Implantable Drug Delivery Device Using Solubilizer for Low Solubility Agents

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Solution Overview

Problem

Existing implantable drug delivery devices face challenges in achieving a controlled and consistent release of therapeutic agents, particularly for low solubility drugs, due to geometric constraints and the need for large solvent volumes, which can lead to inefficient drug administration and compliance issues.

Innovation Solution

The use of a solubilizer with low miscibility in a reservoir containing nanochannels or microchannels to control the release of therapeutic agents, allowing for a more steady concentration of the drug over time, enabling the administration of drugs with poor water solubility through a non-aqueous formulation.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Quantity of substance

If a large volume of solvent is used to dissolve low solubility therapeutic agents, then the drug can be administered at effective dosing levels, but the implantable delivery device becomes prohibitively large

Engineering Contradiction:
Improvedosing levelVSAvoiddevice volume
Core Design Contradiction:
Quantity of substanceVSVolume of stationary object

Solution Approach 1:

The invention changes the physical-chemical parameters of the formulation by using co-solvents and surfactants to alter the solubility characteristics of the therapeutic agent, enabling high concentration of drug in a small volume of solvent

Inventive Principle:
Principle #35Parameter changes

Solution Approach 2:

The invention uses composite formulations combining multiple solvents and surfactants with the therapeutic agent to create a stable, high-concentration solution that fits within a small implantable device volume

Inventive Principle:
Principle #40Composite materials

2Productivity

If geometric constraints such as nanochannels are used to control diffusion rate, then the release rate can be controlled, but it becomes difficult or impossible to create appropriate constraints for small therapeutic molecules

Engineering Contradiction:
Improverelease rate controlVSAvoidgeometric constraint fabrication
Core Design Contradiction:
ProductivityVSEase of manufacture

Solution Approach 1:

The invention replaces the mechanical geometric constraint system (nanochannels) with a chemical formulation system using co-solvents and surfactants to control drug release, enabling effective control for small molecules that cannot be constrained by physical barriers

Inventive Principle:
Principle #28Mechanics substitution (Replace mechanical system)

3Reliability

If traditional saline-based formulations are used to match the physiologic environment, then molecular diffusion is promoted, but drugs with poor water solubility cannot be effectively administered

Engineering Contradiction:
Improvemolecular diffusionVSAvoiddrug concentration
Core Design Contradiction:
ReliabilityVSQuantity of substance

Solution Approach 1:

The invention changes the solvent parameters from aqueous saline to organic co-solvent systems, fundamentally altering the solubility and diffusion characteristics to enable administration of poorly water-soluble drugs while maintaining effective release

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

This approach allows for a controlled and prolonged release of therapeutic agents, improving patient compliance and reducing side effects by maintaining a consistent drug concentration, even for drugs with low solubility, and enabling the administration of drugs that would be difficult to deliver consistently with traditional methods.

Implementation Method 1

The solubility of certain therapeutic agents can provide dosing and application challenges

Methodology Applied
Scientific EffectMiscibility:

Implementation Method 2

certain implantable drug delivery devices may utilize nanochannels to restrict the rate at which therapeutic molecules can diffuse from the device

Methodology Applied
Scientific EffectDiffusion: Diffusion

Implementation Method 3

a therapeutic agent with poor water solubility requires a greater volume of solvent to dissolve the therapeutic agent

Methodology Applied
Scientific EffectSolubility: Solvation

Data Source

PatentUS10369340B2Device and method for sustained release of low water solubility therapeutic agent in solubilizer
Publication Date: 2019.08.06 NANOMEDICAL SYST
  • US10369340B2 patent drawing
  • US10369340B2 patent drawing
  • US10369340B2 patent drawing

AI summary

Devices and methods for administering a therapeutic agent, including an implantable delivery device. Exemplary embodiments include a reservoir in fluid communication with a channeled member, and a compound including the therapeutic agent and a solubilizer disposed within the reservoir.