transdermal patch

透皮贴剂
  • 文章类型: English Abstract
    分配是药剂师执行的任务中最需要和最重要的服务,在他的日常工作中,在社区药房。配药的目的是保证患者以充分和受控的方式获得药物。在这个过程中,社区药剂师有义务,作为一名医疗保健专业人士,以承诺的方式积极参与检测可能的药物或药物相关错误。SEFAC的患者安全小组已经发展,作为一系列未来项目的开始,作为透皮贴剂配制的药物的清单和最佳指南,改良释放形式或口腔分散片。这一举措的目的是尽可能减少,通过事先与病人面谈和使用这些工具,这些药物可能出现的任何错误或问题,从而确保患者安全。预计将在2023年与SEFAC患者安全小组合作的社区药房开始一个试点项目。因此,他们将能够收集和报告获得的结果。
    Dispensing is the most requested and important service within the tasks performed by the pharmacist, in his day-to-day work, in the community pharmacy. The aim of dispensing is to guarantee the patient\'s access to the medicine in an adequate and controlled manner. During that process, the community pharmacist has the obligation, as a healthcare professional, to actively participate in a committed manner in the detection of possible medication or medication-related errors.SEFAC´s patient safety group has developed, as the beginning of a series of future projects, checklists and best guidelines for medicines formulated as transdermal patches, modified release forms or orodispersible tablets. The aim of this initiative is to minimize as far as possible, by means of a prior interview with the patient and the use of these tools, any errors or problems that might arise with these drugs, thereby ensuring patient safety.A pilot project is expected to begin throughout 2023 in community pharmacies that collaborate with SEFAC\'s patient safety group. Therefore, they will be able to collect and report the results obtained.
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  • 文章类型: Journal Article
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  • 文章类型: Journal Article
    近年来,甲状腺疾病的患病率显着增加,尤其是甲状腺功能减退.在这项研究中,我们研究了化学渗透增强(CPE)对左旋甲状腺素钠(L-T4)贴剂透皮渗透的影响和机制。我们发现油酸(OA)和氮酮(NZ)的组合对L-T4产生最佳的透皮渗透效果。随后,我们还研究了相关的性质机制。结果表明,与单独应用相比,OA和NZ的联合应用显着增强了L-T4的透皮渗透,它归因于两个机制:首先,OA通过增加压敏粘合剂(PSA)基质的流动性来改善药物释放;其次,OA和NZ都作用于角质层,特别是促进L-T4通过毛囊途径的渗透。这些最终贴剂没有观察到皮肤刺激或细胞毒性,对甲状腺功能减退症有显著的治疗效果。这项研究有助于L-T4透皮制剂的开发。
    In recent years, there has been a significant increase in the prevalence of thyroid diseases, particularly hypothyroidism. In this study, we investigated the impact and mechanisms of Chemical permeation enhancement(CPE) on transdermal permeation of levothyroxine sodium (L-T4) patches.We found that the combination of oleic acid (OA) and Azone (NZ) yielded the best transdermal permeation effect for L-T4.Subsequently, we also investigated the relevant propermeability mechanism.The results demonstrate that the combined application of OA and NZ significantly enhances the transdermal permeation of L-T4 compared to individual applications,it is attributed to two mechanisms: firstly, OA improves drug release by increasing the flowability of the pressure-sensitive adhesive (PSA) matrix; secondly, both OA and NZ act on the stratum corneum, especially facilitating L-T4 permeation through the hair follicle pathway. No skin irritation or cytotoxicity is observed with these final patches, which exhibit a remarkable therapeutic effect on hypothyroidism. this study contributes to the development of transdermal formulations of L-T4.
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  • 文章类型: Journal Article
    背景:股骨近端骨折在老年人中很常见,在实现有效的术后镇痛方面存在挑战。年龄相关的合并症限制了该人群中镇痛药的选择。这项研究旨在比较经皮丁丙诺啡(TDB)贴片与传统镇痛药在股骨近端囊外骨折固定后的安全性和有效性。
    方法:进行了为期2年的前瞻性随机对照研究,包括60例接受了股骨转子间囊外骨折固定术的患者。采用随机信封法将患者随机分为两组。A组接受对乙酰氨基酚和曲马多的静脉注射制剂,最初48小时,然后是口服制剂。B组在手术后立即接受经皮丁丙诺啡(TDB)贴剂,以5mcg/小时的速度输送,术后持续2周。在14天的监测期内,使用视觉模拟量表(VAS)评估患者休息时和运动时的疼痛评分.主要目标是维持4或更低的VAS评分。如果VAS评分达到6,则给予抢救镇痛药。次要目标包括评估所需的抢救镇痛药的数量并监测任何不良反应或并发症。
    结果:B组在所有时间点休息和运动过程中的疼痛评分均显着降低(p值0.0006-≤0.0001),该组的抢救镇痛需求也显著降低。TDB贴剂的施用没有导致任何显著的副作用。
    结论:TDB贴剂是安全的,在治疗股骨近端囊外骨折时,在术后期间比其他镇痛药提供更好的依从性和镇痛效果。
    BACKGROUND: Proximal femur fractures are common among older individuals and pose challenges in achieving effective post-operative analgesia. Age-related co-morbidities limit the selection of analgesics in this population. This study aimed to compare the safety and effectiveness of transdermal buprenorphine (TDB) patch with traditional analgesics after fixation of an extracapsular fracture of the proximal femur.
