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Sterile Basics of Compounding: Intravenous Admixture Compounding, Part 3: Preparation Procedures. 配制的无菌基础:静脉混合物配制,第3部分:制备程序。
Q4 Medicine Pub Date : 2023-07-01
Loyd V Allen

Intravenous admixture compounding is common practice in most hospitals throughout the world, regardless of the country. Compounding intravenous medications medications involves risk as there is a high potential for error due to their complexity in compounding, and working in an aseptic environment itself poses issues for the compounder. Part 1 of this series presented an introduction and an overview of the series; part 2 presented parenteral vehicle considerations and examples; and part 3 discusses preparation procedures as well as discussions on standardization (both formulas and procedures), competency, compliance issues, issues with using commercial product additives, and look-alike drugs.

静脉混合制剂在世界各地的大多数医院都是常见的做法,无论在哪个国家。配制静脉注射药物涉及风险,因为配制过程复杂,很有可能出错,而在无菌环境中工作本身也会给配制人员带来问题。本系列的第1部分介绍了该系列的简介和概述;第2部分介绍了胃肠外载体的考虑因素和实例;第3部分讨论了制备程序以及关于标准化(包括配方和程序)、能力、合规性问题、使用商业产品添加剂的问题以及类似药物的讨论。
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引用次数: 0
PreScription: Our Lives Are Shaped by the Decisions We Make! 预言:我们的生活是由我们所做的决定决定的!
Q4 Medicine Pub Date : 2023-07-01
Loyd V Allen
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引用次数: 0
Topical Vehicles: A Dermatologist's Perspective. 主题载体:皮肤科医生的观点。
Q4 Medicine Pub Date : 2023-07-01
Stephanie Adame, Michael E Collins, Abraham M Korman

Topical treatment is mainstay for a variety of dermatologic conditions. There are several different types of topical vehicles, and choosing the most appropriate one is an essential part of treatment. Selection can vary depending on factors such as patient preference and anatomical location. Each topical vehicle has unique advantages and disadvantages that are important to consider. This article reviews some of the most common topical vehicles used in dermatology.

局部治疗是治疗各种皮肤病的主要方法。有几种不同类型的局部载体,选择最合适的载体是治疗的重要组成部分。选择可能因患者偏好和解剖位置等因素而异。每种主题车辆都有独特的优点和缺点,这些优点和缺点都是需要考虑的重要因素。本文综述了皮肤病学中一些最常见的外用载体。
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引用次数: 0
Formulation and In Vitro Evaluation of a Ramipril Entrapped in a Microsponge-based Drug-delivery System. 雷米普利在基于微球的药物递送系统中的制剂和体外评价。
Q4 Medicine Pub Date : 2023-07-01
Hassanien Sagban Taghi, Mustafa R Abdulbaqi, Laith Hamza Samein, Maha H Philip Rahmani

Microsponges are porous cross-linked polymers, which have the ability to load a wide range of pharmaceutical active ingredients. They are used topically for long-term treatment applications in addition to the oral route of administration. They are characterized by the efficient distribution of active ingredients, which are loaded at a low quantity to release the drug over longer periods of time by altering the release characteristics. The objective of this study was to develop a novel drug-delivery system that included ramipril microsponges. Ramipril is an antihypertensive drug used in the treatment of elevated blood pressure. It has about 28% oral bioavailability and is eliminated through the kidneys. When administered in an instant dosage form, this medicine produces several side effects, including postural hypotension, hyperkalemia, and angioedema. Included in this study were six distinct formulas of microsponges containing ramipril and Eudragit L 100 at varied ratios that were prepared by using the Quasi-emulsion solvent diffusion technique to avoid side effects. The particle size and physical characteristics of these formulations were investigated. The effects of the polymer/drug ratio on the physical features of a microsponge's physical and compatibility study was performed by using the Fourier transform infrared spectroscopy, differential scanning calorimetry, loading efficiency, surface morphology, and particle sizes. In addition, an in vitro drug-release profile was conducted. The physical characterization showed that the loading efficiency and production yield were both improved for microsponge formulation F1. In vitro dissolution studies were performed on all formulations, and the findings were analyzed kinetically, revealing that the ramipril release rate was altered in all formulations. This study offers a new medication delivery method based on microsponge technology.

