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Gastrointestinal symptoms from theoretical knowledge to pharmaceutical approach during COVID-19 pandemic COVID-19大流行期间胃肠道症状从理论知识到药物方法
Pub Date : 2021-07-30 DOI: 10.37897/rjphp.2021.s.2
Florentina Simona-Maria Tatarusanu, F. Lupașcu, L. Herciu, I. Vasincu
Usually gastrointestinal discomfort is a very common complaint and most of the time it’s easy to manage in daily pharmaceutical practice. But some conditions can lead to further complications or become worse over time, so it’s really important that patients can access advice and support when they need it. Pharmacists are in the position to guide the selection of the best treatment by confirming the diagnosis, sending patients with alarm symptoms to physicians and educating patients on the proper use of their OTC medication. Gastrointestinal symptoms such as diarrhea and nausea/vomiting are often recognized among the patients with COVID-19. The impact of pharmacist intervention is needed in order to ensure reliable information for preventing, detecting, treating and managing coronavirus infection.
通常胃肠道不适是一种非常常见的主诉,并且在日常药学实践中大多数情况下很容易处理。但有些情况会导致进一步的并发症或随着时间的推移变得更糟,所以病人在需要的时候能够获得建议和支持是非常重要的。药剂师可以通过确认诊断,将有警示症状的患者送到医生那里,并教育患者正确使用OTC药物,来指导最佳治疗方案的选择。腹泻和恶心/呕吐等胃肠道症状在COVID-19患者中经常被发现。为了确保预防、检测、治疗和管理冠状病毒感染的可靠信息,需要药师干预的影响。
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引用次数: 0
Prediction of the particle size and flow characteristics of powder blends for tableting by near-infrared spectroscopy and chemometrics 用近红外光谱和化学计量学预测压片用混合粉末的粒径和流动特性
Pub Date : 2021-03-31 DOI: 10.37897/RJPHP.2021.1.3
R. Iovanov, A. Vonica, I. Tomuță
The purpose of this research was to apply near-infrared (NIR) spectroscopy in combination with chemometrics to predict particle size and flow characteristics of a meloxicam powder blends for tableting. In order to develop calibration models for particle size (mean particle size, poly-dispersion index), and flow properties (angle of repose and time of flow) prediction, the NIR reflection spectra of different meloxicam powder blends prepared according to an experimental design were analyzed using different preprocessing methods by partial last-square (PLS) regression followed by leaveone-out cross-validation. Very good prediction ability was found for mean particle size, poly-dispersion index, angle of repose, and time of flow in models in whose development no preprocessing spectrum was applied. Also, a good prediction was found preprocessing spectrum such smoothing - moving average for particle size characteristics, and unit vector normalization for powder flow properties. Therefore, NIR-chemometric methods developed in this work can be useful for the prediction of the granulometric properties and parameters related to the flowability of the meloxicam powder blends and may be used as process analytical technology (PAT) tools for process control during meloxicam tablets manufacturing.
