雾化吸入剂的空气动力学粒径分布
雾化吸入器将液体转换成可吸入的气溶胶。 传统雾化吸入器在医院和家庭得到广泛使用。 使用雾化吸入器的主要优点是基本无需患者 的自身配合,这一点与其他装置不同。 2006年,欧洲药品管理局(EMA) 发布了新的 《吸入和鼻用产品质量指南》, 其中包括有关雾化吸入器药物方面的监管指南,依据是雾化吸入器的安 全性和功 效取决于雾化吸入器/药物组合, 而不单取决于雾化吸入器。 如2004年发布的结果所示, NGI可以使用如下所示的系统 来满足未来标准的要求。
吸嘴适配器
查看产品NGI人工喉
查看吸入制剂手册新一代撞击器(NGI)
查看吸入制剂手册内部/外部过滤器
查看吸入制剂手册按压吸气量控制器BAC100i
查看产品低流量真空泵LCP6
查看产品流量传感器 (FRS)
查看产品NGI降温柜
查看产品Inhalytix® – 空气动力学粒径分布分析计算软件
查看产品EnviroMate™ – 台式环境箱
查看产品温度/湿度传感器
查看吸入制剂手册NGI收集盘架
查看吸入制剂手册NGI承载/清洗架
查看吸入制剂手册DFM 2000 – 流量计
查看产品高流量真空泵HCP6
查看产品雾化吸入剂的DDU递送剂量均一性测试
查看系统相关应用程序
我们还提供一系列的设备,用于额外的对雾化吸入产品测试应用的支持:
省工工具
级联撞击器是怎样运作?
播放视频相关新闻与资源
Copley推出新式流量传感器 —— 吸入制剂测试系统的专用装置。
2023年6月27日;英国诺丁汉 (Nottingham):新式流量传感器 (FRS) 是Copley Scientific经口吸入制剂及鼻用制剂 (OINDP) 测试产品组合中的最新成员,为创新、高效、可靠的吸入制剂测试解决方案树立了标杆。FRS是一种坚固耐用、阻力低的双向流量传感器,通过与适当的流量控制器直接连接提供快速的数据输出,不仅精简了操作流程,同时也保持着较小的测试装置占用空间。该产品是Copley工程设计的卓越体现,专为吸入制剂测试而设计,它能提供标杆性的流量测量,使测试达到药典要求,并帮助用户准确地跟踪复杂的吸入曲线。 对于通过逐级碰撞进行的递送剂量均一性 (DDU) 测试和空气动力学粒径分布 (APSD),OINDP药典方法规定了如何设置它们的代表性流量。精确控制对于APSD测量尤其重要,因为多级撞击器的性能是作为气流流速的函数来校准的。随着开发商致力于提高产品对特定患者人群的性能,除了药典方法之外,评估上升时间等吸入曲线特征的影响也越来越普遍。 FRS使用简单,可以无缝接入到标准测试装置中,为各类经口吸入制剂及鼻用制剂 (包括干粉吸入制剂、定量吸入制剂、液滴吸入制剂、喷雾剂、鼻腔粉雾剂和鼻腔粉末制剂) 提供稳定而准确的流量测量。其关键特性包括: 设计简单,坚固耐用,指定用于通过BAC 100i呼吸促动控制器或TPK 100i临界流量控制器进行集成、控制和显示 双向流动,安装灵活 每1 ms进行一次流量、压力和温度数据输出 流动阻力低,适用于高流量测试,影响降至最低 点击此处,了解新式FRS的更多信息,以及它如何让您的OINDP测试装置如虎添翼。 图片文字:Copley新式流量传感器 (FRS):吸入制剂测试装置的专用低阻力流量传感器。…
了解详情二合一解决方案Copley Impactor Genie™ IG 200i上市 —— 更快速、更高效的吸入制剂产品测试装置
2023年4月25日;英国诺丁汉 (Nottingham):Copley Scientific推出的全新Impactor Genie™ IG 200i是一种具有成本效益、节省空间的半自动化工具,可使用安德生多级撞击器 (ACI) 或新一代撞击器 (NGI) 进行符合监管和药典要求的空气动力学粒径分布 (APSD) 测量,是大多数经口吸入制剂及鼻用制剂 (OINDP) 产品的理想撞击器。 这种二合一装置可自动进行撞击表面涂布和药物溶解,不仅能提高吸入制剂测试的速度和生产率,同时还能降低可变性。IG 200i是Copley推出的一套全新解决方案,公司是世界领先的吸入制剂测试设备供应商,带来了首创的ACI和NGI自动化解决方案。全系列产品包括用于收集板和收集杯涂布的新型Impactor Coater™ IC 200i,以及用于药物溶解的增强型Gentle Rocker GR 200i;而IG 200i将这两者的功能集于一身。选择与实验室工作流程最匹配的产品,确保每位客户都能获得具有成本效益的结果。 “这些解决方案将有价值的NGI半自动化功能扩展到ACI上。IG…
了解详情Copley launches EnviroMate™, an efficient, benchtop environmental chamber for inhaler testing
14 September 2022; Nottingham, UK: EnviroMate™ is a benchtop environmental control chamber from Copley, the world’s leading manufacturer and supplier of inhaler testing equipment,…
了解详情Introducing Inhalytix™: a new solution for analysing and managing inhaler test data from Copley
18 March 2021; Nottingham, UK: Inhalytix™ is a completely new software solution from Copley, the global leader in inhaler testing equipment, that brings a…
了解详情New e-Training service from Copley for pharmaceutical testing
14 January 2021; Nottingham, UK: Copley Scientific is now delivering e-Training, offering customers across the globe remote access to expert tuition on in vitro…
了解详情Copley launches a new webinar series on inhaler testing
20 April 2020; Nottingham, UK: Copley Scientific will shortly begin the company’s inaugural series of technical webinars, offering valuable, easy to understand overviews on…
