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.
改进吸入药物体内外相关性研究的试验系统
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…
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