Nicotine Composition Stabilization via Agar and Antioxidants
Find Innovative SolutionsGenerate Solutions
Solution Overview
Problem
Existing nicotine-free or low-tobacco pouches face challenges with chemical and physical instability, particularly due to high moisture content, which affects nicotine stability, palatability, and shelf life.
Innovation Solution
A composition comprising 0.2-5 wt% nicotine in free base form, 35-60 wt% native cellulose material, at least 35 wt% water, 0.5-3 wt% pH control salts, 0.1-2 wt% agar agar as a release and stabilizing agent, and optional additional ingredients, designed to maintain high moisture content while ensuring nicotine stability and fast release.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Ease of operation
If high moisture content (at least 35 wt% water) is used in the composition, then palatability and mouthfeel are improved, but nicotine stability deteriorates due to oxidative degradation and coloration
Solution Approach 1:
Vitamin E (tocopherol) is introduced as an intermediary substance that mediates between moisture and nicotine. The antioxidant protects nicotine from oxidative degradation even in the presence of high moisture content, allowing the composition to maintain both palatability and stability simultaneously
Solution Approach 2:
The patent converts the potentially harmful effect of moisture (which promotes nicotine degradation) into a beneficial feature by adding antioxidant protection. The moisture that would normally cause deterioration is now tolerated and even utilized for palatability, while the harmful oxidative effect is counteracted by vitamin E
2Reliability
If nicotine is provided in salt form with buffering salts to increase alkalinity, then nicotine stability is improved, but user comfort deteriorates due to gum irritation at pH greater than 9
Solution Approach 1:
The patent changes the pH parameter from the typical alkaline range (pH 9-10) to a more neutral range (pH 6.5-8.5) by using nicotine free base instead of nicotine salts with buffering salts. This parameter change maintains adequate nicotine stability while eliminating gum irritation
Solution Approach 2:
The patent extracts and removes the buffering salt component from the formulation. By using nicotine free base without buffering salts, the composition achieves the desired pH range that prevents gum irritation while maintaining nicotine stability through the antioxidant system
3Reliability
If low moisture content (less than 10 wt%) is used in nicotine salt formulations, then nicotine stability is improved, but palatability deteriorates due to hard and unpalatable texture
Solution Approach 1:
The patent changes the moisture content parameter from low (less than 10 wt%) to high (at least 35 wt%), which would normally destabilize nicotine. However, this parameter change is made possible by introducing vitamin E as an antioxidant protective mechanism
Solution Approach 2:
Vitamin E acts as an intermediary that enables the high moisture content formulation to maintain nicotine stability. The antioxidant mediates the interaction between moisture and nicotine, allowing the composition to achieve both high palatability through moisture and high stability through antioxidant protection
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 composition achieves high nicotine stability and fast, consistent release, maintaining a pleasant mouthfeel and long shelf life, while avoiding issues of lumping, discoloration, and dusting associated with high moisture content.
Implementation Method 1
WO2020244721 discloses a composition of free-base nicotine wherein the latter is stabilized using an ion exchange resin, e.g., polacrilex resin
Implementation Method 2
a release control agent comprising agar agar and/or derivatives of agar agar
Implementation Method 3
water in an amount at least 35 wt %
Implementation Method 4
enabling the release and absorption of nicotine through oral mucosa
Implementation Method 5
the formulations contain significant quantities of buffering salts to increase the alkalinity of the formulation. Increased alkalinity shifts the dissociation constant of the nicotine such that the free base form is made in solution
Data Source
AI summary
The present invention describes a composition, such as a tobacco free or low tobacco nicotine containing composition, comprising: a. From about 0.2 wt % to about 2 wt % nicotine in free base form; b. a native cellulose material in an amount from about 35 wt % to about 60 wt %; c. water in an amount at least 35 wt %; d. one or more pH control salts in an amount from about 0.5 wt % to about 3 wt %; e. a release control agent comprising agar agar in an amount from about 0.1 wt % to about 2 wt % f. optional additional ingredients, preferably in an amount up to about 12 wt %. The composition may be provided in pouches for oral delivery to a user.