Abstract
The development of any inhalation product that does not consider the patient needs will fail. The needs of the patients must be identified and aligned with engineering options and physical laws to achieve a robust and intuitive-to-use inhaler. A close interaction between development disciplines and real-use evaluations in clinical studies or in human factor studies is suggested. The same holds true when a marketed product needs to be changed. Caution is warranted if an inhaler change leads to a change in the way the patient handles the device. Finally, the article points out potential problems if many inhaler designs are available. Do they confuse the patients? Can patients recall the correct handling of each inhaler they use? How large is the risk that different inhaler designs pose to the public health? The presentations were given at the Orlando Inhalation Conference: Approaches in International Regulation co-organised by the University of Florida and the International Pharmaceutical Aerosol Consortium on Regulation & Science (IPAC-RS) in March 2014.