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Bio-markers of immuno-oncology 免疫肿瘤学的生物标志物
Pub Date : 2024-02-15 DOI: 10.18231/j.jpbs.2023.017
Tulsi Dipakbhai Patel, Gunjan, V. G. Vanteddu
Since its inception until the rapid advancements, the immuno-oncology (I-O) landscape has undergone significant modifications. Thousands of possible I-O medicines and therapy combinations are being tested in clinical trials as part of the current drug development pipeline. Suppose these assets are to be developed effectively and successfully. In that case, it is necessary to invest in and use the proper techniques and technology to speed up the transition from preclinical evaluation to clinical development. These tools, which include suitable preclinical models, pharmacodynamics-related biomarkers, prediction and monitoring capabilities, and developing clinical trial designs, enable quick and effective evaluation during the development process.The possibility of new findings and insights in each of these three areas to further address the clinical care needs of patients with cancer.These tools include. 1. Appropriate preclinical models, 2. Biomarkers of pharmacodynamics, predictive and monitoring utility, and. 3. Evolving clinical trial designs allow rapid and efficient evaluation during the development process.This article provides an overview of how novel discoveries and insights into each of these three areas have the potential further to address the clinical management needs of patients with cancer.
自免疫肿瘤学(I-O)诞生以来,其发展日新月异。在目前的药物开发流程中,成千上万种可能的 I-O 药物和疗法组合正在接受临床试验。假设要有效、成功地开发这些资产。在这种情况下,有必要投资并使用适当的技术和工艺,以加快从临床前评估到临床开发的过渡。这些工具包括合适的临床前模型、药效学相关的生物标记物、预测和监测能力以及开发临床试验设计,能够在开发过程中进行快速有效的评估。这三个领域中的每一个领域都有可能出现新的发现和见解,以进一步满足癌症患者的临床治疗需求。1.这些工具包括:1. 适当的临床前模型;2. 药效学生物标志物、预测和监测效用;3.3.不断发展的临床试验设计允许在开发过程中进行快速有效的评估。本文概述了这三个领域中每个领域的新发现和新见解如何有可能进一步满足癌症患者的临床治疗需求。
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引用次数: 0
Fabrication of biodegradable nano medical patches incorporating a sustained-release pharmacological agent using electro-spinning technique 利用电纺丝技术制造含有缓释药剂的生物可降解纳米医疗贴片
Pub Date : 2024-02-15 DOI: 10.18231/j.jpbs.2023.015
Afroj Ayyaj Shaikh, S. J. Anbhule
Nano-polymer (self-disappearing) medical patches loaded with a long-acting drug (each substance separately) were created by electro-spinning synthetic polymers PVA and PVP at a rate of 10%W for each polymer and adding various medicinal substances, such as diclofenac de ethylamine and gentamicin, in concentrations of 5%w each. The morphological structure of the produced samples was further studied using a scanning electron microscope (SEM) and X-ray diffraction (XRD) before they were turned into a medical adhesive and tested directly on a human hand. This approach has already proven to be effective in delivering the medicine to the affected area without the use of any intermediaries. It is relatively simple to use, safe for medical usage, and inexpensive due to the lack of expensive industrial apparatus required for production.
通过电纺合成聚合物 PVA 和 PVP(每种聚合物 10%W),并添加各种药物(如双氯芬酸脱乙胺和庆大霉素,浓度各为 5%W),制成了负载长效药物(每种药物单独)的纳米聚合物(自显影)医用贴片。使用扫描电子显微镜(SEM)和 X 射线衍射(XRD)进一步研究了制得样品的形态结构,然后将其制成医用粘合剂,并直接在人手上进行测试。事实证明,这种方法可以有效地将药物输送到患处,而无需使用任何中间媒介。这种方法使用相对简单,可安全用于医疗用途,而且成本低廉,因为生产过程中不需要昂贵的工业设备。
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引用次数: 0
Pharmacological activities of essential oils from some flowers, plants and aromatic seeds – A review 一些花卉、植物和芳香种子精油的药理活性 - 综述
Pub Date : 2024-02-15 DOI: 10.18231/j.jpbs.2023.013
M. Murali Krishna Kumar, Vijayalakshmi Nandikatti, K. P. Nagasree
Volatile oils or essential oils are the secondary plant metabolites producing from different plant parts like flowers, leaves, fruits, seeds, stem, roots and their barks. These are chemically classified as terpenoids, which are hydrocarbons with a hydroxyl or carbonyl group. These are having different organic exercises and utilized as cure in Gastrointestinal issues, cold, hack, skin illnesses and so forth. These oils revealed for their pharmacological impacts like enemy of oxidant, hostile to bacterial, mitigating exercises and as Carminative. Ayurveda's founding country is India. There are numerous plants in India that can produce essential oils, which are frequently used in our daily lives. In this review, we want to talk about the biological activities of essential oils that come from flowers (like rose, jasmine, chrysanthemum, marigold), plant leaves (like marjoram, coriander, and mentha), and aromatic seeds (like fennel, caraway, cumin, and coriander), all of which are consumed on a daily basis and contribute to the cleanliness of our environment and health.