    METHODS: A prospective randomized controlled study was conducted over a 2-year period, involving 60 patients who underwent surgery for extra capsular intertrochanteric fracture fixation. The patients were randomly assigned to two groups by random envelope method. Group A received an intravenous formulation of paracetamol and tramadol for the initial 48 h, followed by an oral formulation. Group B received a transdermal buprenorphine (TDB) patch delivering 5 mcg/hour immediately after surgery, which continued for 2 weeks postoperatively. During the 14-day monitoring period, patients\' pain scores were assessed using the Visual Analog Scale (VAS) at rest and during movement. The primary objective was to maintain a VAS score of 4 or lower. Rescue analgesics were administered if the VAS score reached 6. The secondary objectives included evaluating the quantity of rescue analgesics required and monitoring for any adverse effects or complications.
    RESULTS: Pain scores at rest and during movement were significantly lower in Group B at all-time points (p-value 0.0006 - ≤ 0.0001), and the requirement for rescue analgesia was also significantly lower in this group. The administration of the TDB patch did not result in any significant adverse effects.
    CONCLUSIONS: TDB patch is secure and offers better compliance and analgesia than other analgesics in the postoperative period whilst treating proximal femur extra capsular fracture.
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  • 文章类型: Journal Article
    外泌体,作为新兴的“下一代”生物治疗剂和药物递送载体,在不同的生物医学领域拥有巨大的潜力,从药物递送和再生医学到疾病诊断和肿瘤免疫疗法。然而,传统弹丸注射的快速清除和外泌体稳定性差限制了其临床应用。微针作为延长外泌体在给药部位的停留时间的解决方案,从而保持药物浓度并促进持续的治疗效果。此外,微针还具有维持生物活性物质稳定性的能力。因此,我们介绍了一种用于加载和递送外来体的微针贴片,并分享了方法,包括外泌体的分离,fabrication,和外泌体加载微针贴片的表征。微针贴片使用海藻糖和透明质酸作为尖端材料并使用聚乙烯吡咯烷酮作为背衬材料通过两步浇铸方法制造。微针表现出强大的机械强度,具有能够承受2N的尖端。猪皮用于模拟人类皮肤,皮肤穿刺后60s内微针尖端完全融化。从微针释放的外泌体表现出形态,颗粒大小,标记蛋白,和与新鲜外泌体相当的生物功能,使树突状细胞摄取并促进其成熟。
    Exosomes, as emerging \"next-generation\" biotherapeutics and drug delivery vectors, hold immense potential in diverse biomedical fields, ranging from drug delivery and regenerative medicine to disease diagnosis and tumor immunotherapy. However, the rapid clearance by traditional bolus injection and poor stability of exosomes restrict their clinical application. Microneedles serve as a solution that prolongs the residence time of exosomes at the administration site, thereby maintaining the drug concentration and facilitating sustained therapeutic effects. In addition, microneedles also possess the ability to maintain the stability of bioactive substances. Therefore, we introduce a microneedle patch for loading and delivering exosomes and share the methods, including isolation of exosomes, fabrication, and characterization of exosome-loaded microneedle patches. The microneedle patches were fabricated using trehalose and hyaluronic acid as the tip materials and polyvinylpyrrolidone as the backing material through a two-step casting method. The microneedles demonstrated robust mechanical strength, with tips able to withstand 2 N. Pig skin was used to simulate human skin, and the tips of microneedles completely melted within 60 s after skin puncture. The exosomes released from the microneedles exhibited morphology, particle size, marker proteins, and biological functions comparable to those of fresh exosomes, enabling dendritic cells uptake and promoting their maturation.
