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Novel HPTLC method for simultaneous estimation from ternary mixture of chlorpheniramine maleate, dextromethorphan hydrobromide and phenylephrine hydrochloride in syrup formulations 同时估算糖浆配方中马来酸氯苯那敏、氢溴酸右美沙芬和盐酸肾上腺素三元混合物的新型 HPTLC 方法。
IF 1.3 Q3 Pharmacology, Toxicology and Pharmaceutics Pub Date : 2024-06-01 DOI: 10.1016/j.pharma.2024.03.001
Adarsh Leuva , Nidhi Hingu , Parthvi Patel , Bhumika Dudhatra , Sanjay Chauhan , Jigna Vadalia , Kashyap Thummar

Objectives

A synergic antihistamine, cough suppressant, and decongestant combination of chlorpheniramine, dextromethorphan, and phenylephrine is used to treat acute respiratory infections caused by seasonal viruses. The effective qualitative and quantitative methods require the simultaneous measurement of a ternary combination in the pharmaceutical syrup dosage form. Therefore, a new, simple, fast and robust high performance thin layer chromatographic (HPTLC) method has been developed and validated for chlorpheniramine maleate (CPM), dextromethorphan hydrobromide (DEXO) and phenylephrine hydrochloride (PE).

Material and methods

The chromatographic separation was carried out on precoated aluminium plates with silica gel 60 F254 as the stationary phase. Mobile phase used was chloroform: methanol: ammonia (2.5:7.5:0.3, v/v/v) for proper separation. The detection was carried out at 270 nm wavelength in absorbance mode. Developed method was validated as per International Council for Harmonization (ICH) Q2 (R1) guideline.

Results

The linearity range is 400 to 1400 ng/band for CPM, 3000 to 11500 ng/band for DEXO and 1000 to 3500 ng/band for PE with correlation coefficient ≥ 0.995. The consistent lower values of relative standard deviation (RSD, %) for precision and robustness study indicate the method reliability. The percent recovery ranged from 97.82 to 102.03% indicates the good accuracy of the method.

Conclusion

The proposed method was complying for the analytical method validation parameters suggested by the ICH Q2 (R1) guideline. The method was found to be simple, rapid and reliable for the simultaneous estimation of CPM, DEXO and PE from its pharmaceutical syrup dosage form. The method was successfully applied to quantify these analytes from the several pharmaceutical syrup dosage form.

Objectifs

Une combinaison synergique d’antihistaminique, d’antitussif et de décongestionnant de chlorphéniramine, de dextrométhorphane et de phényléphrine est utilisée pour traiter les infections respiratoires aiguës causées par des virus saisonniers. Les méthodes qualitative et quantitative efficace nécessitent la mesure simultanée d’une combinaison ternaire sous la forme pharmaceutique de sirop. Par conséquent, une nouvelle méthode de chromatographie sur couche mince haute performance (HPTLC), simple, rapide et robuste a été développée et validée pour le maléate de chlorphéniramine (CPM), le bromhydrate de dextrométhorphane (DEXO) et le chlorhydrate de phényléphrine (PE).

Matériels et méthodes

La séparation chromatographique a été réalisée sur des plaques d’aluminium prérevêtues de gel de silice 60 F254 comme phase stationnaire. La phase mobile utilisée était du chloroforme : méthanol : ammoniaque (2,5: 7,5: 0,3, v/v/v) pour une séparation appropriée. La détection a été réalisée à une