挥发油或精油是植物的次级代谢产物,产生于植物的不同部位,如花、叶、果实、种子、茎、根和树皮。它们在化学上被归类为萜类化合物,是带有羟基或羰基的碳氢化合物。它们具有不同的有机作用,可用于治疗胃肠道疾病、感冒、黑客攻击、皮肤病等。这些精油的药理作用包括抗氧化、抗菌、缓解症状和祛斑。阿育吠陀的创始国是印度。印度有许多植物可以生产精油,这些精油在我们的日常生活中经常被使用。在这篇综述中,我们想谈谈来自花朵(如玫瑰、茉莉、菊花、万寿菊)、植物叶子(如马郁兰、芫荽和薄荷)和芳香种子(如茴香、胡荽、小茴香和芫荽)的精油的生物活性,所有这些植物都是我们日常食用的,有助于清洁我们的环境和健康。
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引用次数: 0
Overview: flexible and versatile approach of quality by design & process analytical technology in industries 概述:灵活多变的工业质量设计和过程分析技术方法
Pub Date : 2024-02-15 DOI: 10.18231/j.jpbs.2023.014
Razia Kutty, Machindra Nikam, Sakshi Chaudhari, Chetana Shinde, Priya Gadakh, Pooja Niphade, Amit Kakad
Quality by Design (QbD) is crucial to the creation of contemporary in pharmaceuticals, microbiology, biotechnology, product management etc. In order to build proactive, scientific, and risk-based processes and products, QbD helps and supports both the industry and the FDA. Instead of waiting until the final quality check of the finished product, it is founded on the idea of establishing quality from the very beginning of the process. A successful plan that lowers batch failures and recalls is finally provided by an efficient QbD approach, which offers insights and crucial upstream information throughout the development process. The purpose of this review is to provide an overview of the implementation of Quality by Design (QbD), its tools, elements, and techniques, the relevancy with various guidelines, and the use in present-day pharmaceutical. The IQ Consortium provides information on the current situation of process analytical technology (PAT) as it relates to the creation of active pharmaceutical ingredients (API) in branded pharmaceutical firms. The article gives concrete examples of why and how the pharmaceutical industry uses PAT tools in API development by using an API process pipeline. PAT can reduce personnel risks involved with sampling dangerous compounds for in-process testing and increase R&D efficiency. Although not all chemical processes or stages are easily suited to applying the features of the PAT toolbox, PAT permits accurate and speedy (real or near time) evaluations of processes that might involve compounds that are highly dangerous, transitory, or heterogeneous when necessary. The major regulatory agencies and the biotech sector have worked hard to assist the application of the ideas of Quality by Design (QbD) and Process Analytical Technology (PAT) over the past ten years, with varying degrees of success. Despite the fact that just one biotech therapy has received approval under the QbD paradigm thus far, the tools and methods associated with these two ideas are deeply ingrained in the work procedures of the majority of international pharmaceutical firms. This overview is mainly focused on the QbD and PAT's development in the first place. Second, give an overview of QbD and PAT implementation and point out any places where more contributions are possible.
