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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
    • 清洁剂测试仪
      • 清洁剂测试仪: TRG 800i
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Go back to News & Events

Copley Scientific launches world’s first commercial apparatus for dissolution testing of inhaled drugs

25 January 2010; Nottingham, UK: Copley Scientific has launched the world’s first commercially available apparatus designed specifically for dissolution testing of inhaled drug formulations. Based on a concept developed by Professor Jason McConville and his team at the College of Pharmacy, University of Texas, a new NGI dissolution cup and membrane holder enables dissolution testing of size-fractionated particles selected from the emitted dose. Simple to use and employing analytical methodology based on established pharmacopoeial techniques for transdermal patches, it provides information that allows developers to more closely tailor inhaled drug delivery. The launch underlines Copley Scientific’s commitment to commercialising new analytical techniques for inhaled product testing and to providing the very best tools for development and QC.

Dissolution testing is widely applied in the development and manufacture of oral dosage forms, but is not yet in widespread use for inhaled products, where the prime focus is successful deposition in the lung. Currently there are no official dissolution test methods for inhaled products. However, increasing use of the pulmonary route to deliver larger molecules and/or systemic therapies means growing emphasis on the rate of active pharmaceutical ingredient dissolution. Dissolution information allows the development of more sophisticated inhalation products with delayed release characteristics and/or more closely controlled drug delivery profiles.

In dissolution testing for inhaled drugs the respirable portion of the emitted dose is of primary interest. The new solution from Copley Scientific addresses this by integrating conventional tablet dissolution testing equipment within the Next Generation Impactor (NGI), a system used routinely for aerodynamic particle size measurement to size fractionate a sample. The NGI dissolution cup fits into a conventional NGI cup tray but has a 50 mm removable insert in the impaction area, allowing the collection of particles lying in a specific size fraction. The collected sample is tested in a dissolution tester using a procedure very similar to the ‘Paddle over Disc’ technique described in the pharmacopoeia for transdermal patches. Copley Scientific also offers a similar solution for use with the Andersen Cascade Impactor. www.copleyscientific.com

CAPTION: Membrane holder in dissolution vessel

About Copley Scientific

Copley Scientific is recognised as the world’s leading manufacturer of inhaler test equipment and is a major supplier of test equipment for pharmaceutical solid dosage forms, including tablet dissolution, disintegration, friability, hardness and powder testers. The company has offices in the UK and Switzerland and a partnership with aerosol particle science experts MSP Corporation in North America. Copley’s broad range of testing products for metered-dose inhalers, dry powder inhalers, nebulizers and nasal sprays are supplied and supported worldwide through close relationships with specialist distributors. Serving the pharmaceutical and associated industries, Copley offers an extensive range of equipment for research, development and quality control, as well as full validation and aftersales service, providing a single source for products that meet individual needs. www.copleyscientific.com

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