Pub Date : 2025-01-22DOI: 10.1016/j.pharma.2025.01.007
Alexia Laflotte, Constance Bretagnolle, Agnès Henry
Introduction: The European regulation 2017/745 requires the delivery of an international implant card to the patient following the implantation of implantable medical devices (IMD). Currently, there are no procedure to describe the process for providing traceability documents to patients in our institution. The objective of this work was to evaluate the practices of the various departments concerned in our institution and to think about actions to meet the current regulation.
Material and method: The evaluation of practices concerning the delivery of traceability documents to patients was evaluated through a questionnaire with 13 departments. Then, for each specialty, three electronic patient record (EPR) were audited. Finally, IMD's suppliers were asked about their ability to provide an international implant card.
Results: In total, 85% (11/13) of the departments sent an IMD traceability document to patients, and in 91% (10/11) of cases, this transmission was done with the international implant card or the operative report. However, 63% of the operative report analyzed did not contain the traceability data of the IMD. Finally, only 60% of the suppliers contacts accompanied their IMD with an international implant card.
Conclusion: While waiting for the suppliers to send an international implant card, it was proposed to the departments to give patients the IMD traceability sheet from the IMD traceability software. However, this document does not allow us to be in full compliance with the European regulation to the absence of regulatory information (UDI, address and manufacturer's website).
{"title":"[Review of practices concerning the delivery of an international implant card following the implantation of a medical device].","authors":"Alexia Laflotte, Constance Bretagnolle, Agnès Henry","doi":"10.1016/j.pharma.2025.01.007","DOIUrl":"10.1016/j.pharma.2025.01.007","url":null,"abstract":"<p><strong>Introduction: </strong>The European regulation 2017/745 requires the delivery of an international implant card to the patient following the implantation of implantable medical devices (IMD). Currently, there are no procedure to describe the process for providing traceability documents to patients in our institution. The objective of this work was to evaluate the practices of the various departments concerned in our institution and to think about actions to meet the current regulation.</p><p><strong>Material and method: </strong>The evaluation of practices concerning the delivery of traceability documents to patients was evaluated through a questionnaire with 13 departments. Then, for each specialty, three electronic patient record (EPR) were audited. Finally, IMD's suppliers were asked about their ability to provide an international implant card.</p><p><strong>Results: </strong>In total, 85% (11/13) of the departments sent an IMD traceability document to patients, and in 91% (10/11) of cases, this transmission was done with the international implant card or the operative report. However, 63% of the operative report analyzed did not contain the traceability data of the IMD. Finally, only 60% of the suppliers contacts accompanied their IMD with an international implant card.</p><p><strong>Conclusion: </strong>While waiting for the suppliers to send an international implant card, it was proposed to the departments to give patients the IMD traceability sheet from the IMD traceability software. However, this document does not allow us to be in full compliance with the European regulation to the absence of regulatory information (UDI, address and manufacturer's website).</p>","PeriodicalId":8332,"journal":{"name":"Annales pharmaceutiques francaises","volume":" ","pages":""},"PeriodicalIF":1.0,"publicationDate":"2025-01-22","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143036274","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 : 2025-01-17DOI: 10.1016/j.pharma.2025.01.005
Isabelle Bodein, Nassir Messaadi, Bertrand Décaudin, Annie Standaert, Antoine Telliez, Anne Garat, Anita Tilly-Dufour, Sabine Bayen, Matthieu Calafiore
Objectives: The aim of this study was to collect the expectations of trainees in general practice towards their observation period in a community pharmacy, in order to contribute to a new definition of the objectives of this training period.
Methods: Data were collected using the nominal group technique. The eleven participants were ninth-year general medical students.
Results: Forty-six proposals were made and ranked according to priority and popularity, resulting in the selection of fourteen.
Conclusions: The fourteen proposals selected can be classified into 4 main categories: the pharmaceutical act, primary care and patient support, the operation of a pharmacy and the diversity of the activities of dispensing pharmacies. The proposals support the development of interprofessional communication and should make it possible to improve the teaching guidelines for observation periods.
{"title":"[Expectations of trainees in general practice about their observation period (internship) in community pharmacy].","authors":"Isabelle Bodein, Nassir Messaadi, Bertrand Décaudin, Annie Standaert, Antoine Telliez, Anne Garat, Anita Tilly-Dufour, Sabine Bayen, Matthieu Calafiore","doi":"10.1016/j.pharma.2025.01.005","DOIUrl":"10.1016/j.pharma.2025.01.005","url":null,"abstract":"<p><strong>Objectives: </strong>The aim of this study was to collect the expectations of trainees in general practice towards their observation period in a community pharmacy, in order to contribute to a new definition of the objectives of this training period.</p><p><strong>Methods: </strong>Data were collected using the nominal group technique. The eleven participants were ninth-year general medical students.</p><p><strong>Results: </strong>Forty-six proposals were made and ranked according to priority and popularity, resulting in the selection of fourteen.</p><p><strong>Conclusions: </strong>The fourteen proposals selected can be classified into 4 main categories: the pharmaceutical act, primary care and patient support, the operation of a pharmacy and the diversity of the activities of dispensing pharmacies. The proposals support the development of interprofessional communication and should make it possible to improve the teaching guidelines for observation periods.</p>","PeriodicalId":8332,"journal":{"name":"Annales pharmaceutiques francaises","volume":" ","pages":""},"PeriodicalIF":1.0,"publicationDate":"2025-01-17","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142998885","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}
Objective: Our aim was to analyze pharmaceutical interventions related to heart failure (HF) outpatient treatment.