质量源于设计(QbD)对制药、微生物学、生物技术、产品管理等领域的当代创造至关重要。为了建立积极、科学、基于风险的流程和产品,QbD 为制药业和美国食品及药物管理局提供了帮助和支持。QbD 建立在从流程一开始就确立质量的基础上,而不是等到成品的最终质量检查。高效的 QbD 方法可在整个开发过程中提供洞察力和重要的上游信息,最终提供一个成功的计划,减少批次失败和召回。本综述旨在概述质量源于设计(QbD)的实施、其工具、要素和技术、与各种指导方针的相关性以及在当今制药业中的应用。IQ Consortium 提供了有关工艺分析技术 (PAT) 现状的信息,因为它与品牌制药公司生产活性药物成分 (API) 有关。文章举例说明了制药行业在原料药开发过程中使用原料药工艺管道的原因和方法。PAT 可以降低对危险化合物取样进行过程中测试所涉及的人员风险,并提高研发效率。虽然并非所有化学工艺或阶段都能轻松应用 PAT 工具箱的功能,但 PAT 可以在必要时对可能涉及高危险性、短暂性或异质性化合物的工艺进行准确、快速(实时或近实时)的评估。在过去的十年中,主要监管机构和生物技术部门一直在努力协助质量源于设计(QbD)和工艺分析技术(PAT)理念的应用,并取得了不同程度的成功。尽管迄今为止只有一种生物技术疗法在 QbD 范式下获得批准,但与这两种理念相关的工具和方法已深深扎根于大多数国际制药公司的工作程序中。本综述首先主要介绍 QbD 和 PAT 的发展。其次,概述 QbD 和 PAT 的实施情况,并指出可能做出更多贡献的地方。
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引用次数: 0
Fabric phase sorptive extraction: A sustainable approach in analysis of pharmaceutical product 织物相吸附萃取:一种可持续的药品分析方法
Pub Date : 2024-02-15 DOI: 10.18231/j.jpbs.2023.019
P. Prajapati, Nutan Patel, Divyesh Kankva
As the pharmaceutical industry continues to evolve, there is an increasing demand for sustainable and efficient analytical techniques in the analysis of pharmaceutical products. This manuscript explores the application of Fabric Phase Sorptive Extraction (FPSE) as a novel and sustainable approach for the extraction and analysis of pharmaceutical compounds. FPSE, a recent advancement in sample preparation, offers a greener alternative by utilizing a fabric-like sorbent material. The environmentally friendly nature of FPSE, with reduced solvent consumption and waste generation, aligns with the principles of green analytical chemistry. Case studies involving the analysis of various pharmaceutical products showcase the versatility and applicability of FPSE in different matrices.
随着制药行业的不断发展,人们对可持续、高效的制药产品分析技术的需求日益增长。本手稿探讨了织物相吸附萃取(FPSE)作为一种新型可持续方法在药物化合物萃取和分析中的应用。织物相吸附萃取是样品制备领域的最新进展,它利用类似织物的吸附材料提供了一种更环保的替代方法。FPSE 对环境友好,减少了溶剂消耗和废物产生,符合绿色分析化学的原则。涉及各种药品分析的案例研究展示了 FPSE 在不同基质中的多功能性和适用性。
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引用次数: 0
Mouth dissolving film as a potential dosage form for paediatric usage 口腔溶解膜作为儿科用药的一种潜在剂型
Pub Date : 2024-02-15 DOI: 10.18231/j.jpbs.2023.021
Bhupendra G. Prajapati, Priyanka Patel, Dhirendra C. Patel
Drug delivery systems using thin films are being researched by the pharmaceutical industry. They're a diverse platform that can provide immediate, local, or systemic actions. Furthermore, these systems can be used independently, which is ideal for patients with dysphagia, elderly, pediatric, or bed-ridden patients, as well as those who may have difficulty consuming water. These drug delivery systems can be given by oral, buccal, sublingual, ocular and trans-dermal routes. This study explores mouth thin films in all of their characteristics from the current perspective, providing insight into the world's growing market share as a result of expanding research fields and technological breakthroughs. Simultaneously, It provides a summary of the key factors involved in formulation development that have an impact on thin films, such as thin film design, morphological and physiological limitations, production process selection, characterization techniques, and polymer and drug physicochemical properties. It also gives an overview of the most recent thin-film products made by major pharmaceutical firms.
