Annales pharmaceutiques francaises最新文献

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.

Objectives: 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.

Materials and methods: 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.

Results: 38 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.

Conclusion: 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.

Montmorillonite (MMT) clay mineral 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.

Introduction: Effective medication adherence, is a real global challenge that emerges as a pivotal factor influencing asthma control, exacerbation frequency, hospitalization rates and ultimately, mortality, morbidity and health care costs. In light of this, our study aimed to assess therapeutic adherence levels among asthmatic patients and identify factors contributing to non-adherence.

Methods: We conducted a descriptive, cross-sectional multicenter study, among asthmatic patients receiving outpatient or inpatient care across seven asthma centers located in two Algerian cities: Algiers (University Hospital Center of Benimessous, University Hospital Center of Bab el oued,EPSP of Zeralda, EPSP of Beraki and EPSP of Rouiba) and Constantine (Constantine University Hospital Center (CHU), EPSP of Constantine), between July and December 2023. We evaluated therapeutic adherence using the Morisky 8-item questionnaire, while a 12-item questionnaire assessed patients' knowledge levels. Logistic regression analysis enabled us to identify factors associated with non-adherence.

Results: Our study, involved 390 patients, with a median age of 34 years and a sex ratio of 1.5. Notably, 38.2% of asthmatic patients exhibited poor adherence to treatment. Multivariate analysis revealed several factors potentially linked to non-adherence, including, age, place of residence, employment status, access to social insurance, treatment type and complexity, auto-medication, occurrence of adverse effects, limited level of education and inadequate knowledge about asthma management. Furthermore, there was a significant correlation between non-adherence and a higher rate of asthma exacerbations, with a reported occurrence of 68%.

Conclusion: Our findings emphasize concerning levels of therapeutic adherence, given its impact on disease control and the quality of life of asthmatic patients. This underscores the importance of implementing a therapeutic education program aimed at improving treatment adherence by addressing the factors identified as barriers in clinical patient management.

Objectives: The aims of the present investigation was to develop and validate stability-indicating RP-HPLC method for the estimation of Lurasidone hydrochloride (LURA-H) followed by its drug product, LURA-H encapsulated poly-D,L lactic-glycolic acid (PLGA) based in situ depot forming implant (LURA-H-PLGA-ISI).

Methods: The LURA-H-PLGA-ISI formulation was developed by simple mixing method. According to international conference on harmonization guidelines, RP-HPLC method was developed and validated using Waters 2695 and discovery C18, 5μ, 250×4.6mm ID column. Force degradation studied were performed by various degradation techniques.

Results: The chromatographic separations of LURA-H as well as LURA-H-PLGA-ISI with good resolutions have been achieved using the mobile phase 0.1% orthophosphoric acid and acetonitrile (50:50). The linearity in the range of 25-150 μg/mL of developed method. LOD and LOQ limits for LURA-H were found to be 0.07μg/mL and 0.22μg/mL, respectively. The % RSD was found to be<2% showing the precision of developed method. The accuracy of developed method was demonstrated which is close to 100±2%. Little modifications in the chromatographic conditions indicated robustness of the developed method. Further, solution stability of LURA-H and LURA-H-PLGA-ISI was stable at room temperature. Furthermore, force degradation studies demonstrated LURA-H was unaffected and stable under thermal, photodegradation and neutral (hydrolytic) stress conditions. AGREE and GAPI assessment demonstrated the developed method is environmentally sustainable.

Conclusion: The developed method is simple, robust, precise, accurate and sensitive which can be utilized for the regular analysis of LURA-H in quality control laboratories of bulk drug substance and PLGA containing formulations of LURA-H.

Introduction: Self-medication, the practice of administering medications without a medical prescription, has become a ubiquitous reality in many homes. Although often seen as a practical solution to alleviate minor ailments, it also raises major concerns, particularly when it involves children. Indeed, self-medication among children by their parents is a complex phenomenon, influenced by various social, cultural and economic factors.

Objectives: The main objective of our study is to evaluate the prevalence of self-medication of the pediatric population by parents in the Midelt region and to identify its determinants.

Methods: A descriptive cross-sectional study was conducted through a questionnaire with 127 parents of children under 12 years old visiting community pharmacies in the region, between May 1 and October 31, 2022.

Results: The prevalence of self-medication was 92.9%, the majority of parents resorted to self-medication of their children for benign pathologies; transient fever, minimal pain and nasopharyngitis. This self-medication is done very early, between 6 months and 2 years. In all, 41.5% of parents used age as a criterion to determine the dose, 49.2% exchanged the dose measurement system between two medications, 76.3% used drug combinations for self-medication, antipyretic analgesics and antibiotics are the therapeutic classes most used in self-medication, 42.2% use the syrup or oral suspension form when self-medicating their children and 64% stated that the pharmacist is their source of information relating to medications.