Methods: An observationnal study was carried out over 6 months at the Abidjan Institute of Cardiology (ICA). Data were collected using a survey form that focused on therapeutic adherence, drugs related-problems (DRP) and pharmaceutical interventions (PI). DRP and PI coding tool of French Society of Clinical Pharmacy was used. Therapeutic adherence was assessed using the GIRERD tool. Prescription review made by Algorithm of Calop. Clinical, economic and organizational impacts of PI accepted by the physician were rated using the CLEO tool.
Results: Study population had a mean age of 51.4 years. DRP prevalence was 59%. These DRP were essentially adherence problem (43%) and drug-drug interactions (39.7%). The PIs were mainly "optimization of administration methods" (43.6%) and "therapeutic monitoring" (38.1%). The acceptance rate of PIs intended for prescribers was 80.8%. Mainly of these PIs were rated "PI with minor clinical impact" (60.2%), "PI without economic impact" (83.8%) and PI with "positive organizational impact" (63.2%).
Conclusion: DRPs and more specifically adherence problems and drug-drug interactions are common in HF outpatient management. The pharmacist can contribute to improve this care through regular assessment of therapeutic adherence and management of DRPs.
{"title":"[Analysis of pharmaceutical interventions related to outpatient treatment of chronic heart failure].","authors":"Elisée Doffou, Aminata Coulibaly, Pascal Danho Abrogoua","doi":"10.1016/j.pharma.2025.01.004","DOIUrl":"10.1016/j.pharma.2025.01.004","url":null,"abstract":"<p><strong>Objective: </strong>Our aim was to analyze pharmaceutical interventions related to heart failure (HF) outpatient treatment.</p><p><strong>Methods: </strong>An observationnal study was carried out over 6 months at the Abidjan Institute of Cardiology (ICA). Data were collected using a survey form that focused on therapeutic adherence, drugs related-problems (DRP) and pharmaceutical interventions (PI). DRP and PI coding tool of French Society of Clinical Pharmacy was used. Therapeutic adherence was assessed using the GIRERD tool. Prescription review made by Algorithm of Calop. Clinical, economic and organizational impacts of PI accepted by the physician were rated using the CLEO tool.</p><p><strong>Results: </strong>Study population had a mean age of 51.4 years. DRP prevalence was 59%. These DRP were essentially adherence problem (43%) and drug-drug interactions (39.7%). The PIs were mainly \"optimization of administration methods\" (43.6%) and \"therapeutic monitoring\" (38.1%). The acceptance rate of PIs intended for prescribers was 80.8%. Mainly of these PIs were rated \"PI with minor clinical impact\" (60.2%), \"PI without economic impact\" (83.8%) and PI with \"positive organizational impact\" (63.2%).</p><p><strong>Conclusion: </strong>DRPs and more specifically adherence problems and drug-drug interactions are common in HF outpatient management. The pharmacist can contribute to improve this care through regular assessment of therapeutic adherence and management of DRPs.</p>","PeriodicalId":8332,"journal":{"name":"Annales pharmaceutiques francaises","volume":" ","pages":""},"PeriodicalIF":1.0,"publicationDate":"2025-01-10","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142969369","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 : 2025-01-07DOI: 10.1016/j.pharma.2025.01.003
Harshada Shewale, Abhishek Kanugo
Objective: The beneficial usefulness is limited because of its deprived solubility and bioavailability. The recent work deals with the advancement of solid lipid nanoparticles of Ambrisentan for the effective therapy of pulmonary hypertension intended for oral delivery.
Material and methods: The solid lipid nanoparticles of Ambrisentan were developed using the melt emulsification method. The characterization of Ambrisentan was carried out with FTIR, DSC, and crystalline nature with XRD. The optimization was accomplished with the Box-Behnken design. The glyceryl monostearate (GMS), Tween 80, and sonication time were considered independent factors and the particle size, and entrapment efficiency were the critical quality attributes in the development of SLN.
