Solid Polymer Drug Delivery Composition
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Solution Overview
Problem
Current methods for local delivery of pharmacologically active agents, such as bupivacaine and antibiotics, face limitations including irregular drug release profiles, toxicity concerns, and the need for continuous monitoring of infusion catheters, highlighting the need for biodegradable and biocompatible drug delivery systems that provide sustained and controlled release.
Innovation Solution
A solid polymer delivery composition featuring a biodegradable, biocompatible polymer carrier layer with a bioactive agent dispersed within, optionally coated with another biodegradable polymer for controlled release, utilizing polymers with specific chemical formulas that degrade enzymatically to release the agent at a controlled rate, and incorporating a barrier layer to prevent solvent-induced drug loss.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Quantity of substance
If bolus injections or infusion catheters are used for local delivery of pharmacologically active agents, then the drug can be delivered to the target site, but the delivery is limited by the volume of liquid that can be injected and requires continuous monitoring to ensure catheter does not migrate
Solution Approach 1:
The patent extracts the drug delivery function from the complex infusion catheter system and concentrates it into a solid polymer implant that is inserted once and then passively degrades over time. This removes the need for continuous monitoring while maintaining effective drug delivery volume.
Solution Approach 2:
The patent uses a biodegradable polymer implant that is designed to be disposed of after its drug delivery function is complete. The polymer naturally degrades over time releasing the drug, then disappears from the body, eliminating the need for removal surgery or continuous monitoring.
2Reliability
If intravenous antibiotics are used for treatment of chronic osteomyelitis, then adequate therapy can be achieved, but six weeks of intravenous antibiotics is necessary and there is a significant relapse rate
Solution Approach 1:
The patent incorporates antibiotics directly into the polymer implant before insertion, so the drug is already positioned at the infection site and released gradually over time. This preliminary loading of the drug eliminates the need for prolonged intravenous treatment and reduces relapse rates by maintaining local antibiotic concentrations.
3Ease of operation
If intra-articular bupivacaine infusion is used for pain control, then local anesthetic effect can be provided, but the delivery is limited by the difficulty in providing effective local anesthetic effect in the relatively large intra-articular space without drug overdose
Solution Approach 1:
The patent segments the drug delivery into multiple small releases over time from the polymer matrix, rather than delivering a large volume at once. This segmentation allows effective anesthetic coverage without exceeding toxic doses, as the polymer releases drug gradually over weeks.
4Ease of operation
If biodegradable polymers are used for drug delivery devices, then the device can be removed automatically after drug release, but the polymer must be designed to degrade at a controlled rate
Solution Approach 1:
The patent controls polymer degradation rate by carefully selecting polymer composition, molecular weight, and crosslinking density during manufacturing. These parameter changes allow precise control over how quickly the polymer degrades, ensuring the device removes automatically after the desired drug release period without requiring manual removal.
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 solution enables a controlled and sustained release of bioactive agents over an extended period, avoiding initial burst release and ensuring consistent delivery, reducing toxicity and the need for continuous monitoring, while being fully biodegradable and non-toxic.
Implementation Method 1
utilizing polymers with specific chemical formulas that degrade enzymatically to release the agent at a controlled rate
Implementation Method 2
incorporating a barrier layer to prevent solvent-induced drug loss
Data Source
Figure 1
AI summary
The present invention provides an implantable solid polymer delivery composition that can be formulated to release a bioactive agent to an interior body site at a controlled rate over an extended period of time by adjusting the various components of the composition. The controlled delivery of the composition avoids an initial drug spike, resulting in a smooth delivery profile over time. Polymer layers in the composition can be porous and are both biodegradable in water and body enzymes and biocompatible. Methods of making the implantable solid polymer compositions and methods of delivering a bioactive agent at a controlled rate to an interior body site are also provided.