微球是一种多孔交联聚合物,能够装载多种药物活性成分。除了口服给药途径外,它们还用于长期治疗应用。它们的特征是活性成分的有效分布,活性成分以较低的量加载,通过改变释放特性在较长的时间内释放药物。本研究的目的是开发一种新型的药物递送系统,包括雷米普利微泵。雷米普利是一种用于治疗高血压的抗高血压药物。它具有约28%的口服生物利用度,并通过肾脏被消除。当以即时剂量给药时,这种药物会产生几种副作用,包括体位性低血压、高钾血症和血管性水肿。本研究包括六种不同配方的微乳液,它们含有不同比例的雷米普利和Eudragit L 100,通过使用准乳液溶剂扩散技术制备,以避免副作用。研究了这些配方的粒度和物理特性。通过使用傅立叶变换红外光谱、差示扫描量热法、负载效率、表面形态和粒径,研究了聚合物/药物比例对微乳液物理特征和相容性的影响。此外,还进行了体外药物释放谱。物理表征表明,微乳液配方F1的负载效率和生产产率都得到了提高。对所有制剂进行了体外溶出度研究,并对结果进行了动力学分析,结果表明雷米普利的释放速率在所有制剂中都发生了变化。本研究提供了一种基于微泵技术的新型药物递送方法。
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引用次数: 0
Case Report in Equine: Highlighting the Benefits of Medisca CopaSil in Burn Scar Management. 马病例报告:强调Medisca CopaSil在烧伤疤痕管理中的益处。
Q4 Medicine Pub Date : 2023-07-01
Jason Heuerman, Halema Haiub, Erica Cull, Rodrigo Lupatini, Brandon Shrum, Raman Sidhu

In this case report, we highlight the benefits of Medisca CopaSil application for scar healing in a horse having sustained second-degree burn injuries covering most of its back. The application of CopaSil started three months after sustaining the burn injury when silver sulfadiazine topical cream treatment showed no significant improvement. CopaSil is formulated with ingredients that may help in reducing inflammation and accelerate healing by modulating the immune response. After using CopaSil for six months, the horse's back was healed, and the hair began to regrow. The complete healing was achieved within six months, and full recovery was reported and confirmed by the horse's owner and pharmacist. This case report highlights the outcomes and benefits of CopaSil in improving the appearance of scars.

在本病例报告中,我们强调了Medisca CopaSil应用程序对一匹背部大部分遭受二度烧伤的马的疤痕愈合的好处。CopaSil的应用在烧伤后三个月开始,当时磺胺嘧啶银外用乳膏治疗没有明显改善。CopaSil的配方成分可能有助于通过调节免疫反应来减少炎症并加速愈合。使用CopaSil六个月后,马的背部痊愈,毛发开始再生。在六个月内完全康复,马的主人和药剂师报告并确认了完全康复。本病例报告强调了CopaSil在改善疤痕外观方面的效果和益处。
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引用次数: 0
Compounding for the Treatment of COVID-19 and Long COVID, Part 4: The Legacy of Chronic COVID. 新冠肺炎和长期新冠肺炎的复合治疗,第4部分:慢性新冠肺炎遗产。
Q4 Medicine Pub Date : 2023-07-01
Mike Riepl, Joe Kaiser

People infected by severe acute respiratory coronavirus 2 (SARS-CoV-2) risk the development of not only acute coronavirus- disease-2019 (COVID-19) - the signs and symptoms of which range from none to severe illness that requires intensive treatment - but also long COVID (i.e., chronic COVID), a cyclical, progressive, multiphasic illness characterized by myriad debilitating conditions that persist long term. In some patients, those sequelae result in psychiatric disorders that can lead to suicide or other forms of self-harm, incidences of which have increased exponentially since before the COVID pandemic. It has been suggested that long COVID develops in an estimated 10% to 35% of people diagnosed as having COVID-19. Because the success of therapy for either form of COVID can be complicated by each patient's pharmacogenomic profile, personal treatment preferences, medical needs, and/or dosing requirements, we have found that in some people so afflicted, manufactured medications are ineffective or intolerable, and that for those individuals, a customized compound often provides relief and promotes recovery. The primary focus of this article is long COVID. The pathogenesis of that disease is reviewed, therapies for the signs and symptoms it engenders are examined, and 2 compounded formulations effective in treating both acute and chronic COVID-19 are presented.