Results: The compatibility, thermal nature, and crystalline behavior were confirmed with FTIR, DSC, and XRD respectively. The preferred batch F10 indicated a particle size of 166.7nm and an entrapment efficiency of 83.96%. The cumulative percentage of drug dissolved from the optimized Ambrisentan-loaded SLN was 87.68% after 24h indicating a sustained release pattern. Furthermore, after lyophilization and estimated with scanning electron microscopy a particle size of 153.5 to 179.8nm was confirmed. The lyophilized powder is intended for oral delivery and has significant bioavailability, minimizing the chances of mortality due to its sustained release action.
Conclusion: The significant improvement in solubility of Ambrisentan was achieved through solid lipid nanoparticles which facilitates greater efficacy.
{"title":"Sustained release of Ambrisentan solid lipid nanoparticles for the treatment of hypertension: Melt emulsification method.","authors":"Harshada Shewale, Abhishek Kanugo","doi":"10.1016/j.pharma.2025.01.003","DOIUrl":"10.1016/j.pharma.2025.01.003","url":null,"abstract":"<p><strong>Objective: </strong>The beneficial usefulness is limited because of its deprived solubility and bioavailability. The recent work deals with the advancement of solid lipid nanoparticles of Ambrisentan for the effective therapy of pulmonary hypertension intended for oral delivery.</p><p><strong>Material and methods: </strong>The solid lipid nanoparticles of Ambrisentan were developed using the melt emulsification method. The characterization of Ambrisentan was carried out with FTIR, DSC, and crystalline nature with XRD. The optimization was accomplished with the Box-Behnken design. The glyceryl monostearate (GMS), Tween 80, and sonication time were considered independent factors and the particle size, and entrapment efficiency were the critical quality attributes in the development of SLN.</p><p><strong>Results: </strong>The compatibility, thermal nature, and crystalline behavior were confirmed with FTIR, DSC, and XRD respectively. The preferred batch F10 indicated a particle size of 166.7nm and an entrapment efficiency of 83.96%. The cumulative percentage of drug dissolved from the optimized Ambrisentan-loaded SLN was 87.68% after 24h indicating a sustained release pattern. Furthermore, after lyophilization and estimated with scanning electron microscopy a particle size of 153.5 to 179.8nm was confirmed. The lyophilized powder is intended for oral delivery and has significant bioavailability, minimizing the chances of mortality due to its sustained release action.</p><p><strong>Conclusion: </strong>The significant improvement in solubility of Ambrisentan was achieved through solid lipid nanoparticles which facilitates greater efficacy.</p>","PeriodicalId":8332,"journal":{"name":"Annales pharmaceutiques francaises","volume":" ","pages":""},"PeriodicalIF":1.0,"publicationDate":"2025-01-07","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142943404","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 : 2025-01-07DOI: 10.1016/j.pharma.2025.01.001
Mathilde Noguero, Aasfa Khan, Arnaud Venet
Objectives: Training of pharmacy technicians in non-sterile compounding unit must meet the requirements of the French Good Manufacturing Practices. Our current training program is composed of one week companionship preceded by a theoretical course and do not allow the acquisition of all the skills and knowledge required. The formation load over the pharmacist and technician also increase due to an important turnover among the technicians. The aim of this work is to improve the current training by the development and implementation of an e-learning training program.
Methods: E-learning program was developed by a multidisciplinary team using the instructional system design model ADDIE. The first two levels of Kirkpatrick's evaluation model were assessed using a satisfaction survey and an evaluation conducted before and after the program by the agents who attended the course.
Results: The online training program include 4 units divided into 10 sequences available in PowerPoint® format. Fifteen pharmacy technicians were able to test the course. Among them, 6 agents finished the program and were satisfied with the training. Evaluation grade improved after the course (18.33/25) compared with the first evaluation (10.25/25).
Conclusion: The development of an e-learning course completed the existing training program by providing standardized knowledge that strengthens practical training. New modules on various topics can be added later to improve ongoing training of pharmacy technicians in the compounding unit.