本研究的目的是将近红外光谱与化学计量学相结合,预测用于压片的美洛昔康粉末混合物的粒度和流动特性。为了开发颗粒尺寸(平均颗粒尺寸、多分散指数)和流动特性(休止角和流动时间)预测的校准模型,通过偏最小二乘回归和leave-out交叉验证,使用不同的预处理方法分析了根据实验设计制备的不同美洛昔康粉末共混物的近红外反射光谱。在没有应用预处理谱的开发模型中,发现对平均粒径、多分散指数、休止角和流动时间的预测能力非常好。此外,还发现了对光谱的预处理,如对颗粒尺寸特性的平滑移动平均,以及对粉末流动特性的单位向量归一化,都有很好的预测效果。因此,本工作中开发的近红外化学计量方法可用于预测美洛昔康粉末混合物的粒度特性和与流动性相关的参数,并可作为美洛昔康片生产过程控制的过程分析技术(PAT)工具。
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引用次数: 0
Water insoluble polymers as efficient binder in fluid bed granulation of metoprolol for preparation hydrophilic matrix extendedrelease tablets 水不溶性聚合物在制备亲水性基质缓释片的美托洛尔流化床造粒中的高效粘结剂
Pub Date : 2020-12-31 DOI: 10.37897/RJPHP.2020.4.4
D. Hales, C. Pharmacy, C. Alecu, I. Tomuță
Objectives. The objective of this study was to investigate the possibility of developing metoprolol extended-release tablets by using hydroxypropyl methylcellulose (HPMC) in order to obtain the hydrophilic matrix and Eudragit NE 40D, Kollicoat SR 30D and Surelease E7 as binders during the granulation process. Material and methods. The extended-release tablets were prepared via fluid bed granulation of metoprolol powder using Eudragit NE 40D / Kollicoat SR 30D / Surelease E7 as binders, followed by compression. The influence of three formulation factors (the type of granulation polymers, the ratio of granulation polymers and the HPMC ratio) on the kinetic metoprolol tartrate release was investigated through a full factorial experimental design. Outcomes. The kinetic release of all 26 formulations was best fitted with Peppas model. According to n values of Peppas equation, the release mechanism of drug consists in water diffusion into the matrix, followed by matrix swelling and erosion. The results also indicated that the formulations containing an increased amount of Eudragit NE (10% or more) as binder in the granulation process presented a satisfactory release rate of metoprolol over 12 hours from the granules incorporated in the hydrophilic matrix. Conclusions. This study demonstrated the possibility of lowering of the burst effect from hydrophilic matrix extendedrelease dosage forms incorporating a freely soluble drug, by granulating the drug with a high amount of Eudragit NE 40D and processing the obtained granules in a hydrophilic matrix by tableting.
目标。研究了羟丙基甲基纤维素(HPMC)制备美托洛尔缓释片的可行性,在造粒过程中制备亲水性基质,以Eudragit NE 40D、Kollicoat SR 30D和Surelease E7为粘结剂。材料和方法。以Eudragit NE 40D / Kollicoat SR 30D / surelee7为粘结剂,采用流化床造粒法制备美托洛尔缓释片。采用全因子试验设计,考察了造粒聚合物类型、造粒聚合物比和HPMC比3个配方因素对酒石酸美托洛尔释放动力学的影响。结果。26个剂型的动力学释放均符合Peppas模型。根据Peppas方程的n值,药物的释放机制是水扩散到基质中,然后是基质溶胀和侵蚀。结果还表明,在造粒过程中添加10%或更多的乌龙茶烯(Eudragit NE)作为粘合剂的配方,在亲水性基质中掺入的颗粒中,美托洛尔在12小时内的释放率令人满意。结论。本研究证明了在含有自由溶性药物的亲水基质缓释剂型中,通过将大量的eudrragit ne40d制成颗粒,并通过片剂在亲水基质中处理获得的颗粒,从而降低爆发效应的可能性。
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引用次数: 1
Preformulation and preliminary formulation studies of mesalazine gastro-resistant tablets 美沙拉嗪抗胃片的预处方及初步处方研究
Pub Date : 2020-12-31 DOI: 10.37897/RJPHP.2020.4.5
Adriana Aurelia Chiș, I. Crăciun, C. Dobrea, F. Gligor, A. Bărbat, L. Rus, Sibiu Romania Polisano Pharmaceuticals Sa
Mesalamine, 5-aminosalicylic acid or mesalazine is the standard therapy of inflammatory bowel disease. A small number of pharmaceutical dosage forms with mesalazine are on the market. The aim of this study was preformulation and preliminary formulation studies of oral gastro-resistant tablets containing 500 mg mesalazine. The reasons why a gastro-resistant tablet was chosen are: increased compliance of the patient, increased chemical stability and modified release modulation (mesalazine has a local effect on mucosa). The raw materials were of pharmaceutical grade. The following analytical techniques were involved: differential scanning chromatography (DCS), in vitro release, particle size determination, high performance liquid chromatography (HPLC). The compatibility of mesalazine with several excipients was tested using DSC. Wet granulation of mesalazine and starch showed that the fourth (LM04) formulation generates the highest amount (69.1%) of granules in the range of 1000–300 μm. Oblong tablets (pilot batches) were produced. The cores were coated with an enteric coating acrylic agent in order to achieve gastro-resistance. A new gastro-resistant tablets mesalazine formulation was developed by means of wet granulation, tableting (oblong tablets) and coating.