目的:一种由氯苯那敏、右美沙芬和苯肾上腺素组成的协同抗组胺剂、止咳剂和减充血剂复方制剂用于治疗季节性病毒引起的急性呼吸道感染。有效的定性和定量方法需要同时测定药物糖浆剂型中的三元复方制剂。因此,针对马来酸氯苯那敏(CPM)、氢溴酸右美沙芬(DEXO)和盐酸去氧肾上腺素(PE)开发了一种新的、简单、快速和稳健的高效薄层色谱(HPTLC)方法,并进行了验证:色谱分离在预涂铝板上进行,固定相为硅胶 60 F254。流动相为氯仿:甲醇:氨水(2.5:7.5:0.3, v/v/v),用于适当分离。检测采用吸光度模式,波长为 270 nm。所开发的方法按照国际协调理事会(ICH)Q2 (R1)指南进行了验证:CPM的线性范围为400-1400纳克/带,DEXO的线性范围为3000-11500纳克/带,PE的线性范围为1000-3500纳克/带,相关系数≥0.995。精密度和稳健性研究中的相对标准偏差(RSD,%)值始终较低,表明该方法可靠。回收率范围为 97.82 - 102.03 %,表明该方法具有良好的准确性:所提出的方法符合 ICH Q2 (R1) 指南建议的分析方法验证参数。该方法简便、快速、可靠,可用于糖浆剂中CPM、DEXO和PE的同时测定。该方法成功地定量了几种药用糖浆剂中的这些分析物。
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引用次数: 0
Validated LC/MS method for simultaneous determination of elbasvir and grazoprevir in human plasma. 经验证的液相色谱/质谱法同时测定人血浆中的艾巴拉韦和格拉唑普韦。
IF 1.3 Q3 Pharmacology, Toxicology and Pharmaceutics Pub Date : 2024-05-31 DOI: 10.1016/j.pharma.2024.05.006
Aymen Labidi, Rafika Bensghaier, Sami Jebali, Latifa Latrous

A sensitive and accurate LC/MS method for the determination of elbasvir (ELB) and grazoprevir (GZP) in human plasma was established using daclatasvir (DCT) as an internal standard. The analytes were separated on a Waters Spherisorb phenyl column (150mm×4.6mm ID, 5μm particle size) maintained at 40°C±2°C. Gradient elution, at a flow rate of 0.8mLmin-1, was used. The mobile phase consists of 90% of acetonitrile mixed to 10% of a 5mM ammonium formate buffer (+0.1% v/v of trimethylamine, pH was adjusted to 3.2 by formic acid) as phase A and 10% of acetonitrile mixed to 90% of the same buffer as phase B. Liquid-liquid extraction with ethyl acetate solvent was used to recuperate compounds from plasma. The method was validated over a concentration range of 2 and 100ng/mL for GZP and between 1 and 50ng/mL for ELB. The intra- and inter-day precision and accuracy of the quality control samples at low, medium, and high concentration levels exhibited relative standard deviations (RSD)<15%, and the accuracy values ranged from 94.2 to 107.8%. The robustness of the method was established using a two-level full factorial design.

以达拉他韦(DCT)为内标物,建立了测定人血浆中艾巴拉韦(ELB)和格拉唑普韦(GZP)的灵敏、准确的LC/MS方法。分析物在 Waters Spherisorb 苯基色谱柱(内径 150 mm x 4.6 mm,粒径 5 µm)上分离,色谱柱温度保持在 40°C ± 2°C。采用梯度洗脱,流速为 0.8 mL min-1。流动相 A 相由 90% 的乙腈与 10% 的 5 mM 甲酸铵缓冲液(+ 0.1% v/v 的三甲胺,pH 值由甲酸调节至 3.2)混合而成,B 相由 10% 的乙腈与 90% 的相同缓冲液混合而成。该方法在 2 至 100 纳克/毫升的浓度范围内对 GZP 进行了验证,在 1 至 50 纳克/毫升的浓度范围内对 ELB 进行了验证。质控样品在低、中、高浓度水平下的日内和日间精密度和准确度的相对标准偏差(RSD)均小于15%,准确度为94.2%至107.8%。采用两级全因子设计确定了该方法的稳健性。
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引用次数: 0
Advances and challenges in serratiopeptidase topical formulation. 血清肽酶局部制剂的进步与挑战。
IF 1.3 Q3 Pharmacology, Toxicology and Pharmaceutics Pub Date : 2024-05-29 DOI: 10.1016/j.pharma.2024.05.008
Sachin D Patil, Manasi J Wagdarikar

Enzymes are a key part of most metabolic processes and are required for the correct functioning of the human body, either directly or indirectly. Proteolytic enzymes aid in the digestion of proteins in the body. Proteolytic enzymes are created in the pancreas naturally, but they can also be found in certain diets. Serratiopeptidase is an enzyme found in the stomach wall of silkworms and produced from S. marcescens strain. Less solubility, toxicity, instability, incompatibility, and less penetration are all common issues with Serratiopeptidase drug delivery. Because of its proteinaceous nature, serratiopeptidase is susceptible to enzymatic breakdown in the gastrointestinal system. It also has a low permeability through the intestinal barrier due to its hydrophilic nature. Depending on the features of the medicine, a suitable delivery mechanism is required. Topical formulation may eliminate the risk of gastric degradation of drug and increase direct permeation through skin and show effects. Topical SRP may effectively lower inflammatory markers, as it has been found to have superior anti-inflammatory effects than topical NSAIDs. Serratiopeptidase topical formulations could be more effective than nonsteroidal anti-inflammatory medications in treating local inflammation. This article reviews studies on various topical formulations.