{"title":"[Development of an e-learning training program for pharmacy technicians' authorization in non-sterile compounding unit].","authors":"Mathilde Noguero, Aasfa Khan, Arnaud Venet","doi":"10.1016/j.pharma.2025.01.001","DOIUrl":"10.1016/j.pharma.2025.01.001","url":null,"abstract":"<p><strong>Objectives: </strong>Training of pharmacy technicians in non-sterile compounding unit must meet the requirements of the French Good Manufacturing Practices. Our current training program is composed of one week companionship preceded by a theoretical course and do not allow the acquisition of all the skills and knowledge required. The formation load over the pharmacist and technician also increase due to an important turnover among the technicians. The aim of this work is to improve the current training by the development and implementation of an e-learning training program.</p><p><strong>Methods: </strong>E-learning program was developed by a multidisciplinary team using the instructional system design model ADDIE. The first two levels of Kirkpatrick's evaluation model were assessed using a satisfaction survey and an evaluation conducted before and after the program by the agents who attended the course.</p><p><strong>Results: </strong>The online training program include 4 units divided into 10 sequences available in PowerPoint® format. Fifteen pharmacy technicians were able to test the course. Among them, 6 agents finished the program and were satisfied with the training. Evaluation grade improved after the course (18.33/25) compared with the first evaluation (10.25/25).</p><p><strong>Conclusion: </strong>The development of an e-learning course completed the existing training program by providing standardized knowledge that strengthens practical training. New modules on various topics can be added later to improve ongoing training of pharmacy technicians in the compounding unit.</p>","PeriodicalId":8332,"journal":{"name":"Annales pharmaceutiques francaises","volume":" ","pages":""},"PeriodicalIF":1.0,"publicationDate":"2025-01-07","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142943400","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 : 2025-01-07DOI: 10.1016/j.pharma.2025.01.002
Yamina Aloui, Raafa Ben Saada, Khadija Ben Chaabane, Ahlem Nahali, Myriam El Iraqui, Adib Bellassoued, Bassem Khattèche, Med Ali Yousfi
Objective: The aim of this study was to analyze the risks associated with the sterilization process for reusable medical devices (RMD) in stomatology, by applying the FMECA method, with a view to implementing the necessary corrective and preventive actions necessary to secure this process.
Methods: The study, which was descriptive, took place between June and July 2024 in the medicine and dental surgery department of our hospital and concerned the moist heat sterilization process of RMD. The study began by defining its scope and the formation of the work team, followed by the functional analysis of the process, the identification of the failure modes (FM), the definition of the rating scales, the rating of the FM and finally the calculation of the criticality index and the development of the action plan.
Results: A total of 64 FM were identified, including 14 of high criticality, 16 of medium criticality and 34 of low criticality. The pre-disinfection and cleaning stage generated the most failures, particularly those of high criticality. High criticality FM were subject to a set of corrective and preventive actions. A new map of the sterilization process highlighting a 'forward march' flow has been proposed.
Conclusion: Our FMECA made it possible to highlight several FM and propose an appropriate action plan. A second FMECA would still be interesting to evaluate the reduction in the overall criticality of our process.
{"title":"[Management of risks linked to the sterilization of reusable medical devices in dentistry].","authors":"Yamina Aloui, Raafa Ben Saada, Khadija Ben Chaabane, Ahlem Nahali, Myriam El Iraqui, Adib Bellassoued, Bassem Khattèche, Med Ali Yousfi","doi":"10.1016/j.pharma.2025.01.002","DOIUrl":"10.1016/j.pharma.2025.01.002","url":null,"abstract":"<p><strong>Objective: </strong>The aim of this study was to analyze the risks associated with the sterilization process for reusable medical devices (RMD) in stomatology, by applying the FMECA method, with a view to implementing the necessary corrective and preventive actions necessary to secure this process.</p><p><strong>Methods: </strong>The study, which was descriptive, took place between June and July 2024 in the medicine and dental surgery department of our hospital and concerned the moist heat sterilization process of RMD. The study began by defining its scope and the formation of the work team, followed by the functional analysis of the process, the identification of the failure modes (FM), the definition of the rating scales, the rating of the FM and finally the calculation of the criticality index and the development of the action plan.