Coated Component for Medicinal Delivery Devices

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Solution Overview

Problem

Medicinal delivery devices, particularly inhalers, face variability in dosing due to undesirable interactions between device components and medicinal formulations, leading to issues like medicament degradation and permeation of ambient water, which affect the consistency and reliability of drug delivery.

Innovation Solution

A coated component for medicinal delivery devices featuring a fluorine-containing coating with two layers: a polyfluoropolyether-containing layer and a non-fluorinated layer, applied using a silane-based primer and coating composition, which reduces surface energy and minimizes interactions with the medicinal formulation, thereby enhancing consistency and reducing variability in dosing.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Strength

If a component material with desirable bulk properties is selected, then mechanical strength and other bulk properties are improved, but surface properties such as surface energy may be unsuitable leading to undesirable interactions with medicinal formulation

Engineering Contradiction:

Improvemechanical strengthVSAvoidundesirable interactions with medicinal formulation

Core Design Contradiction:

StrengthVSObject-affected harmful factors

Solution Approach 1:

The patent applies a coating to the surface of the component to provide locally different properties from the bulk material. The coating layer has low surface energy and minimal interaction with medicinal formulation, while the bulk material maintains its mechanical strength and structural integrity. This resolves the contradiction by having different parts of the component (surface vs bulk) serve different functions.

Inventive Principle:

Principle #3Local quality

Solution Approach 2:

The patent creates a composite structure consisting of the base component material combined with a surface coating layer. The coating comprises fluorinated compounds that provide desirable surface properties (low surface energy, minimal permeation, minimal adsorption) while the substrate provides mechanical strength. This composite approach allows both bulk strength and surface compatibility to be optimized simultaneously.

Inventive Principle:

Principle #40Composite materials

2Use of energy by moving object

If materials with high surface energy are used for certain components, then adhesion properties are improved, but operation of movable components may be adversely affected

Engineering Contradiction:

Improveadhesion propertiesVSAvoidoperation of movable components

Core Design Contradiction:

Use of energy by moving objectVSEase of operation

Solution Approach 1:

The coating is applied selectively to surfaces where low adhesion is desirable for movable components, while allowing high adhesion elsewhere if needed. The fluorinated coating reduces surface energy specifically at interfaces where material buildup or sticking would impede movement, resolving the contradiction between adhesion and ease of operation.

Inventive Principle:

Principle #3Local quality

3Device complexity

If ambient water permeation is not prevented, then device simplicity is maintained, but medicament degradation and dosing variability occur

Engineering Contradiction:

Improvedevice simplicityVSAvoiddosing consistency

Core Design Contradiction:

Device complexityVSReliability

Solution Approach 1:

The patent applies a thin film coating to the component surface that acts as a barrier to water permeation. This coating is sufficiently thin and lightweight that it does not significantly increase device complexity, while effectively preventing ambient water from penetrating into the medicinal formulation, thereby maintaining dosing consistency and preventing medicament degradation.

Inventive Principle:

Principle #30Flexible shells and thin films

Solution Approach 2:

The fluorinated coating changes the surface properties of the component, specifically reducing surface energy and creating a hydrophobic barrier. This parameter change prevents water permeation without requiring additional structural components, maintaining device simplicity while improving reliability.

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

The coated component significantly reduces dose-to-dose and unit-to-unit variability in medicinal delivery devices, improving the consistency and reliability of drug delivery by minimizing medicament deposition on device surfaces and maintaining the integrity of the formulation.

Implementation Method 1

reduces surface energy and minimizes interactions with the medicinal formulation

Methodology Applied

Scientific EffectSurface energy reduction: Surface Tension

Implementation Method 2

minimizes interactions with the medicinal formulation, thereby enhancing consistency and reducing variability in dosing

Methodology Applied

Scientific EffectPermeation barrier: Permeation

Data Source

PatentEP3561004B1Coated component

Publication Date: 2021.07.14 KINDEVA DRUG DELIVERY LP

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Figure 1b
Figure 2a~2b

AI summary

Methods of making components for a medicinal delivery device are described, in which a primer composition comprising a silane having two or more reactive silane groups separated by an organic linker group is applied to a surface of a component, then a coating composition comprising an at least partially fluorinated compound is applied to the primed surface. The surface may be a polymer surface. Corresponding coated components and a medicinal delivery device are disclosed. Methods of making metal components are described in which a coating composition comprising an at least partially fluorinated compound is applied to a surface cleaned with a solvent.