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  • 文章类型: Journal Article
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  • 文章类型: English Abstract
    肥胖/超重人数的急剧增加是全球公共卫生挑战,迫切需要新颖有效的治疗方法。在这项研究中,我们设计了一种快速溶解聚合物微针阵列贴片(SGN-PVP/PVA-MN),以西格列汀作为治疗肥胖的模型药物,重点介绍贴剂的制备过程。然后我们表征了SGN-PVP/PVA-MN的形态和尺寸。此外,我们深入研究了机械性能,溶解度,皮肤穿刺能力,SGN-PVP/PVA-MN的经皮药物扩散和释放动力学。结果表明,SGN-PVP/PVA-MN具有良好的形貌和力学性能,有效地穿透角质层和创建微通道快速经皮药物扩散。体外透皮扩散试验显示,药物在2分钟内释放了64.5%,在10分钟内释放了95.7%。具有快速的溶出和高的药物扩散效率,SGN-PVP/PVA-MN有望成为肥胖个体的有效和安全的治疗选择。
    The dramatic rise in the number of obese/overweight people is a global public health challenge that urgently requires novel and effective therapies. In this study, we designed a fast dissolving polymer microneedle array patch (SGN-PVP/PVA-MN) with sitagliptin as a model drug for treating obesity, focusing on the preparation process of the patch. We then characterized the morphology and dimensions of SGN-PVP/PVA-MN. Furthermore, we delved into the mechanical properties, solubility, skin-puncturing capability, and transdermal drug diffusion and release kinetics of SGN-PVP/PVA-MN. The results demonstrated that SGN-PVP/PVA-MN exhibited favorable morphology and mechanical properties, effectively penetrating the stratum corneum and creating microchannels for rapid transdermal drug diffusion. The in vitro transdermal diffusion assays revealed the release of 64.5% of the drug within 2 min and 95.7% within 10 min. With rapid dissolution and high drug diffusion efficiency, SGN-PVP/PVA-MN is poised to serve as an effective and safe treatment option for the individuals with obesity.
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  • 文章类型: Journal Article
    背景:胃感觉运动障碍(功能性消化不良[FD]和胃轻瘫[GP])是普遍存在和繁重的。使用无线贴片进行长时间的动态记录可以为这些患者提供新颖的信息。
    方法:连续接受胃排空闪烁显像(GES)检查的成年患者(年龄≥18岁)符合纳入研究的条件。如果患者先前曾进行前肠手术;正在服用阿片类药物或其他已知会影响胃排空的药物;HgbA1C>10;或最近住院,则将其排除在外。在GES之前将三个无线运动贴片应用于皮肤。患者在记录进餐时戴了6天的贴片,症状,使用iPhone应用程序排便。
    结果:纳入23名连续成年人(87%为女性;平均年龄=43.9岁;平均BMI=26.7kg/m2)。胃直方图显示胃肌电活动的三个水平:弱,中度,和强大。4小时胃排空延迟的患者胃肌电活动较弱。恶心和呕吐的患者有强烈的肠道活动。FD患者的胃和肠肌电活动较弱,胃里有微弱的进餐反应,肠,和结肠与单独恶心或单独呕吐的人相比。
    结论:FD患者,那些胃排空延迟的人,有独特的胃肠肌电活动模式。餐后肠肌电活动减少可能解释某些患者的FD症状。在门诊环境中长时间记录胃肠道活动有可能识别独特的病理生理模式和膳食相关活动,从而区分具有不同胃感觉运动疾病状态的患者。
    BACKGROUND: Gastric sensorimotor disorders (functional dyspepsia [FD] and gastroparesis [GP]) are prevalent and burdensome. Prolonged ambulatory recording using a wireless patch may provide novel information in these patients.
    METHODS: Consecutive adult patients (age ≥ 18 years) referred for gastric emptying scintigraphy (GES) were eligible for study inclusion. Patients were excluded if they had prior foregut surgery; were taking opioids or other medications known to affect gastric emptying; had a HgbA1C > 10; or were recently hospitalized. Three wireless motility patches were applied to the skin prior to GES. Patients wore the patches for 6 days while recording meals, symptoms, and bowel movements using an iPhone app.
    RESULTS: Twenty-three consecutive adults (87% women; mean age = 43.9 years; mean BMI = 26.7 kg/m2) were enrolled. A gastric histogram revealed three levels of gastric myoelectric activity: weak, moderate, and strong. Patients with delayed gastric emptying at 4 h had weak gastric myoelectrical activity. Patients with nausea and vomiting had strong intestinal activity. Those with FD had weak gastric and intestinal myoelectric activity, and a weak meal response in the stomach, intestine, and colon compared to those with nausea alone or vomiting alone.
    CONCLUSIONS: Patients with FD, and those with delayed gastric emptying, had unique gastrointestinal myoelectrical activity patterns. Reduced postprandial pan-intestinal myoelectric activity may explain the symptoms of FD in some patients. Recording gastrointestinal activity over a prolonged period in the outpatient setting has the potential to identify unique pathophysiologic patterns and meal-related activity that distinguishes patients with distinct gastric sensorimotor disease states.
