Two-Part Rotary Die Encapsulation for Multi-Phase Uniformity
Find Innovative SolutionsGenerate Solutions
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 formulation instability, particularly when dealing with systems that have different densities or large particle sizes, and require high viscosity to prevent segregation.
Innovation Solution
A two-part rotary die encapsulation system and method that separately formulates and controls the introduction of each phase, using independent mechanical dispensing mechanisms to minimize phase segregation and ensure precise dosing, even with low viscosity multi-phase systems.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Stability of the object's composition
If the viscosity of multi-phase 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 while avoiding the need to increase overall formulation viscosity, thereby eliminating manufacturing problems associated with high viscosity.
Solution Approach 2:
The invention changes the processing parameters by controlling the timing and sequence of phase introduction rather than altering the fundamental viscosity parameter of the formulation. Each phase is dispensed at controlled rates independently, maintaining content uniformity without requiring high viscosity that would cause manufacturing issues.
2Stability of the object's composition
If rheology-modifying excipients are added to prevent phase separation, then content uniformity is improved, but undesirable properties are introduced such as slowed dispersion and adverse stability effects
Solution Approach 1:
The invention extracts and removes the need for rheology-modifying excipients by using a different approach - independent mechanical dispensing of each phase. This eliminates the harmful effects of excipients such as slowed dispersion and adverse stability while still achieving content uniformity through precise control of phase incorporation.
Solution Approach 2:
The system introduces a mechanical dispensing mechanism as an intermediary between the multi-phase formulation and the encapsulation process. This intermediary device controls the introduction of each phase separately, achieving content uniformity without relying on chemical excipients that would introduce harmful properties.
3Device complexity
If a single dispensing pump is used to inject fill composition, then the process is simple, but phase segregation occurs leading to content uniformity issues
Solution Approach 1:
The system segments the single dispensing function into multiple independent dispensing mechanisms, each handling a specific phase. This increases device complexity slightly but dramatically improves content uniformity by preventing phase segregation through independent control of each phase's introduction.
Solution Approach 2:
The invention introduces dynamic control capabilities where each dispensing mechanism can independently adjust its dispensing rate and timing. This dynamic control allows the system to adapt to the specific properties of each phase, maintaining content uniformity while providing precise control over the encapsulation process.
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 system achieves uniform multi-phase encapsulation with minimal API content variability, reduces the need for rheology-modifying excipients, and minimizes damage to processing equipment, while allowing in-situ adjustment of API dosage strength.
Implementation Method 1
in instances when the fill system is comprised of multiple phases that can settle or separate prior to being injected between the ribbons
Implementation Method 2
the motion of the liquid can impart centrifugal forces that can cause an otherwise homogenous system to segregate
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.