• 简体中文
    • English (英语)
sales@copleyscientific.co.uk
+44 (0)115 961 6229
立即咨询
  • 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
  • 资源
    • 培训
    • 服务
    • 支持
    • 下载
  • 新闻与事件
  • 关于我们
    • 发展历程
    • 高管团队
    • 与我们合作
      • 我们的文化和价值观
      • 空缺职位
      • 认识我们的员工
      • 为什么为科普利工作?
      • 发展历程
      • 我们的办公室
  • 联系方式
    • 联系方式
    • 办事处和经销商
      • 办事处和经销商
      • 成为经销商
  • 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
  • 资源
    • 培训
    • 服务
    • 支持
    • 下载
  • 新闻与事件
  • 关于我们
    • 发展历程
    • 高管团队
    • 与我们合作
      • 我们的文化和价值观
      • 空缺职位
      • 认识我们的员工
      • 为什么为科普利工作?
      • 发展历程
      • 我们的办公室
  • 联系方式
    • 联系方式
    • 办事处和经销商
      • 办事处和经销商
      • 成为经销商
Go back to News & Events

Copley Scientific launches new equipment for bioequivalence testing of popular inhaled generics

24 June 2014; Nottingham, UK: Copley Scientific has launched new accessories for testing generic inhaled products to support the efficient demonstration of bioequivalence with existing drugs. The new accessories make it possible to develop generics for treating respiratory conditions in accordance with new US Pharmacopeia (USP) product specific monographs for Fluticasone Propionate (FP) Inhalation Powder and Inhalation Aerosol. Product-specific monographs and regulatory guidance (such as that recently issued by the US FDA for a number of inhaled products) help generic manufacturers to identify appropriate testing equipment and methods to robustly demonstrate bioequivalence with named drug products.

Drugs such as salbutamol (albuterol), budesonide and FP are well-established, widely used treatments for asthma and chronic obstructive pulmonary disease (COPD). They are therefore a target for generic drug development. Product-specific FDA guidance and USP monographs ease the process of developing these generic products. They help manufacturers to establish appropriate test regimes for demonstrating bioequivalence, while simultaneously rationalising the content of submissions to the regulatory authorities. The stated in-vitro test equipment and methods in some cases reflect the specific testing regimes applied during development of the original (reference) product and therefore differ from what is currently specified in the general pharmacopoeial monographs applicable to inhaled products.

For FP Inhalation Powders, a new Glass Sample Collection Apparatus for delivered dose uniformity (DDU) has been developed, along with an FP Preseparator for the Andersen Cascade Impactor (ACI) which is used to perform aerodynamic particle size distribution (APSD) measurements for this product. For FP Inhalation Aerosols, there is a separate Glass Sample Collection Apparatus and an FP Inlet Cone for use with the ACI. The new FP Induction Port is common to both powder and aerosol APSD testing.

All these components are developed in accordance with the new USP 36 Second Supplement monographs for FP Inhalation Powders and Aerosols with the FP Induction Port, Preseparator and Inlet Cone being modified versions of those already specified in USP Chapter <601> and European Pharmacopoeia (Ph.Eur.) Chapter 2.9.18. In combination with the BAC 2000, a timer-controlled solenoid valve used as part of the system for determining the APSD of PF Inhalation Powders, these accessories enable standard test equipment, including the Andersen Cascade Impactor, to be tailored to meet the specifications of the new monographs.

To support the testing of metered dose inhalers (MDIs) originally developed using test methods specified in the British Pharmacopoeia (BP), Copley Scientific has also introduced the BP MDI Content Uniformity Apparatus. Although the BP and European Pharmacopoeias are essentially harmonised for inhaled products, this simple accessory is uniquely referenced in the BP. It enables a modified test set-up for measuring DDU, which, like APSD, is a performance-defining parameter for inhaled products.

To find out more about any of the products visit the website www.copleyscientific.com

CAPTION: Copley Scientific introduces new accessories for demonstrating bioequivalence for Fluticasone Propionate Inhalation Powder (FP), a globally used asthma treatment.

About Copley Scientific

Copley Scientific is 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 is also active in detergent testing, air sampling and aerosol characterisation.

Copley Scientific’s pharmaceutical product range includes test equipment for: delivered dose uniformity and aerodynamic particle size measurement of metered-dose inhalers, dry powder inhalers, nebulizers and nasal sprays; as well as tablets (dissolution, disintegration, friability and hardness) capsules, powders, suppositories and transdermals.

Copley Scientific has offices in the UK and Switzerland. The company works in partnership with aerosol particle science experts MSP Corporation in North America, and also distributes MSP Corporation’s air sampling and aerosol characterisation products throughout Europe.

Serving the pharmaceutical and associated industries, Copley Scientific offers an extensive range of equipment for research, development and quality control, as well as full validation and aftersales services. This broad range of products is supplied and supported worldwide through a network of specialist distributors. www.copleyscientific.com

Previous
Next
立即联系我们

我们的团队成员热情友好, 经验丰富,在此竭诚为您提供帮助。

T: +44 (0)115 961 6229 E: sales@copleyscientific.co.uk
Contact Us (China)

Contact Us (China)

We would like to hear from you. Please send us a message by filling out the form below and we will get back with you shortly.

Please review our privacy policy so you understand how we collect and use your personal data.
Quality Logos
  • 联系方式
  • 新闻与事件
  • 下载
  • 隐私政策
  • 反贿赂政策
  • 条款和条件
  • Join Our Mailing List
Copley Scientific Limited, Colwick Quays Business Park, Road No. 2, Nottingham, NG4 2JY, United Kingdom
+44 (0)115 961 6229 +44 (0)115 961 7637 sales@copleyscientific.co.uk
© 2023 Copley Scientific Limited. Website by Fifteen
  • 简体中文
  • English (英语)