制药业正在研究使用薄膜的给药系统。它们是一个多样化的平台,可以提供即时、局部或全身作用。此外,这些系统可以独立使用,非常适合吞咽困难患者、老人、儿童或卧床患者,以及饮水困难的患者。这些给药系统可通过口腔、颊部、舌下、眼部和经皮途径给药。本研究从当前的角度探讨了口腔薄膜的所有特性,深入分析了随着研究领域的不断扩大和技术的不断突破,口腔薄膜的市场份额也在不断增长。同时,本研究还总结了影响薄膜配方开发的关键因素,如薄膜设计、形态和生理限制、生产工艺选择、表征技术以及聚合物和药物的物理化学特性。本书还概述了主要制药公司最新生产的薄膜产品。
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引用次数: 0
Tides of healing: Unlocking the therapeutic potential of marine drugs 治愈之潮:挖掘海洋药物的治疗潜力
Pub Date : 2024-02-15 DOI: 10.18231/j.jpbs.2023.012
F. Tamboli
{"title":"Tides of healing: Unlocking the therapeutic potential of marine drugs","authors":"F. Tamboli","doi":"10.18231/j.jpbs.2023.012","DOIUrl":"https://doi.org/10.18231/j.jpbs.2023.012","url":null,"abstract":"","PeriodicalId":517289,"journal":{"name":"Journal of Pharmaceutical and Biological Sciences","volume":"428 13","pages":""},"PeriodicalIF":0.0,"publicationDate":"2024-02-15","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"139893878","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
Aptamers based targeted drug delivery system: A newer trend in cancer treatment therapy 基于贴体的靶向给药系统:癌症治疗的新趋势
Pub Date : 2024-02-15 DOI: 10.18231/j.jpbs.2023.016
Paramita Dey, Anushmita Ghosh, Subhrajit Sarker
The investigation of targeted drug delivery systems as a way to improve therapeutic efficacy while minimizing adverse effects is a result of the development of novel cancer treatment strategies. This subject explores the exciting field of aptamer-based targeted drug delivery systems for the treatment of cancer. Short single-stranded DNA or RNA molecules called aptamers have a remarkable capacity to bind to particular target molecules with high specificity and affinity. Aptamers have drawn attention as excellent possibilities for creating targeted drug delivery systems by taking use of their special characteristic. The applications, choice, and modification of aptamers to precisely identify cancer-associated biomarkers, such as receptors overexpressed on cancer cells, are covered in detail in this topic. Additionally, it emphasizes various techniques for aptamer-drug conjugation optimization which ensure effective carrier delivery and regulated drug release inside the tumor microenvironment. It is investigated if aptamer-based systems have the ability to overcome problems such drug resistance, heterogeneity, and insufficient drug penetration within solid tumors.In conclusion, this article illuminates how aptamer-based targeted drug delivery systems have transformed the world of cancer treatment. It advances knowledge of these systems and their potential to transform cancer treatment by providing insights into design principles, delivery systems, and therapeutic results.
随着新型癌症治疗策略的发展,人们开始研究靶向给药系统,以此来提高疗效,同时尽量减少不良反应。本课题探讨了令人兴奋的基于适配体的靶向给药系统治疗癌症的领域。被称为适配体的单链 DNA 或 RNA 短分子具有极强的特异性和亲和力,能与特定的靶分子结合。适配体利用其特殊性创造靶向给药系统的极佳可能性已引起人们的关注。本专题将详细介绍如何应用、选择和改造适配体,以精确识别癌症相关生物标记物,如癌细胞上过度表达的受体。此外,本专题还强调了各种适配体-药物共轭优化技术,这些技术可确保在肿瘤微环境中进行有效的载体输送和调节药物释放。总之,本文阐明了基于适配体的靶向给药系统如何改变了癌症治疗领域。文章通过对设计原理、给药系统和治疗效果的深入分析,增进了人们对这些系统及其改变癌症治疗的潜力的了解。
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引用次数: 0
Novel positioning of L. (Black seed) from farm to pharma indexed in pharmacopeia 从农场到药典收录的 L.(黑种子)的新定位
Pub Date : 2024-02-15 DOI: 10.18231/j.jpbs.2023.020
Rania I.M. Almoselhy, Afreen Usmani, Rania I.M. Almoselhy
The current study examines the regulatory status and inclusion of in pharmacopeias across diverse regions. The regulatory landscape varies globally, with some countries recognizing it as a traditional medicine in pharmacopeias, while others impose restrictions due to safety and efficacy concerns. The lack of standardized guidelines complicates its status, ranging from dietary supplement to traditional herbal medicine in different regions. A pivotal shift is observed in the Egyptian Herbal Monograph Volume 3, marking Black Seed's evolution from traditional medicinal use to a recognized pharmaceutical preparation in the pharmacopeia. This transition signifies a move towards evidence-based medicine, emphasizing rigorous scientific scrutiny and standardization. The integration of Black Seed underscores growing recognition of its efficacy and safety, transforming it into a pharmaceutical product and consolidating its position in mainstream healthcare. The inclusion not only enhances patient accessibility but also instills confidence among healthcare practitioners, solidifying Black Seed as a trusted therapeutic agent. The debate around N. sativa's inclusion continues, with traditional medicine systems endorsing its value, while modern pharmacopeias grapple with standardization and quality control. N. sativa emerges as a promising natural resource, necessitating comprehensive documentation for its prospective inclusion in evidence-based healthcare practices and official guidelines.
