Fibrous Dosage Form Manufacturing via Extrusion and Structuring
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Solution Overview
Problem
Current pharmaceutical dosage forms, particularly 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 to manufacture.
Innovation Solution
A method and apparatus for manufacturing fibrous dosage forms using a liquid-based processing approach, where solid constituents are injected into an extrusion channel, solvated, and extruded as plasticized fibers, which are then structured into a three-dimensional network with precise control over microstructure and properties, enabling predictable and controlled drug release.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Reliability
If powder processing is used to manufacture dosage forms, then the manufacturing process is established and widely used, but particle segregation and agglomeration occur leading to unpredictable microstructure and drug release
Solution Approach 1:
The invention changes the physical state parameter of the material from solid powder to liquid melt, eliminating particle segregation and agglomeration issues inherent in powder processing. The molten state allows homogeneous mixing at the molecular level, ensuring predictable microstructure and drug release profiles.
Solution Approach 2:
The invention replaces the mechanical powder mixing and compaction system with a thermal melting and extrusion system. Instead of mechanically mixing powders and compacting them into tablets, the invention melts the materials, extrudes them through a die, and forms fibers that are then assembled into dosage forms, eliminating the harmful effects of mechanical powder processing.
2Productivity
If batch processing is used for dosage form manufacture, then the process is simple to implement, but the manufacturing process is resource-intensive and time-consuming
Solution Approach 1:
The invention implements continuous extrusion processing where materials are continuously melted, extruded, and formed into dosage forms without interruption. This continuous process eliminates the repeated heating, cooling, and processing cycles inherent in batch manufacturing, dramatically reducing manufacturing time and increasing productivity while maintaining simplicity.
3Manufacturing precision
If powder mixing and compacting is used, then the dosage form structure is simple to create, but the porosity and microstructure are non-deterministic
Solution Approach 1:
The invention changes the material state from solid powder to liquid melt during processing, enabling deterministic control over microstructure through parameters such as extrusion temperature, extrusion pressure, and die geometry. This allows precise control of porosity and fiber arrangement, transforming non-deterministic powder compaction into a precision process.
Solution Approach 2:
The invention performs preliminary mixing of drug and excipient materials in the molten state before extrusion, ensuring homogeneous distribution of components. This preliminary homogenization in the liquid phase, followed by controlled extrusion, allows precise control over the final microstructure without requiring complex post-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
This approach allows for the rapid and economical production of dosage forms with a wider range of properties, including drug release rates and content, and enables continuous manufacturing of personalized forms with precise control over microstructure and properties.
Implementation Method 1
at least one solvent is injected into said extrusion channel to solvate at least one injected solid constituent so that the one or more injected solid constituents form a plasticized matrix
Implementation Method 2
The plasticized matrix is conveyed towards an exit port of the extrusion channel by applying mechanical work on the plasticized matrix. Then the plasticized matrix is extruded through an exit port to form at least one plasticized fiber
Data Source
AI summary
Recently, we have introduced fibrous dosage forms that enable predictable microstructures with a greater range of pharmaceutically relevant properties. Presented herein, accordingly, are a method and an apparatus for the manufacture of such fibrous dosage forms. The method includes extruding a plasticized matrix through an exit port of an extrusion channel to form at least one plasticized fiber, and structuring said at least one plasticized fiber to a three dimensional structural network of fibers. The apparatus includes an internally hollow housing defining an extrusion channel, a conveying element for extruding a plasticized matrix in the extrusion channel through an exit port to form at least one plasticized fiber, and a unit for structuring said at least one plasticized fiber to a three dimensional structural network of fibers.