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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
    • 粉末测试
      • 振实密度:JVi系列
      • 堆密度:斯科特体积计
      • 流动性:BEP2
    • 片剂厚度测试
      • 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
    • 半固体测试
      • 立式扩散池测试仪:HDT 1000
      • 立式扩散池测试仪:HDT 1
  • 洗涤剂试验
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      • 清洁剂测试仪: TRG 800i
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Go back to News & Events

Copley Scientific releases new accessories for testing nebulisers with facemasks

31 May 2018; Nottingham, UK: New accessories from Copley Scientific simplify the rigorous investigation of how a facemask impacts potential critical quality attributes of the delivered dose from a nebuliser, enhancing the clinical realism of Quality by Design and bioequivalence studies. Prescribing clinicians routinely use facemasks in place of a mouthpiece to ease nebuliser use, especially for children or the infirm, but this can significantly impact drug delivery. The new Facemask Test Stand (FMS) and Next Generation Impactor (NGI) to FMS Interface Accessory make it straightforward to extend existing pharmacopoeia methods to investigate this effect.

Current pharmacopoeia methods for delivered dose uniformity (DDU) and aerodynamic particle size distribution (APSD) measurement for nebulisers, as specified in USP Chapter <1601> and Ph. Eur. 2.9.44, are based on the use of mouthpieces. However, the use of facemasks has the potential to alter both DDU and APSD. Testing with a facemask in situ is therefore advantageous both for rigorous, clinically realistic performance assessment and for product comparison (test to reference), and mirrors the approach already specified for spacer/valved holding chamber (VHC) equipped metered-dose inhalers (MDIs) in USP Chapter <1602>.

The FMS can be used with the full range of Copley face models – infant, child or adult – or with a user-validated alternative, as required. It enables secure interfacing of the nebuliser, with facemask in place, with the standard DDU filter holder apparatus specified for nebulisers. The corresponding test set-up for APSD measurement additionally uses the NGI to FMS Interface Accessory to ease connection of the nebuliser, via the facemask (except infant), to the NGI, which is typically the impactor of choice for nebuliser testing. In combination the two accessories support the efficient generation of DDU and APSD data for nebulisers, with a facemask in place.

To find out more about the FMS, FMS to NGI accessory or any other aspect of nebuliser testing contact: sales@copleyscientific.co.uk

To see Copley’s full range of equipment for inhaled drug testing download “Quality Solutions for Inhaled Testing” from: http://www.copleyscientific.com/downloads/brochures

Copley Scientific Accessories

CAPTION: Measuring the critical quality attributes of a nebuliser dose with a facemask in place – delivered dose uniformity (left) and aerodynamic particle size distribution (right) – improves the clinical realism of test data.

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 Scientific’s pharmaceutical product range includes test equipment for all types of orally inhaled and nasal drug products – metered-dose inhalers, dry powder inhalers, nebulizers 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 Scientific products.

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