</p><p><strong>Results: </strong>A total of 64 FM were identified, including 14 of high criticality, 16 of medium criticality and 34 of low criticality. The pre-disinfection and cleaning stage generated the most failures, particularly those of high criticality. High criticality FM were subject to a set of corrective and preventive actions. A new map of the sterilization process highlighting a 'forward march' flow has been proposed.</p><p><strong>Conclusion: </strong>Our FMECA made it possible to highlight several FM and propose an appropriate action plan. A second FMECA would still be interesting to evaluate the reduction in the overall criticality of our process.</p>","PeriodicalId":8332,"journal":{"name":"Annales pharmaceutiques francaises","volume":" ","pages":""},"PeriodicalIF":1.0,"publicationDate":"2025-01-07","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142943402","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 : 2025-01-01DOI: 10.1016/j.pharma.2024.09.005
Boddu Kishore Kumar, Gubbiyappa Shiva Kumar
<div><h3>Objective</h3><div>The objective of this study was to develop and optimize palbociclib-loaded nanobubbles for targeted breast cancer therapy.</div></div><div><h3>Materials and methods</h3><div>Biocompatible poly(DL-lactide-co-glycolide) was used to create nanobubbles loaded with palbociclib. The formulation process was meticulously crafted using a three-level Box-Behnken design and a double emulsion solvent evaporation method to precisely tailor the nanobubbles’ properties.</div></div><div><h3>Results</h3><div>The Derringer's desirability method optimized variables by transforming responses into a desirability scale, resulting in a global desirability value. Optimal settings, A: 526.97<!--> <!-->mg, B: 250<!--> <!-->mg,<!--> <!-->C: 2.0% w/v, D: 6101<!--> <!-->rpm, achieved a D value of 0.949. Palbociclib nanobubbles demonstrated a smaller particle size (31.78<!--> <!-->±<!--> <!-->2.12) than plain nanobubbles (38.56<!--> <!-->±<!--> <!-->3.56). PDI values indicated a uniform size distribution. The zeta potential remained consistent, with values of −31.34<!--> <!-->±<!--> <!-->3.36 for plain and −31.56<!--> <!-->±<!--> <!-->3.12 for drug-loaded nanobubbles. Encapsulation efficiency was 70.12%, highlighting effective drug encapsulation. Palbociclib release was significantly higher from nanobubbles in pH 7.4, especially with ultrasound, releasing almost 99.34% of the drug. Hemolytic activity assays confirmed safety for injection. Fluorescent intensity analysis revealed a two-fold increase in cellular uptake of palbociclib facilitated by ultrasound. The MTT assay demonstrated enhanced cytotoxicity of palbociclib-loaded nanobubbles, especially with ultrasound, emphasizing their potential for improved therapeutic efficacy. The IC<sub>50</sub> values for palbociclib, without ultrasound, and with ultrasound were 98.3<!--> <!-->μM, 72.34<!--> <!-->μM, and 61.34<!--> <!-->μM, respectively.</div></div><div><h3>Conclusion</h3><div>The significant findings of this study emphasize the potential of palbociclib-loaded nanobubbles as a promising therapeutic system for improved breast cancer treatment.</div></div><div><h3>Objectif</h3><div>L’objectif de cette étude était de développer et d’optimiser la formulation de nanobulles chargées en palbociclib comme thérapie ciblée du cancer du sein<em>.</em></div></div><div><h3>Matériel et méthodes</h3><div>Un copolymère poly(acide lactique-co-glycolique) [PLAGA] biocompatible a été utilisé pour créer des nanobulles chargées en palbociclib. Le processus de formulation a été méticuleusement conçu en utilisant un plan d’expérience de Box-Behnken à trois niveaux et une méthode par double émulsion évaporation de solvant a pu être optimisée pour ajuster précisément les propriétés des nanobulles.</div></div><div><h3>Résultats</h3><div>La méthode de désirabilité de Derringer a permis d’optimiser les variables en transformant les réponses en une échelle de désirabilité, ce qui a abouti à une valeur de désirabilité globa
{"title":"Development and characterization of palbociclib-loaded PLGA nanobubbles for targeted cancer therapy","authors":"Boddu Kishore Kumar, Gubbiyappa Shiva Kumar","doi":"10.1016/j.pharma.2024.09.005","DOIUrl":"10.1016/j.pharma.2024.09.005","url":null,"abstract":"<div><h3>Objective</h3><div>The objective of this study was to develop and optimize palbociclib-loaded nanobubbles for targeted breast cancer therapy.</div></div><div><h3>Materials and methods</h3><div>Biocompatible poly(DL-lactide-co-glycolide) was used to create nanobubbles loaded with palbociclib. The formulation process was meticulously crafted using a three-level Box-Behnken design and a double emulsion solvent evaporation method to precisely tailor the nanobubbles’ properties.</div></div><div><h3>Results</h3><div>The Derringer's desirability method optimized variables by transforming responses into a desirability scale, resulting in a global desirability value. Optimal settings, A: 526.97<!--> <!-->mg, B: 250<!--> <!-->mg,<!--> <!-->C: 2.0% w/v, D: 6101<!--> <!-->rpm, achieved a D value of 0.949. Palbociclib nanobubbles demonstrated a smaller particle size (31.78<!--> <!-->±<!--> <!-->2.12) than plain nanobubbles (38.56<!--> <!-->±<!--> <!-->3.56). PDI values indicated a uniform size distribution. The zeta potential remained consistent, with values of −31.34<!--> <!-->±<!