酶是大多数新陈代谢过程的关键部分,是人体直接或间接正常运作所必需的。蛋白水解酶有助于消化体内的蛋白质。蛋白质分解酶是在胰腺中自然产生的,但也可以在某些饮食中找到。Serratiopeptidase 是一种存在于蚕胃壁中的酶,由 S. marcescens 菌株产生。溶解度低、毒性、不稳定性、不相容性和渗透性差都是塞拉提肽酶给药的常见问题。由于其蛋白质性质,丝拉提肽酶在胃肠道系统中容易被酶分解。此外,由于其亲水性,通过肠道屏障的渗透性也很低。根据药物的特点,需要一种合适的给药机制。外用制剂可消除药物在胃中降解的风险,增加通过皮肤的直接渗透性并显示效果。外用 SRP 可有效降低炎症指标,因为它的抗炎效果优于外用非甾体抗炎药。在治疗局部炎症方面,塞拉提肽酶外用制剂可能比非甾体抗炎药更有效。本文回顾了有关各种外用制剂的研究。
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引用次数: 0
Spilanthes filicaulis (Schumach. &Thonn.) C. D. Adams: An insights into ethnopharmacologically important but scientifically understudied species. Spilanthes filicaulis (Schumach. &Thonn.) C. D. Adams:对民族药理学上重要但科学上研究不足的物种的见解。
IF 1.3 Q3 Pharmacology, Toxicology and Pharmaceutics Pub Date : 2024-05-29 DOI: 10.1016/j.pharma.2024.05.010
Olusesan Ojo, Ruth Etiosa Olusola, Oluwabukola Oluwafunmilayo Ojo

Spilanthes filicaulis (Schumach. & Thonn.) C. D. Adams is synonymous to Acmella caulirhiza Delile. The plant, also known as cock's eye or African cress, is a medicinal herb that belongs to the Asteraceae family. In this paper, the holistic and current applications of S. filicaulis were synthesized and critically discussed by summarizing, for the first time, its botany, traditional medicinal uses, active components, and pharmacological properties. We employed the databases of ScienceDirect, Scopus, Online Wiley library, PubMed, and Google Scholar to retrieve data on S. filicaulis from inception till February 2024, resulting in more than 70 electronic references. Based on literature reports, S. filicaulis has rich ethnopharmacological uses in different disease areas but their scientific validations are still in early stage, or not verified yet. In general, 16 phytochemicals have been identified so far. They include spilanthol, piperine, erucic acid, and isoquinoline derivative among others. The plant extracts possess anticancer, antioxidant, antimicrobial, anti-inflammatory, hepato-protective, anthelminthic, and analgesic activities. In the future, the phytochemical components, and biological activities of S. filicaulis need to be further investigated. Similarly, mechanistic studies need to be incorporated to the biological testing, to uncover the modes of actions of the species extracts and active components. Considering the species' rich ethnopharmacological applications, and the dearth of robust and established toxicity reports, the study on the safety of S. filicaulis would be an interesting and rewarding approach for further research.

Spilanthes filicaulis (Schumach. & Thonn.) C. D. Adams 与 Acmella caulirhiza Delile 同源。这种植物又名鸡眼或非洲芹,是一种药用植物,属于菊科。在本文中,通过首次总结 S. filicaulis 的植物学、传统药用、活性成分和药理特性,对其整体和当前应用进行了归纳和批判性讨论。我们利用 ScienceDirect、Scopus、Online Wiley library、PubMed 和 Google Scholar 等数据库检索了 S. filicaulis 从开始到 2024 年 2 月的数据,共获得 70 多条电子参考文献。根据文献报道,S. filicaulis 在不同疾病领域具有丰富的民族药理学用途,但其科学验证仍处于早期阶段,或尚未得到验证。总的来说,目前已鉴定出 16 种植物化学物质。其中包括斯皮兰醇、胡椒碱、芥酸和异喹啉衍生物等。这些植物提取物具有抗癌、抗氧化、抗菌、消炎、保肝、驱虫和镇痛活性。今后,还需要进一步研究 S. filicaulis 的植物化学成分和生物活性。同样,还需要在生物测试中加入机理研究,以揭示该物种提取物和活性成分的作用模式。考虑到该物种丰富的民族药理学应用,以及缺乏可靠和成熟的毒性报告,对 S. filicaulis 的安全性研究将是一个有趣和有益的进一步研究方法。
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引用次数: 0
Microneedles: A minimally invasive delivery system for ocular treatment. 微针:用于眼科治疗的微创传输系统
IF 1 Q3 Pharmacology, Toxicology and Pharmaceutics Pub Date : 2024-05-29 DOI: 10.1016/j.pharma.2024.05.007
Jayesh Jathar, Hitendra Mahajan, Pankaj Nerkar

