3D-Printed Solid Dosage Structure for Uniform Drug Release
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Solution Overview
Problem
Existing pharmaceutical dosage forms, such as oral immediate-release tablets and capsules, face challenges in uniform fluid percolation and require multiple excipients, leading to resource-intensive and time-consuming development and manufacture, with some excipients causing adverse effects in patients, while non-porous forms lack immediate drug release suitability.
Innovation Solution
A solid dosage form with interconnected void spaces and controlled microstructure, manufactured via 3D printing, comprising extruded structural elements with specific spacing and hydrophilic excipients for predictable drug release.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Productivity
If traditional compacted particulate dosage forms are used, then drug dissolution can be rapid due to large surface area-to-volume ratio, but fluid percolation is not uniform and requires numerous excipients and multiple process steps
Solution Approach 1:
The dosage form is segmented into a three-dimensional network of struts or beams, creating a structured framework that enables uniform fluid percolation while maintaining rapid drug dissolution. This segmentation replaces the need for numerous excipients and multiple process steps with a geometrically controlled structure.
Solution Approach 2:
The invention employs a porous three-dimensional network structure with controlled pore size and distribution. This porous framework allows uniform fluid percolation throughout the dosage form, eliminating the need for superdisintegrants and other excipients typically required to achieve uniform disintegration.
2Reliability
If numerous excipients are added to ensure dosage form specifications are met, then manufacturing reliability improves, but resource consumption and development time increase
Solution Approach 1:
The invention changes the fundamental parameters of dosage form design by transitioning from compacted particulate structures to three-dimensional printed network structures. This parameter change enables control of fluid percolation and drug release through geometric design rather than excipient selection, reducing development time while maintaining specification compliance.
Solution Approach 2:
The three-dimensional network structure is self-sufficient in achieving uniform fluid percolation and controlled drug release without requiring additional excipients. The structure itself provides the functionality that would otherwise require multiple excipients and process steps, reducing both resource consumption and development time.
3Ease of manufacture
If non-porous solid dosage forms are used, then manufacturing is simpler, but immediate drug release is not achieved
Solution Approach 1:
The invention employs a porous three-dimensional network structure that maintains manufacturing simplicity through additive manufacturing while enabling immediate drug release. The controlled porosity allows rapid fluid penetration and drug dissolution without requiring complex post-processing steps.
Solution Approach 2:
The three-dimensional network structure incorporates local quality variations through controlled strut thickness, pore size, and network density in different regions. This enables optimization of both manufacturing simplicity and drug release speed by tailoring the local structure to specific release requirements.
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 rapid disintegration and uniform drug release within 45 minutes, reducing manufacturing complexity and minimizing adverse effects from excipients.
Implementation Method 1
said extruded structural elements further comprising segments separated and spaced from adjoining segments by free spacings, said free spacings defining one or more substantially interconnected free spaces through the drug-containing solid
Implementation Method 2
said extruded structural elements comprising at least one pharmaceutically active ingredient and at least a hydrophilic excipient
Data Source
AI summary
At present, the most prevalent pharmaceutical dosage forms, the oral immediate-release tablets and capsules, are porous solids of compacted drug and excipient powders. Upon ingestion, physiological fluid percolates the open pores, and the dosage form disintegrates and the drug dissolves. Because the pores in the compacted solids are not well connected, however, fluid percolation generally is not uniform, and the drug release rate is difficult to predict and control. To overcome such limitations, therefore, herein a structured solid dosage form is disclosed. The structured solid dosage form comprises a structural assembly of one or more repeatably arranged, extruded structural elements. The elements comprise segments separated and spaced from adjoining segments by free spacings defining one or more substantially interconnected free spaces, or channels, in the dosage form through which a physiological fluid may percolate. The disclosed dosage form enables more predictable drug release rates, and can be readily manufactured by 3D-printing.