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  • 吸入制剂试验
    • 递送剂量均一性(DDU)
      • 定量吸入气雾剂(MDI)递送剂量均一性测试(DDU)
      • 干粉吸入剂(DPI)的DDU递送剂量均一性测试
      • 雾化吸入剂的DDU递送剂量均一性测试
      • 混悬液水雾喷雾剂吸入制剂(ADI)的DDU递送剂量均一性测试
      • 鼻用产品的DDU递送剂量均一性测试
    • 配件
      • 呼吸模拟器
      • 流量控制器
      • 流量计
      • 真空泵
      • 环境控制
      • NGI散热器
      • 吸入器测试工作站 (ITW)
      • 玻璃膨胀室
      • 喉舌和鼻托适配器
    • 特殊应用
      • 冲击器缩写 (AIM)
      • 美国药典专著(仿制药开发)
    • 空气动力学粒径分布(APSD)
      • 定量吸入气雾剂(MDI)空气动力学粒径分布(APSD)
      • 干粉吸入剂(DPI)的APSD空气动力学粒径分布
      • 雾化吸入剂的空气动力学粒径分布
      • 水雾喷雾吸入制剂(ADI)的APSD
      • 鼻用产品的APSD
    • 改善IVIVC
      • 用于DDU和APSD的IVIVC测试系统
      • 吸入药物溶出度
      • 面罩测试
      • 形态学
      • 冷媒效应
    • 半自动化
      • 半自动 – MDI振摇与喷射系统
      • 加快递送剂量均一性测试的省工工具
      • 加快空气动力学粒径分布测试的省工工具
    • APSD数据分析软件
      • Inhalytix®
  • 药物测试
    • 片剂崩解时限测试
      • DTGi系列
    • 片剂硬度测试(断裂力)
      • 片剂硬度计:TBF 100i
      • 片剂硬度计:TH3
    • 栓剂测试
      • 栓剂融变时限试验:SDT 1000
      • 阴道片融变时限测试仪:VTT
    • 片剂溶出度测试
      • DISi系列
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      • 振实密度:JVi系列
      • 堆密度:斯科特体积计
      • 流动性:BEP2
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      • 547型片剂厚度仪
      • 700型片剂厚度仪
      • 500型数字卡尺
    • 片剂脆度测试
      • Friabimat:包衣片剂
      • FRVi系列:未包衣片剂
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Go back to News & Events

New accessory completes Copley’s solution for automated nasal drug product testing

26 October 2021; Nottingham, UK: The latest accessory from Copley Scientific, the global leader in inhaled product testing equipment, simplifies the measurement of delivered dose uniformity for nasal drug products in accordance with the recently revised specifications in European Pharmacopoeia (Ph. Eur.)1 Chapter 0676 and US Pharmacopoeia (USP) Chapter <601>2. The new nasal dose uniformity sampling apparatus (DUSA) interface plate enables simple, leak-free connection between a standard DUSA and the nasal drug product to ensure complete dose capture. Designed for use with a Vertus II/Plus, Copley’s automated shake and fire system, it supports automated, high productivity, high repeatability testing. Introduction of the new interface means that all routine test set-ups for nasal drug products are now easily automated using Copley’s complete integrated solution.

Dose uniformity is a critical quality attribute for nasal drug products because of its direct impact on clinical efficacy. Dose uniformity measurements involve vertical or near vertical firing of the nasal drug product and capture of the released dose. Leakage and loss of dose, back on to the product nozzle, is a common problem, as is variability arising from manual product actuation.

The Vertus II/Plus is a well-established fully automated shake and fire system for nasal drug product actuation. Automated actuation of the nasal drug product reduces analytical variability, at the same time improving test productivity and reducing health and safety risks for analysts. With the introduction of the new interface, the Vertus II/Plus can now be used with:

  • A standard metered dose inhaler DUSA – as specified in recent revisions to the Ph. Eur. and USP, which are more prescriptive than preceding versions with respect to dose capture.
  • A Nasal Spray Dose Collector – an accessory designed specifically for nasal drug product testing that combines highly efficient drug capture and ease-of-use.
  • A Nasal Spray Waste Collector – for firing to waste under representative conditions.

Together these products represent a complete solution for dose uniformity for nasal drug product dose uniformity testing. Furthermore, the Vertus II/Plus can be interfaced with any routinely used cascade impactor, via an expansion chamber or Alberta Idealised Nasal Inlet, to measure the aerodynamic particle size distribution of the respirable fraction of the dose, to assess the risk of drug delivery via the lungs. Such testing is recommended by the regulators for both new and generic products.

To find out more about Copley’s full range for nasal drug product testing and how it can help with faster, more effective product development go to www.copleyscientific.com.

1 Ph. Eur. 10.5 Nasal Preparations, Nasalia. 01/2021:0676.
2 USP Chapter <601> ‘Aerosols, Nasal Sprays, Metered Dose Inhalers and Dry Powder Inhalers’

ENDS

DUSA Interface Plate for Nasal Sprays

CAPTION: The new nasal DUSA interface combines with the Vertus II/Plus to provide an efficient, productive, easy-to-use solution for nasal spray drug product testing.

 

About Copley Scientific
Copley Scientific is widely recognised as the world’s leading manufacturer and supplier of inhaler test equipment and is a major provider of testing systems for other pharmaceutical dosage forms. The company also supplies equipment for detergent testing.

Copley’s pharmaceutical product range includes test equipment for all types of orally inhaled and nasal drug products – metered-dose inhalers, dry powder inhalers, nebulisers and nasal sprays – with a particular focus on solutions for delivered dose uniformity and aerodynamic particle size distribution measurement. It also includes testers for tablets (dissolution, disintegration, friability and hardness) capsules, powders, suppositories, semisolids and transdermals.

Used from R&D through to QC, this extensive range of equipment is supported by a full validation and aftersales service. Copley Scientific has offices in the UK and Switzerland and works in partnership with aerosol particle science experts MSP Corporation in North America; specialist distributors extend localised support across the world. This network provides expert help and training to every customer, directly enhancing the application of all Copley products. www.copleyscientific.com

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