This review article delves into the extensive use of microneedles in ocular therapy, emphasizing their efficacy in delivering drug substances to the posterior region of the eye. The conventional methods of drug delivery, while widely employed, are marred by inherent drawbacks such as neovascularization, abrasion, and infiltration. To address these limitations, the review explores various approaches to microneedle fabrication, shedding light on the diverse materials employed in the process. Furthermore, the article meticulously examines the delivered drug substances using distinct microneedle approaches and their applications in ocular therapy. By critically evaluating the drawbacks associated with conventional ophthalmic drug delivery, the review seeks to pave the way for a paradigm shift. It advocates for a novel approach centered around minimally invasive microneedles, presenting them as a promising solution to overcome the limitations of current drug delivery methods. The comprehensive discussion within this article not only offers insights into the fabrication techniques and materials used for microneedles but also provides a nuanced understanding of the applications and advantages associated with this innovative approach. As the exploration of microneedle technology continues to evolve, this review serves as a valuable resource for researchers, clinicians, and pharmaceutical professionals seeking to enhance ocular therapy by embracing the potential of minimally invasive microneedles.

这篇综述文章深入探讨了微针在眼科治疗中的广泛应用,强调了微针在向眼球后部输送药物物质方面的功效。传统的给药方法虽然应用广泛,但也存在一些固有的缺陷,如新生血管、磨损和浸润。针对这些局限性,这篇综述探讨了微针制造的各种方法,揭示了制造过程中使用的各种材料。此外,文章还仔细研究了使用不同微针方法输送的药物物质及其在眼科治疗中的应用。通过批判性地评估与传统眼科给药相关的弊端,这篇综述力图为模式转变铺平道路。文章倡导以微创微针为中心的新方法,并将其作为克服当前给药方法局限性的一种有前途的解决方案。本文的全面论述不仅深入探讨了微针的制造技术和材料,还对这一创新方法的应用和优势提供了细致入微的理解。随着微针技术探索的不断发展,这篇综述将成为研究人员、临床医生和制药专业人士的宝贵资源,他们希望通过利用微创微针的潜力来提高眼科治疗水平。
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引用次数: 0
Metric identification and mapping of reimbursable implant codes in Morocco to the global nomenclature (GMDN) and European (EUDAMED) of medical devices. 摩洛哥可报销植入物代码与全球医疗器械命名法(GMDN)和欧洲医疗器械命名法(EUDAMED)的度量识别和映射。
IF 1.3 Q3 Pharmacology, Toxicology and Pharmaceutics Pub Date : 2024-05-29 DOI: 10.1016/j.pharma.2024.05.005
Meryem Qouhafa, Brahim Benaji, Souad Lebbar, Abdelmajid Soulaymani, Benayad Nsiri, My Hachem El Yousfi Alaoui, Mokhtari Abdelrhani, Mohammed Azougagh

Background: The list of medical devices (MD) eligible for reimbursement under the Compulsory Health Insurance in Morocco is set by Ministerial Order comprising 869 items between life-support equipment, external prostheses, and implants. The objective of the present study is to analyze the nomenclature of implantable medical devices (IMD) appearing on this list and compare them with the global nomenclature of MD (GMDN) and the European nomenclature of MD (EMDN).

Methods: The study deals with (i) the mapping of the codes of the IMD list with 170 DM per cardinality and (ii) a metric identification by Sørensen-Dice coefficient of terminological similarity of the IMD with respect to the two databases.