美沙拉秦、5-氨基水杨酸或美沙拉秦是炎症性肠病的标准治疗方法。市场上有少量含有美沙拉秦的药物剂型。本研究的目的是对含有500毫克美沙拉秦的口服胃耐药片剂进行处方前和初步配方研究。选择胃耐药片剂的原因是:患者的依从性增加、化学稳定性增加和改良的释放调节(美沙拉秦对粘膜有局部影响)。这些原料是制药级的。涉及以下分析技术:差示扫描色谱(DCS)、体外释放、粒度测定、高效液相色谱(HPLC)。使用DSC测试了美沙拉秦与几种赋形剂的兼容性。氨基水杨酸和淀粉的湿法制粒表明,第四种(LM04)制剂产生的颗粒量最高(69.1%),在1000–300μm范围内。生产Oblong片剂(中试批次)。将核用肠溶性丙烯酸包衣剂包衣,以实现胃耐受性。采用湿法制粒、压片(长方形片剂)和包衣的方法开发了一种新的耐胃片剂美沙拉秦制剂。
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引用次数: 0
Development of fast release foaming vaginal tablets with clotrimazole. II. The influence of the environmental conditions on preparation and stability 氯霉唑阴道快速释放泡沫片的研制。2环境条件对制备及稳定性的影响
Pub Date : 2020-12-31 DOI: 10.37897/RJPHP.2020.4.6
E. László, R. Cluj-Napoca, I. Tomuță, S. Leucuta
Objectives. The aim of this study was to evaluate the stability over time after storage under normal environmental thermo-hygrometric conditions of immediate release foaming vaginal tablets. Material and methods. 15 formulation of foaming vaginal tablets prepared according with a Box-Bhenken experimental design were packaged in tightly sealed bottles with anhydrous sodium sulphate as desiccant and stored in normal thermo-hygrometric conditions (temperature of 25°C, relative humidity 40-75%). Immediate after preparation, after 1 and 3 months the tablets pharmaceutical characteristics were analysed and modification over time evaluated. Outcomes. The formulation factors studied with experimental design have, in general, the same influence on tablets characteristics after 1 or 3 months storage as immediate after preparation After one month storage in normal thermohygrometric conditions, an increase of the tablets hardness and the foaming time was observed, and a decrease of the volume of the foam, the mass of carbon dioxide released by the foaming. These modifications are accentuated especially by an increased effervescent mixture ratio and not significantly influenced by the other formulation variables. The results obtained after three months storage show that the changes on the tablets characteristics become slower than in the first month. The tablets hardness reaches maximum values after one month, but also there are slower changes regarding the maximum volume of the foam, the resistance of the foam, or the mass of carbon dioxide released after foaming. Low modification was observed for the pH generated in the water, which has a fairly high stability over time, both at one month and after three months storage. Conclusions. Foaming vaginal tablets stored in normal thermo-hygrometric conditions, suffer a sudden modification of their characteristics during the first month of storage, a phenomenon that is due to both the humidity of the environment and the preparation conditions. This modification can be minimized by preparing and storing tablets in low humidity conditions (lower that 10%) or by preparation the formulations with a low effervescent mixture ratio (less than 25%).
