Fast Track to Phase I: Rethinking Nebulizers in Early Phase Development
Young PM, Reed MD.
Respiratory Drug Delivery 2022. Volume , 2022: 113-122.
Abstract:
The use of nebulizers to undertake pre-clinical and first in human (FIH) clinical trials provides a means of uniform dosing that overcomes challenges encountered when using powder or pressurized metered dose inhalers at early stages of product development. By using a breath actuated nebulizer it becomes possible to conduct trials with one or two formulations, using a breath-by-breath dosing regimen. This reduces the complexity associated with generating multiple formulations for a dose escalation study and ensures that subjects receive a consistent respirable lung fraction as delivered dose is increased. This abstract presents a case study based on our approach to take a new chemical entity through formulation development and Good Laboratory Practice (GLP) preclinical trials, using a breath-by-breath nebulizer formulation design strategy that minimizes the path to first in human trials by providing a wide dosing regimen with minimal Chemistry, Manufacturing and Control (CMC) requirements.
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