Functional-Seam Orodispersive Tablets for Precise Dose Splitting
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Solution Overview
Problem
Conventional scored tablets often break unevenly, leading to inaccurate dosages and loss of mass, requiring sharp instruments for division, which is problematic for pediatric and geriatric patients and results in undesired miniature pieces.
Innovation Solution
A dividable tablet with functional seams that allows for precise division into sub-dosage units, utilizing a three-dimensionally printed structure with planar or curved segments and a lower porosity seam to ensure equal mass distribution and resistance to bending forces.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Ease of operation
If conventional scoring techniques are used to facilitate tablet breakage, then ease of division is improved, but breaking precision and dosage accuracy deteriorate due to unequal breaking and mass loss
Solution Approach 1:
The tablet is segmented into multiple sub-dosage units with functional seams that define precise breakage planes. The functional seam creates a controlled separation interface that ensures each sub-unit contains the exact intended dosage, eliminating the unequal breaking problem of conventional scored tablets.
Solution Approach 2:
The functional seam introduces a localized structural feature with different mechanical properties than the bulk tablet material. This local modification creates a preferred breakage path with lower fracture toughness, guiding the breakage to occur precisely at the seam location while maintaining dosage accuracy.
2Strength
If tablet hardness is increased to maintain structural integrity, then strength is improved, but ease of breakage deteriorates requiring sharp instruments
Solution Approach 1:
The functional seam creates a localized region with reduced mechanical strength and altered fracture properties compared to the bulk tablet. This local weakness allows the tablet to be broken easily along the seam plane while the rest of the tablet structure maintains its integrity and hardness for handling and storage.
Solution Approach 2:
The tablet structure is segmented such that the functional seam acts as a predetermined weak plane. This segmentation allows the bulk material to remain strong while the seam provides the necessary breakage facilitation, eliminating the need for sharp instruments.
3Productivity
If conventional breakage methods are used, then division into sub-dosage units is achieved, but material loss and undesired miniature pieces increase
Solution Approach 1:
The functional seam divides the tablet into clearly defined sub-dosage units with minimal intermediate material. The seam geometry is optimized to ensure clean separation without generating excessive miniature fragments or material loss, improving the yield of usable sub-dosage units.
Solution Approach 2:
The functional seam acts as an intermediary structure that mediates the breakage process. It provides a controlled interface that manages the separation of sub-dosage units, preventing random fragmentation and minimizing material loss during the division process.
Data Source
AI summary
A dividable tablet with a functional seam for functionally dividing the dividable tablet into substantially equivalent sub-dosage units along the functional seam. The functional seam is configured to subdivide the sub-dosage units into the same mass within a tolerance of about 3% or less, and typically of 1.0% or less. The functional seam is configured reduce the amount of lost material that separates from the divided sub-dosage units after division of the dividable tablet along the functional seam, to less than 3%, and typically less than 1.0%, and more typically less than 0.1% of the mass of the undivided dividable tablet.


