Continuous Droplet Dehydration for Low-Void Circular Biologic Particles
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Solution Overview
Problem
Current methods for forming circular particles with therapeutic biologics lack sufficient control over size uniformity, shape selectivity, and surface functionality, leading to difficulties in achieving low internal void spaces and reproducible morphology.
Innovation Solution
A method involving continuous droplet formation and dehydration of aqueous liquid droplets comprising a therapeutic biologic, where the Peclet number determines the morphology, resulting in circular particles with less than 10% internal void spaces and a circularity of 0.80 to 1.00.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Manufacturing precision
If conventional methods are used to form circular particles with therapeutic biologics, then particle formation is achieved, but control over size uniformity, shape selectivity, and surface functionality is insufficient, resulting in high internal void spaces and poor morphology reproducibility
Solution Approach 1:
The patent applies parameter changes by systematically varying droplet formation parameters (flow rates, sizes, composition) and dehydration conditions (temperature, humidity, time) to achieve precise control over particle morphology. The Peclet number is used as a key parameter to characterize and control the dehydration process, enabling reproducible circular particle formation with controlled internal void spaces
Solution Approach 2:
The patent employs dynamic control of the dehydration process by adjusting environmental conditions (temperature, humidity) and dehydration rate to achieve desired particle morphology. The continuous monitoring and adjustment of dehydration parameters enables real-time optimization of particle formation, improving both manufacturing precision and morphology reproducibility
2Productivity
If rapid dehydration is applied to form particles, then production speed increases, but internal void spaces increase and morphology control deteriorates
Solution Approach 1:
The patent implements continuous droplet formation and dehydration processes where aqueous droplets are continuously generated, dehydrated, and collected. This continuous operation maintains steady-state conditions that ensure consistent dehydration rates and uniform particle morphology, achieving both high productivity and precise manufacturing control
Solution Approach 2:
The patent applies preliminary action by pre-conditioning the dehydration environment and optimizing droplet parameters before the actual dehydration process begins. This includes pre-setting temperature and humidity conditions, and pre-determining optimal flow rates based on desired particle characteristics, ensuring that the dehydration process proceeds with controlled morphology development
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 method enables the production of pharmaceutically relevant particles with controlled morphology and low internal void spaces, enhancing the stability and functionality of therapeutic biologics for applications in pharmaceutical compositions and therapies.
Implementation Method 1
contacting the aqueous first liquid comprising the therapeutic biologic with an organic second liquid by a continuous process, thereby forming a mixture comprising aqueous liquid droplets
Implementation Method 2
removing the aqueous first liquid and organic second liquid from the mixture, thereby forming particles comprising the therapeutic biologic
Data Source
AI summary
The present disclosure relates to methods that enable the continuous formation of droplets and dehydration of droplets to provide pharmaceutically relevant particles that can be used for therapy. In particular, the methods disclosed herein allow the controlled continuous droplet formation and dehydration that produce circular particles having low internal void spaces comprising bioactive therapeutic biologies.