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  • 文章类型: Journal Article
    背景:微针是微小的针头,通常长度从几十到几百微米,用于各种医疗程序和治疗。测试的医疗设备命名为“CELLADEEP贴片”可溶解微针治疗系统(MTS),由透明质酸和胶原蛋白制成。离子电渗技术也应用于该系统。该研究旨在评估“CELLADEEP贴片”在改善皮肤方面的有效性。
    方法:本研究使用离体人源皮肤组织模型,将其分为三个不同的组,即,未治疗组,阴性对照组,和测试组分别。未治疗组没有接受治疗措施,阴性对照组暴露于紫外线B(UVB)照射,测试组暴露于UVB照射并用“CELLADEEP贴片”处理。皮肤水分含量,透皮失水,通过三种临床设备评估皮肤弹性。此外,还分析了组织学染色和相关的mRNA表达水平。
    结果:皮肤水分含量的结果,透皮失水,和皮肤弹性评估一致表明,“CELLADEEP贴片”的应用导致显著的皮肤改善。组织学染色图像的分析也证实了“CELLADEEP贴片”的有效性,特别是增加胶原蛋白密度。此外,胶原1a(COL1A1)和透明质酸合酶3mRNA表达上调,基质金属蛋白酶1(MMP-1)和白细胞介素1β(IL-1β)mRNA表达降低反映了其皱纹的改善,保湿和抗炎功能。
    结论:\"CELLADEPP修补程序\",MTS结合离子电渗技术,展示其保湿功效,改善皮肤弹性,和抗炎功能,当应用于离体的人源皮肤组织模型的实验。该研究有助于理解“CELLADEPP贴片”,并为随后的动物实验和临床试验奠定了基础。
    BACKGROUND: Microneedles are tiny needles, typically ranging from tens to hundreds of micrometers in length, used in various medical procedures and treatments. The tested medical device named \"CELLADEEP Patch\" a dissolvable microneedle therapy system (MTS), made of hyaluronic acid and collagen. And the iontophoresis technique is also applied in the system. The study aimed to evaluate the effectiveness of the \"CELLADEEP Patch\" in skin improvement.
    METHODS: Ex vivo human-derived skin tissue models were used in this study and they were divided into three different groups, namely, the Untreated Group, the Negative Control Group, and the Test Group respectively. The Untreated Group received no treatment measures, the Negative Control Group was exposed to ultraviolet B radiation (UVB) irradiation, and the Test Group was exposed to UVB irradiation and treated with \"CELLADEEP Patch\". Skin moisture content, transdermal water loss, and skin elasticity were evaluated by three clinical devices. Additionally, histological staining and related mRNA expression levels were also analyzed.
    RESULTS: The results of skin moisture content, transdermal water loss, and skin elasticity evaluation consistently illustrated that the application of \"CELLADEEP Patch\" led to remarkable skin improvement. And the analysis of histological staining images also confirmed the effectiveness of the \"CELLADEEP Patch\", especially for increasing collagen density. Moreover, the upregulation of Collagen type 1 a (COL1A1) and hyaluronan synthase 3 mRNA expression and the decrease of Matrix metalloproteinase 1 (MMP-1) and Interleukin-1 beta (IL-1β) mRNA expression reflected its wrinkle improvement, moisturizing and anti-inflammation function.
    CONCLUSIONS: \"CELLADEPP Patch\", the MTS combined with the iontophoresis technique, exhibits its effectiveness in moisturizing, skin elasticity improvement, and anti-inflammatory function when applied to ex vivo human-derived skin tissue models in experiments. The study has contributed to the understanding of the \"CELLADEPP Patch\" and laid the foundation for subsequent animal experiments and clinical trials.
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  • 文章类型: Case Reports
    在文献中尚未很好地描述将患有慢性疼痛的患者从芬太尼贴剂过渡到丁丙诺啡贴剂。即使在病人取出芬太尼贴剂后,皮肤中残留的芬太尼持续数小时被吸收。由于在开始丁丙诺啡时存在沉淀戒断的风险,这种转变对于安全计划而言是更具挑战性的阿片类药物轮换.我们报告了一例患者,该患者使用芬太尼贴片超过10年,并成功地直接旋转到丁丙诺啡贴片。
    Transitioning a patient with chronic pain from a fentanyl patch to a buprenorphine patch has not been well described in the literature. Even after a patient removes their fentanyl patch, the residual fentanyl in the skin continues to be absorbed for hours. Due to the risk of precipitated withdrawal when initiating buprenorphine, this transition is a more challenging opioid rotation to plan safely. We report a case of a patient who had been using a fentanyl patch for over 10 years and was successfully rotated directly to a buprenorphine patch.
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