantially elevate the risk of cardiovascular complications. Olmesartan medoxomil works by competitively blocking the angiotensin II receptors, preventing angiotensin II from constructing the blood vessels and releasing aldosterone. This discussion is focused on the critical analytical methods used to analyze olmesartan medoxomil in pharmaceutical and biological samples. A variety of analytical methods have been employed to both qualitatively and quantitatively determine the analyte, including high-performance thin-layer chromatography (HPTLC), high-performance liquid chromatography (HPLC), voltammetry, capillary zone electrophoresis, UV/Vis spectrophotometry, and 96-microwell assays. The review also includes official methods published in the Indian Pharmacopoeia. Based on existing literature, simple spectrophotometry and liquid chromatography are commonly used to analyze olmesartan medoxomil. These findings provide a solid foundation for future olmesartan medoxomil drug analysis research.</p>","PeriodicalId":8332,"journal":{"name":"Annales pharmaceutiques francaises","volume":" ","pages":""},"PeriodicalIF":1.0,"publicationDate":"2024-10-15","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142456830","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 : 2024-10-14DOI: 10.1016/j.pharma.2024.10.003
Arian Salimi, Maryam Hamzeloo-Moghaddam, Mahboobeh Irani, Somayeh Esmaeili
Objectives: World Health Organization (WHO) has reported 249 million cases infected by malaria worldwide and 608 thousands deaths in 2022. Investigations for new antimalarial drugs from traditional medicine have proven to be more effective and less expensive. The medicinal plants that have been used for treatment of malaria, generally known as types of fevers in traditional medicine, can be suitable candidates for evaluating antimalarial effects. The aim of the present study was to evaluate the in-vitro mechanism of antimalarial action of selected medicinal plants by inhibition test of heme detoxification (ITHD).
Material and methods: The methanol extract and fractions were prepared through maceration of the dry powdered plants. The ITHD method was carried in 96-wells plate and the percentage of heme polymerization inhibition was determined. The cytotoxicity of the effective plants were examined on MDBK cell line by MTT assay. Bioassay guided fractionation was performed exposing to size exclusion column chromatography and liquid-liquid fractionation and was assayed by the ITHD method for the sample with the least IC50 value and lowest cytotoxic effect.
Results: The methanol fraction of Viola odorata whole plant showed the most considerable results among the tested plants with IC50 171.8 μg.mL-1 beside the lowest cytotoxic effects. This fraction by the bioassay guided fractionation led to fraction SB2 and this fraction demonstrated the most effective result with lowest IC50 = 14.8 ± 3µg.mL-1 in ITHD assay.
Conclusion: Regarding the results of the present study and the traditional use of V. odorata for overcoming fever in Iranian traditional medicine, the final fraction of the plant could be proper candidate for further phytochemical and antimalarial studies.
{"title":"Anti-malarial evaluation of selected medicinal plants traditionally used for treatment of fever, by inhibition test of heme polymerization.","authors":"Arian Salimi, Maryam Hamzeloo-Moghaddam, Mahboobeh Irani, Somayeh Esmaeili","doi":"10.1016/j.pharma.2024.10.003","DOIUrl":"https://doi.org/10.1016/j.pharma.2024.10.003","url":null,"abstract":"<p><strong>Objectives: </strong>World Health Organization (WHO) has reported 249 million cases infected by malaria worldwide and 608 thousands deaths in 2022. Investigations for new antimalarial drugs from traditional medicine have proven to be more effective and less expensive. The medicinal plants that have been used for treatment of malaria, generally known as types of fevers in traditional medicine, can be suitable candidates for evaluating antimalarial effects. The aim of the present study was to evaluate the in-vitro mechanism of antimalarial action of selected medicinal plants by inhibition test of heme detoxification (ITHD).</p><p><strong>Material and methods: </strong>The methanol extract and fractions were prepared through maceration of the dry powdered plants. The ITHD method was carried in 96-wells plate and the percentage of heme polymerization inhibition was determined. The cytotoxicity of the effective plants were examined on MDBK cell line by MTT assay. Bioassay guided fractionation was performed exposing to size exclusion column chromatography and liquid-liquid fractionation and was assayed by the ITHD method for the sample with the least IC<sub>50</sub> value and lowest cytotoxic effect.</p><p><strong>Results: </strong>The methanol fraction of Viola odorata whole plant showed the most considerable results among the tested plants with IC<sub>50</sub> 171.8 μg.mL<sup>-1</sup> beside the lowest cytotoxic effects. This fraction by the bioassay guided fractionation led to fraction SB<sub>2</sub> and this fraction demonstrated the most effective result with lowest IC<sub>50</sub> = 14.8 ± 3µg.mL<sup>-1</sup> in ITHD assay.</p><p><strong>Conclusion: </strong>Regarding the results of the present study and the traditional use of V. odorata for overcoming fever in Iranian traditional medicine, the final fraction of the plant could be proper candidate for further phytochemical and antimalarial studies.</p>","PeriodicalId":8332,"journal":{"name":"Annales pharmaceutiques francaises","volume":" ","pages":""},"PeriodicalIF":1.0,"publicationDate":"2024-10-14","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142456831","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 : 2024-10-05DOI: 10.1016/j.pharma.2024.09.009
Olivier Pierrefiche
Alcohol consumption is a major public health issue. Patients with Alcohol Use Disorder (AUD) can benefit from five treatments that preferentially target membrane receptors, and whose efficacy is generally modest. However, a large body of experimental evidence points to an important role for epigenetics in the effects of alcohol consumption, and epidrugs that modify the epigenome offer an interesting alternative to current therapeutic options. This article reviews the most striking experimental evidence obtained at different ages in animal models, before comparing it with data obtained in humans and concluding on the relevance of using epidrugs. Finally, a new therapeutic option is suggested between psychedelics, recent molecules of interest, and epigenetic factors in alcohol intake.
