Microneedles

微针
  • 文章类型: Video-Audio Media
    在本文中,我们为令人兴奋和动态的药物输送领域之一的监管批准提供了路线图,微针,通过使用设计质量(QBD)方法来开发药品。在这方面,确定微针的质量目标产品概况(QTPP)和关键质量属性(CQA)。我们讨论了我们最近获得专利的完全由治疗剂制造玻璃微针的方法的案例研究,从而消除了对额外赋形剂的要求。玻璃微针,ArrayPatch,是一种适当的可穿戴设备,具有平台潜力,由一系列锐器组成,但无痛,用100%药物制造的可溶性微针。微针在施用时穿透皮肤并溶解以递送局部有效剂量。将描述在WHO指导的稳定性条件下微针CQA的体外表征,以评估ArrayPatch的制造准备情况。现场技术视频,还提供了,提出了一种通过猪动物模型的耳静脉进行颈静脉插管的独特程序,以研究ArrayPatch的体内药代动力学。本文受版权保护。保留所有权利。
    In this paper, a roadmap is provided for the regulatory approval of one of the exciting and dynamic drug delivery fields, microneedles, by using a Quality by Design approach to pharmaceutical product development. In this regard, a quality target product profile (QTPP) and the critical quality attributes (CQA) of microneedles are identified. A case study of the recently patented method of fabricating glass microneedles entirely from a therapeutic agent, thus eliminating the requirement for additional excipients is discussed. The glass microneedle, ArrayPatch, is a propriety wearable device with platform potential consisting of an array of sharp, but painless, dissolvable microneedles manufactured with 100% drug. The microneedles penetrate the skin on application and dissolve to deliver a locally effective dose. The in vitro characterization of the microneedle CQAs under WHO-guided stability conditions will be described to assess the manufacturing readiness of ArrayPatch.  A live technical video is also provided, presenting a unique procedure of jugular vein cannulation through the ear vein of a pig animal model to study the in vivo pharmacokinetics of ArrayPatch compared to standard-of-care marketed products.
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  • 文章类型: Journal Article
    微针具有临床优势,能够以方便和舒适的方式在皮肤上输送复杂的药物,但尚未成功过渡到医疗实践。糖尿病是一种复杂的疾病,通常每天注射多次胰岛素,导致治疗依从性差。首先,本综述确定了微针的临床前景,在微针技术可以从工作台转换到床边之前应该解决的问题。此后,我们将糖尿病作为一个案例研究来考虑如何成功利用基于微针的技术.这里,引用胰岛素微针的出版物进行了评估,以了解是否插入效率,插入角度,成功的剂量输送,剂量可调性,材料的生物相容性和治疗稳定性正在早期研究中得到解决。此外,审查了1970-2019年的3,000多项专利,搜索词为““微针”和“胰岛素”,以了解该领域的现状。总之,早期微针研究的报告表明,与所解决的翻译因素有关的缺乏一致性。此外,更合理的设计,基于以患者为中心的方法是必要的,在监管批准后,基于微针的递送系统可以用于彻底改变糖尿病患者的生活。
    Microneedles have the clinical advantage of being able to deliver complex drugs across the skin in a convenient and comfortable manner yet haven\'t successfully transitioned to medical practice. Diabetes mellitus is a complicated disease, which is commonly treated with multiple daily insulin injections, contributing to poor treatment adherence. Firstly, this review determines the clinical prospect of microneedles, alongside considerations that ought to be addressed before microneedle technology can be translated from bench to bedside. Thereafter, we use diabetes as a case study to consider how microneedle-based-technology may be successfully harnessed. Here, publications referring to insulin microneedles were evaluated to understand whether insertion efficiency, angle of insertion, successful dose delivery, dose adjustability, material biocompatibility and therapeutic stability are being addressed in early stage research. Moreover, over 3,000 patents from 1970-2019 were reviewed with the search term \'\"microneedle\" AND \"insulin\"\' to understand the current status of the field. In conclusion, the reporting of early stage microneedle research demonstrated a lack of consistency relating to the translational factors addressed. Additionally, a more rational design, based on a patient-centred approach is required before microneedle-based delivery systems can be used to revolutionise the lives of people living with diabetes following regulatory approval.
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