Abstract
Although the manufacture of inhaled medications is a multibillion dollar industry,
virtually no pharmaceutical drug/device combination has been approved for inhalation
across the range of pediatric patient ages and sizes. The clinician who treats neonates,
infants, or toddlers is often faced with the dilemma of prescribing inhaled medications
that may be disease appropriate but have not been approved for use in patients in
these age categories. Their use is thus technically “off label,” with limited empirical
data to guide both dose and device selection. This dilemma requires the prescribing
physician to go beyond the limitations of the product label, often without benefit
of appropriately designed clinical trials, in an attempt to select safe and effective
doses for use with these smallest of patients. The vast majority of drugs approved
for inhalation were studied by using aerosol devices designed for older children and
adults using a mouthpiece interface, which may not be practical for use in infants
and patients aged <4 years. The selection of the most age-appropriate device and interface
is critical for the effective administration of the prescribed therapy. In the absence
of industry-sponsored clinical trials in neonates, infants, and toddlers, in vitro
and in vivo strategies may help guide age-appropriate dosing, device, and interface
selection to better inform clinical practice. In this commentary, the challenges in
developing and prescribing effective formulations for aerosol delivery across the
range of pediatric ages and sizes are explored, with guidance for device and interface
selection. Recommendations for future collaborative sharing of in vitro models and
age-specific breathing patterns between academic and industry researchers could help
regulators and clinicians better understand the impact age and size have on pulmonary
drug delivery.
Key words
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Article info
Publication history
Accepted:
October 11,
2012
Footnotes
Publication of this supplement was supported by The Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) of the National Institutes of Health (NIH).
Identification
Copyright
© 2012 Elsevier HS Journals, Inc. Published by Elsevier Inc. All rights reserved.
