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专为经口吸入制剂 (OIP) 打造的溶出度测试方案

吸入溶出度仪™ (IDA) 是专用平台,旨在解决经口吸入制剂 (OIP) 测试中一项长期存在的行业挑战:从雾化药物样品中获得可重复、可对比的溶出度曲线。

IDA的核心在于简单三步工作流程 – 收集、转移、溶出 – 旨在简化测试过程,并确保结果令人信服。

该装置性能经数据验证,能够重复区分不同配方,帮助团队发现临时方法难以察觉的显著差异。

专利申请中

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IDA:简化吸入溶出度测试工作流程

播放视频

IDA产品主要亮点

可重复、可比较的溶出度数据

配方区分能力

专为OIP设计

优化的搅拌浆/容器设计

灵活的入口兼容性

集成式溶出度测试平台

自动化技术兼容性

经科学验证的性能

How the IDA Works: A Simple 3-Step Process

步骤1:收集

使用所需入口配置将雾化药物收集到过滤器上。这样可以确保剂量采集的一致性,为溶出度评估奠定基础。

步骤2:转移

IDA采用专门设计的过滤器支架,可将收集到的样品直接转移至溶出度测试装置中。过滤器支架可安装到溶出桨上,实现从收集到溶出的平稳过渡,同时尽量减少人工操作,并支持一致的工作流程。

步骤3:溶出

将过滤器浸入装有介质的溶出容器,在受控条件下进行溶出曲线测定。平底容器与搅拌桨结构经过专门设计,可支持与OIP相关的介质体积,有助于生成可重复、可比较的溶出度数据。

 

IDA技术规格

流量兼容性:
5 – 100 L/min
流量曲线选项:
支持恒定流量和呼吸模拟 (潮汐式/仅吸气)
入口兼容性:
与常见配置兼容,包括NGI吸入口、NGI预分离器、快速筛选撞击器、阿尔伯特理想化人工喉、阿尔伯特理想化鼻腔入口 (AINI)、玻璃膨胀室
可用工位:
6工位或8工位配置
介质体积范围:
200 – 500 mL
自动化兼容性:
兼容Vertus® III,可实现自动摇振和喷射

Inhaled Dissolution Apparatus™ IDA: FAQs

Explore our most frequently asked questions on the Inhaled Dissolution Apparatus IDA and inhaled dissolution testing, covering workflow, configurations, and key benefits.

What is the IDA used for?

The Inhaled Dissolution Apparatus™ IDA is used to support inhaled dissolution testing by collecting aerosolised drug onto a filter and enabling dissolution profiling under controlled conditions. It was purpose-designed to address long-standing challenges in this area, where laboratories have often relied on adapted or inconsistent approaches that can make results difficult to repeat or compare. With its consistent Collect > Transfer > Dissolve workflow, the IDA helps generate repeatable, comparable dissolution profiles to support product understanding and comparative studies, in line with growing regulatory and industry demand for more robust in vitro performance evidence.

What products can the IDA be used with?

The Inhaled Dissolution Apparatus™ IDA supports testing of a wide range of orally inhaled and nasal drug products, and is compatible with a wide range of common inlet configurations. This allows dissolution assessment to be performed using the same collection approaches and interfaces routinely used in established in vitro testing, helping IDA complement and extend existing compendial workflows rather than requiring a completely different setup. Compatible configurations include the NGI Induction Port, NGI Preseparator, FSI, Alberta Throat (adult and child), AINI, and glass expansion chambers.

Why not adapt standard dissolution equipment?

The IDA provides a purpose-built workflow specifically developed for orally inhaled products (OIPs), addressing the practical challenges of measuring dissolution from the small mass of drug typically collected during testing. The system uses a reduced-diameter paddle and a dedicated flat-bottom vessel to support OIP-relevant media volumes, helping maintain consistent circulation around the filter during testing. This optimised geometry supports repeatable, comparable dissolution profiling and reduces the uncertainty that can arise when adapting traditional dissolution equipment for inhaled applications.

How does the IDA improve repeatability?

The IDA is designed to support a consistent, repeatable inhaled dissolution workflow by reducing the number of handling steps between sample collection and dissolution testing. A key feature is the specially designed Filter Holder, which allows the collected sample to be transferred directly into the dissolution setup by attaching it directly to the specially adapted dissolution paddle. This minimises manual filter handling, helping protect the integrity of the collected dose and reducing the risk of sample disturbance, loss, or variability between tests. By supporting a standardised Collect > Transfer > Dissolve process, the IDA enables more repeatable dissolution profiling and more comparable data across studies and laboratories.

What flow conditions can be used with the IDA?

The IDA can be used with constant flow rate test setups (for example using a vacuum pump and flow controller) and can also be configured for more physiologically relevant flow conditions using a breathing simulator. This includes tidal breathing and inhalation-only breathing profiles, allowing the collection step to be aligned with the intended application and test objective.

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