用于DDU和APSD的IVIVC测试系统
Two factors have been identified as being critical to improving the clinical relevance of DDU testing and APSD measurement: realistic breathing profiles and realistic throat and nasal models.
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Copley推出DUSA Shaker™ DTS 100i:成就更快速、更安全、更具可重复性的吸入制剂测试
2023年2月8日;英国诺丁汉 (Nottingham):DUSA Shaker™ DTS 100i是Copley Scientific推出的全新半自动解决方案,公司是吸入制剂及鼻用制剂测试设备的全球领导企业,支持更快速、更高效且符合监管和药典规定的递送剂量均一性 (DDU) 测试。该产品是Copley DUSA振摇器的全新升级版本,可为定量吸入剂 (MDI) 和干粉吸入制剂 (DPI) 的剂量均一性取样装置 (DUSA) 提供全面、快速、可重复的冲洗操作。Copley对吸入制剂的测试理解独到,因此设计坚固的DTS 100i能加快测试进程,提高可重复性和准确性,让分析人员放手去执行价值更高的任务。 通过DDU测试,可以确认单个吸入制剂在整个使用寿命期间以及每批产品的剂量递送的一致性。关键的步骤是冲洗DUSA,使其恢复递送剂量。这一过程可以手动进行,但从确保完全恢复、健康和安全以及效率的角度考虑,自动化方法更加理想。 DTS 100i是一种模块化解决方案,可轻松嵌入任何现有装置或工作流程,而且成本低,是用户体验半自动化优势的理想入门产品。十几年来,独特的DUSA振摇器在全世界忙碌的吸入制剂测试实验室中一直占有一席之地;DTS 100i经过全面的重新设计和更新,可以提供: 与手动操作相比,药物回收速度加快10倍 触摸屏界面直观明了,操作简单 横向振摇和/或旋转运动经过优化,实现可重复的完整冲洗流程 灵活处理满负载或部分负载…
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Copley Scientific joins the Industries Forum of the Taskforce for Lung Health
23 June 2021; Nottingham, UK: Copley Scientific has joined the Industries Forum of the Taskforce for Lung Health. The Taskforce is a collaboration of over…
了解详情Copley announces a major upgrade of the world’s ‘go to’ inhaler testing portfolio
01 March 2021, Nottingham, UK: Copley Scientific, the global leaders in inhaler testing equipment, is marking the company’s 75th anniversary with a significant upgrade…
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Improving clinical realism: Upgraded IVIVC testing systems from Copley Scientific
29th June 2018; Nottingham, UK: New products from Copley Scientific enhance its offering for improving IVIVCs for orally inhaled and nasal drug products (OINDPs)….
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New research demonstrates the ability of the Child Alberta Idealised Throat to deliver better IVIVRs
28 May 2015; Nottingham, UK: New experimental studies using the Child Alberta Idealised Throat (C-AIT) from Copley Scientific confirm that it provides data more…
了解详情Copley Scientific introduces improved test set-up for more representative inhaled product testing
5 August 2014; Nottingham, UK: The desire to gain a better understanding of how inhaled products perform in patients has highlighted the importance and…
了解详情Introducing the new Alberta Idealized Throats from Copley Scientific – closer IVIVC in inhaled product testing
1 December 2010; Nottingham, UK: The Alberta Idealized Throat is a new product from Copley Scientific designed to improve in vivo/in vitro correlation (IVIVC)…
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…
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