目标。本研究的目的是评价立即释放泡沫阴道片在正常环境热湿条件下贮存后的稳定性。材料和方法。采用Box-Bhenken实验设计制备的15种阴道发泡片配方,以无水硫酸钠为干燥剂,密封瓶内包装,常温(温度25℃,相对湿度40-75%)保存。制备后立即、1个月和3个月分析片剂的药物特性,并评价片剂随时间的变化。结果。通过实验设计所研究的配方因素,一般来说,1个月或3个月后对制剂特性的影响与制备后立即的影响相同。在正常热湿条件下储存1个月后,观察到片剂硬度增加,起泡时间延长,泡沫体积减小,发泡释放的二氧化碳量减少。这些变化特别因泡腾化混合物比例的增加而加强,而不受其他配方变量的显著影响。贮藏3个月后的结果表明,与第1个月相比,片剂特性的变化有所减缓。片剂的硬度在一个月后达到最大值,但在泡沫的最大体积、泡沫的阻力或泡沫后释放的二氧化碳质量方面也有较慢的变化。观察到水中产生的pH值变化很小,随着时间的推移,无论是在一个月还是在三个月后,都具有相当高的稳定性。结论。在正常的热湿条件下储存的泡沫阴道片,在储存的第一个月内会突然改变其特性,这种现象是由于环境的湿度和制备条件造成的。可以通过在低湿度条件下(低于10%)制备和储存片剂或通过制备低起泡混合物比例(小于25%)的制剂来最大限度地减少这种改性。
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引用次数: 0
Ibuprofen in the current practice of the pharmacist in the community pharmacy 布洛芬在当前社区药房执业药师中的应用
Pub Date : 2020-09-30 DOI: 10.37897/RJPHP.2020.3.1
P. Antonoaea, N. Todoran, E. Rédai, R. Vlad, M. Bîrsan, Aura Rusu, A. Ciurba, I. Pharmacy
The pharmacist from the community pharmacy plays a key role in the case of patients who seek directly for pathologies related to pain. Being a health specialist, he has the ability to offer pharmaceutical healthcare for drugs that need a medical prescription and also for the ones that are registered as OTC’s. Ibuprofen (IBU) is a part of the drug group called nonsteroidal anti-inflammatory drugs (NSAIDs) being registered in Romania under 17 pharmaceutical formulation by the National Agency of Drugs and Medical Devices. Due to its pharmacological profile which consists of a low risk of gastro intestinal side effects, IBU is an OTC recommended and frequently prescribed for decreasing the low and moderate pain. World Health Organization (WHO) indicates IBU as a drug that can be used to babies aged over three months. Through this paper, we try to analyze the pharmacist’s vision from the community pharmacy in IBU recommendation. In this paper were mentioned some legal aspects that are linked to the pharmacist competences, and also its approach regarding IBU recommendation during pregnancy and breastfeeding and also to children and to a category of patients who have various associated pathologies.
社区药房的药剂师在直接寻求疼痛相关病理的患者中起着关键作用。作为一名健康专家,他有能力为需要医疗处方的药物以及注册为OTC的药物提供药物保健。布洛芬(IBU)是罗马尼亚国家药品和医疗器械管理局(National Agency of drugs and Medical Devices)在17种药物配方下注册的非甾体类抗炎药(NSAIDs)的一部分。由于其药理特征包括低风险的胃肠道副作用,IBU是一种推荐的非处方药,经常用于减少轻度和中度疼痛。世界卫生组织(WHO)指出,IBU是3个月以上婴儿可以使用的药物。通过本文,我们试图从社区药房在IBU推荐中分析药师的愿景。在本文中提到了一些与药剂师能力相关的法律方面,以及在怀孕和哺乳期间以及对儿童和具有各种相关病理的患者推荐IBU的方法。
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引用次数: 0
Development of foaming vaginal tablets with clotrimazole. Part I. Optimization of the formulation using design of experiments approach 氯霉唑阴道泡沫片的研制。第一部分:采用实验设计法对配方进行优化
Pub Date : 2020-06-30 DOI: 10.37897/rjphp.2020.2.5
E. László, C. Pharmacy, I. Tomuță, S. Leucuta
Objectives. The aim of this study was to optimize the formulation of certain immediate release foaming vaginal tablets, with fast vaginal disintegration (part I), fallowing their time stability (part II). Material and methods. Modde optimizing software and a Box-Bhenken experimental design was used to establish an optimal formula that would provide maximum “in vitro” behaviour advantages, including stability during preservation; and the improvement of the foaming effect. There were prepared 15 formulations of foaming vaginal tablets in order to choose the optimal