{"title":"[Epigenetic changes in alcohol addiction and therapeutic perspectives].","authors":"Olivier Pierrefiche","doi":"10.1016/j.pharma.2024.09.009","DOIUrl":"10.1016/j.pharma.2024.09.009","url":null,"abstract":"<p><p>Alcohol consumption is a major public health issue. Patients with Alcohol Use Disorder (AUD) can benefit from five treatments that preferentially target membrane receptors, and whose efficacy is generally modest. However, a large body of experimental evidence points to an important role for epigenetics in the effects of alcohol consumption, and epidrugs that modify the epigenome offer an interesting alternative to current therapeutic options. This article reviews the most striking experimental evidence obtained at different ages in animal models, before comparing it with data obtained in humans and concluding on the relevance of using epidrugs. Finally, a new therapeutic option is suggested between psychedelics, recent molecules of interest, and epigenetic factors in alcohol intake.</p>","PeriodicalId":8332,"journal":{"name":"Annales pharmaceutiques francaises","volume":" ","pages":""},"PeriodicalIF":1.0,"publicationDate":"2024-10-05","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142387478","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}
Mastering and monitoring immunosuppressant concentrations is central to the care of lung transplant patients and involves multiple stakeholders. The objective is to conduct a risk analysis to evaluate the impact of various actions taken. The lung transplantation team was convened to carry out a failure mode effect analysis. The process was divided into stages where different risks were identified. The risk priority number (RPN) (severity, frequency, detectability) and risk level of criticality (frequency, severity) were established before implementation of actions (before 2009) and then after (in 2022) to classify risks according to four levels of criticality. The implemented actions included the establishment of a quality assurance process, computerization of monitoring, and double analysis by a physician/pharmacist pair. Thirty-two risks were identified during the four stages of the process: biological sampling (n=13), reception (n=3), analysis and treatment of levels (n=5), transmission of information/prescriptions to the patient (n=11). The total raw RPN (before 2009) was 839, with 12 major risks. The current total RPN (in 2022) was 452 (a decrease of 46.1%), with 7 major risks identified. The analysis enabled the objective evaluation of the effectiveness of the actions taken. The most secure stage of the process is the reception of residual level results. Efforts should focus on empowering and involving patients, as well as engaging local stakeholders in collaboration with the specialized transplantation team.
