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Related Experiment Video

Updated: Jun 4, 2026

Characterizing Multiscale Mechanical Properties of Brain Tissue Using Atomic Force Microscopy, Impact Indentation, and Rheometry

Characterizing Multiscale Mechanical Properties of Brain Tissue Using Atomic Force Microscopy, Impact Indentation, and Rheometry

Published on: September 6, 2016

Product lifecycle approach to cascade impaction measurements.

Terrence P Tougas¹, Dave Christopher, Jolyon Mitchell

¹Analytical Development, Boehringer Ingelheim, Ridgefield, Connecticut, USA.

AAPS Pharmscitech

|February 3, 2011

Summary

Efficiently assess orally inhaled products (OIPs) using abbreviated impactor measurements (AIM) with efficient data analysis (EDA) for quality control, reserving full-resolution cascade impactor (CI) testing for development and investigations.

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Area of Science:

Pharmaceutical Sciences
Drug Delivery Systems
Analytical Chemistry

Background:

Orally inhaled products (OIPs) require aerodynamic particle size distribution (APSD) assessment throughout their lifecycle.
Full-resolution cascade impactor (CI) measurements are informative but resource-intensive and variable, making them suboptimal for routine quality control (QC).
Efficient Data Analysis (EDA) combined with Abbreviated Impactor Measurement (AIM) systems offers a more efficient alternative for OIP assessment.

Purpose of the Study:

To discuss a strategic approach for utilizing both abbreviated and full-resolution CI systems based on measurement objectives.
To ensure adequate, accurate, and efficient APSD testing of OIPs across their entire lifecycle.
To optimize resource allocation for APSD characterization during OIP development and commercialization.

Main Methods:

Conduct comprehensive testing using full-resolution CI during OIP development to establish baseline APSD.
Establish correlations between selected AIM CIs and full-resolution CI systems, aiming for common specifications.
Implement AIM/EDA for commercial batch release, reserving full-resolution CI for investigations and change control.

Main Results:

A strategy is proposed for selecting appropriate CI methods (full-resolution vs. AIM) based on the testing phase and purpose.
AIM/EDA can be effectively used for OIP release testing in the commercial phase, optimizing resource utilization.
AIM with a focus on the pulmonary region (AIM-pHRT) can serve as a rapid indicator for changes in clinically relevant fractions.

Conclusions:

A hybrid approach using both full-resolution CI and AIM/EDA optimizes APSD testing throughout the OIP lifecycle.
AIM/EDA provides an efficient QC method, while full-resolution CI remains crucial for in-depth analysis and troubleshooting.
AIM-pHRT can be a valuable tool for post-approval change management, ensuring the consistency of therapeutically relevant particle sizes.