Project 4D Haler

Intelligent Inhaler for Biologicals and mRNA active ingredients

New pharmaceutical active ingredients, such as biologicals, mRNA, genes, tissue- or cell-based formulations, enable novel treatment options for diseases. Applying these medications through the lungs using innovative inhalation systems is a promising way to achieve affordable, safe, and efficient therapies. 

4D Haler Aerosolsensor, der im Fraunhofer-Projekt 4D Haler entwickelt wurde.
© Fraunhofer EMFT, Bernd Müller
4D Haler Aerosolsensor

Researchers at Fraunhofer ITEM, together with three other Fraunhofer Institutes, are working on an intelligent inhaler that allows control and monitoring of drug administration efficiency down to the smallest detail. 

This requires precise, efficient, gentle and safe dosing of the highly potent, sensitive active ingredients. Precise delivery of the amount/dose of active ingredient by the device alone is not enough. Patient-related inadequacies, which can lead to 90% deviations from the actually planned (prescribed) lung dose with current systems, need to be compensated for.

State-of-the-art inhalation systems already feature breath triggering and can measure the flow rate during the inhalation phase. However, there is currently no way to determine and precisely control the deposited and actually effective dose in the lungs. This is where the research project 4D Haler comes in: The consortium of the Fraunhofer Institutes ILT, IWU, EMFT and ITEM combines new technological approaches with detailed knowledge of the healthcare sector and the framework conditions in this highly regulated market (medicines, medical devices), to develop an intelligent inhaler platform. As a result, the planned inhaler is the first solution to allow precise dosing of the active ingredient actually remaining in the lungs.

The pursued technological approaches also enable individual adjustment of the dosage by specifically changing various inhaler parameters: total dose, dose rate, particle size (1.5 - 5 μm), and targeted lung area (via bolus administration; central airways, peripheral airways). In principle, the data collected in the inhaler is also available for further use, e.g. for diagnostic purposes.

The project is funded by the internal Fraunhofer research program PREPARE.