Inhalable Nicotine Formulation Deep Lung Delivery
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Solution Overview
Problem
Existing inhalable nicotine formulations for smoking cessation often cause throat irritation and fail to deliver nicotine effectively to the deep lungs, due to the high volatility of nicotine and challenges in formulating suitable particle sizes.
Innovation Solution
An inhalable formulation comprising nicotine, a hydrofluorocarbon propellant, a C1 to C6 alcohol such as ethanol, and a glycol such as propylene glycol, carefully balanced to control nicotine volatility and ensure delivery to the deep lungs without heating.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Quantity of substance
If nicotine is delivered through inhalation to facilitate smoking cessation, then nicotine delivery to the user is achieved, but throat irritation occurs due to nicotine deposition in the oropharynx
Solution Approach 1:
The patent changes the physical and chemical parameters of the formulation by using a specific propellant (HFA 134a) combined with co-solvents (ethanol and propylene glycol) in controlled ratios. This parameter optimization controls nicotine volatility and particle formation, ensuring nicotine reaches the lungs without depositing in the oropharynx, thereby reducing throat irritation while maintaining effective nicotine delivery
Solution Approach 2:
The patent employs a composite formulation system combining nicotine with hydrofluorocarbon propellant, ethanol, and propylene glycol. This composite material approach creates a balanced system where each component serves multiple functions: the propellant provides aerosolization, ethanol enhances solubility and controls volatility, and propylene glycol stabilizes the formulation. Together, they achieve deep lung delivery while minimizing oropharyngeal deposition and associated throat irritation
2Quantity of substance
If heating is used to deliver nicotine (as in e-cigarettes), then nicotine vaporization is achieved, but harmful by-products such as aldehydes and ketones are generated
Solution Approach 1:
The patent replaces the thermal/chemical heating mechanism with a mechanical aerosolization system. Instead of using heat to vaporize nicotine, the invention uses pressurized hydrofluorocarbon propellant to mechanically aerosolize and deliver nicotine directly to the user. This substitution eliminates the thermal decomposition process that generates harmful by-products like aldehydes and ketones, while still achieving effective nicotine delivery through the generated aerosol
3Object-affected harmful factors
If MDI is used to deliver nicotine without heating, then harmful by-products are avoided, but formulation balance is challenging due to nicotine volatility
Solution Approach 1:
The patent optimizes multiple formulation parameters simultaneously: the ratio of ethanol to propylene glycol (specifically 2:1 to 4:1), the nicotine concentration (4-10 mg/mL), and the propellant type (HFA 134a). These parameter changes create a thermodynamically balanced system that controls nicotine volatility, ensures proper aerosol formation, and maintains stability without requiring heating, thereby avoiding harmful by-products while managing formulation complexity
Solution Approach 2:
The patent introduces ethanol and propylene glycol as intermediary substances that mediate between nicotine and the propellant system. These co-solvents act as intermediaries that enhance nicotine solubility, control its volatility, and facilitate proper aerosolization. The intermediaries create a balanced formulation system that manages nicotine's inherent volatility challenges while enabling effective MDI delivery without heating
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 effectively delivers nicotine to the deep lungs, reducing throat irritation and providing a satisfying sensation, while avoiding the formation of harmful by-products associated with heating.
Implementation Method 1
produce almost instantaneous evaporation of multiple formulation components
Implementation Method 2
rapidly cooling and condensing
Data Source
AI summary
This disclosure relates to an improved inhalable formulation comprising nicotine, or a pharmaceutically acceptable derivative or salt thereof, a propellant, a C1 to C6 alcohol and a glycol. The disclosure further relates to a metered dose inhaler containing the inhalable nicotine formulation and a method of treating a nicotine addiction with the formulation.