Two-Part Rotary Die Encapsulation for Uniform Multi-Phase Fills
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Solution Overview
Problem
Conventional rotary die encapsulation processes face challenges in maintaining content uniformity for multi-phase formulations due to phase segregation, which can lead to manufacturing issues and equipment damage, particularly when dealing with formulations containing multiple phases with different densities or large particle sizes.
Innovation Solution
A two-part rotary die encapsulation system that separately formulates and introduces each phase of the multi-phase formulation using independent mechanical dispensing mechanisms, allowing precise control over the amount and synchronization with die rotation to minimize phase segregation and equipment damage.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Stability of the object's composition
If the viscosity of the formulation is increased to prevent phase segregation, then content uniformity is improved, but manufacturing problems occur such as high line loss and pump metering issues
Solution Approach 1:
The system divides the multi-phase formulation into separate phases and processes them independently through separate dispensing mechanisms, then combines them during encapsulation. This segmentation prevents phase segregation issues while avoiding the need to increase overall formulation viscosity, thereby maintaining ease of manufacture.
2Device complexity
If a single dispensing pump is used to inject fill composition, then the process is simple, but content uniformity cannot be maintained for multi-phase formulations due to phase separation
Solution Approach 1:
The single dispensing pump is replaced with multiple independent dispensing mechanisms, each dedicated to a specific phase of the multi-phase formulation. This allows each phase to be metered separately without segregation, maintaining content uniformity while managing device complexity through modular design.
Solution Approach 2:
The system introduces a multi-channel dispensing system with separate metering mechanisms for each phase, acting as intermediaries between the formulation reservoirs and the encapsulation zone. This intermediary structure enables precise control over each phase's delivery, preventing phase separation issues.
3Stability of the object's composition
If rheology-modifying excipients are added to prevent phase separation, then content uniformity is improved, but the formulation suffers from undesirable properties such as slowed dispersion and adverse stability effects
Solution Approach 1:
The invention extracts and removes the need for rheology-modifying excipients by fundamentally changing the processing approach. Instead of modifying the formulation's rheology to prevent phase separation, the system processes each phase separately and combines them during encapsulation, eliminating harmful excipients while maintaining phase stability.
4Stability of the object's composition
If high viscosity formulation is used to prevent sedimentation, then phase stability is improved, but line loss increases due to material adhering to transfer line walls
Solution Approach 1:
The system segments the multi-phase formulation into separate phases processed through independent pathways. Each phase can be optimized for its own flow characteristics without requiring high overall viscosity, thereby reducing line loss while maintaining phase stability during processing.
Data Source
AI summary
Disclosed herein are a rotary die encapsulation system and process for manufacturing capsules and uses thereof. The rotary die encapsulation system and process may be used for improving content uniformity of a multi-phase fill composition in a capsule. The rotary die encapsulation system and process may also be used for tuning dose strength of a fill composition in a capsule.