In Vitro Characterisation of Devices and Drugs

Using state-of-the-art equipment our experienced INAMED team, consisting of physicists, engineers, chemists and technicians, investigates your devices in different ways.

We are able to help improve the performance of your devices and your drug formulations:

• Device/Drug Characterisation (e.g. Emitted Dose/Particle Size/Flow Dependency)
• Deposition Modelling
• Handling Studies
• Analytical Services
• Radio Labelling of Aqueous Solutions and Suspensions for Nebulisers, Solutions and Suspensions for MDIs, and different Powder Formulations for DPIs

Emitted dose –
Reliability and dependence on different breathing patterns

The investigation of the emitted dose is the first step to characterise your inhalation device in vitro. Since the output is dependent on the inhalation pattern, this has to be checked carefully. This test is performed according to USP methods and European Standards.

Particle size distribution –
Is the produced particle size adequate?

Particle size influences the deposition in the respiratory tract. Therefore, it is essential to control this sensitive parameter in pre-clinical studies. Using different techniques, we investigate the effect of inhalation flow and breathing pattern on particle size. With our breath simulator we are able to imitate any desired breathing pattern in vitro. With the in vitro data we can determine the expected in vivo deposition data. This is the second step to characterise your inhalation device.

Flow dependency

Flow resistance is an important parameter of your inhalation device, especially for dry powder inhalers. Flow resistance influences the ability of many patients to inhale through the device in a correct way.

Deposition modelling

Stability tests –
How does nebulisation or dispersion change your substance?

For sensitive molecules, such as proteins, we investigate the degradation and deactivation during nebulisation.

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