Functional-Seam Orodispersive Tablets for Precise Dose Splitting

Resolve Bottlenecks,
Find Innovative Solutions
Generate Solutions

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

VSEngineering 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

Engineering Contradiction:
Improveease of tablet divisionVSAvoidbreaking precision and dosage accuracy
Core Design Contradiction:
Ease of operationVSManufacturing precision

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.

Inventive Principle:
Principle #1Segmentation

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.

Inventive Principle:
Principle #3Local quality

2Strength

If tablet hardness is increased to maintain structural integrity, then strength is improved, but ease of breakage deteriorates requiring sharp instruments

Engineering Contradiction:
Improvetablet structural integrityVSAvoidease of breakage
Core Design Contradiction:
StrengthVSEase of operation

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.

Inventive Principle:
Principle #3Local quality

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.

Inventive Principle:
Principle #1Segmentation

3Productivity

If conventional breakage methods are used, then division into sub-dosage units is achieved, but material loss and undesired miniature pieces increase

Engineering Contradiction:
Improvesub-dosage unit productionVSAvoidmaterial loss and undesired pieces
Core Design Contradiction:
ProductivityVSLoss of substance

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.

Inventive Principle:
Principle #1Segmentation

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.

Inventive Principle:
Principle #24Intermediary (Mediator)

Data Source

PatentUS20250295593A1Functionally-dividable orodispersive dosage form
Publication Date: 2025.09.25 APRECIA PHARMACEUTICALS LLC
  • US20250295593A1 patent drawing
  • US20250295593A1 patent drawing
  • US20250295593A1 patent drawing

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.