Implantable Drug Delivery pH Control for Sustained Release

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Solution Overview

Problem

Existing implantable devices for long-term therapeutic agent delivery lack effective methods to control the rate of release, particularly for peptides and proteins, necessitating improved adherence and stability.

Innovation Solution

Utilizing a pH controlling agent within a titania nanoporous membrane system to regulate the release of therapeutic agents by adjusting the pH of the formulation, thereby controlling the release rate and duration.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Duration of action of stationary object

If an implantable device releases a therapeutic agent continuously, then long-term treatment adherence is improved, but the ability to control the release rate is insufficient

Engineering Contradiction:
Improveduration of therapeutic agent releaseVSAvoidcontrol of release rate
Core Design Contradiction:
Duration of action of stationary objectVSAdaptability or versatility

Solution Approach 1:

The patent applies parameter changes by adjusting the pH of the formulation to control the release rate of the therapeutic agent. The pH is selected at a level suitable to achieve a desired rate of release, transforming a static release system into one that can be tuned by modifying chemical parameters of the formulation.

Inventive Principle:
Principle #35Parameter changes

2Productivity

If the release rate of therapeutic agent is increased, then treatment effectiveness is improved, but stability of the therapeutic agent decreases

Engineering Contradiction:
Improverelease rate of therapeutic agentVSAvoidstability of therapeutic agent
Core Design Contradiction:
ProductivityVSStability of the object's composition

Solution Approach 1:

The patent resolves this contradiction by changing the pH parameter of the formulation. By selecting an appropriate pH level, the system achieves the desired release rate while maintaining therapeutic agent stability, as the pH controls both the release kinetics and the stability profile of the peptide or protein.

Inventive Principle:
Principle #35Parameter changes

3Adaptability or versatility

If a titania nanoporous membrane is used to control release, then release rate control is improved, but device complexity increases

Engineering Contradiction:
Improverelease rate control capabilityVSAvoidcomplexity of implantable device
Core Design Contradiction:
Adaptability or versatilityVSDevice complexity

Solution Approach 1:

The patent uses the titania nanoporous membrane as an intermediary component between the therapeutic agent reservoir and the external environment. The membrane provides the release control function without requiring complex active control systems, serving as a passive but effective mediator that regulates drug release based on pH conditions.

Inventive Principle:
Principle #24Intermediary (Mediator)

4Measurement precision

If pH is adjusted to control release rate, then release control precision is improved, but formulation complexity increases

Engineering Contradiction:
Improveprecision of release rate controlVSAvoidformulation complexity
Core Design Contradiction:
Measurement precisionVSDevice complexity

Solution Approach 1:

The patent employs parameter changes by adjusting the pH of the formulation to precisely control the release rate. This approach uses a fundamental chemical parameter that can be modified through standard formulation techniques, achieving precise control without introducing complex multi-component systems.

Inventive Principle:
Principle #35Parameter changes

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

Achieves a controlled and sustained release of therapeutic agents, optimizing stability and adherence by adjusting pH levels to manage release rates effectively.

Implementation Method 1

a titania nanoporous membrane with a plurality of pores attached to the capsule and providing a diffusion path for release of the therapeutic agent out of the reservoir

Methodology Applied
Scientific EffectDiffusion: Diffusion

Implementation Method 2

use of a pH controlling agent to control a rate of release of a therapeutic agent, which is a peptide or protein, from an implantable device

Methodology Applied
Scientific EffectpH control:

Data Source

PatentEP4178536B1Methods to control the rate of release of therapeutic agents from implantable devices
Publication Date: 2025.10.29 NANO PRECISION MEDICAL INC
  • EP4178536B1 patent drawingFigure 1~2
  • EP4178536B1 patent drawingFigure 3
  • EP4178536B1 patent drawingFigure 4

AI summary

The present disclosure provides compositions of a therapeutic agent and a release rate controlling agent for controlling the rate of release of the therapeutic agent from a reservoir of an implantable drug delivery system. The present disclosure also includes an implantable drug delivery systems incorporating the compositions of the present disclosure as well as methods of treating diabetes using the compositions and implantable drug delivery systems.