{"title":"[Risk analysis applied to the monitoring of immunosuppressor concentrations in lung transplant recipients].","authors":"Agathe Landoas, Romane Chapuis, Amandine Briault, Quentin Perrier, Pierrick Bedouch","doi":"10.1016/j.pharma.2024.09.010","DOIUrl":"10.1016/j.pharma.2024.09.010","url":null,"abstract":"<p><p>Mastering and monitoring immunosuppressant concentrations is central to the care of lung transplant patients and involves multiple stakeholders. The objective is to conduct a risk analysis to evaluate the impact of various actions taken. The lung transplantation team was convened to carry out a failure mode effect analysis. The process was divided into stages where different risks were identified. The risk priority number (RPN) (severity, frequency, detectability) and risk level of criticality (frequency, severity) were established before implementation of actions (before 2009) and then after (in 2022) to classify risks according to four levels of criticality. The implemented actions included the establishment of a quality assurance process, computerization of monitoring, and double analysis by a physician/pharmacist pair. Thirty-two risks were identified during the four stages of the process: biological sampling (n=13), reception (n=3), analysis and treatment of levels (n=5), transmission of information/prescriptions to the patient (n=11). The total raw RPN (before 2009) was 839, with 12 major risks. The current total RPN (in 2022) was 452 (a decrease of 46.1%), with 7 major risks identified. The analysis enabled the objective evaluation of the effectiveness of the actions taken. The most secure stage of the process is the reception of residual level results. Efforts should focus on empowering and involving patients, as well as engaging local stakeholders in collaboration with the specialized transplantation team.</p>","PeriodicalId":8332,"journal":{"name":"Annales pharmaceutiques francaises","volume":" ","pages":""},"PeriodicalIF":1.0,"publicationDate":"2024-09-29","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142364229","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}
The pharmaceutical research on natural excipients with diverse physicochemical properties useful in various novel drug delivery systems is a growing interest. The market for natural gums like hupu gum (gum kondagogu) is growing globally, driven by increasing consumer preference for natural and sustainable ingredients. This review covers botanical origin, geographical distribution, chemical constituents, identification tests, toxicology studies and potential applications of hupu gum in novel drug delivery systems. Emphasis is placed on its traditional uses in indigenous medicine and current research findings and patents that highlight its emulsifying, stabilizing, film forming, and thickening properties. Hupu gum is a tree exudate from Cochlospermum religiosum belonging to the family Bixaceae. It is traditionally used for various medicinal and industrial purposes as it has a unique chemical composition and physical properties. Moreover, the current research and use of hupu gum as a biopolymer in the formulation and stabilization of nanoparticles (NP) is expanding the application spectrum of hupu gum. This writeup typically conclude with insights into future research directions, such as, exploring new applications, or enhancing its functional properties through modification.
{"title":"Review on novel pharmaceutical applications of hupu gum: A versatile natural polymer.","authors":"Rajeswari Aleti, Monika Nijhawan, Pavan Kumar Thota, Bhavana Jidige","doi":"10.1016/j.pharma.2024.09.008","DOIUrl":"10.1016/j.pharma.2024.09.008","url":null,"abstract":"<p><p>The pharmaceutical research on natural excipients with diverse physicochemical properties useful in various novel drug delivery systems is a growing interest. The market for natural gums like hupu gum (gum kondagogu) is growing globally, driven by increasing consumer preference for natural and sustainable ingredients. This review covers botanical origin, geographical distribution, chemical constituents, identification tests, toxicology studies and potential applications of hupu gum in novel drug delivery systems. Emphasis is placed on its traditional uses in indigenous medicine and current research findings and patents that highlight its emulsifying, stabilizing, film forming, and thickening properties. Hupu gum is a tree exudate from Cochlospermum religiosum belonging to the family Bixaceae. It is traditionally used for various medicinal and industrial purposes as it has a unique chemical composition and physical properties. Moreover, the current research and use of hupu gum as a biopolymer in the formulation and stabilization of nanoparticles (NP) is expanding the application spectrum of hupu gum. This writeup typically conclude with insights into future research directions, such as, exploring new applications, or enhancing its functional properties through modification.</p>","PeriodicalId":8332,"journal":{"name":"Annales pharmaceutiques francaises","volume":" ","pages":""},"PeriodicalIF":1.0,"publicationDate":"2024-09-19","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142279854","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 : 2024-09-18DOI: 10.1016/j.pharma.2024.09.007
Mohammed Tahar Ben Moussa, Said Nadji, Nawel Achachi, Safa Chaira, Rafika Laiche, Soumaya Boudjemaa, Abdelhakim Bounab, Hassina Harkat, Youcef Hadef
Brocchia cinerea is a North African plant belonging to the Asteraceae family, widely utilized in Algerian folk medicine to treat a variety of illnesses. These therapeutic virtues are mainly due to the plant essential oil. The chemical components of this oil were identified using GC-MS, and the variability in these components' levels was examined in nine samples that were taken at different times from two locations in Algeria's northern Sahara. The contents of the essential oil were found to consist of eight components, varying in concentrations: beta-thujone (46.80%), 1-Methyl-2-(1' methylethenyl) -3'- ethenylcyclopropylmethanol (14.59%), 1,8-Cineole (12.63%), limonen-10-ol (9.47%), 1(7),3,8 o Menthatriene (3.45%), and (-)-Camphor (2.11%). Toxicity studies were conducted in order to assess the safety of the essential oil, namely: LD50 estimation and biochemical blood parameters evaluation. The results showed an LD 50 of 507.5mg/kg close to the LD50 of Beta-thujone (442mg/kg): the main component of the essential oil, making it accountable for the major toxicity. The apparition of seizures as toxic manifestations for higher concentrations confirmed that. The essential oil of Brocchia was noted to be classified as slightly, weakly toxic, and the Beta-thujone contents showed to be within the regulatory accepted values, which makes the use of Brocchia safe within the indicated standards.