感染严重急性呼吸道冠状病毒2型(SARS-CoV-2)的人不仅有发展急性冠状病毒疾病2019(新冠肺炎)的风险,其体征和症状从无症状到需要强化治疗的严重疾病,还有发展长期COVID(即慢性COVID)的风险,多相性疾病,其特征是长期存在大量使人衰弱的疾病。在一些患者中,这些后遗症会导致精神障碍,从而导致自杀或其他形式的自残,自新冠肺炎疫情之前以来,这种情况的发生率呈指数级增长。据估计,在被诊断为患有新冠肺炎的人中,有10%至35%的人会患上长期新冠肺炎。由于每名患者的药物基因组特征、个人治疗偏好、医疗需求和/或给药要求可能会使治疗任何一种形式的新冠肺炎的成功变得复杂,我们发现,在一些受影响的人中,制造的药物是无效或无法忍受的,而对于这些人来说,定制的复合物通常提供缓解和促进恢复。本文的主要关注点是长期新冠肺炎。综述了该疾病的发病机制,检查了其引起的体征和症状的治疗方法,并提出了2种有效治疗急性和慢性新冠肺炎的复合制剂。
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引用次数: 0
Stability of Omeprazole Extemporaneous Oral Solution in Chopin Base. 奥美拉唑临时口服液在肖邦碱中的稳定性。
Q4 Medicine Pub Date : 2023-05-01
Antonio Spennacchio, Angela Assunta Lopedota, Flavia Maria la Forgia, Sergio Fontana, Nunzio Denora, Antonio Lopalco

Omeprazole is the progenitor of proton pump inhibitors. It is used for the treatment of ulcer and gastroesophageal reflux in dosages ranging from 10 mg/day to 40 mg/day, calibrated according to the patient's age and body weight. In this study, the authors provide a report on the preparation of an extemporaneous liquid formulation of omeprazole using fast oral solution Chopin a hydroxypropyl-?-cyclodextrin liquid base (pH 8 to 9) that is able to solubilize the drug. A solubility study of the drug in the liquid vehicle and a physical-chemical stability study of the 1-mg/mL formulation at 4°C and 25°C were performed. Analyses were carried out by using a high-pressure liquid chromatographic analytical method. Results showed that the intrinsic solubility of the drug in Chopin base was 5.33 mg/mL ± 0.23 mg/mL at 25°C and that omeprazole was chemically stable when the formulation was stored at 4°C over a period of 3 months, while its shelf life at 25°C was only 9 days. This study has demonstrated that the resulting liquid formulation is suitable for all patients, in particular children or adults who are unable to take other pharmaceutical dosage forms, which overcomes the limitations of the medicines currently available on the market.

奥美拉唑是质子泵抑制剂的前身。它用于治疗溃疡和胃食管反流,剂量范围为10mg /天至40mg /天,根据患者的年龄和体重进行校准。在这项研究中,作者报告了用快速口服溶液肖邦a羟丙基-?-环糊精液体碱(pH值8 ~ 9),能溶解药物。进行了药物在液体载体中的溶解度研究和1 mg/mL制剂在4°C和25°C下的物理化学稳定性研究。采用高压液相色谱分析方法进行分析。结果表明,药物在肖邦碱25℃下的固有溶解度为5.33 mg/mL±0.23 mg/mL,奥美拉唑在4℃下保存3个月化学稳定,而在25℃下的保质期仅为9天。这项研究表明,所得到的液体配方适用于所有患者,特别是无法服用其他药物剂型的儿童或成人,这克服了目前市场上可用药物的局限性。
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引用次数: 0
Compounding for the Treatment of COVID-19 and Long COVID, Part 3: The Role of Toll-like Receptors in SARS-CoV-2 Infection and COVID Development. 复方治疗COVID-19和长型COVID,第3部分:toll样受体在SARS-CoV-2感染和COVID发展中的作用
Q4 Medicine Pub Date : 2023-05-01
Mike Riepl, Joe Kaiser