Results: The 170 IMD codes are mapped onto 493 terms in the GMDN and 344 terms in the EMDN. The 37.7% of implants are mapped to more than or equal to 2 terms of GMDN while 36.5% are mapped to more than or equal to 2 terms to the EMDN. The comparison of cardinality distributions has revealed no significant difference (P=0.430) between the two databases. The implants examined are divided into 11 categories whose strong similarity is given to active cardiovascular implants in the EMDN database with simDice=0.534.

Conclusion: Healthcare authorities need to align with nomenclature standards to improve interoperability and rely on a more efficient and rational regulatory process.

背景:摩洛哥强制医疗保险中符合报销条件的医疗器械(MD)清单是由部长令制定的,包括生命维持设备、外部假体和植入物等 869 个项目。本研究的目的是分析该清单中出现的植入式医疗器械(IMD)的命名,并将其与全球 MD 命名(GMDN)和欧洲 MD 命名(EMDN)进行比较:研究内容包括:(i) IMD 列表中的代码与 170 个 DM 的每一明细度的映射;(ii) 通过索伦森-戴斯系数(Sørensen-Dice coefficient)确定 IMD 与这两个数据库在术语上的相似性:结果:170 个 IMD 代码与 GMDN 中的 493 个术语和 EMDN 中的 344 个术语进行了映射。37.7%的植入物被映射到多于或等于 2 个 GMDN 术语,而 36.5% 的植入物被映射到多于或等于 2 个 EMDN 术语。通过比较心率分布,发现两个数据库之间没有明显差异(p = 0.430)。所研究的植入物被分为 11 个类别,其与 EMDN 数据库中的活动心血管植入物具有很高的相似度(simDice=0.534):医疗机构需要与术语标准保持一致,以提高互操作性,并依靠更有效、更合理的监管流程。
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引用次数: 0
Sommaire / Contents 目录
IF 1.3 Q3 Pharmacology, Toxicology and Pharmaceutics Pub Date : 2024-04-16 DOI: 10.1016/S0003-4509(24)00051-8
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引用次数: 0
Biomolecular interactions between Plasmodium and human host: A basis of targeted antimalarial therapy 疟原虫与人类宿主之间的生物分子相互作用:靶向抗疟治疗的基础。
IF 1.3 Q3 Pharmacology, Toxicology and Pharmaceutics Pub Date : 2024-03-20 DOI: 10.1016/j.pharma.2024.03.005
Anamika Jain , Rajeev Sharma , Laxmikant Gautam , Priya Shrivastava , Kamalinder K. Singh , Suresh P. Vyas

Malaria is one of the serious health concerns worldwide as it remains a clinical challenge due to the complex life cycle of the malaria parasite and the morphological changes it undergoes during infection. The malaria parasite multiplies rapidly and spreads in the population by changing its alternative hosts. These various morphological stages of the parasite in the human host cause clinical symptoms (anemia, fever, and coma). These symptoms arise due to the preprogrammed biology of the parasite in response to the human pathophysiological response. Thus, complete elimination becomes one of the major health challenges. Although malaria vaccine(s) are available in the market, they still contain to cause high morbidity and mortality. Therefore, an approach for eradication is needed through the exploration of novel molecular targets by tracking the epidemiological changes the parasite adopts. This review focuses on the various novel molecular targets.

Le paludisme est l’un des problèmes de santé les plus graves au monde, car il reste un défi clinique en raison du cycle de vie complexe du parasite du paludisme et des changements morphologiques qu’il subit au cours de l’infection. Le parasite du paludisme se multiplie rapidement et se propage dans la population en changeant d’hôte. Ces différents stades morphologiques du parasite chez l’hôte humain provoquent des symptômes cliniques (anémie, fièvre et coma). Ces symptômes sont dus à la biologie préprogrammée du parasite en réponse à la réaction physiopathologique de l’homme. L’élimination complète du parasite devient donc l’un des principaux défis sanitaires. Bien que des vaccins contre le paludisme soient disponibles sur le marché, ils continuent de provoquer une morbidité et une mortalité élevées. Par conséquent, une approche de l’éradication est nécessaire grâce à l’exploration de nouvelles cibles moléculaires en suivant les changements épidémiologiques adoptés par le parasite. Cette revue se concentre sur les différentes nouvelles cibles moléculaires.