{"title":"Study of the toxicity of the essential oil of Brocchia cinerea.","authors":"Mohammed Tahar Ben Moussa, Said Nadji, Nawel Achachi, Safa Chaira, Rafika Laiche, Soumaya Boudjemaa, Abdelhakim Bounab, Hassina Harkat, Youcef Hadef","doi":"10.1016/j.pharma.2024.09.007","DOIUrl":"10.1016/j.pharma.2024.09.007","url":null,"abstract":"<p><p>Brocchia cinerea is a North African plant belonging to the Asteraceae family, widely utilized in Algerian folk medicine to treat a variety of illnesses. These therapeutic virtues are mainly due to the plant essential oil. The chemical components of this oil were identified using GC-MS, and the variability in these components' levels was examined in nine samples that were taken at different times from two locations in Algeria's northern Sahara. The contents of the essential oil were found to consist of eight components, varying in concentrations: beta-thujone (46.80%), 1-Methyl-2-(1' methylethenyl) -3'- ethenylcyclopropylmethanol (14.59%), 1,8-Cineole (12.63%), limonen-10-ol (9.47%), 1(7),3,8 o Menthatriene (3.45%), and (-)-Camphor (2.11%). Toxicity studies were conducted in order to assess the safety of the essential oil, namely: LD50 estimation and biochemical blood parameters evaluation. The results showed an LD 50 of 507.5mg/kg close to the LD50 of Beta-thujone (442mg/kg): the main component of the essential oil, making it accountable for the major toxicity. The apparition of seizures as toxic manifestations for higher concentrations confirmed that. The essential oil of Brocchia was noted to be classified as slightly, weakly toxic, and the Beta-thujone contents showed to be within the regulatory accepted values, which makes the use of Brocchia safe within the indicated standards.</p>","PeriodicalId":8332,"journal":{"name":"Annales pharmaceutiques francaises","volume":" ","pages":""},"PeriodicalIF":1.0,"publicationDate":"2024-09-18","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142279855","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}
Introduction: European regulations have recently moved towards more stringent requirements for demonstrating the safety and performance of medical devices (MDs).
Objective: To apply an innovative testing method using medical simulation to the evaluation of three medical devices at different stages of their life cycle.
Method: The methodology for evaluating DMs using simulation is based on seven stages: definition of the context, training, construction of a scenario to test the DM, validation of the scenario, realization of the scenario, evaluation of the scenario by the players and validation and exploitation of the results.
Results: Our evaluation methodology enabled us to assess three DMs at different stages of their development: a respiratory protection device at the initial stage (prototype definition), a respiratory protection mask (prototype optimization) and bottle adapters (post-marketing).
Conclusion: Simulation is a valuable tool for evaluating DM. The proposed methodology enables it to be used and adapted to different contexts. It responds to the specificities of clinical evaluation of this class of products, and helps to better anticipate certain risks.
{"title":"[Construction of a methodology for clinical evaluation of medical devices using simulation tools and illustration through three studies].","authors":"Cordélia Salomez-Ihl, Claire Chapuis, Pierre Albaladejo, Marielle Picard, Aline Baron, Paz Pardo Garcia, Jean-Noël Evain, Joris Giai, Maud Barbado, Alexandre Moreau-Gaudry, Jean-Luc Bosson, Julien Picard, Pierrick Bedouch","doi":"10.1016/j.pharma.2024.09.003","DOIUrl":"10.1016/j.pharma.2024.09.003","url":null,"abstract":"<p><strong>Introduction: </strong>European regulations have recently moved towards more stringent requirements for demonstrating the safety and performance of medical devices (MDs).</p><p><strong>Objective: </strong>To apply an innovative testing method using medical simulation to the evaluation of three medical devices at different stages of their life cycle.</p><p><strong>Method: </strong>The methodology for evaluating DMs using simulation is based on seven stages: definition of the context, training, construction of a scenario to test the DM, validation of the scenario, realization of the scenario, evaluation of the scenario by the players and validation and exploitation of the results.</p><p><strong>Results: </strong>Our evaluation methodology enabled us to assess three DMs at different stages of their development: a respiratory protection device at the initial stage (prototype definition), a respiratory protection mask (prototype optimization) and bottle adapters (post-marketing).</p><p><strong>Conclusion: </strong>Simulation is a valuable tool for evaluating DM. The proposed methodology enables it to be used and adapted to different contexts. It responds to the specificities of clinical evaluation of this class of products, and helps to better anticipate certain risks.</p>","PeriodicalId":8332,"journal":{"name":"Annales pharmaceutiques francaises","volume":" ","pages":""},"PeriodicalIF":1.0,"publicationDate":"2024-09-12","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142279838","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}