Contactless Filter Collection for Inhalable Dose Dissolution
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Solution Overview
Problem
Current methods for collecting and analyzing inhalable drug formulations lack consistency in dissolution rates due to in-situ agglomeration on filters, leading to unreliable bioequivalence assessments and challenges in developing generic drugs.
Innovation Solution
An apparatus with a dose collection section featuring a quick-release system and a filter unit supported by upper and lower members, allowing for aerosolized particles to be collected without human contact and minimizing handling, ensuring uniform deposition and easy transfer for dissolution testing.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Measurement precision
If the inhalable dose is collected on a filter in an inertial impactor, then the deposition can be separated according to particle size, but the dissolution rate decreases with increasing collected mass due to in-situ agglomerates formation
Solution Approach 1:
The patent extracts the filter from the impactor chamber, allowing the filter to be removed and transferred to a dissolution vessel without remaining in the impactor. This separation eliminates the agglomeration problem caused by particles depositing on the filter while still in the impactor, while maintaining the particle size separation benefit of the impactor design.
Solution Approach 2:
The patent introduces a transfer mechanism (magnetic coupling system) as an intermediary between the impactor and dissolution vessel. This intermediary allows the filter to be transferred without direct contact, preventing contamination and maintaining sample integrity, thus ensuring reliable dissolution rate measurements.
2Quantity of substance
If the number of actuations is increased to collect more mass, then the collected dose increases, but the dissolution rate slows down due to agglomeration
Solution Approach 1:
By removing the filter from the impactor and transferring it to a dissolution vessel, the patent prevents further agglomeration that would occur if the filter remained in the impactor. This allows collection of larger masses through multiple actuations while maintaining consistent dissolution rates.
3Ease of operation
If manual handling of the filter is required for transfer, then the process is simple, but human contact may contaminate the sample and affect dissolution results
Solution Approach 1:
The patent replaces manual mechanical handling with a magnetic coupling system. The filter contains magnetic elements that couple with a magnet in the transfer device, enabling contactless transfer from the impactor to the dissolution vessel. This eliminates human contact and potential contamination while maintaining operational simplicity.
Solution Approach 2:
The magnetic coupling system acts as an intermediary mechanism that transfers the filter without direct physical contact. This intermediary preserves sample integrity by preventing contamination from human hands or tools, while still enabling easy transfer between devices.
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
Facilitates reliable and reproducible dissolution testing by reducing agglomeration effects, enabling accurate prediction of drug delivery to the lung and simplifying the handling process.
Implementation Method 1
a filter, extending across the pathway of the aerosolized respirable particles so as to retain particulate material thereon
Implementation Method 2
a quick-release system allowing for the filter unit to be removed from the lower body without any human contact on the filter unit
Data Source
AI summary
An apparatus for collecting aerosolized respirable particles of an inhalable medicinal formulation, having a dose collection section having an air-permeable filter extending across the pathway of the aerosolized respirable particles to retain particulate material on the filter. The dose collection section having an upper filter support member and a lower filter support member, the filter being circumferentially retained between the upper and lower support members to form a filter unit; a lower body receiving the filter unit, the lower body having recesses; and a quick-release system having hooks, movable between an open position and a closed position The hooks, in the open position, can enter the recesses around the filter unit, and in the closed position, can grab the filter unit, allowing removal of the filter unit without any human contact.