Bioerodible Ocular Insert for Sustained Drug Release
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Solution Overview
Problem
Existing implantable drug delivery systems face challenges in achieving a controlled and sustained release of drugs, particularly for ocular conditions like age-related macular degeneration, with non-biodegradable materials causing discomfort and repeated dosing leading to high systemic concentrations and potential toxicity.
Innovation Solution
A bioerodible drug delivery insert comprising a solid matrix core with vorolanib and PVA, designed for intraocular administration, providing sustained release of the API with zero-order kinetics and minimal systemic exposure, suitable for conditions like AMD.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Ease of operation
If conventional dosing methods are used, then the drug can be administered easily, but the patient is chronically exposed to undesirably high levels of the drug and requires frequent dosing
Solution Approach 1:
The patent uses an implantable drug delivery insert as an intermediary device that locally delivers the drug to the target site (eye) while controlling systemic exposure. The insert acts as a mediator between the drug and the body, providing controlled release and minimizing toxic effects through localized delivery rather than systemic administration
Solution Approach 2:
The patent changes the delivery parameters by transitioning from intermittent systemic dosing to continuous local delivery. By controlling the release rate and duration of drug delivery through the insert, the system maintains therapeutic levels while avoiding the peak-trough concentration cycles that cause toxicity in conventional dosing
2Duration of action of moving object
If implantable drug delivery inserts contain non-biodegradable materials, then the device can provide sustained drug delivery, but the device accumulates in the patient's body and requires repeated implantations
Solution Approach 1:
The patent applies the discarding principle by designing an insert that naturally degrades and is eliminated from the body after delivering the drug. The biodegradable polymer matrix breaks down into harmless byproducts that are metabolized or eliminated by the body, eliminating the need for surgical removal or repeated implantations
Solution Approach 2:
The patent uses composite materials consisting of biodegradable polymers (such as PLGA, PLA, or PCL) combined with the drug payload. This composite structure provides both the sustained delivery function and the biodegradability needed to avoid accumulation, merging the benefits of non-biodegradable sustained release with the safety of biodegradable materials
3Object-affected harmful factors
If the implantable device is made small for minimal discomfort, then patient comfort is improved, but the device cannot contain sufficient drug for sustained delivery
Solution Approach 1:
The patent uses a thin-film or micro-scale insert design that minimizes the physical burden on the patient while maximizing drug loading density. The flexible, thin structure can be implanted with minimal discomfort yet contains sufficient drug through high-concentration formulation and efficient use of the available volume
Solution Approach 2:
The patent changes the concentration parameter by formulating the drug at high concentrations within the insert matrix. This allows a small device volume to contain the required total drug amount, and the controlled release mechanism extends the delivery duration without requiring larger device size
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 insert achieves sustained drug release for up to 270 days with minimal systemic toxicity, reducing the need for frequent dosing and minimizing discomfort by eroding completely within the eye.
Implementation Method 1
comprising a matrix polymer and vorolanib or a pharmaceutically acceptable salt
Implementation Method 2
providing sustained release of the API
Data Source
AI summary
This invention relates to implantable bioerodible inserts for delivering an active pharmaceutical ingredient to the eye. The invention also relates to methods of treatment using such inserts as well as methods of manufacturing such inserts.