Shelf-Stable Biodegradable Polymer Depot for Post-Operative Pain

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Solution Overview

Problem

Traditional surgical procedures often result in significant post-operative pain due to tissue trauma, leading to prolonged recovery times and potential chronic pain, and existing pain management solutions do not provide effective, long-lasting relief without noticeable dimensional changes during storage.

Innovation Solution

Development of shelf-stable pharmaceutical depots comprising biodegradable polyesters with a glass transition temperature of 20 degrees centigrade or less, containing at least 25% wt solid particles and a post-operative pain relieving therapeutic agent like clonidine, which provide extended release profiles and maintain dimensional stability at room temperature.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Reliability

If traditional surgical procedures are used to treat deep body pathologies, then effective treatment can be achieved, but significant tissue trauma and prolonged recovery time occur

Engineering Contradiction:
Improvetreatment effectivenessVSAvoidrecovery time
Core Design Contradiction:
ReliabilityVSLoss of time

Solution Approach 1:

The pharmaceutical depot is implanted before the surgical procedure to provide preemptive pain management and reduce tissue trauma effects. The depot contains pre-formulated therapeutic agents that will be released during and after the surgery, eliminating the need for prolonged post-operative recovery.

Inventive Principle:
Principle #10Preliminary action

Solution Approach 2:

The biodegradable polymer matrix acts as an intermediary carrier that releases therapeutic agents slowly over time. This intermediary system bridges the gap between surgical intervention and healing, providing continuous pain relief and reducing the need for invasive procedures.

Inventive Principle:
Principle #24Intermediary (Mediator)

2Duration of action of moving object

If pharmaceutical depots are designed for extended release, then long-duration pain relief is achieved, but dimensional stability during storage deteriorates

Engineering Contradiction:
Improvepain relief durationVSAvoiddimensional stability
Core Design Contradiction:
Duration of action of moving objectVSStability of the object's composition

Solution Approach 1:

The glass transition temperature of the biodegradable polymer is precisely controlled to be between -50°C and -20°C, ensuring the depot remains dimensionally stable at storage temperatures while maintaining extended release capabilities at physiological temperatures. This parameter optimization resolves the contradiction between stability and duration.

Inventive Principle:
Principle #35Parameter changes

Solution Approach 2:

The pharmaceutical depot uses a composite structure combining biodegradable polymer matrix with embedded therapeutic agents and adjuvants. This composite design allows the polymer to provide structural stability during storage while the embedded components enable extended release of pain relieving agents in the target tissue.

Inventive Principle:
Principle #40Composite materials

3Duration of action of moving object

If biodegradable polyesters with low glass transition temperature are used, then extended release profiles are achieved, but dimensional stability at room temperature deteriorates

Engineering Contradiction:
Improverelease durationVSAvoiddimensional stability
Core Design Contradiction:
Duration of action of moving objectVSShape

Solution Approach 1:

The glass transition temperature is optimized to a specific range (-50°C to -20°C) that balances two opposing requirements: low enough to ensure extended release at body temperature, but high enough to maintain dimensional stability at room temperature during storage and handling.

Inventive Principle:
Principle #35Parameter changes

Solution Approach 2:

The patent employs model compounds and simulated annealing calculations to predict and optimize the glass transition temperature properties before actual synthesis. This virtual modeling approach allows precise control over the polymer's thermal properties to achieve the desired balance between release duration and dimensional stability.

Inventive Principle:
Principle #26Copying

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 pharmaceutical depots offer effective, long-duration pain relief for several days by evenly distributing the therapeutic agent within surgical wounds, maintaining stability and preventing noticeable deformation, thus addressing the challenge of post-operative pain management.

Implementation Method 1

a biodegradable polymer having a glass transition temperature of 20 degrees centigrade or less

Methodology Applied
Scientific EffectGlass transition temperature:

Implementation Method 2

at least 25% wt solid particles suspended in the biodegradable polymer

Methodology Applied
Scientific EffectDiffusion: Diffusion

Data Source

PatentUS9005634B2Shelf stable pharmaceutical depot
Publication Date: 2015.04.14 COMPANION SPINE LLC

AI summary

A pharmaceutical depot includes a biodegradable polymer having a glass transition temperature of 20 degrees centigrade or less and at least 25% wt solid particles suspended in the biodegradable polymer. The pharmaceutical depot also includes a post-operative pain relieving therapeutic agent.