Flowable Drug Composition Viscosity Transition for Depot Migration

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Solution Overview

Problem

Existing localized drug delivery methods face challenges with drug depot migration from the implant site, leading to reduced efficacy and increased physical and psychological trauma, especially in chronic diseases like osteoarthritis and sciatica, where precise and long-term drug placement is difficult to achieve.

Innovation Solution

A flowable composition comprising a solvent, polymer, and therapeutic agent that increases in viscosity or forms a denser surface film upon contact with physiological fluids, allowing for precise and minimally invasive implantation and sustained drug release at the target site, preventing migration and ensuring accurate drug placement.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Duration of action of moving object

If a drug depot is delivered locally to the treatment site, then the therapeutic agent can be released over extended periods, but the drug depot may migrate from the implant site prior to surgical closure or as physiological conditions change

Engineering Contradiction:
Improveduration of drug releaseVSAvoidplacement accuracy of drug depot
Core Design Contradiction:
Duration of action of moving objectVSReliability

Solution Approach 1:

The composition changes its physical state from flowable to substantially non-flowable by changing viscosity parameters in response to physiological conditions (temperature, pH, ionic strength), thereby preventing migration while maintaining extended drug release capability

Inventive Principle:
Principle #35Parameter changes

Solution Approach 2:

The composition is designed to undergo gelation or densification before complete drug release occurs, establishing physical containment at the implant site prior to the extended release phase, thus preventing migration during the treatment period

Inventive Principle:
Principle #10Preliminary action

2Ease of operation

If a flowable composition is used for minimally invasive injection, then accurate and precise placement can be achieved, but the composition may diffuse away from the injection site

Engineering Contradiction:
Improveease of injectionVSAvoidplacement precision of drug
Core Design Contradiction:
Ease of operationVSManufacturing precision

Solution Approach 1:

The composition transitions from a dynamic flowable state during injection to a static substantially non-flowable state at the implant site, allowing easy administration followed by precise localization and prevention of diffusion

Inventive Principle:
Principle #15Dynamics

Solution Approach 2:

The composition undergoes a phase transition from liquid/flowable to gel/solid state in response to physiological conditions, enabling easy injection followed by stable retention at the target site without diffusion

Inventive Principle:
Principle #36Phase transitions

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 solution enables accurate and prolonged drug delivery at the target site, reducing trauma and maintaining therapeutic efficacy while preventing drug depot migration, thus improving treatment outcomes for chronic diseases.

Implementation Method 1

the flowable composition remaining substantially viscous at physiological temperature or wherein the solvent substantially increases in viscosity in response to contact with bodily fluid

Methodology Applied
Scientific EffectViscosity change:

Implementation Method 2

the composition reacts with the physiological fluids of the patient to produce a denser exterior surface or film on the viscous carrier composition

Methodology Applied
Scientific EffectSurface film formation:

Data Source

PatentUS9504698B2Flowable composition that sets to a substantially non-flowable state
Publication Date: 2016.11.29 WARSAW ORTHOPEDIC INC
  • US9504698B2 patent drawing
  • US9504698B2 patent drawing

AI summary

Flowable compositions and methods are provided for delivering a therapeutic agent at or near a target tissue site beneath the skin of a patient, the flowable composition comprising (i) a solvent, (ii) a polymer and (iii) an effective amount of the therapeutic agent, the flowable composition being capable of setting to form a substantially non-flowable composition at a physiological temperature or as the solvent contacts bodily fluid at or near the target tissue site, wherein the substantially non-flowable composition is capable of releasing the therapeutic agent over a period of at least one day and the target tissue site comprises at least one muscle, ligament, tendon, cartilage, spinal disc, spinal foraminal space near the spinal nerve root, facet or synovial joint, or spinal canal.