3D-Printed Solid Dosage Forms with Integrated Channels
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Solution Overview
Problem
Existing 3D printing technologies for solid dosage forms face challenges such as sub-optimal disintegration and dissolution profiles, complexity in manufacturing, and limited regulatory approval due to the need for multiple printing cartridges and poor stability of drug substances in liquid ink formulations.
Innovation Solution
The development of 3D-printed solid dosage forms with integrated channels, printed using fused filament fabrication (FFF) technologies, which improve disintegration and dissolution characteristics by creating void spaces or channels within the dosage form.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Productivity
If conventional manufacturing techniques are used for solid dosage forms, then mass production is achieved, but manufacturing complexity and cost increase, and consumer choice is limited
Solution Approach 1:
The patent uses 3D printing technology to create physical copies of dosage forms directly from digital designs, eliminating the need for complex manufacturing facilities. The printing head deposits material layer by layer to replicate the desired dosage form geometry, enabling small-batch production with simplified equipment.
Solution Approach 2:
The patent changes the manufacturing approach from conventional mass production parameters to additive manufacturing parameters, allowing customization of dosage forms without increasing facility complexity. This enables variation in dosage strength, shape, and release profile through software control rather than physical manufacturing changes.
2Adaptability or versatility
If multiple printing cartridges are used in 3D printing systems, then dosage form versatility is achieved, but system complexity and regulatory approval difficulty increase
Solution Approach 1:
The patent employs a single multi-functional printing cartridge that can deposit different materials (pharmaceutical composition, excipient, coating) through the same nozzle. This universal cartridge design reduces system complexity while maintaining versatility, as one cartridge performs multiple functions that would otherwise require separate cartridges.
Solution Approach 2:
The printing system dynamically switches between depositing different materials within the same dosage form structure. The single cartridge can change deposition parameters, material composition, and layer characteristics on-the-fly, enabling customization without physical cartridge changes or complex multi-cartridge systems.
3Ease of manufacture
If liquid ink formulations are used for 3D printing, then dosage forms can be printed, but drug substance stability and shelf-life are compromised
Solution Approach 1:
The patent changes the physical state of the pharmaceutical composition from liquid ink to a different form (such as paste, slurry, or solid particulate material) that maintains drug stability. This parameter change preserves printability while eliminating the degradation issues associated with liquid formulations, achieving both manufacturing ease and compositional stability.
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 use of channels in 3D-printed solid dosage forms enhances their disintegration and dissolution profiles, improving regulatory compliance and patient outcomes, while also simplifying manufacturing processes and reducing costs.
Implementation Method 1
The development of 3D-printed solid dosage forms with integrated channels, printed using fused filament fabrication (FFF) technologies
Implementation Method 2
The use of channels in 3D-printed solid dosage forms enhances their disintegration and dissolution profiles
Data Source
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Figure 5~6(b)
AI summary
The present invention relates to a solid form, particularly to a 3D-printed immediate release solid dosage form (e.g. based on a pharmaceutical, nutraceutical, or food supplement composition). To overcome some of the solubility and disintegration problems inherited by 3D-printed solid dosage forms, the solid form comprises one or more channels, generally in the form of tubular passages or grooves, through the body of the solid form or the surface thereof.