Nicotine-Containing Product Using Polymeric Substrate for Controlled Release

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Solution Overview

Problem

Existing nicotine-containing products face challenges in achieving a uniform and controlled release of nicotine without using high nicotine concentrations or polyol additives, which can cause adverse side effects such as bitter taste and irritation, and require high production costs and complex handling due to nicotine's volatility and toxicity.

Innovation Solution

A nicotine-containing product comprising a pharmaceutically acceptable polymeric substrate that binds cations, such as a cation exchange resin or polysaccharide, combined with nicotine and pharmaceutically acceptable inorganic cations, allowing for a controlled release of nicotine without extreme peak releases and eliminating the need for polyol additives, achieved through a method involving pre-treatment with a solvent and nicotine application.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Manufacturing precision

If high nicotine concentrations are used to achieve controlled release, then nicotine release control is improved, but adverse side effects such as bitter taste and irritation increase

Engineering Contradiction:
Improvenicotine release controlVSAvoidadverse side effects
Core Design Contradiction:
Manufacturing precisionVSObject-affected harmful factors

Solution Approach 1:

A polymeric substrate acts as an intermediary carrier that binds nicotine through ion exchange mechanisms. The polymer releases nicotine gradually without requiring high nicotine concentrations, thereby maintaining controlled release while avoiding adverse side effects associated with high nicotine levels.

Inventive Principle:
Principle #24Intermediary (Mediator)

Solution Approach 2:

The invention changes the physical and chemical parameters of nicotine delivery by using a polymeric matrix system. This transforms the delivery mechanism from direct nicotine application to polymer-mediated release, enabling controlled kinetics without high nicotine concentrations.

Inventive Principle:
Principle #35Parameter changes

2Manufacturing precision

If polyol additives are used to achieve controlled nicotine release, then nicotine release control is improved, but production costs and handling complexity increase

Engineering Contradiction:
Improvenicotine release controlVSAvoidproduction complexity
Core Design Contradiction:
Manufacturing precisionVSDevice complexity

Solution Approach 1:

The invention extracts and eliminates the need for polyol additives from the formulation. By using a polymeric substrate with ion exchange capacity, the system achieves controlled nicotine release without requiring additional polyol components, thereby simplifying production and handling.

Inventive Principle:
Principle #2Taking out (Extraction)

Solution Approach 2:

The polymeric substrate serves multiple functions simultaneously: it acts as a nicotine carrier, provides controlled release through ion exchange, and eliminates the need for separate polyol additives. This multi-functionality reduces overall formulation complexity.

Inventive Principle:
Principle #6Universality (Multi-functionality)

3Reliability

If pure nicotine is used for its therapeutic effects, then therapeutic efficacy is improved, but stability and handling safety worsen due to volatility and toxicity

Engineering Contradiction:
Improvetherapeutic efficacyVSAvoidnicotine stability
Core Design Contradiction:
ReliabilityVSStability of the object's composition

Solution Approach 1:

Nicotine is nested within the polymeric substrate matrix, where it is bound through ion exchange interactions. This nesting protects nicotine from volatility and degradation while maintaining its therapeutic availability through controlled release from the polymer matrix.

Inventive Principle:
Principle #7Nested doll (Nesting)

Solution Approach 2:

The polymeric substrate acts as a protective intermediary between the environment and nicotine. It stabilizes nicotine by binding it in a solid matrix, preventing volatility and oxidative degradation, while still allowing controlled therapeutic release.

Inventive Principle:
Principle #24Intermediary (Mediator)

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 solution enables a controlled nicotine release rate of at least 70% within ten minutes without adverse side effects, reduces nicotine content, and simplifies production, ensuring lower material costs and safer handling by using well-known, non-toxic inorganic cations like Mg2+, Ca2+, and Zn2+, thus minimizing risks and costs.

Implementation Method 1

a pharmaceutically acceptable polymeric substrate which is able to bind cations, such as a cation exchange resin or polysaccharide

Methodology Applied
Scientific EffectIon exchange: Ion Exchange

Data Source

PatentUS9585967B2Nicotine-containing product
Publication Date: 2017.03.07 SIEGFRIED AG

AI summary

A nicotine-containing product comprising a pharmaceutically acceptable polymeric substrate, which is able to bind cations, nicotine or a pharmaceutically acceptable nicotine derivative, and pharmaceutically acceptable inorganic cations. It further pertains to a method for the preparation of such a nicotine-containing product and to the use thereof for the preparation of a pharmaceutical product.