FFF Solid Dosage Printing with Active-Ingredient Filaments
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Solution Overview
Problem
Existing 3D printing technologies for solid dosage forms face challenges such as high complexity, user-unfriendliness, manufacturing errors, regulatory hurdles, limited solubility of drugs, and poor stability of liquid ink formulations, which limit customization and regulatory approval.
Innovation Solution
A fused filament fabrication (FFF) 3D printer system using active ingredient-containing filaments and optional carriers, controlled by a computer, allows for on-demand production of customizable solid dosage forms with minimal input variables, high active ingredient concentrations, and aesthetic customization without compromising structural integrity.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Adaptability or versatility
If conventional 3D printing systems are used to produce solid dosage forms, then customization and on-demand production are enabled, but device complexity increases due to the large number of different ingredients and printing cartridges required
Solution Approach 1:
The system segments the dosage form production into modular layers, where each layer can be independently designed and printed. This allows complex dosage forms to be created by combining simple, standardized printing elements, reducing the number of required printing cartridges while maintaining customization capability.
Solution Approach 2:
A single universal printing cartridge design is used that can print multiple different dosage forms by varying the software control parameters. This multi-functional approach eliminates the need for multiple specialized cartridges, reducing device complexity while maintaining adaptability across different dosage form types.
2Ease of manufacture
If liquid ink formulations are used in 3D printing, then drug delivery is enabled, but stability deteriorates due to poor stability of drug substances in liquid ink formulations
Solution Approach 1:
The system changes the physical state parameter of the drug formulation from liquid to solid, using solid dosing materials that can be directly deposited and fused. This parameter change eliminates the stability issues associated with liquid formulations while maintaining the drug delivery function through controlled melting and solidification during the printing process.
Solution Approach 2:
The printing process utilizes phase transitions of the drug substance, depositing it in a solid state and then locally melting it during printing, followed by solidification to form the final dosage form. This phase transition approach ensures stability during storage and handling while enabling controlled drug delivery during the printing process.
3Adaptability or versatility
If multiple different ingredients are used to produce viable dosage forms, then dosage customization is improved, but reliability decreases due to increased likelihood of manufacturing errors and machine breakdown
Solution Approach 1:
The system uses self-contained printing elements that are pre-prepared with specific drug formulations, eliminating the need for complex in-situ mixing operations. This self-service approach reduces manufacturing errors by removing variables related to ingredient preparation and mixing, while still allowing dosage customization through selective combination of pre-prepared elements.
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
Enables high-resolution, customizable, and stable production of solid dosage forms suitable for regulatory approval, facilitating prototyping and reducing manufacturing errors, while allowing for varied drug release profiles and shapes.
Implementation Method 1
a fused filament fabrication (FFF) 3D printer
Data Source
AI summary
The present invention utilizes 3D printing technology, specifically fused filament fabrication (FFF) 3D printing, to produce solid dosage forms, such as pharmaceutical tablets. The production process utilizes novel printing filaments, typically on a spool, which contain the active ingredient. Such active-containing filaments have proved to be extremely robust and the principles outlined in the present disclosure provide access to a variety of viable formulations directly from a 3D printer. This, for the first time, affords a viable means for the in situ (e.g. within a pharmacy) 3D printing of personalized medicines tailored to a patient's needs. The invention also relates to purpose-built software for operating the printing apparatus, as well as local, national and global systems for monitoring the real time operation of a plurality of printing apparati to enable facile detection of malfunctions, thereby making regulatory approval viable and facilitating regulatory compliance.