Conclusions: This research found widespread use of self-medication among children by their parents, particularly among those with secondary education living in urban area. These findings underline the need to develop a therapeutic education program intended for families, in collaboration with community pharmacists and various health professionals. The aim is to strengthen the safety of children by encouraging more responsible medical practices within homes.

Objectives: Chronic total occlusion (CTO) of coronary arteries is defined as complete absence of antegrade coronary flow without iodine passage, since more than 3 months. Coronary revascularization is a highly resource-intensive angioplasty procedure involving numerous medical devices (MDs). Its consumption and associated costs are not covered by either the medical act classification (CCAM) or the hospitalization fees and additional MD funding. The primary aim of this study is to analyze the financial sustainability of this activity for a public healthcare institution and to assess the budgetary impact of CTO treatment on the most expensive items of expenditure. The secondary aim is to describe the patient's intra-hospital pathway.

Methods: CTO revascularization stays are categorized under the code 05K06 "Vascular Stents without Myocardial Infarction". Major cost items were identified using national coded expenditure data and compared with those from our cost study. Every CTO intervention from January to November 2021 were retrospectively retrieved. Establishment purchase prices in 2021 were used to determine MD costs. Clinical data were extracted from electronic patient records. Operative data (procedure duration, professionals involved, and MD used) were extracted. Human Resources (HR) costs were integrated into the calculations. A Sankey diagram was created. Data are expressed as mean±standard deviation.

Results: In our study, 41 patients underwent 45 interventions. The median was 65 years. Seventy-eight percent of interventions were successful with a median duration of 113minutes. Two hundred and two different MD references were used, with 27% reimbursed additionally and 73% funded within the homogeneous group of stays (HGS). The total cost of MD described in the coded expenditure data is 2142€, of which 721€ is funded within the HGS. In our cohort, it represented averages of 2736€±1393€ and 1710€±926€, respectively. Regarding HR, the total cost described in the coded expenditure data was 442€ compared to 410€±169€ in our cohort. Finally, patient pathway analysis showed an average length of stay (LOS) of 1.8 days. Two pathways were identified depending on admission context: weekday hospitalization or cardiac intensive care.

Conclusions: CTO revascularization is a planned intervention with a short LOS and a highly standardized patient pathway. Our study highlights a proliferation of MD references used during CTO revascularization due to innovative industrial developments. The cost differential with coded expenditure data confirms the need for a revision of the procedure and its categorization within an HGS, which is currently non-specific.

Objective: Recent advancements in scientific understanding of free radicals have stimulated progress in medicine. Antioxidants are known to neutralize free radicals by giving up electrons. The current research was carried out to explore the antioxidant capabilities and phytochemical composition of a synergy-based combined extracts of Spondias mombin,Spilanthes filicaulis, and Piper guineense, with the goal to determine the optimal ratio for the most effective antioxidant activity, suitable for herbal product development.

Material and methods: Combined extracts H1 and H2 were obtained through aqueous maceration of S. mombin leaves, S. filicaulis plants, and P. guineense fruits. Antioxidant activity of combined extract was evaluated in 2, 2-diphenyl-1-picrylhydrazyl (DPPH) and ferric ion reducing power (FRAP) assay. Evaluations included total phenolic and flavonoid content determination. Furthermore, the phytochemical constituents were determined using Gas Chromatography-Mass Spectrometry (GC-MS).

Results: The combined extract H1 exhibited better free radical scavenging ability in DPPH (IC₅₀=72.87±0.63μg/mL) than H2 (IC₅₀=150.2±1.08μg/mL). The FRAP assay results revealed its highest reducing power (12.385±0.002 AAE/mg/g) compared to H2 (11.657±0.002 AAE/mg/g). Additionally, H1 had higher of both total phenolic and flavonoid content. GC-MS profiling revealed 28 compounds within H1 and 17 compounds within H2.

Conclusion: This study demonstrated that the combined extract H1 has significant antioxidant potential, with consistently positive results across all conducted assays. It contains a variety of phytochemical constituents, mainly phenolic and flavonoids that could be explored in pharmaceutical industries to develop antioxidant agents.

Given its good tolerance and broad-spectrum, isavuconazole is increasingly used off-label as an empirical therapy of invasive fungal infections. We retrospectively reviewed isavuconazole empirical treatment during a 12-month period in four hospitals. During isavuconazole treatment (n=27), none of the patients had a mycological evidence for fungal infection, but 19% (5/27) developed liver test abnormalities without leading to isavuconazole discontinuation. Isavuconazole could be considered as an off-label empirical therapy only if patients cannot receive caspofungin or liposomal amphotericin B.