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. Researchers at Fraunhofer EMFT, 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. 

© Fraunhofer EMFT/Bernd Müller
Piezoelectric micro pump for more precise and efficient drug administration

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 ITEM, ILT, IWU, and EMFT 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.

Fraunhofer EMFT contributes to the project with its extensive expertise in the field of developing active drug delivery using piezoelectric micro pumps and sensor technologies. With the help of the deployed sensor and actuator components, a new type of high-precision inhaler platform with exact dose control is to be realized.

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.