Nicotine Formulation for Inhalation via Nebulizer

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Solution Overview

Problem

Current nicotine replacement therapies and e-cigarettes fail to replicate the pharmacokinetic profile of combustible cigarettes, leading to inadequate smoking cessation and generate harmful by-products due to heating, which also affects passive smokers.

Innovation Solution

A pharmaceutical formulation comprising 0.1-8% nicotine as a salt in an acidic pH solution with at least 65% water, minimizing the need for high-temperature heating and reducing harmful by-products, delivered via inhalation using a nebulizer or e-cigarette.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Ease of operation

If nicotine is delivered via heating (combustible cigarettes or e-cigarettes), then nicotine is vaporized for inhalation, but harmful by-products are generated

Engineering Contradiction:
Improvenicotine deliveryVSAvoidharmful by-products
Core Design Contradiction:
Ease of operationVSObject-generated harmful factors

Solution Approach 1:

The invention changes the temperature parameter from high-temperature heating (combustion or vaporization) to ambient temperature aerosolization. The formulation uses water as the primary vehicle (at least 65% w/w) instead of organic solvents, enabling nicotine delivery at ambient temperature through aerosol generation, thereby eliminating thermal decomposition and harmful by-product formation

Inventive Principle:
Principle #35Parameter changes

Solution Approach 2:

The invention extracts and eliminates the heating step from the nicotine delivery process. By using a water-based formulation with high water content, the system achieves nicotine aerosolization without thermal energy input, removing the source of harmful by-products while maintaining effective nicotine delivery

Inventive Principle:
Principle #2Taking out (Extraction)

2Ease of operation

If conventional e-cigarettes use viscous solvents like vegetable glycerine and propylene glycol, then nicotine can be vaporized, but toxicants and heavy metals are generated

Engineering Contradiction:
Improvenicotine vaporizationVSAvoidtoxicants and heavy metals
Core Design Contradiction:
Ease of operationVSObject-generated harmful factors

Solution Approach 1:

The invention fundamentally changes the solvent composition parameter by using water (at least 65% w/w) instead of viscous organic solvents like vegetable glycerine and propylene glycol. This parameter change enables nicotine delivery through aerosolization at ambient temperature, eliminating the need for high-temperature vaporization that generates toxicants and heavy metals

Inventive Principle:
Principle #35Parameter changes

Solution Approach 2:

The invention converts the typically harmful role of solvents into a beneficial one by using water - the safest and most benign solvent - as the primary vehicle for nicotine. This eliminates the toxicological concerns associated with organic solvents while maintaining effective nicotine delivery through aerosol generation

Inventive Principle:
Principle #22Blessing in disguise (Convert harm into benefit)

3Reliability

If nicotine replacement therapies are used, then smoking cessation is attempted, but pharmacokinetic profile is inferior to combustible cigarettes

Engineering Contradiction:
Improvesmoking cessationVSAvoidpharmacokinetic profile
Core Design Contradiction:
ReliabilityVSQuantity of substance

Solution Approach 1:

The invention replaces the mechanical/thermal vaporization system with an aerosolization system that operates at ambient temperature. By using a nebulizer or ultrasonic atomizer to generate fine aerosol particles from the water-based nicotine formulation, the system achieves rapid pulmonary absorption and a pharmacokinetic profile comparable to combustible cigarettes, thereby improving smoking cessation reliability

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

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 formulation achieves a pharmacokinetic profile similar to combustible cigarettes, reduces harmful by-product formation, and minimizes passive smoking impact by delivering nicotine in aerosolized form without heating, enhancing smoking cessation efficacy and safety.

Implementation Method 1

providing an aerosolised formulation comprising 0.1-8% wt % of nicotine and at least 65 wt. % water; and administering the aerosolised formulation via inhalation

Methodology Applied
Scientific EffectAerosol: Aerosol

Data Source

PatentUS11833145B2Nicotine formulation
Publication Date: 2023.12.05 YATZZ LTD
  • US11833145B2 patent drawing

AI summary

The invention relates to a pharmaceutical formulation comprising nicotine. The formulation can be aerosolised at ambient temperature for delivery via inhalation. The invention also relates to a method of delivering nicotine to a subject via inhalation, and specifically via the use of a nebuliser.