Transdermal Drug Device Using Porous Ceramic Polymer Composite

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Solution Overview

Problem

Current transdermal opioid analgesic formulations face challenges with dose dumping, misuse, and abuse due to their susceptibility to extraction and manipulation, which compromises patient safety and compliance in chronic pain management.

Innovation Solution

A transdermal drug administration device featuring a sustained-release pharmaceutical composition where the active pharmaceutical ingredient is interspersed within a solid, continuous network of a carrier material with high mechanical strength, formed through chemical reactions or ceramic materials, providing uniform and prolonged release, and incorporating a film-forming agent to enhance tamper resistance.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Reliability

If conventional transdermal opioid formulations are used, then pain relief is provided, but the formulations are susceptible to dose dumping, misuse, and abuse due to easy extraction and manipulation

Engineering Contradiction:

Improveresistance to dose dumping and abuseVSAvoidsusceptibility to extraction and manipulation

Core Design Contradiction:

ReliabilityVSObject-affected harmful factors

Solution Approach 1:

The patent employs a composite material system consisting of an opioid analgesic dispersed within a polymer matrix that has been impregnated into a porous ceramic structure. The ceramic provides mechanical strength and structural integrity, while the polymer matrix controls drug release and resists extraction. This composite architecture prevents both dose dumping and abuse by combining the drug-release properties of polymers with the mechanical robustness of ceramics.

Inventive Principle:

Principle #40Composite materials

Solution Approach 2:

The patent utilizes a porous ceramic structure as the foundational scaffold. The porous architecture provides high surface area for drug loading, controlled porosity for sustained release, and structural framework for the polymer impregnation. The porous structure allows the opioid to be distributed throughout the three-dimensional network, enabling controlled diffusion while maintaining mechanical integrity resistant to manipulation.

Inventive Principle:

Principle #31Porous materials

2Reliability

If sustained release formulations are designed to prevent abuse, then patient safety improves, but the device complexity increases

Engineering Contradiction:

Improvepatient safetyVSAvoidformulation structure

Core Design Contradiction:

ReliabilityVSDevice complexity

Solution Approach 1:

The porous ceramic structure serves as a pre-formed scaffold that can be directly impregnated with the polymer-drug composition. This approach avoids the need to create pores in dense materials or to sinter complex structures, thereby simplifying manufacturing while maintaining the sustained-release and abuse-resistance functions.

Inventive Principle:

Principle #31Porous materials

Solution Approach 2:

The ceramic structure is prepared with its porous architecture before the polymer impregnation step. This preliminary preparation of the scaffold allows subsequent straightforward impregnation with the drug-containing polymer, eliminating the need for complex multi-step formation processes and reducing overall device complexity while achieving the desired sustained-release performance.

Inventive Principle:

Principle #10Preliminary action

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 ensures a stable and prolonged release of the active ingredient, minimizing the risk of dose dumping and abuse by maintaining mechanical integrity and preventing extraction, thereby improving patient safety and compliance in chronic pain management.

Implementation Method 1

sustained-release pharmaceutical composition comprising an active pharmaceutical ingredient co-formedly interspersed (dispersed) within pores of a solid, continuous network comprising a carrier material

Methodology Applied

Scientific EffectDiffusion: Diffusion

Implementation Method 2

provides for the controlled release of active ingredients

Methodology Applied

Scientific EffectErosion: Erosion

Implementation Method 3

carrier material for the active pharmaceutical ingredient and possessing a high mechanical strength

Methodology Applied

Scientific EffectMechanical strength: Mechanical Force

Implementation Method 4

incorporating a film-forming agent to enhance tamper resistance

Methodology Applied

Scientific EffectFilm formation: Coatings

Data Source

PatentUS10251834B2Transdermal drug administration device

Publication Date: 2019.04.09 EMPLICURE AB

AI summary

A transdermal drug administration device comprising a drug delivery element (10) defining a contact surface (12) for location, in use, against a patient's skin. The drug delivery element (10) includes a sustained-release pharmaceutical composition. The composition comprises a network of a carrier material having a high mechanical strength and an active pharmaceutical ingredient. The active pharmaceutical ingredient is co-formedly interspersed within pores in the solid, continuous network of the carrier material.