Double Extrusion Ocular Implant for Sustained Dexamethasone Release

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Solution Overview

Problem

Current treatments for ocular conditions, such as macular degeneration and uveitis, face challenges with delivering therapeutic agents effectively to the posterior segment of the eye due to limited intraocular concentration and systemic side effects from conventional administration methods, including short drug half-lives and frequent injections that increase the risk of complications.

Innovation Solution

A bioerodible implant comprising a biodegradable polymer matrix with a therapeutic agent, specifically dexamethasone, is implanted in the vitreous to provide sustained release, bypassing blood-eye barriers and minimizing systemic toxicity, using a double extrusion process for uniform distribution and controlled release.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Quantity of substance

If conventional administration methods are used to deliver therapeutic agents to the posterior segment of the eye, then the treatment can be administered, but the intraocular concentration is limited and systemic side effects occur

Engineering Contradiction:
Improveintraocular concentrationVSAvoidsystemic side effects
Core Design Contradiction:
Quantity of substanceVSObject-affected harmful factors

Solution Approach 1:

The invention divides the drug delivery system into separate compartments: a reservoir containing the therapeutic agent (dexamethasone) and a biodegradable polymer matrix. This segmentation allows the drug to be delivered directly to the posterior segment of the eye while preventing systemic distribution, thereby achieving high intraocular concentration without systemic side effects

Inventive Principle:
Principle #1Segmentation

Solution Approach 2:

The biodegradable polymer matrix acts as an intermediary carrier that transports the therapeutic agent from the reservoir to the target site in the posterior segment of the eye. This intermediary enables controlled local delivery while preventing the drug from entering the systemic circulation

Inventive Principle:
Principle #24Intermediary (Mediator)

2Duration of action of moving object

If conventional administration methods are used, then treatment can be provided, but the drug half-life is short requiring frequent injections

Engineering Contradiction:
Improvedrug half-lifeVSAvoidfrequency of injections
Core Design Contradiction:
Duration of action of moving objectVSEase of operation

Solution Approach 1:

The invention incorporates a large reservoir of therapeutic agent within the biodegradable polymer matrix before implantation. This preliminary loading of the reservoir provides a sustained supply of drug that releases over an extended period (months), eliminating the need for frequent reinjections and extending the duration of action

Inventive Principle:
Principle #10Preliminary action

Solution Approach 2:

The biodegradable polymer matrix provides continuous controlled release of the therapeutic agent from the reservoir over an extended period. This continuous action maintains therapeutic levels in the posterior segment of the eye without interruption, replacing the discontinuous administration required by conventional short-half-life drugs

Inventive Principle:
Principle #20Continuity of useful action

3Reliability

If conventional administration methods are used, then treatment can be administered, but frequent injections increase the risk of complications

Engineering Contradiction:
Improvetreatment effectivenessVSAvoidrisk of complications
Core Design Contradiction:
ReliabilityVSObject-affected harmful factors

Solution Approach 1:

By segmenting the drug delivery into a implanted reservoir system that provides sustained release, the invention eliminates the need for repeated invasive injections. This single implantation event maintains treatment effectiveness over months while reducing cumulative procedural risks

Inventive Principle:
Principle #1Segmentation

Solution Approach 2:

The biodegradable polymer matrix with its embedded reservoir provides self-sustained drug delivery without requiring external intervention or repeated injections. The system automatically maintains therapeutic levels through controlled diffusion, reducing the frequency of medical procedures and associated complications

Inventive Principle:
Principle #25Self-service

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 implant achieves prolonged therapeutic levels of dexamethasone in the vitreous humor with reduced side effects, maintaining effective drug concentrations for extended periods, thereby improving treatment outcomes for ocular conditions like macular edema and uveitis while minimizing systemic exposure.

Implementation Method 1

The implant is made by a double extrusion process... providing sustained release, bypassing blood-eye barriers

Methodology Applied
Scientific EffectDiffusion: Diffusion

Implementation Method 2

bioerodible implant comprising an active agent and a bioerodible polymer matrix

Methodology Applied
Scientific EffectErosion: Erosion

Data Source

PatentUS20240238312A1Ocular implant made by a double extrusion process
Publication Date: 2024.07.18 ALLERGAN INC
  • US20240238312A1 patent drawing
  • US20240238312A1 patent drawing
  • US20240238312A1 patent drawing

AI summary

The invention provides biodegradable implants sized for implantation in an ocular region and methods for treating medical conditions of the eye. The implants are formed from a mixture of hydrophilic end and hydrophobic end PLGA, and deliver active agents into an ocular region without a high burst release.