疟疾是全球严重的健康问题之一,由于疟原虫复杂的生命周期及其在感染过程中发生的形态变化,疟疾仍然是一个临床难题。疟原虫通过更换宿主在人群中迅速繁殖和传播。寄生虫在人类宿主体内的这些不同形态阶段会导致临床症状(贫血、发烧和昏迷)。这些症状的出现是由于寄生虫针对人类病理生理反应而预设的生物学特性。因此,彻底消除疟疾成为主要的健康挑战之一。虽然市场上有疟疾疫苗,但它们仍然会导致高发病率和高死亡率。因此,需要通过追踪寄生虫的流行病学变化,探索新型分子靶标,从而找到根除疟疾的方法。本综述重点介绍各种新型分子靶标。
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引用次数: 0
Sommaire / Contents 目录
IF 1.3 Q3 Pharmacology, Toxicology and Pharmaceutics Pub Date : 2024-02-21 DOI: 10.1016/S0003-4509(24)00015-4
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引用次数: 0
État des lieux des modalités de poursuite en ville des préparations pharmaceutiques à usage pédiatrique initiées au sein de l’Assistance publique des Hôpitaux de Marseille [在马赛公立大学医院系统内启动的儿科准备工作的医院城市补偿概述]。
IF 1.3 Q3 Pharmacology, Toxicology and Pharmaceutics Pub Date : 2024-02-20 DOI: 10.1016/j.pharma.2024.02.009
Cyrielle Bouguergour , Florence Peyron , Christophe Curti , Nathalie Baillié , Sébastien Gallice

Objectifs

Les pharmacies à usage intérieur sont amenées à réaliser des préparations pharmaceutiques afin d’obtenir un médicament à un dosage et/ou une forme galénique (FG) adaptés à l’usage pédiatrique. L’objectif de ce travail est de faire un état des lieux des modalités de poursuite en ville des préparations pharmaceutiques initiées au sein de l’Assistance publique des Hôpitaux de Marseille.

Méthodes

Des ordonnances de sorties d’hospitalisation et/ou de consultations comportant des préparations magistrales pédiatriques et émanant de notre Centre hospitalier ont été recueillies dans deux officines ayant une importante activité de préparation au niveau national. Une analyse de la conformité réglementaire, ainsi qu’une comparaison de la formulation des préparations réalisées en ville et à l’hôpital ont été effectuées.

Résultats

Au total, 45 ordonnances ont été recueillies, soit 52 lignes de préparations. L’analyse réglementaire a mis en évidence que la totalité des ordonnances présentent au moins une non-conformité dont 60,8 % sont relatives aux traitements médicamenteux. La FG préparée diffère en ville par rapport à l’hôpital dans 46,2 % des cas et lorsque celle-ci est une forme orale liquide le véhicule et la concentration du principe actif utilisés diffèrent dans 56 % des cas.

Conclusion

L’absence de prescriptions hospitalières claires et complètes rend compliquée la réalisation en ville du traitement initié à l’hôpital. La multiplicité des systèmes d’information inter-hôpitaux et en ville sont des obstacles à l’interopérabilité nécessaire à la coordination de la prise en charge thérapeutique des patients notamment en pédiatrie. Il convient d’améliorer la qualité des prescriptions de sortie pour optimiser le parcours de soin.

Objectives

Hospital internal-use pharmacies are required to make pharmaceutical preparations in order to obtain a medication in a dosage and/or Galenic form (FG) suitable for pediatric use. The aim of this study is to assess the procedures for continuing pharmaceutical preparations initiated within the Assistance Publique des Hôpitaux de Marseille in an outpatient setting.

Methods

Hospital discharge prescriptions and/or consultation prescriptions involving paediatric magistral preparations and issued by our Hospital Centre were collected from two pharmacies with significant preparation activity at national level. An analysis of regulatory compliance was carried out, as well as a comparison of the formulation of preparations made in the outpatient setting and in the hospital.