--> <!-->3.36 for plain and −31.56<!--> <!-->±<!--> <!-->3.12 for drug-loaded nanobubbles. Encapsulation efficiency was 70.12%, highlighting effective drug encapsulation. Palbociclib release was significantly higher from nanobubbles in pH 7.4, especially with ultrasound, releasing almost 99.34% of the drug. Hemolytic activity assays confirmed safety for injection. Fluorescent intensity analysis revealed a two-fold increase in cellular uptake of palbociclib facilitated by ultrasound. The MTT assay demonstrated enhanced cytotoxicity of palbociclib-loaded nanobubbles, especially with ultrasound, emphasizing their potential for improved therapeutic efficacy. The IC<sub>50</sub> values for palbociclib, without ultrasound, and with ultrasound were 98.3<!--> <!-->μM, 72.34<!--> <!-->μM, and 61.34<!--> <!-->μM, respectively.</div></div><div><h3>Conclusion</h3><div>The significant findings of this study emphasize the potential of palbociclib-loaded nanobubbles as a promising therapeutic system for improved breast cancer treatment.</div></div><div><h3>Objectif</h3><div>L’objectif de cette étude était de développer et d’optimiser la formulation de nanobulles chargées en palbociclib comme thérapie ciblée du cancer du sein<em>.</em></div></div><div><h3>Matériel et méthodes</h3><div>Un copolymère poly(acide lactique-co-glycolique) [PLAGA] biocompatible a été utilisé pour créer des nanobulles chargées en palbociclib. Le processus de formulation a été méticuleusement conçu en utilisant un plan d’expérience de Box-Behnken à trois niveaux et une méthode par double émulsion évaporation de solvant a pu être optimisée pour ajuster précisément les propriétés des nanobulles.</div></div><div><h3>Résultats</h3><div>La méthode de désirabilité de Derringer a permis d’optimiser les variables en transformant les réponses en une échelle de désirabilité, ce qui a abouti à une valeur de désirabilité globa","PeriodicalId":8332,"journal":{"name":"Annales pharmaceutiques francaises","volume":"83 1","pages":"Pages 81-99"},"PeriodicalIF":1.0,"publicationDate":"2025-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142279851","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 : 2025-01-01DOI: 10.1016/j.pharma.2024.09.002
Audumbar Mali , Anil Bhanwase
<div><h3>Background</h3><div>Carmustine is used in the treatment of glioblastoma (GBM). GBM is a well-known life-threatening type of cancerous tumor. GBM covers 60.00% among all primary brain tumors, with an occurrence of 74,000 cases across the globe. Management for GBM is still very difficult because most of the medicines are unable to cross the blood-brain barrier (BBB). The present work observed that flexible liposomes embedded <em>in situ</em> nasal gel of carmustine is the best brain-targeted medicine delivery system for the management of GBM through the nasal route.</div></div><div><h3>Aim</h3><div>To evaluate <em>in vivo</em> pharmacokinetic parameters of carmustine formulations administered through nasal routes in Wistar rats.</div></div><div><h3>Methods</h3><div>In this work, different pharmacokinetic parameters were determined for carmustine formulations viz. carmustine API (Active Pharmaceutical Ingredient) solution, flexible liposomes, <em>in situ</em> thermoreversible intranasal gel, optimized flexible liposomes embedded <em>in situ</em> thermoreversible intranasal gel via intranasal administration in rats, and compared with marketed intravenous injection of carmustine administered through intravenous route. Carmustine was estimated with the help of a validated high-performance liquid chromatography (HPLC) approach. Three to four-months-old normal Wistar rats of either sex, having a weight of 200–250 grams were used in this study.</div></div><div><h3>Results</h3><div>Intranasal administration of optimized flexible liposomes embedded <em>in situ</em> nasal gel showed greater C<sub>max</sub> (∼two-fold), AUC<sub>0→t</sub> (∼three-fold), AUC<sub>0→∞</sub> (∼six-fold), and decreased T<sub>max</sub> (1<!--> <!-->h) data in the brain, than commercial intravenous injection of carmustine. The plasma concentration of carmustine administered through nasal route was found to be comparatively lower than intravenous administration, indicating lower systemic exposure to carmustine via the nasal route.</div></div><div><h3>Conclusion</h3><div><em>In vivo</em> pharmacokinetics results revealed that the optimized flexible liposomes embedded <em>in situ</em> nasal gel of carmustine can effectively deliver carmustine to brain by nasal drug delivery system in Wistar rats.</div></div><div><h3>Contexte</h3><div>La carmustine est utilisée dans le traitement du glioblastome (GBM). Le GBM est un type bien connu de tumeur cancéreuse potentiellement mortelle. Le GBM couvre 60,00 % de toutes les tumeurs cérébrales primitives, avec une survenue de 74 000 cas dans le monde. La prise en charge du GBM reste très difficile, car la plupart des médicaments sont incapables de traverser la barrière hémato-encéphalique (BBB). Le présent travail a observé que des liposomes flexibles incorporés dans un gel nasal de carmustine <em>in situ</em> constituent le meilleur système d’administration de médicaments ciblé sur le cerveau pour la gestion du GBM par la voie nasale.</div