Toll-like receptors, which are type I transmembrane proteins and pattern recognition receptors found on cell surfaces and in intracellular membranes, serve as central mediators of both initial innate-immune responses and secondary adaptive/acquired-immune responses. Toll-like receptor 4, the activation of which leads to the synthesis of proinflammatory cytokines and chemokines, has been shown to have a vital role in the innate immune response to severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection. In our practice of pharmaceutical compounding, we noted that some individuals with coronavirus disease- 2019 (COVID-19) or long COVID achieved limited or no benefit from commercially manufactured treatments designed to alleviate symptoms and enable recovery. We suggest that in such cases, a compounded formulation, which can be easily customized to provide that support, may be of benefit. This article provides a brief review of the ways in which toll-like receptors in general, and toll-like receptor 4 in particular, affect the development and progression of SARS-CoV-2 infection and COVID-19, especially with respect to the human respiratory and central nervous systems and people rendered vulnerable by a comorbid condition (diabetes, obesity) or age. Instructions for compounding 2 customized preparations useful in the treatment of COVID-19 and long COVID are also provided.

toll样受体是在细胞表面和细胞膜上发现的I型跨膜蛋白和模式识别受体,是初始先天免疫反应和继发性适应性/获得性免疫反应的中心介质。toll样受体4的激活导致促炎细胞因子和趋化因子的合成,已被证明在对严重急性呼吸综合征冠状病毒2 (SARS-CoV-2)感染的先天免疫反应中发挥重要作用。在我们的药物配制实践中,我们注意到一些冠状病毒疾病- 2019 (COVID-19)或长期COVID患者从旨在缓解症状和恢复的商业生产治疗中获得的益处有限或没有。我们建议,在这种情况下,复合配方,可以很容易地定制,以提供这种支持,可能是有益的。本文简要回顾了toll样受体,特别是toll样受体4,影响SARS-CoV-2感染和COVID-19的发生和发展的方式,特别是与人类呼吸和中枢神经系统以及因合并症(糖尿病、肥胖)或年龄而变得脆弱的人有关。还提供了用于配制用于治疗COVID-19和长COVID的2种定制制剂的说明。
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引用次数: 0
An Alternative Approach to Tablet Splitting and Grinding for Medication Administration. 一种用于给药的片剂拆分研磨的替代方法。
Q4 Medicine Pub Date : 2023-05-01
Rajneesh Taneja, Joseph Scarim, Poonam G Pande, Anthony Scarim, Milap C Nahata, Rita K Jew, Koteswara Rao Inabathina

Tablet formulations fail to meet the needs of patients unable to swallow tablets such as pediatric, elderly, and patients that must receive medications via feeding tubes. Our objective was to develop and test a new, simple device (XTEMP-R) and the methodology for converting tablets into a homogeneous suspension for medication administration. We developed a new device comprised of a flexible receptacle, a tight-fitting cap, and a suction cup bottom to convert tablets into liquid preparations. Tuberculosis treatment drugs, TBAJ-876 and TBI-223, were dispersed within the device utilizing water and commonly available suspending vehicles. We investigated the effectiveness of the XTEMP-R device in dispersing tablets. This was accomplished by visual observations, determining the fineness of dispersion, and measuring the total drug recovery from the dispersions in XTEMP-R. We investigated the accuracy and reproducibility of delivering aliquots from these suspensions by determining the dose reproducibility upon suspension and upon redispersion after 24 hours. The effectiveness of the device was also evaluated using commercially available tablets of acetaminophen, amlodipine, glimepiride, metformin, and valsartan. The suspensions were visually uniform without any large particles. The suspensions passed through a #18 sieve confirming that the particles were less than 1000 µm. The average total dose recovery of three suspensions each was determined to be 101.3% and 99.2% for TBI-223 and TBAJ-876, respectively. Reproducibility from aliquots of 2 mL each was 98.9% to 99.7% for three replicates of TBI-223 suspensions, and 102.6% to 103.2% for TBAJ-876 suspensions. Aliquots tested after 24 hours confirmed uniform redispersibility. We have demonstrated that XTEMP-R can be utilized to prepare homogeneous suspensions conveniently and efficiently in less than 10 minutes without any drug loss. Aliquots for partial dose delivery can be withdrawn accurately. These findings demonstrate that XTEMP-R can be used to accurately deliver doses of suspensions for patients who cannot swallow tablets.

