In-vitro Characterization of Devices & Drugs

Using state-of-the-art equipment, our experienced INAMED team—a group of physicists, engineers, chemists and technicians—investigates your devices in a variety of ways. We are able to help to improve the performance of your devices and your drug formulations.

Emitted Dose

Reliability and dependence on different breathing patterns

The investigation of the emitted dose is the first step in characterizing 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 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 characterizing 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 the correct way.

 

Deposition Modeling

Using deposition modeling, we’re able to predict the in-vivo performance, in healthy lungs, of your device on the data acquired during in-vitro testing.

Stability Tests

Certain molecules are sensitive to mechanical stress or oxidation. Therefore the investigation of degradation and deactivation after nebulization is very important during the process of developing a liquid formulation for inhalation.

We investigate the degradation and deactivation of such sensitive molecules as proteins during nebulization.