What needs to change in the design of a passive DPI to make it suitable for young children?

Dr Anne Lexmond

Clinical Development of Novel Inhaled Products, University of Groningen

Children constitute a special and highly challenging target population for pulmonary drug delivery. Significant developmental changes in lung physiology and cognitive abilities occur over the years and even within an age group large variability exists between children. This variability makes it impossible to develop a “one-fits-all” inhalation system for the different age groups.

In their reflection paper on formulations of choice for the paediatric population, the EMA’s Committee for Medicinal Products for Human Use (CHMP) state that inhalation is a suitable way to administer active substances to the lungs of children, especially for local applications (1), such as asthma and respiratory tract infections in cystic fibrosis (CF). Based on the experience with locally administered asthma therapeutics, a summary is given of the appropriate delivery devices in relation to the age of the child. An important recognition in this paper is that the applicability of a specific dosage form largely depends on the paediatric patients themselves. Children, also those of the same age, behave and feel differently and they have different abilities regarding the handling of a dosage form. A generalised judgement of applicability and acceptability might therefore not be applicable to an individual paediatric patient.