Results

Au total, 45 prescriptions were collected, representing 52 preparation lines. The regulatory analysis revealed that all the prescriptions contained at least one non-conformity, 60.8% of which related to drug treatments. The prepared FG differed in the outpatient setting co

目的 :医院内用药房必须进行药物制剂,以获得适合儿科使用的药物剂量和/或加仑尼西制剂(FG)。本研究的目的是评估马赛公共援助医院在门诊环境下继续配制药物的程序。方法 :从两家在全国范围内开展大量制剂业务的药房收集本医院中心开具的涉及儿科药剂的出院处方和/或就诊处方。对符合法规的情况进行了分析,并对门诊和医院的制剂配方进行了比较。结果 :共收集到 45 份处方,代表 52 种制剂。法规分析表明,所有处方中至少有一项不符合规定,其中 60.8%与药物治疗有关。46.2% 的病例中,门诊与医院制备的 FG 存在差异;56% 的病例中,当 FG 为口服液时,所使用的载体和活性成分浓度存在差异。结论 :由于缺乏清晰完整的医院处方,因此很难在门诊开展在医院开始的治疗。医院和门诊之间信息系统的多样性阻碍了协调病人治疗所需的互操作性,尤其是在儿科。需要提高出院处方的质量,以优化病人护理路径。
{"title":"État des lieux des modalités de poursuite en ville des préparations pharmaceutiques à usage pédiatrique initiées au sein de l’Assistance publique des Hôpitaux de Marseille","authors":"Cyrielle Bouguergour ,&nbsp;Florence Peyron ,&nbsp;Christophe Curti ,&nbsp;Nathalie Baillié ,&nbsp;Sébastien Gallice","doi":"10.1016/j.pharma.2024.02.009","DOIUrl":"10.1016/j.pharma.2024.02.009","url":null,"abstract":"<div><h3>Objectifs</h3><p>Les pharmacies à usage intérieur sont amenées à réaliser des préparations pharmaceutiques afin d’obtenir un médicament à un dosage et/ou une forme galénique (FG) adaptés à l’usage pédiatrique. L’objectif de ce travail est de faire un état des lieux des modalités de poursuite en ville des préparations pharmaceutiques initiées au sein de l’Assistance publique des Hôpitaux de Marseille.</p></div><div><h3>Méthodes</h3><p>Des ordonnances de sorties d’hospitalisation et/ou de consultations comportant des préparations magistrales pédiatriques et émanant de notre Centre hospitalier ont été recueillies dans deux officines ayant une importante activité de préparation au niveau national. Une analyse de la conformité réglementaire, ainsi qu’une comparaison de la formulation des préparations réalisées en ville et à l’hôpital ont été effectuées.</p></div><div><h3>Résultats</h3><p>Au total, 45 ordonnances ont été recueillies, soit 52 lignes de préparations. L’analyse réglementaire a mis en évidence que la totalité des ordonnances présentent au moins une non-conformité dont 60,8 % sont relatives aux traitements médicamenteux. La FG préparée diffère en ville par rapport à l’hôpital dans 46,2 % des cas et lorsque celle-ci est une forme orale liquide le véhicule et la concentration du principe actif utilisés diffèrent dans 56 % des cas.</p></div><div><h3>Conclusion</h3><p>L’absence de prescriptions hospitalières claires et complètes rend compliquée la réalisation en ville du traitement initié à l’hôpital. La multiplicité des systèmes d’information inter-hôpitaux et en ville sont des obstacles à l’interopérabilité nécessaire à la coordination de la prise en charge thérapeutique des patients notamment en pédiatrie. Il convient d’améliorer la qualité des prescriptions de sortie pour optimiser le parcours de soin.</p></div><div><h3>Objectives</h3><p>Hospital internal-use pharmacies are required to make pharmaceutical preparations in order to obtain a medication in a dosage and/or Galenic form (FG) suitable for pediatric use. The aim of this study is to assess the procedures for continuing pharmaceutical preparations initiated within the <em>Assistance Publique des Hôpitaux</em> de Marseille in an outpatient setting.</p></div><div><h3>Methods</h3><p>Hospital discharge prescriptions and/or consultation prescriptions involving paediatric magistral preparations and issued by our Hospital Centre were collected from two pharmacies with significant preparation activity at national level. An analysis of regulatory compliance was carried out, as well as a comparison of the formulation of preparations made in the outpatient setting and in the hospital.</p></div><div><h3>Results</h3><p>Au total, 45 prescriptions were collected, representing 52 preparation lines. The regulatory analysis revealed that all the prescriptions contained at least one non-conformity, 60.8% of which related to drug treatments. The prepared FG differed in the outpatient setting co","PeriodicalId":8332,"journal":{"name":"Annales pharmaceutiques francaises","volume":null,"pages":null},"PeriodicalIF":1.3,"publicationDate":"2024-02-20","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"139929750","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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Annales pharmaceutiques francaises
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