Direct Compressible Dextrose via Roller Compaction
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Solution Overview
Problem
Current methods for preparing dextrose compositions for pharmaceutical or food formulations lack sufficient flowability, friability, and compressibility, making them inefficient and costly to produce, especially when direct compression methods are not feasible due to the nature of active ingredients.
Innovation Solution
A dry granulation process involving roller compaction or slugging of a high-dextrose composition, followed by crushing and screening to produce granules with specific particle size distribution, enhancing the dextrose's compressibility and flowability, allowing for the production of tablets with higher hardness and reduced friability.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Productivity
If direct compression method is used, then production steps are reduced, but the method is only employable if ingredients have good flow properties and compaction characteristics
Solution Approach 1:
The invention changes the physical parameters of dextrose by converting it from crystalline form to amorphous form through melt granulation. This parameter change transforms the flow and compaction properties of dextrose, making it suitable for direct compression methods that were previously not applicable to crystalline dextrose.
Solution Approach 2:
The invention utilizes phase transition of dextrose from solid crystalline state to molten state and then to amorphous solid state. This phase transition process fundamentally alters the material properties, enabling direct compression while maintaining versatility with different active ingredients.
2Manufacturing precision
If granulation method is used to improve flow and compaction properties, then tablet quality is improved, but the process becomes more complex and costly
Solution Approach 1:
The invention merges the granulation process with the dextrose processing step by incorporating amorphous dextrose production directly into the granulation operation. This combination eliminates separate granulation equipment and steps, reducing process complexity while maintaining tablet quality improvements.
Solution Approach 2:
By changing dextrose to amorphous form, the invention inherently improves flow and compaction properties without requiring complex granulation machinery. The parameter change of dextrose itself serves as the primary mechanism for quality improvement, simplifying the overall process.
3Quantity of substance
If conventional dextrose is used, then cost is reduced, but flowability, friability, and compressibility are insufficient
Solution Approach 1:
The invention changes the physical state of dextrose from crystalline to amorphous, fundamentally altering its flowability, friability, and compressibility parameters. This parameter transformation enables conventional dextrose to achieve superior processing characteristics without changing the chemical composition or adding expensive additives.
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
The process results in a direct compressible dextrose composition that enables the production of tablets with higher hardness, increased active ingredient incorporation, and reduced capping, while maintaining lower compression forces and improved resistance to handling and shipment.
Implementation Method 1
compacting the starting dextrose composition by roller compaction to form flakes
Implementation Method 2
compacting the starting dextrose composition by slugging to form slugs
Implementation Method 3
crushing the flakes or the slugs obtained in step (b) to form granules
Data Source
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AI summary
This invention relates to a direct compressible dextrose composition, a process for preparing such a direct compressible dextrose composition by compression and subsequent granulation, and processes for preparing pharmaceutical formulations or food formulations in tablet form using the direct compressible dextrose composition. The invention further concerns pharmaceutical or food formulations, which comprise the directly compressible dextrose composition, and the use of the direct compressible dextrose composition for the preparation of pharmaceutical and food formulations.