{"title":"In vivo pharmacokinetic study of carmustine in rats after giving single-dose of carmustine API solution, flexible liposomes, in situ nasal gel, optimized flexible liposomes embedded in situ nasal gel, and marketed formulation","authors":"Audumbar Mali , Anil Bhanwase","doi":"10.1016/j.pharma.2024.09.002","DOIUrl":"10.1016/j.pharma.2024.09.002","url":null,"abstract":"<div><h3>Background</h3><div>Carmustine is used in the treatment of glioblastoma (GBM). GBM is a well-known life-threatening type of cancerous tumor. GBM covers 60.00% among all primary brain tumors, with an occurrence of 74,000 cases across the globe. Management for GBM is still very difficult because most of the medicines are unable to cross the blood-brain barrier (BBB). The present work observed that flexible liposomes embedded <em>in situ</em> nasal gel of carmustine is the best brain-targeted medicine delivery system for the management of GBM through the nasal route.</div></div><div><h3>Aim</h3><div>To evaluate <em>in vivo</em> pharmacokinetic parameters of carmustine formulations administered through nasal routes in Wistar rats.</div></div><div><h3>Methods</h3><div>In this work, different pharmacokinetic parameters were determined for carmustine formulations viz. carmustine API (Active Pharmaceutical Ingredient) solution, flexible liposomes, <em>in situ</em> thermoreversible intranasal gel, optimized flexible liposomes embedded <em>in situ</em> thermoreversible intranasal gel via intranasal administration in rats, and compared with marketed intravenous injection of carmustine administered through intravenous route. Carmustine was estimated with the help of a validated high-performance liquid chromatography (HPLC) approach. Three to four-months-old normal Wistar rats of either sex, having a weight of 200–250 grams were used in this study.</div></div><div><h3>Results</h3><div>Intranasal administration of optimized flexible liposomes embedded <em>in situ</em> nasal gel showed greater C<sub>max</sub> (∼two-fold), AUC<sub>0→t</sub> (∼three-fold), AUC<sub>0→∞</sub> (∼six-fold), and decreased T<sub>max</sub> (1<!--> <!-->h) data in the brain, than commercial intravenous injection of carmustine. The plasma concentration of carmustine administered through nasal route was found to be comparatively lower than intravenous administration, indicating lower systemic exposure to carmustine via the nasal route.</div></div><div><h3>Conclusion</h3><div><em>In vivo</em> pharmacokinetics results revealed that the optimized flexible liposomes embedded <em>in situ</em> nasal gel of carmustine can effectively deliver carmustine to brain by nasal drug delivery system in Wistar rats.</div></div><div><h3>Contexte</h3><div>La carmustine est utilisée dans le traitement du glioblastome (GBM). Le GBM est un type bien connu de tumeur cancéreuse potentiellement mortelle. Le GBM couvre 60,00 % de toutes les tumeurs cérébrales primitives, avec une survenue de 74 000 cas dans le monde. La prise en charge du GBM reste très difficile, car la plupart des médicaments sont incapables de traverser la barrière hémato-encéphalique (BBB). Le présent travail a observé que des liposomes flexibles incorporés dans un gel nasal de carmustine <em>in situ</em> constituent le meilleur système d’administration de médicaments ciblé sur le cerveau pour la gestion du GBM par la voie nasale.</div","PeriodicalId":8332,"journal":{"name":"Annales pharmaceutiques francaises","volume":"83 1","pages":"Pages 112-123"},"PeriodicalIF":1.0,"publicationDate":"2025-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142279853","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 : 2025-01-01DOI: 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
<div><div><em>Brocchia cinerea</em> 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 507.5<!--> <!-->mg/kg close to the LD50 of Beta-thujone (442<!--> <!-->mg/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 <em>Brocchia</em> 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 <em>Brocchia</em> safe within the indicated standards.</div></div><div><div>La <em>Brocchia cinerea</em> est une plante nord-africaine appartenant à la famille des Astéracées, largement utilisée dans la médecine populaire algérienne pour traiter diverses maladies. Ces vertus thérapeutiques sont principalement dues à l’huile essentielle végétale. Les composants chimiques de l’huile essentielle ont été identifiés par GC-MS, et la variabilité des niveaux de ces composants a été examinée dans neuf échantillons prélevés à des moments différents dans deux endroits du nord du Sahara algérien. Le contenu de l’huile essentielle s’est avéré être constitué de huit composants, dont les concentrations varient: bêta-thuyone (46,80 %), 1-méthyl-2-(1’ méthyléthényl)-3’- éthénylcyclopropylméthanol (14,59 %), 1,8 -Cinéole. (12,63 %), limonène-10-ol (9,47 %), 1(7), 3,8 o Menthatriène (3,45 %) et (-)-Camphre (2,11 %). Des études de toxicité ont été menées afin d’évaluer la sécurité de l’huile essentielle, à savoir: estimation de la DL50 et évaluation des paramètres biochimiques sanguins. Les résultats ont montré une DL 50 de 507,5<!--> <!-->mg/kg proche de la DL50 de la Bêta-thuyone (442<!--> <!-->mg/kg): composant principal de l’huile essentielle, ce qui le rend responsable de la majeure toxicité de la plante. L’apparition de convulsions comme manifestations toxiques à des concentrations plus élevées le confirme. L’huile essentielle de <em>Brocchia</em> a été classée comme légèrement, faiblement toxique, et la teneur en bêta-thuyone s’est avérée conforme aux valeurs réglementaires a