目前的研究探讨了不同地区药典的监管状况以及将其纳入药典的情况。全球的监管情况各不相同,一些国家在药典中将其视为传统药物,而另一些国家则出于安全和疗效方面的考虑对其加以限制。由于缺乏标准化指南,其地位变得更加复杂,在不同地区从膳食补充剂到传统草药不等。在《埃及草药专著》第 3 卷中可以看到一个关键的转变,标志着黑种子从传统药用演变为药典中公认的药物制剂。这一转变标志着向循证医学的发展,强调严格的科学审查和标准化。黑种子的纳入表明其疗效和安全性日益得到认可,使其成为一种药品,巩固了其在主流医疗保健领域的地位。黑木耳的纳入不仅提高了患者的可及性,还增强了医疗从业人员的信心,巩固了黑木耳作为一种值得信赖的治疗药物的地位。围绕黑茶藨子是否入药的争论仍在继续,传统医学体系认可其价值,而现代药典则在标准化和质量控制方面煞费苦心。黑茶藨子是一种前景广阔的自然资源,有必要对其进行全面记录,以便将其纳入循证医疗实践和官方指南。
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引用次数: 0
Phytochemical and pharmacological review of cynodon dactylon grass with its potential effects 仙人掌草的植物化学和药理学研究及其潜在功效
Pub Date : 2024-02-15 DOI: 10.18231/j.jpbs.2023.018
Shruti Amritkar, Jagruti Chavan, Amit V. Kakad, M.R.N. Shaikh
Perennial herb Cynodon dactylon (L) Pers, family: Poeaceae, widespread throughout India. In several Indian languages, it is referred to by different names, including Durva in Marathi, Durba in Bengali, Dhro in Gujarati, Garichgaddi in Telugu, Arukampillu in Tamil, and Shataparva in Sanskrit. In traditional medical systems and ethnomedical practices, Cynodon dactylon plays a significant role. It is used in the form of powder, paste, or juice to treat a wide range of ailments due to its extensive therapeutic properties. Flavanoids, alkaloids, glycosides, terpenoides, triterpenoids, steroids, saponins, tannins, resins, phytosterols, reducing sugars, carbohydrates, proteins, volatile oils, and fixed oils were all found in Cynodon dactylon, according to the phytochemical examination. According to earlier research, Cynodon dactylon has properties that are protective, antimicrobial, antiparasitic, insecticidal, gastrointestinal, antioxidant, immunological, antiallergic, antiinflammatory, antipyretic, analgesic, anticancer, dermatological, diuretic, and immune system-related was found. In given review we studied some pharmacological aspects of Perennial herb Cynodon dactylon as well its versitile potential effect. The wide range of future aspects we can consider as best alternative medicine over chemical drugs.
多年生草本植物 Cynodon dactylon (L) Pers,科:广泛分布于印度各地。在多种印度语言中,它有不同的名称,包括马拉地语中的 Durva、孟加拉语中的 Durba、古吉拉特语中的 Dhro、泰卢固语中的 Garichgaddi、泰米尔语中的 Arukampillu 和梵语中的 Shataparva。在传统医学体系和民族医学实践中,仙人掌发挥着重要作用。由于其广泛的治疗特性,它以粉末、糊状或果汁的形式被用于治疗各种疾病。根据植物化学检查,在 Cynodon dactylon 中发现了黄酮类、生物碱、苷类、萜类、三萜类、类固醇、皂甙、单宁、树脂、植物甾醇、还原糖、碳水化合物、蛋白质、挥发油和固定油。根据早期的研究,发现仙人掌具有保护、抗菌、抗寄生虫、杀虫、胃肠道、抗氧化、免疫、抗过敏、抗炎、解热、镇痛、抗癌、皮肤病、利尿和免疫系统相关的特性。在这篇综述中,我们研究了多年生草本植物仙人掌的一些药理学方面及其多方面的潜在作用。在未来的广泛领域中,我们可以将其视为替代化学药物的最佳药物。
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引用次数: 0
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