Biodegradable PRINT Implants for Sustained Ocular Drug Release

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Solution Overview

Problem

Current intravitreal implants for ocular conditions, such as macular edema and uveitis, face challenges with short drug release duration, repeated injections causing discomfort and adverse effects, and prolonged exposure leading to corticosteroid-associated issues like cataract formation and increased intraocular pressure.

Innovation Solution

A biodegradable drug delivery system using Particle Replication in Non-wetting Template (PRINT) technology, which creates uniformly sized and shaped implants with a biodegradable polymer matrix homogenously dispersed with corticosteroids like dexamethasone or fluocinolone acetonide, providing a sustained release for extended periods without the need for frequent injections.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Reliability

If repeated bolus injections of corticosteroids are administered, then therapeutic effect is achieved, but adverse effects such as cataract formation and increased intraocular pressure occur

Engineering Contradiction:

Improvetherapeutic effectVSAvoidadverse effects

Core Design Contradiction:

ReliabilityVSObject-affected harmful factors

Solution Approach 1:

The implant is pre-loaded with corticosteroid medication and implanted directly into the vitreous humor, establishing sustained drug delivery before adverse effects can occur from repeated injections. The preliminary action of implanting the drug reservoir eliminates the need for subsequent injection visits.

Inventive Principle:

Principle #10Preliminary action

Solution Approach 2:

The biodegradable polymer matrix acts as an intermediary carrier that slowly releases corticosteroids over time. This intermediary system provides controlled drug delivery, maintaining therapeutic levels while avoiding the peak concentrations that cause adverse effects from bolus injections.

Inventive Principle:

Principle #24Intermediary (Mediator)

2Loss of time

If intravitreal implants are used for sustained drug release, then treatment frequency is reduced, but manufacturing precision and uniformity are challenging

Engineering Contradiction:

Improvetreatment frequencyVSAvoidimplant uniformity

Core Design Contradiction:

Loss of timeVSManufacturing precision

Solution Approach 1:

The manufacturing process parameters are precisely controlled, including polymer composition ratios, drug loading concentration, implant size, and porosity. By optimizing these parameters, the system achieves both reduced treatment frequency and consistent implant performance across batches.

Inventive Principle:

Principle #35Parameter changes

Solution Approach 2:

The implant uses composite materials consisting of biodegradable polymers (such as PLGA) combined with corticosteroid medication. This composite structure allows tailored drug release kinetics and mechanical properties, achieving both extended treatment duration and manufacturing consistency through material science principles.

Inventive Principle:

Principle #40Composite materials

3Duration of action of moving object

If prolonged corticosteroid exposure is provided, then sustained therapeutic effect is achieved, but corticosteroid-associated adverse effects increase

Engineering Contradiction:

Improvetherapeutic durationVSAvoidcorticosteroid-associated adverse effects

Core Design Contradiction:

Duration of action of moving objectVSObject-affected harmful factors

Solution Approach 1:

The implant utilizes a porous biodegradable polymer matrix that controls drug release through diffusion and erosion mechanisms. The porous structure allows sustained corticosteroid release over months while maintaining therapeutic levels, avoiding the accumulation that leads to adverse effects from prolonged exposure.

Inventive Principle:

Principle #31Porous materials

Solution Approach 2:

The implant provides periodic drug release as the polymer matrix gradually degrades over time. This periodic release pattern maintains therapeutic efficacy while preventing continuous high-level exposure that would increase adverse effects, as the drug is released in controlled amounts over the implant's degradation timeline.

Inventive Principle:

Principle #19Periodic action

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 biodegradable implants offer a safer and more effective sustained release of corticosteroids directly to the posterior of the eye, reducing adverse events and improving patient compliance by maintaining therapeutic levels for several months, thus effectively treating ocular inflammation with minimized side effects.

Implementation Method 1

releases fluocinolone acetonide over a period of approximately 3 years

Methodology Applied

Scientific EffectDiffusion: Diffusion

Implementation Method 2

biodegradable polymer matrix that contains a homogenously dispersed therapeutic agent therein

Methodology Applied

Scientific EffectBiodegradation: Decomposition (biological)

Data Source

PatentUS11116776B2Intravitreal drug delivery systems for the treatment of ocular conditions

Publication Date: 2021.09.14 ALCON INC

AI summary

The disclosure teaches precisely engineered biodegradable drug delivery systems and methods of making and utilizing such systems. In aspects, the biodegradable drug delivery systems taught herein comprise intravitreal ocular implants suitable for delivery of corticosteroids to the posterior segment of a human eye. The intravitreal ocular implants described herein have a desired extended drug release profile suitable for treating inflammation of the human eye.