{"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":"<div><div><em>Brocchia cinerea</em> 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 507.5<!--> <!-->mg/kg close to the LD50 of Beta-thujone (442<!--> <!-->mg/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 <em>Brocchia</em> 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 <em>Brocchia</em> safe within the indicated standards.</div></div><div><div>La <em>Brocchia cinerea</em> est une plante nord-africaine appartenant à la famille des Astéracées, largement utilisée dans la médecine populaire algérienne pour traiter diverses maladies. Ces vertus thérapeutiques sont principalement dues à l’huile essentielle végétale. Les composants chimiques de l’huile essentielle ont été identifiés par GC-MS, et la variabilité des niveaux de ces composants a été examinée dans neuf échantillons prélevés à des moments différents dans deux endroits du nord du Sahara algérien. Le contenu de l’huile essentielle s’est avéré être constitué de huit composants, dont les concentrations varient: bêta-thuyone (46,80 %), 1-méthyl-2-(1’ méthyléthényl)-3’- éthénylcyclopropylméthanol (14,59 %), 1,8 -Cinéole. (12,63 %), limonène-10-ol (9,47 %), 1(7), 3,8 o Menthatriène (3,45 %) et (-)-Camphre (2,11 %). Des études de toxicité ont été menées afin d’évaluer la sécurité de l’huile essentielle, à savoir: estimation de la DL50 et évaluation des paramètres biochimiques sanguins. Les résultats ont montré une DL 50 de 507,5<!--> <!-->mg/kg proche de la DL50 de la Bêta-thuyone (442<!--> <!-->mg/kg): composant principal de l’huile essentielle, ce qui le rend responsable de la majeure toxicité de la plante. L’apparition de convulsions comme manifestations toxiques à des concentrations plus élevées le confirme. L’huile essentielle de <em>Brocchia</em> a été classée comme légèrement, faiblement toxique, et la teneur en bêta-thuyone s’est avérée conforme aux valeurs réglementaires a","PeriodicalId":8332,"journal":{"name":"Annales pharmaceutiques francaises","volume":"83 1","pages":"Pages 146-152"},"PeriodicalIF":1.0,"publicationDate":"2025-01-01","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}
Pub Date : 2025-01-01DOI: 10.1016/j.pharma.2024.09.009
Olivier Pierrefiche
La consommation d’alcool est un enjeu de santé publique majeur. Les patients présentant un trouble de l’usage d’alcool (TUA) peuvent bénéficier de cinq traitements qui ciblent préférentiellement des récepteurs membranaires et dont l’efficacité est en général modeste. Cependant, de nombreuses preuves expérimentales indiquent un rôle important de l’épigénétique dans les effets de la consommation d’alcool et les épidrogues qui modifient l’épigénome offrent une alternative intéressante aux options thérapeutiques actuelles. Cet article propose un bilan des preuves expérimentales les plus marquantes obtenues à différents âges sur des modèles animaux, avant de les confronter aux données obtenues chez l’homme et de conclure sur la pertinence de l’utilisation des épidrogues. Enfin, une nouvelle option thérapeutique est suggérée entre psychédéliques, récentes molécules d’intérêts, et facteurs épigénétiques dans la prise d’alcool.
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":"Modifications épigénétiques dans l’addiction à l’alcool et perspectives thérapeutiques","authors":"Olivier Pierrefiche","doi":"10.1016/j.pharma.2024.09.009","DOIUrl":"10.1016/j.pharma.2024.09.009","url":null,"abstract":"<div><div>La consommation d’alcool est un enjeu de santé publique majeur. Les patients présentant un trouble de l’usage d’alcool (TUA) peuvent bénéficier de cinq traitements qui ciblent préférentiellement des récepteurs membranaires et dont l’efficacité est en général modeste. Cependant, de nombreuses preuves expérimentales indiquent un rôle important de l’épigénétique dans les effets de la consommation d’alcool et les épidrogues qui modifient l’épigénome offrent une alternative intéressante aux options thérapeutiques actuelles. Cet article propose un bilan des preuves expérimentales les plus marquantes obtenues à différents âges sur des modèles animaux, avant de les confronter aux données obtenues chez l’homme et de conclure sur la pertinence de l’utilisation des épidrogues. Enfin, une nouvelle option thérapeutique est suggérée entre psychédéliques, récentes molécules d’intérêts, et facteurs épigénétiques dans la prise d’alcool.</div></div><div><div>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.</div></div>","PeriodicalId":8332,"journal":{"name":"Annales pharmaceutiques francaises","volume":"83 1","pages":"Pages 13-21"},"PeriodicalIF":1.0,"publicationDate":"2025-01-01","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}
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