formula. Outcomes. The main factor, with influence over all the studied parameters, is the percentage of the effervescent mixture in the formulation. The excess of citric acid has a main role in the assurance of local pH; in the improvement of the flowing properties of the powder mixtures before compression; and in the improvement of the effervescent process, having, on the other hand, an effect of decreasing the stability of tablets and increasing their humidity adsorption. Sodium lauryl sulphate, at the chosen concentration levels (0.5-1.5%), did not influence the dependent variables, it only produced a strong-er resistance of the foam. The optimal formula of a foaming vaginal tablet with an optimal stability during preservation must contain 0.5% sodium lauryl sulphate, while the effervescent mixture must contain a percentage of 24% excess of citric acid, and it must represent 44% of the total amount of excipients. Conclusions. The experimental determinations of the optimal formula were close to the theoretical values predicted by the program, this certifying the validity of the optimization and the conclusion draw after analysis the experimental design.
目标。本研究的目的是优化某些阴道快速崩解的速释发泡阴道片的配方(第一部分),并考察其时间稳定性(第二部分)。材料和方法。Modde优化软件和Box-Bhenken实验设计用于建立最佳配方,该配方将提供最大的“体外”行为优势,包括保存期间的稳定性;以及发泡效果的改善。为筛选最佳配方,制备了15种阴道发泡片。结果。影响所有研究参数的主要因素是配方中泡腾混合物的百分比。过量的柠檬酸在保证局部pH值方面起着主要作用;在压缩之前改善粉末混合物的流动特性;以及在改进泡腾过程中,另一方面具有降低片剂稳定性和增加其吸湿性的效果。十二烷基硫酸钠,在选定的浓度水平(0.5-1.5%)下,不会影响因变量,它只会产生泡沫的强er阻力。在保存过程中具有最佳稳定性的阴道发泡片剂的最佳配方必须含有0.5%的十二烷基硫酸钠,而泡腾混合物必须含有24%的过量柠檬酸,并且必须占赋形剂总量的44%。结论。优化公式的实验确定与程序预测的理论值接近,验证了优化的有效性和对实验设计进行分析后得出的结论。
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引用次数: 1
High-throughput NIR-chemometric method for direct quantification of loratadine in powder blends for tableting and tablets 片剂和片剂混合粉末中氯雷他定的高通量近红外化学计量法直接定量
Pub Date : 2020-06-30 DOI: 10.37897/rjphp.2020.2.4
B. Sylvester, C. Pharmacy, Alina Porfire, M. Achim, I. Tomuță
Objectives. The aim of this study was to develop and validate a NIR-chemometric method for direct quantification of loratadine in powder blends for tableting and tablets, without any sample preparation. Material and methods. Calibration samples were prepared according to an experimental design with 1 variable and 5 level, containing from 8 to 12 mg loratadine/tablet. Outcomes. For the powder blends, the model generated with the use of spectral range 9,000-4,000 cm-1 and FD+SNV pre-treatment method had the best results, considering the number of PLS factors 9, R2 = 0.984 and RMSECV = 0.267%. For the tablets, the model using the spectral range 11,100-7,128 cm-1 and mMN pre-treatment method had the best results, considering the number of PLS factors 10, R2 = 0.985 and RMSECV = 0.170 mg. Using these calibration models, the method was fully validated according to the ICH guidance. For both powder blends and tablets, the best accuracy was obtained at the concentration level of 10 mg/tablet and the relative bias had values between 0.05% and 1.98% respectively -0.360% and 0.618%. Conclusions. The NIR-chemometric method has good reproducibility and satisfactory accuracy and linearity profiles, indicating that this method could be used for direct determination of loratadine in powder blends for tableting and tablets, without any sample preparation.
