Single-Dose Mannitol Powder for Complete Bowel Prep Dissolution
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Solution Overview
Problem
Existing mannitol solutions for bowel cleansing prior to colonoscopy face issues such as incomplete dissolution due to undissolved portions, which can lead to bowel explosions and incomplete cleansing, especially in elderly patients, affecting diagnosis accuracy.
Innovation Solution
A single-dose composition of finely divided mannitol powder with a specific particle size distribution and bulk density, packaged in a hermetically sealed container or sachet, is used with a dissolving container and funnel to ensure complete dissolution in a controlled water volume.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Reliability
If mannitol is pre-dissolved in water for bowel cleansing, then the colon can be emptied effectively, but incomplete dissolution leads to precipitates and bowel explosion risks
Solution Approach 1:
The patent changes the physical parameters of mannitol by controlling particle size distribution (90-100% of particles between 1-500 μm) and bulk density (0.50-0.62 g/ml), which fundamentally alters dissolution behavior to ensure complete dissolution and eliminate precipitate formation
Solution Approach 2:
The patent performs preliminary action by pre-processing mannitol into specific particle size and density characteristics before dissolution, and by providing a dissolving container with mixing elements that initiate dissolution immediately upon water addition, preventing precipitate formation before it can cause harm
2Reliability
If mannitol powder is used for dissolution, then complete dissolution can be achieved, but the manufacturing and handling of fine powder presents technological challenges
Solution Approach 1:
The patent optimizes the bulk density parameter to a specific range (0.50-0.62 g/ml) that balances flowability for manufacturing handling with dissolution performance, and controls particle size distribution to ensure both manufacturability and complete dissolution
Solution Approach 2:
The patent employs a disposable single-dose container system that eliminates the need for complex manufacturing and handling of fine powders in industrial settings, as each patient receives a pre-prepared, hermetically sealed unit requiring no further processing
3Reliability
If elderly patients use mannitol solution, then bowel cleansing can be achieved, but limited shaking ability due to joint pain reduces dissolution effectiveness
Solution Approach 1:
The dissolving container is designed to perform the mixing function automatically through pre-installed mixing elements that dissolve mannitol with minimal patient effort, making the system self-servicing and eliminating the need for vigorous shaking by elderly patients
Solution Approach 2:
The patent introduces a dissolving container with mixing elements as an intermediary device between the mannitol powder and the patient, which performs the mechanically demanding mixing function that would otherwise require patient effort
4Manufacturing precision
If mannitol is administered in powder form, then complete and reproducible dissolution can be obtained, but quantitative dissolution control is difficult to achieve
Solution Approach 1:
The patent establishes precise parameter specifications for particle size distribution (90-100% between 1-500 μm) and bulk density (0.50-0.62 g/ml) that create reproducible dissolution behavior, allowing quantitative control of mannitol dissolution in a clinical setting
Solution Approach 2:
The patent incorporates visual indicators in the dissolving container that provide feedback to patients and administrators on dissolution progress, ensuring complete dissolution before administration and enabling quantitative verification of the process
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
Ensures quantitative and reproducible dissolution of mannitol, reducing precipitates and facilitating safe administration, enhancing bowel cleansing efficacy and diagnosis accuracy.
Implementation Method 1
a single-dose composition for use in the treatment of constipation, or for use as a purgative to be administered to a patient prior to a colonoscopy examination
Data Source
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AI summary
The present invention regards a single-dose composition consisting of mannitol at an amount from 50 to 200 grams, wherein said mannitol is in powder form, wherein said powder has a bulk density comprised from 0,40 g/ml to 0,65 g/ml and it comprises powder particles, and wherein a percentage comprised from 90% to 100% by weight of the powder particles has a particle size distribution comprised from 1 pm to 500 pm. The present invention also regards a container, preferably a single-dose container, a kit comprising a single-dose composition and a method of use of a kit comprising a single-dose composition.