Pressurized Canister Coating and PEG Formulation for Inhaler Dose Accuracy

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Solution Overview

Problem

Current metered dose inhalers often result in a significant reduction of active pharmaceutical ingredients being wasted due to lower actual doses compared to theoretical doses, and there is a lack of suitable metered dose inhalers for certain medications like umeclidinium and vilanterol, particularly for patients who cannot inhale deeply enough to receive drugs from dry powder inhalers.

Innovation Solution

A pressurized canister formulation containing umeclidinium or vilanterol, or both, combined with poly(ethylene glycol) and coated with a poly(fluoroalkylene) polymer, which improves the delivery of active pharmaceutical ingredients by increasing the actual dose closer to the theoretical dose and reducing waste.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Loss of substance

If conventional metered dose inhalers are used, then the device structure is simple, but the actual dose delivered is significantly lower than the theoretical dose, resulting in waste of active pharmaceutical ingredients

Engineering Contradiction:
Improvewaste of active pharmaceutical ingredientsVSAvoidconsistency between theoretical and actual dose
Core Design Contradiction:
Loss of substanceVSReliability

Solution Approach 1:

The patent changes the physical and chemical parameters of the canister interior by applying a fluoropolymer coating and formulating with poly(ethylene glycol), which modifies the surface properties and formulation characteristics to reduce drug loss and improve dose consistency

Inventive Principle:
Principle #35Parameter changes

Solution Approach 2:

The patent uses composite materials including fluoropolymer coatings on the canister interior and poly(ethylene glycol) in the formulation, combining multiple materials with complementary properties to achieve both improved dose delivery and reduced waste

Inventive Principle:
Principle #40Composite materials

2Ease of operation

If dry powder inhalers are used, then the device structure is simple, but patients who cannot inhale deeply enough cannot receive the drug effectively

Engineering Contradiction:
Improvebreathing effort requiredVSAvoiddrug delivery effectiveness
Core Design Contradiction:
Ease of operationVSReliability

Solution Approach 1:

The patent uses pressurized aerosol technology where propellants provide the mechanical force to deliver the drug, eliminating the need for deep patient inhalation while maintaining effective drug delivery through pressure-driven aerosolization

Inventive Principle:
Principle #29Pneumatics and hydraulics

3Reliability

If poly(ethylene glycol) and poly(fluoroalkylene) coatings are added to the canister formulation, then the actual dose delivery is improved and waste is reduced, but the device complexity increases

Engineering Contradiction:
Improveactual dose consistencyVSAvoidformulation and canister complexity
Core Design Contradiction:
ReliabilityVSDevice complexity

Solution Approach 1:

The patent modifies the canister interior surface properties through fluoropolymer coating and adjusts formulation parameters by incorporating poly(ethylene glycol), changing physical and chemical parameters to improve performance without fundamentally altering the device structure

Inventive Principle:
Principle #35Parameter changes

Data Source

PatentUS20220362225A1Aerosol formulation, canister, and inhaler containing the formulation, and method of use
Publication Date: 2022.11.17 KINDEVA DRUG DELIVERY LP

AI summary

Pressurized canisters coated with poly(fluoroalkylene) polymer or a copolymer of poly(fluoralkylenes) and containing a formulation comprising one or more active pharmaceutical ingredients comprising umeclidinium or a salt thereof, vilanterol or a salt thereof, or a combination of two or more of the foregoing, poly(ethylene glycol), and a propellant, inhalers comprising the pressurized canister, as well as methods of using the pressurized canisters and inhalers.