了解详情Advancing the science of OINDPs: Copley Scientific joins IPAC-RS
28 February 2018; Nottingham, UK: Copley Scientific, a global leader in the design and manufacture of inhaler testing equipment, is pleased to announce that…
了解详情Confused about cascade impaction? Watch the new animations from Copley Scientific to improve your understanding of inhaled drug product testing.
22nd August 2016; Nottingham, UK: Copley Scientific, the world’s leading manufacturer and supplier of inhaler test equipment, has released two new educational animations that…
了解详情New maintenance tools from Copley Scientific help optimise inhaler testing
30 June 2009; Nottingham, UK: New pinning kits from Copley Scientific provide users of cascade impactors with a valuable tool for maintaining the longterm…
了解详情More precise nebuliser testing as Copley Scientific launches NGI Cooler
29 April 2009; Nottingham, UK: The new NGI Cooler from Copley Scientific is a practical, easy to use system that improves the accuracy and…
了解详情New, state-of-the-art vision system central to Copley Scientific’s cascade impactor validation service
24 July 2007; Nottingham, UK: The accuracy of cascade impactors used in the pharmaceutical industry for characterising inhaled products depends heavily on the size…
了解详情ONdrugDelivery Article: November 2020
Semi-Automation in Inhaler Testing – Exploring the Potential and Practicalities In this article, João Pereira, Team Leader R&D Analytical Development, and Raquel Borda D’Água,…
了解详情Q&A: OINDPnews 2022
Reducing Inhaler Testing Variability Through Test Environment Control In this Q&A with OINDPnews, our CEO Mark Copley answers questions about the importance of the…
了解详情PMPS Q&A (Samedan): April 2021
Putting Inhalers to the Test Anna Sipitanou has worked for Copley Scientific for four years, expanding her drug discovery and pharma science background. She…
了解详情Inhalation Article: December 2019
Optimizing the role of automation in variability reduction strategies for delivered dose uniformity (DDU) and aerodynamic particle size distribution (APSD) testing of inhaled drug…
了解详情Inhalation Article: April 2019
The regulatory landscape for OINDPs – the biggest shake-up in a generation?
了解详情ONdrugDelivery Article: December 2018
Variability in cascade impaction: sources, impact and strategies for reduction In this article, Mark Copley, Chief Executive Officer, Copley Scientific, considers cascade impaction as…
了解详情Drug Development & Delivery Article: April 2018
Optimizing the Application of In Vitro Test Methods for the Demonstration of Bioequivalence in Orally Inhaled Products
了解详情White Paper: February 2018
Optimising the application of in vitro test methods for the demonstration of BE in OIPs
了解详情PMPS Article (Samedan): February 2018
Demonstrating Bioequivalence of Orally Inhaled Products Safe and cost-effective treatments for respiratory diseases are facing a growing demand. The demonstration of bioequivalence within locally…
了解详情