Biodegradable PCL Capsule for Sustained Antibody Release

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Solution Overview

Problem

Current methods for delivering monoclonal antibodies, such as bevacizumab and dexamethasone, face challenges due to the need for frequent injections or implants that are not biodegradable, causing discomfort and requiring surgical removal, and existing biodegradable systems struggle to sustainably release antibodies over a long period without immune responses or toxicity.

Innovation Solution

A biodegradable capsule implant made of polycaprolactone (PCL) with nano-pores is developed to absorb and desorb therapeutic agents like antibodies, allowing for controlled release over several months, using a method that involves stacking polymer sheets, rolling them into a cylindrical shape, and creating pores through sonication or water bath treatment to house and release the agents.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Reliability

If frequent intravitreal injections are administered to maintain therapeutic levels of monoclonal antibodies, then therapeutic efficacy is maintained, but patient discomfort and risk of complications increase

Engineering Contradiction:

Improvetherapeutic efficacyVSAvoidpatient discomfort and complications

Core Design Contradiction:

ReliabilityVSObject-affected harmful factors

Solution Approach 1:

The invention segments the therapeutic delivery into multiple small doses released over time from a single implantable capsule, rather than requiring one large injection. The capsule contains monoclonal antibodies that are gradually released through diffusion and degradation of the biodegradable polymer matrix, providing sustained therapeutic levels while eliminating the need for repeated injections

Inventive Principle:

Principle #1Segmentation

Solution Approach 2:

The invention performs preliminary action by pre-loading the therapeutic agent into a biodegradable capsule implant that is surgically positioned at the treatment site. The capsule is designed to release the monoclonal antibody over a predetermined period, thereby preparing the system in advance to maintain therapeutic levels without requiring subsequent interventions

Inventive Principle:

Principle #10Preliminary action

2Duration of action of moving object

If non-biodegradable implants are used for sustained antibody release, then injection frequency is reduced, but surgical removal is required

Engineering Contradiction:

Improveduration of antibody releaseVSAvoidsurgical removal requirement

Core Design Contradiction:

Duration of action of moving objectVSEase of manufacture

Solution Approach 1:

The invention applies the discarding principle by using a biodegradable polymer matrix that automatically degrades and is absorbed by the body over time. The capsule and its contents are designed to be transient, with the polymer breaking down into harmless byproducts that are metabolized and eliminated, thereby eliminating the need for surgical removal while maintaining sustained release functionality

Inventive Principle:

Principle #34Discarding and recovering

3Ease of manufacture

If high temperature melt-extrusion method is used for implant fabrication, then polymer mixing is achieved, but antibody stability is compromised

Engineering Contradiction:

Improvepolymer mixingVSAvoidantibody stability

Core Design Contradiction:

Ease of manufactureVSStability of the object's composition

Solution Approach 1:

The invention replaces the thermal-mechanical melt-extrusion process with a cold-forming technique. The biodegradable polymer is dissolved in a solvent to form a homogeneous solution, then cast or molded into the desired implant shape, allowing the antibody to be uniformly distributed throughout the polymer matrix without exposure to high temperatures that would denature the protein

Inventive Principle:

Principle #28Mechanics substitution (Replace mechanical system)

Solution Approach 2:

The invention uses a solvent as an intermediary medium to achieve uniform mixing of the antibody and polymer. The polymer is dissolved in the solvent along with the therapeutic agent, creating a homogeneous solution that can be directly formed into the implant structure, thereby achieving thorough mixing without thermal degradation

Inventive Principle:

Principle #24Intermediary (Mediator)

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 PCL capsule implant achieves sustained release of therapeutic agents for at least 50 days, with accelerated degradation methods validating long-term release kinetics, reducing the frequency of injections and minimizing immune responses, while maintaining therapeutic efficacy and safety.

Implementation Method 1

The capsule body is configured to absorb the therapeutic agent at the inner surface and desorb the therapeutic agent out of the outer surface

Methodology Applied

Scientific EffectAdsorption: Adsorption

Implementation Method 2

Biodegradable polycaprolactone capsule for antibody release and degradation

Methodology Applied

Scientific EffectHydrolysis: Hydrolysis

Data Source

PatentUS20230355533A1Biodegradable polycaprolactone capsule for antibody release and degradation

Publication Date: 2023.11.09 UNIVERSITY OF CINCINNATI

AI summary

A biodegradable capsule implant is provided. The biodegradable capsule includes a capsule body having an inner surface and an outer surface. The capsule body includes a polymer, and the inner surface defines a hollow interior space. The biodegradable capsule further includes a therapeutic agent housed in the hollow interior space. The biodegradable capsule further includes a plurality of pores on the capsule body. The capsule body is configured to absorb the therapeutic agent at the inner surface and desorb the therapeutic agent out of the outer surface.