Silk-Based Ocular Drug Delivery via Controlled Release Hydrogels

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Solution Overview

Problem

There is a need for silk-based products that leverage the polymer strength, flexibility, and biocompatibility of silk to address medical applications, particularly for ocular indications, where existing solutions are inadequate.

Innovation Solution

The development of silk-based products (SBPs) incorporating processed silk and ocular therapeutic agents, formulated as rods or hydrogels, which can be administered intraocularly, incorporating excipients like lactose, sorbitol, and polysorbate 80, to deliver therapeutic agents such as NSAIDs or proteins directly to the eye, with controlled release profiles.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Quantity of substance

If existing ocular delivery solutions are used, then administration is simple, but therapeutic agent concentration and sustained release are inadequate

Engineering Contradiction:

Improvetherapeutic agent concentrationVSAvoiddelivery system complexity

Core Design Contradiction:

Quantity of substanceVSDevice complexity

Solution Approach 1:

The invention uses silk fibroin as a biocompatible polymer matrix composite material that can encapsulate and sustainably release therapeutic agents. The composite structure combines the mechanical properties of silk with the therapeutic functionality of embedded drugs or proteins, achieving high local concentration and prolonged release without requiring complex external delivery devices

Inventive Principle:

Principle #40Composite materials

Solution Approach 2:

The invention modifies the physical and chemical parameters of the delivery system by controlling silk fibroin concentration, molecular weight, and processing conditions to achieve desired release profiles. By adjusting parameters such as fibroin concentration (5-30% w/v) and processing temperature, the system optimizes therapeutic agent encapsulation and release kinetics

Inventive Principle:

Principle #35Parameter changes

2Reliability

If high concentrations of therapeutic agents are delivered, then treatment efficacy improves, but stability and controlled release become challenging

Engineering Contradiction:

Improvetreatment efficacyVSAvoidtherapeutic agent stability

Core Design Contradiction:

ReliabilityVSStability of the object's composition

Solution Approach 1:

Silk fibroin acts as an intermediary matrix that protects therapeutic agents from degradation while enabling controlled release. The fibroin structure provides a biocompatible environment that maintains agent stability through hydrogen bonding and hydrophobic interactions, preventing premature degradation while allowing sustained therapeutic release

Inventive Principle:

Principle #24Intermediary (Mediator)

Solution Approach 2:

The silk fibroin matrix is processed to create a porous structure that facilitates controlled diffusion of therapeutic agents. The porosity allows high drug loading capacity while maintaining structural integrity and enabling tunable release rates through controlled pore size and interconnectivity

Inventive Principle:

Principle #31Porous materials

3Duration of action of stationary object

If silk-based products are developed for ocular use, then biocompatibility and sustained release are achieved, but manufacturing precision and formulation complexity increase

Engineering Contradiction:

Improvesustained release durationVSAvoidformulation precision

Core Design Contradiction:

Duration of action of stationary objectVSManufacturing precision

Solution Approach 1:

The silk fibroin is pre-processed and purified to specific molecular weights and concentrations before therapeutic agent incorporation. This preliminary preparation ensures consistent matrix properties and facilitates precise control over subsequent drug loading and release characteristics, reducing variability in final product performance

Inventive Principle:

Principle #10Preliminary 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 SBPs effectively stabilize and deliver ocular therapeutic agents, providing sustained release and high concentrations in the eye, reducing inflammation and addressing various ocular indications like glaucoma and age-related macular degeneration, while being biocompatible and non-immunogenic.

Implementation Method 1

The SBPs effectively stabilize and deliver ocular therapeutic agents, providing sustained release and high concentrations in the eye

Methodology Applied

Scientific EffectControlled release:

Implementation Method 2

Silk fibroin is a fibrous material that forms a polymeric matrix bonded together with sericin

Methodology Applied

Scientific EffectPolymer matrix bonding:

Data Source

PatentUS11771769B2Ocular applications of silk-based products

Publication Date: 2023.10.03 COCOON BIOTECH INC

AI summary

The embodiments disclosed and embraced by the present invention include silk-based products useful in the treatment, diagnosis, palliation, and/or amelioration of ocular diseases or conditions of the eye including those of the structures of the eye and surrounding tissue. Such silk-based products may effect beneficial outcomes alone or in combination with therapeutic modalities, compounds or medicaments.