Journal
PHARMACEUTICAL RESEARCH
Volume 29, Issue 6, Pages 1670-1688Publisher
SPRINGER/PLENUM PUBLISHERS
DOI: 10.1007/s11095-012-0691-y
Keywords
aerosol deposition; bioequivalence testing of inhalers; inhaler performance; respiratory drug delivery; stochastic lung modeling
Funding
- United States Food and Drug Administration [HHSF223201000093C]
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Deposition characteristics of MDI and DPI aerosols were compared throughout the conducting airways for the first time using a combination of experiments and a newly developed stochastic individual path (SIP) model for different inhalation profiles. experiments were used to determine initial particle distribution profiles and to validate computational fluid dynamics (CFD) model results for a MDI and DPI delivering the same dose of drug in a geometry of the mouth-throat and tracheobronchial airways. The validated CFD model was then used to predict the transport and deposition of the drug using correct and incorrect inhalation profiles for each inhaler. The MDI delivered approximately two times more drug to the tracheobronchial region compared with the DPI for both correct and incorrect inhalation profiles. Errors in inhalation reduced the deposited tracheobronchial dose by approximately 30% for both inhalers. The DPI delivered the largest dose to the mouth-throat (70%) and the MDI delivered the largest dose to the alveolar airways (50%). The developed model provides new insights into the lung delivery of pharmaceutical aerosols and can be applied in future studies in combination with pharmacokinetic analysis to establish bioequivalence between devices.
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