Disintegratable Films for Diagnostic Reagent Delivery
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Solution Overview
Problem
Conventional diagnostic devices face challenges in controlling reagent concentration due to static effects in plastic and glass containers, leading to reagent wastage and instability, especially with magnetic particles, which are difficult to handle and dispense quantitatively.
Innovation Solution
Development of disintegratable films containing a mixture of high and low molecular weight water-soluble components, including reagents, that rapidly disintegrate in aqueous media, providing sufficient film strength and minimizing reagent wastage, with optional starch, glucose, plasticizer, and humectant components to enhance disintegration profiles.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Quantity of substance
If conventional spraying, coating, or striping techniques are used to apply reagents on test strips, then reagents can be delivered to the testing device, but reagent wastage occurs and control over reagent concentration is difficult
Solution Approach 1:
The reagent is segmented into discrete film segments or zones on the test strip, each containing a controlled amount of reagent. This segmentation allows precise delivery of required reagent quantities while minimizing wastage from overspray or uneven distribution.
Solution Approach 2:
The reagent is pre-loaded into film structures during manufacturing, allowing precise control of reagent concentration and quantity before the test is performed. This preliminary preparation eliminates the need for conventional spraying techniques that cause reagent wastage.
2Ease of operation
If aqueous reagent solutions are used, then reagents can be easily applied, but reagents become unstable requiring specialized storage such as refrigeration
Solution Approach 1:
The reagent formulation parameters are changed from aqueous solutions to non-aqueous or semi-solid formulations (waxes, oils, gels, pastes). This parameter change improves reagent stability for storage at room temperature while maintaining ease of application through the film delivery system.
Solution Approach 2:
The invention uses composite material systems combining reagents with carriers such as waxes, oils, gels, or pastes. These composite formulations provide both stability for storage and controlled release properties when applied through the film, eliminating the need for refrigeration while maintaining ease of operation.
3Reliability
If magnetic particles are used as reagents, then diagnostic testing capability is improved, but handling and quantitative dispensing becomes difficult due to static effects
Solution Approach 1:
Magnetic particles are merged with other reagents and carriers within the film matrix. This combination allows the magnetic particles to be delivered quantitatively along with the rest of the reagent formulation, overcoming the handling difficulties caused by static effects that plague separate magnetic particle dispensing.
Solution Approach 2:
The film acts as an intermediary vehicle that facilitates the quantitative delivery of magnetic particles. By embedding magnetic particles within the film structure, the film mediates the transfer of particles from storage to application, eliminating static-related handling issues.
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
The films enable efficient and stable reagent delivery, reducing wastage and handling issues, while maintaining film strength for processing and administration, allowing for precise reagent release and improved diagnostic test accuracy.
Implementation Method 1
water soluble films containing soluble or dispersed reagents
Implementation Method 2
reagents for use in diagnostic assay devices
Data Source
AI summary
The invention provides disintegratable film compositions for diagnostic test devices. The films are prepared with a combination of components that yield films of sufficient film strength and desired disintegration profiles. A disintegratable film according to the present invention contains a water soluble high molecular weight component, a water soluble low molecular weight component, and one or more reagents for use in a diagnostic device. Optionally, the films further contain a starch component, a glucose component, a plasticizer and/or a humectant, and/or a filler. The invention further provides a diagnostic testing device, which includes a film according to an embodiment of the invention, and methods of using such devices.