Extrusion Apparatus for Solid Dosage Forms with 3D Fiber Structuring
Find Innovative SolutionsGenerate Solutions
Solution Overview
Problem
Current methods for manufacturing solid pharmaceutical dosage forms, such as porous oral-delivery tablets, face challenges with particle segregation and agglomeration during powder processing, leading to unpredictable microstructure, drug content, and drug release rates, and are resource-intensive and time-consuming.
Innovation Solution
A novel apparatus for manufacturing solid dosage forms with a predictable microstructure, involving an internally hollow housing with an extrusion channel, feeding ports for excipients and solvents, and a conveying element for extruding plasticized fibers, which are structured into a three-dimensional network using a translating or rotating stage to control the microstructure and properties.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Manufacturing precision
If powder processing methods are used to manufacture solid dosage forms, then the manufacturing process is simple and widely used, but particle segregation and agglomeration occur leading to unpredictable microstructure and drug release rates
Solution Approach 1:
The invention changes the physical state parameter of the material from powder to melt, eliminating particle segregation and agglomeration issues inherent in powder processing. By processing the material in a molten state and then cooling it to form a solid matrix, the process achieves predictable microstructure and uniform drug distribution without the reliability problems of powder-based methods
Solution Approach 2:
The invention replaces the mechanical powder processing system (mixing, compacting, granulation) with a thermal processing system (melting, extruding, cooling). This substitution eliminates the mechanical forces that cause particle segregation and agglomeration, resulting in more reliable and predictable dosage form properties
2Productivity
If traditional batch processing is used for dosage form manufacture, then the process is flexible, but it is resource-intensive and time-consuming
Solution Approach 1:
The invention implements continuous processing where materials are continuously fed, melted, extruded, and cooled in an uninterrupted flow. This eliminates the batch-to-batch interruptions, setup times, and idle periods inherent in traditional batch processing, significantly improving productivity while reducing overall processing time and resource consumption
3Manufacturing precision
If powder mixing and compacting are used, then the manufacturing process is established and simple, but the microstructure and drug release rate are difficult to control tightly
Solution Approach 1:
The invention controls drug release rate by adjusting parameters in the melt processing system, such as extrusion temperature, cooling rate, and mold geometry, rather than relying on powder compaction parameters. This provides tighter control over the microstructure and release characteristics while maintaining relatively simple processing equipment
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 the production of dosage forms with precisely controlled properties, such as drug release rates and drug content, and a wider range of properties, improving the predictability and efficiency of the manufacturing process.
Implementation Method 1
at least one conveying element for extruding the plasticized matrix in the extrusion channel through at least one exit port and form at least one plasticized fiber
Implementation Method 2
a translating or rotating stage for structuring one or more of the extruded plasticized fibers to a three dimensional structural network by depositing said fibers along a path defined by motion of said stage
Data Source
AI summary
In this specification, an apparatus for the manufacture of solid dosage forms is disclosed. The apparatus includes means for extruding plasticized matrix through an exit port to form fibrous extrudate, and a movable stage for depositing the fibrous extrudate and form a three dimensional structural framework defined by motion of said stage.