In Vitro Determination of Respimat^® Dose Delivery in Children: An Evaluation Based on Inhalation Flow Profiles and Mouth-Throat Models.

ABSTRACT:

Background

Aerosol therapy in young children can be difficult. A realistic model based on handling studies and in vitro investigations can complement clinical deposition studies and be used to enable dose-to-the-lung (DTL) predictions.

Methods

Predictions on dose delivery to the lung were based on (1) representative inhalation flow profiles from children enrolled in a Respimat^® handling study, (2) in vitro measurement of the fine-particle DTL using mouth-throat models derived from nuclear magnetic resonance/computed tomography (NMR/CT) scans of children, and (3) a mathematical model to predict the tiotropium DTL. Accuracy of the prediction was confirmed using pharmacokinetic (PK) data from children with cystic fibrosis enrolled in a phase 3 clinical trial of tiotr

SUBMITTER: Bickmann D 

PROVIDER: S-EPMC4739345 | biostudies-literature | 2016 Feb

REPOSITORIES: biostudies-literature