Polymer Delivery Device Surface Fluid Treatment
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Solution Overview
Problem
Pharmaceutical depot formulations often experience rapid release of bioactive agents due to high loading, leading to uncontrollable release rates, and pose challenges in microbial contamination and surface smoothness for administration.
Innovation Solution
The surface of the delivery system is modified by exposing the polymer to a fluid, reducing permeability and enhancing tensile strength, while allowing for controlled release kinetics and reduced microbial contamination, achieved through a method involving admixing a polymer and agent, processing into a desired shape, and contacting with a fluid to alter surface morphology.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Quantity of substance
If a high amount of bioactive agent is incorporated inside the implant to achieve dose and duration requirements, then the dose and duration requirements are met, but the release rate becomes too fast or uncontrollable
Solution Approach 1:
The patent applies local quality by creating a distinct polymer skin layer with different properties from the bulk matrix. The fluid treatment modifies only the surface region to reduce permeability, while the interior maintains high bioactive agent loading. This localized modification allows the surface to control release rate while the interior provides sufficient drug quantity.
Solution Approach 2:
The implant is segmented into two functional zones: a bulk matrix containing high levels of bioactive agent and a treated polymer skin layer with reduced permeability. This segmentation allows the interior to provide high drug loading while the exterior skin controls the release rate, resolving the contradiction between quantity and release control.
2Ease of manufacture
If the polymer surface is left untreated, then the manufacturing process is simpler, but the surface is rougher and microbial contamination is higher
Solution Approach 1:
A fluid intermediary is introduced to treat the polymer surface. The fluid contacts the polymer skin and modifies its properties, reducing microbial contamination and improving surface smoothness. This intermediary step effectively addresses the harmful factors while maintaining manufacturing feasibility.
Solution Approach 2:
The fluid treatment changes the physical and chemical parameters of the polymer surface, including permeability, surface roughness, and microbial load. These parameter changes occur during or after manufacturing, improving product quality without significantly complicating the manufacturing process.
3Productivity
If the polymer surface permeability is high, then the bioactive agent release rate is faster, but the release becomes uncontrollable and duration is reduced
Solution Approach 1:
The polymer skin is locally treated with fluid to reduce permeability specifically at the surface, while the bulk matrix retains its original permeability characteristics. This creates a gradient structure where the surface controls release rate and the interior maintains drug availability, achieving both controlled release and extended duration.
Solution Approach 2:
The polymer surface is pre-treated with fluid during or after manufacturing to establish the desired permeability characteristics before the implant is used. This preliminary action ensures that when the implant is deployed, the release rate is already controlled and duration is extended, preventing uncontrollable release from the outset.
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 results in a controlled and sustained release of bioactive agents, improved surface smoothness for easier administration, and reduced microbial load, enabling higher loading capacities with longer release durations and increased stability.
Implementation Method 1
The present invention solves this rapid release problem, i.e., the bioactive agent being released too fast, by modifying the polymeric surface or polymer skin of a delivery system by exposing the polymer present in the system to a fluid. The fluid-treatment causes the properties of the polymer on the surface of the delivery system to change such that the system is less permeable.
Implementation Method 2
In addition, the methods described herein can lower the bioburden of the delivery system by reducing the presence of microorganisms present on the system.
Data Source
AI summary
Described herein are methods for reducing and achieving the desired release of an agent from a delivery system. The desired release kinetics are achieved by exposing the surface of the delivery system with a fluid for a desired period of time.