目标。本研究的目的是开发和验证一种近红外化学计量方法,用于直接定量片剂和片剂混合粉末中氯雷他定,无需任何样品制备。材料和方法。校准样品是根据实验设计制备的,具有1个变量和5个水平,含有8-12 mg氯雷他定/片。结果。对于粉末混合物,考虑到PLS因子9的数量,R2=0.984和RMSECV=0.267%,使用光谱范围9000-4000 cm-1和FD+SNV预处理方法生成的模型具有最好的结果。对于片剂,使用光谱区域11100-7128 cm-1和mMN预处理法生成的模型获得最好的结果,考虑PLS因子10的数量,R2=0.985和RMSECV=0.170 mg。使用这些校准模型,根据ICH指南对该方法进行了充分验证。对于混合粉末和片剂,在10mg/片的浓度水平下获得了最佳的准确度,相对偏差分别在0.05%和1.98%之间——0.360%和0.618%。结论。近红外化学计量法具有良好的重现性、令人满意的准确性和线性特征,表明该方法可用于片剂和片剂混合粉末中氯雷他定的直接测定,无需任何样品制备。
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引用次数: 0
Collaboration between pharmacist and family doctor in the Netherlands 荷兰药剂师与家庭医生的合作
Pub Date : 2020-03-31 DOI: 10.37897/RJPHP.2020.1.3
M. Olăroiu, secretar Soaze
Collaboration between health professionals contributes to improving and maintaining a high level of quality of health services. In the first line, the family doctor and the pharmacist have in common the autonomy of organizing their own activity and the fact that they have developed models of collaboration and integration of activities to work together for the benefit of patients. Collaboration between family doctors and pharmacists can be done in working groups, projects, in an organized, struc-tured or informal setting whenever needed. Topics covered include prescribing and issuing medical recipes, avoiding and limiting incidents, side effects and polypharmacy or training the patients, limiting costs and evaluating new drugs. In the Netherlands there is a long tradition and different ways of collaboration between the family doctor and the pharmacist in order to meet the growing and especially changing medical needs of patients.
卫生专业人员之间的合作有助于提高和保持高质量的卫生服务。首先,家庭医生和药剂师共同拥有组织自己活动的自主权,并且他们开发了合作和整合活动的模式,共同为患者造福。家庭医生和药剂师之间的合作可以在工作组、项目中进行,只要需要,可以在有组织、有结构或非正式的环境中进行。涵盖的主题包括开处方和开具处方、避免和限制事故、副作用和多药治疗或培训患者、限制成本和评估新药。在荷兰,家庭医生和药剂师之间有着悠久的传统和不同的合作方式,以满足患者日益增长、尤其是不断变化的医疗需求。
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引用次数: 0
Fruits – essential foods 水果——必备食品
Pub Date : 2020-03-31 DOI: 10.37897/RJPHP.2020.1.2
T. Rosca, Societatea Română de Neurooftalmologie, M. Suliman, Societatea Română de Istoria Medicinei, Societatea Română de Istoria Farmaciei
{"title":"Fruits – essential foods","authors":"T. Rosca, Societatea Română de Neurooftalmologie, M. Suliman, Societatea Română de Istoria Medicinei, Societatea Română de Istoria Farmaciei","doi":"10.37897/RJPHP.2020.1.2","DOIUrl":"https://doi.org/10.37897/RJPHP.2020.1.2","url":null,"abstract":"","PeriodicalId":33513,"journal":{"name":"Practica Farmaceutica","volume":" ","pages":""},"PeriodicalIF":0.0,"publicationDate":"2020-03-31","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"44676855","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}
引用次数: 0
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Practica Farmaceutica
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