Solid Dosage Form Extrusion for Microstructure Control
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Solution Overview
Problem
Current methods for manufacturing pharmaceutical solid dosage forms, such as porous oral-delivery tablets, face limitations in controlling microstructure, drug content, and drug release rate due to particle segregation and non-deterministic porosity during powder processing, leading to resource-intensive and time-consuming batch processes.
Innovation Solution
A method involving the injection of excipients into an extrusion channel where they form a plasticized matrix with a solvent, which is then extruded and structured into a three-dimensional fiber network, allowing for precise control of fiber thickness, inter-fiber spacing, and drug release properties through mechanical work and solvent evaporation or cooling.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Manufacturing precision
If powder mixing and compacting methods are used to manufacture oral-delivery tablets, then the manufacturing process is simple and widely used, but the microstructure control, drug content uniformity, and drug release rate precision are poor due to particle segregation and non-deterministic porosity
Solution Approach 1:
The invention changes the physical state parameter of the material from solid powder to liquid solution. The liquid-based extrusion process allows precise control of microstructure parameters such as porosity, fiber diameter, and inter-fiber spacing, which cannot be achieved with powder mixing and compacting methods
Solution Approach 2:
The invention replaces the mechanical powder processing system (mixing, compacting) with a liquid-based extrusion system. The extrusion process uses controlled flow of liquid solution through a die to form fibers with predetermined microstructure, eliminating particle segregation and non-deterministic porosity issues
2Productivity
If powder mixing and compacting methods are used, then the manufacturing process is established and simple, but the process is resource-intensive and time-consuming due to batch processing requirements
Solution Approach 1:
The invention implements continuous liquid-based extrusion processing, where the liquid solution is continuously pumped through the extrusion die to form fibers. This continuous process eliminates the batch processing steps inherent in powder manufacturing, significantly improving productivity and reducing processing time
Solution Approach 2:
The drug and excipients are pre-dissolved in the liquid solution before extrusion, ensuring uniform distribution at the molecular level. This preliminary mixing in liquid phase eliminates the need for extensive powder mixing and ensures consistent drug content in the final product
3Manufacturing precision
If liquid-based extrusion processing is used to form plasticized fibers and three-dimensional networks, then the microstructure and drug release rate are precisely controllable, but the process complexity and equipment requirements increase
Solution Approach 1:
The invention creates local quality variations in the extruded fibers by controlling the liquid solution composition and extrusion parameters. Different regions of the three-dimensional network can have different fiber diameters, porosity, and drug concentrations, allowing precise control of drug release rates at different locations
Solution Approach 2:
The invention transitions from two-dimensional powder compaction to three-dimensional fiber network formation. The extrusion process creates fibers with controlled cross-sectional geometry, and the assembly of fibers into three-dimensional networks provides additional degrees of freedom for controlling microstructure and drug release properties
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 enables the production of dosage forms with predictable microstructure and controlled drug release rates, offering a wider range of properties and improving manufacturing efficiency by transitioning from powder-based to liquid-based processing.
Implementation Method 1
at least one solvent that solvates at least one injected excipient is injected into said extrusion channel so that the one or more injected solid excipients and the solvent 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
Implementation Method 3
the plasticized matrix is extruded through an exit port to form at least one plasticized fiber
Implementation Method 4
said at least one plasticized fiber is structured to a three dimensional structural network of one or more fibers
Implementation Method 5
said at least one plasticized fiber is structured to a three dimensional structural network of one or more fibers
Data Source
AI summary
In this specification, a method for the manufacture of solid dosage forms is disclosed. The method includes extruding a plasticized matrix through an exit port of an extrusion channel to form one or more plasticized fibers, structuring said fibers to a three dimensional structural network by patterning on a translating or rotating stage, and solidifying the patterned structure.