Dry Powder Inhaler Particulate Analysis Apparatus
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Solution Overview
Problem
Current methods for analyzing foreign particulate matter in dry powder inhaler products are laborious, subjective, and inefficient for routine monitoring, requiring improvements for faster analysis times and larger sample sizes while minimizing operator subjectivity and extraneous particulate contamination.
Innovation Solution
A particulate matter collection apparatus connected directly to an inhaler device, using a vacuum to draw the emitted dose into a collection chamber with a robust filter, where the dry powder is mixed with a solution using a magnetic stir-bar, sonification, and mechanical inversion to suspend particulates for analysis by light obscuration.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Measurement precision
If microscopic techniques are used to analyze foreign particulate matter, then qualitative and quantitative data can be collected, but the analysis is laborious and inefficient for routine monitoring
Solution Approach 1:
The patent replaces manual microscopic analysis with automated light obscuration technology. The system uses a light source, detector, and automated particle counter to measure particulate matter, eliminating the need for manual microscopy while maintaining measurement capability and significantly improving throughput for routine monitoring.
Solution Approach 2:
The patent introduces a light beam as an intermediary to detect particulate matter. Instead of direct microscopic observation, particles are detected by their obscuration of light, providing an automated measurement pathway that maintains quantitative accuracy while enabling high-throughput analysis.
2Productivity
If light obscuration techniques are used for particulate matter analysis, then analysis time is reduced and sample size is increased, but operator subjectivity is removed
Solution Approach 1:
The patent replaces subjective operator judgment with automated electronic detection. The light obscuration system uses a detector and computer-controlled particle counter to automatically measure and enumerate particles, eliminating operator subjectivity while maintaining measurement precision through standardized algorithms.
Solution Approach 2:
The system incorporates automated feedback mechanisms where the detector continuously monitors light obscuration and the computer adjusts measurements and enumerations based on real-time data, ensuring consistent and objective results across all samples without operator intervention.
3Quantity of substance
If multiple actuations are performed to collect sufficient sample for analysis, then larger sample sizes can be obtained, but the risk of introducing extraneous particulate contamination increases
Solution Approach 1:
The patent combines multiple actuations into a single integrated collection process. The system collects particles from multiple inhaler actuations simultaneously into one sealed collection chamber, maintaining a controlled environment that prevents extraneous contamination while accumulating sufficient sample material for analysis.
Solution Approach 2:
The patent uses a sealed collection chamber as an intermediary between the inhaler and the analysis system. This isolated environment allows multiple samples to be collected without exposure to external particulate contamination, and the chamber can be directly connected to the light obscuration analyzer for immediate analysis.
Applied Scientific Principles
This section explains which scientific principles are used to turn an abstract innovation direction into a practical engineering solution.
Function Achieved in This Case
This method enables efficient and accurate collection and enumeration of foreign particulates, reducing operator subjectivity and extraneous contamination, allowing for faster analysis and larger sample sizes while maintaining industry standards.
Implementation Method 1
Vacuum sources can be used to pull the emitted dose through the filter and into the collection chamber
Implementation Method 2
The collection chamber can include a magnetic stir-bar suspended therein for mixing the solution added to the collection chamber
Implementation Method 3
light obscuration techniques generally allow for faster analysis times and larger sample sizes
Data Source
AI summary
An apparatus and method are provided for collection and analysis of dry powder inhaler products to determine foreign particulate matter found therein. The apparatus includes a collection chamber that communicates directly with the mouthpiece of a dry powder inhaler device. The collection chamber is used to both collect product samples, as well as to mix the samples with a diluent that places the active pharmaceutical components and excipients in solution, while the foreign particulate matter remains suspended. Analysis of a sample is preferably conducted by light obscuration wherein a probe is inserted directly within the collection chamber of the apparatus. An integral magnetic stir-bar incorporated within the apparatus eliminates the need to transfer the collected sample to a secondary vessel for mixing or analysis.