片剂配方不能满足不能吞咽片剂的患者的需求,如儿童、老年人和必须通过喂食管接受药物治疗的患者。我们的目标是开发和测试一种新的、简单的设备(XTEMP-R)和方法,将片剂转化为均匀的悬浮液用于给药。我们开发了一种新的装置,由一个灵活的容器、一个紧密的盖子和一个吸盘底部组成,可以将药片转化为液体制剂。结核治疗药物TBAJ-876和TBI-223利用水和常用的悬浮车辆分散在装置内。我们考察了XTEMP-R装置在分散片中的有效性。这是通过目视观察,确定分散体的细度,并测量XTEMP-R中分散体的总药物回收率来完成的。通过测定悬浮液和24小时后再分散时的剂量再现性,我们研究了从这些悬浮液中递送等量的准确性和再现性。还使用市售的对乙酰氨基酚、氨氯地平、格列美脲、二甲双胍和缬沙坦片评估了该装置的有效性。悬浮液在视觉上均匀,没有任何大颗粒。悬浮液通过18号筛,确认颗粒小于1000µm。TBI-223和TBAJ-876三种混悬液的平均总剂量回收率分别为101.3%和99.2%。TBI-223混悬液的重复性为98.9% ~ 99.7%,TBAJ-876混悬液的重复性为102.6% ~ 103.2%。24小时后测试的等价物确认了均匀的再分散性。我们已经证明,XTEMP-R可以在不到10分钟的时间内方便有效地制备均匀的混悬液,而不会有任何药物损失。可准确地提取部分剂量分配的等价物。这些发现表明,XTEMP-R可以用于准确地为不能吞咽片剂的患者提供混悬剂剂量。
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引用次数: 0
Extemporaneous Topical Minoxidil Solutions for the Treatment of Alopecia: Stability Studies and Incorporation Tests of Active Ingredients in ALOPLUS FAST Base. 临时外用米诺地尔溶液治疗脱发:稳定性研究和ALOPLUS FAST碱中有效成分的掺入试验。
Q4 Medicine Pub Date : 2023-05-01
Antonio Spennacchio, Angela Assunta Lopedota, Antonio Lopalco, Maria Teresa Dibenedetto, Flavia Maria la Forgia, Sergio Fontana, Massimo Franco, Nunzio Denora

Minoxidil is a vasodilator drug generally employed for the treatment of various forms of alopecia. In this article, the authors propose an alternative to the formulation reported in the British Pharmacopoeia for the realization of topical minoxidil -based solutions using ALOPLUS FAST. This liquid vehicle is an ethanol- and propylene glycol-free base which allows the complete solubilization of minoxidil, thanks to the presence of hydroxypropyl-ß-cyclodextrin. Solubility and chemical stability studies of the active ingredient in the formulation at a concentration of 5% w/w and physical stability studies of this extemporaneous preparation are reported. Incorporation tests of various active pharmaceutical ingredients that can be combined with minoxidil for alopecia synergic treatment have been carried out. Analyses were performed by using a high-pressure liquid chromatography analytical method. The results showed that the intrinsic solubility of the drug in the liquid base was 62.37 mg/mL ± 0.85 mg/mL (5.24 w/w ± 0.07% w/w) at 25°C; minoxidil was chemically stable in ALOPLUS FAST; and the formulation was physically stable for more than six months, under different storage conditions. Incorporation tests of several active pharmaceutical ingredients in 2% to 4% w/w minoxidil formulations were successful as well.

米诺地尔是一种血管扩张药物,通常用于治疗各种形式的脱发。在本文中,作者提出了一种替代英国药典中报道的配方,用于使用ALOPLUS FAST实现局部米诺地尔溶液。这种液体载体是一种不含乙醇和丙二醇的碱,由于羟丙基-ß-环糊精的存在,它可以完全溶解米诺地尔。报道了配方中活性成分在5% w/w浓度下的溶解度和化学稳定性研究以及该临时制剂的物理稳定性研究。对可与米诺地尔联合治疗脱发的各种活性药物成分进行了掺入试验。采用高压液相色谱法进行分析。结果表明:25℃时该药物在液基中的固有溶解度为62.37 mg/mL±0.85 mg/mL (5.24 w/w±0.07% w/w);米诺地尔在ALOPLUS FAST中化学稳定;在不同的贮存条件下,该制剂均能保持6个月以上的物理稳定性。几种有效药物成分在2%至4% w/w米诺地尔制剂中的掺入试验也取得了成功。
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引用次数: 0
期刊
International journal of pharmaceutical compounding
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