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

Copley Scientific introduces new test equipment for generic product development at RDD 2018

5 April 2018; Nottingham, UK: Generic developers looking to apply the recently proposed draft US Pharmacopoeia (USP) monograph for Albuterol Inhalation Aerosols will find relevant new testing equipment at the Copley Scientific stand at Respiratory Drug Delivery 2018 (April 22nd to 26th, Tucson, Arizona). The new TPK™ 2100 Critical Flow Controller, a highly automated unit for reproducible, cost-efficient dry powder inhaler (DPI) testing, will also make its US debut. Copley Scientific is proud to be sponsoring this key event in the inhalation calendar and experts from the company will be in attendance throughout to discuss any aspect of inhaler testing.

Albuterol, a popular generic target also known as Salbutamol, is a β2 agonist (bronchodilator) used globally for the treatment of asthma and chronic obstructive pulmonary disease. Product-specific USP monographs and FDA guidances directly support the development of important generic drugs but frequently call for the application of unique test equipment, associated with the original product development. The proposed USP monograph for Albuterol Inhalation Aerosols, which was released in January 2018, specifies a non-standard sampling apparatus for delivered dose uniformity (DDU) testing, and an alternative to the standard USP induction port for aerodynamic particle size distribution (APSD) measurement using an Andersen Cascade Impactor (ACI). Copley Scientific will use the conference to launch new equipment to directly meet these requirements along with an accessory that allows the use of existing mouthpiece adapters, to simplify interfacing the inhaler with the induction port.

Copley Critical Flow Controllers are an internationally recognised standard for DPI testing that enable the set-up, control and documentation of all the parameters associated with both DDU and APSD measurement. The third generation TPK™ 2100 breaks new ground in terms of ease of use, improved reproducibility, and enhanced data output and recording. It exemplifies a suite of innovative designs that Copley has introduced over the last year to minimise the potential impact of user variability in inhaler testing and boost analytical productivity.

To find out more about the new test equipment for Albuterol or the TPK™ 2100 drop by the stand at RDD 2018. Alternatively contact: sales@copleyscientific.co.uk or visit: www.copleyscientific.com

Albuterol Inhalation Aerosol Sampling Apparatus

CAPTION: Albuterol Inhalation Aerosol Sampling Apparatus for delivered dose uniformity (DDU) testing as described in the proposed USP monograph

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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