EP4704588A1

EP4704588A1 - Natural chewing gum with nicotine and manufacturing method

Info

Publication number: EP4704588A1
Application number: EP25729039.5A
Authority: EP
Inventors: Ramin WARDA
Original assignee: Vont AB
Current assignee: Vont AB
Priority date: 2024-01-18
Filing date: 2025-01-10
Publication date: 2026-03-11
Also published as: WO2025155229A1; GB2641602A; GB202509148D0; SE2450053A1; SE547629C2

Abstract

The invention pertains to a natural chewing gum with nicotine (20) comprising a natural gum base (30) and active substance nicotine (34, 36, 38). The natural gum base (30) includes components or ingredients such as a gum base made of chicle with gum arabic or acacia, heat mixed with nicotine (34, 36, 38) in specific quantities. The chewing gum (20) is designed to administer nicotine during buccal use (70) up to 30 minutes while quickly releasing nicotine substance the first 5 minutes. The gum base (30) is covered with a glazing layer (40) with flavors (42) such as mint, strawberry, and taste enhancers with natural ingredients (44) such as xylitol, stevia, glycerin; beet powder, or spirulina, or a combination. A method for manufacturing the natural chewing gum (20) is disclosed, involving manufacturing of the gum base (100), addition of nicotine (200), manufacturing of the glazing mix (300), a glazing process (400), before packaging (500).

Description

NATURAL CHEWING GUM WITH NICOTINE AND MANUFACTURING METHOD

Technical field

The invention pertains to a natural chewing gum designed for oral buccal administration of nicotine, aiming to provide a more sustainable and environmentally friendly alternative to synthetic-based nicotine chewing gums.

Background

Nicotine chewing gum based on a synthetic chewing gum base provides environmental impact and health considerations for consumer groups.

Chewing gums for oral buccal administration of nicotine have been presented in the past but with contents of synthetic ingredients. Synthetic chewing gum remains in the environment for an extended time if deposited in the ground. For a short while a country restricted the import of chewing gum to certain areas to avoid chewing gum litter.

Pouches and chewing gum comprising natural gum arabica have been presented for drug administration of cannabis according to patent application WO 2023/002199 Composition comprising a constituent, derivative, or extract of cannabis, also in combination with nicotine, while not presenting any method for manufacturing of a pure nicotine chewing gum.

A group of consumers recognize chewing gum with nicotine as a favorable nicotine administration option compared to nicotine pouches.

Natural chewing gum base has different and challenging properties than synthetic chewing gum base. Nicotine is known to have an unpleasant taste for most users.

Hence, there is a need for an efficient and user attractive nicotine chewing gum with less environmental and health concerns than previous nicotine chewing gums, while providing a preferable nicotine administration effect, and respecting a sustainability lifecycle perspective and ethical usage of natural vs synthetic products.

Summary of the Invention

While there is interest in using natural gum bases for nicotine delivery, specific publications detailing the use of gum Arabic or chicle in nicotine chewing gums are limited. The development of such products would require extensive research to ensure consistent nicotine release, stability, and consumer acceptability.

Considerations that must be made include

Nicotine Release: The gum base must allow for controlled release of nicotine to effectively aid in smoking cessation.

Stability: Natural bases may have variability in composition, potentially affecting the product's shelf life and performance.

Regulatory Approval: Any new formulation would need to meet regulatory standards for safety and efficacy.

In summary, while natural gum bases like chicle are used in some chewing gums, their application in nicotine delivery systems remains an area for potential research and development.

It should be noted that “natural” as used herein refers to a natural ingredient as opposed to a synthetic ingredient.

It should be noted that since nicotine chewing gums are to help users get over or at least handle their nicotine habit, something that is very difficult, the nicotine chewing gum must be highly appealing to chew or the user will be more likely to choose to relapse instead of chewing. This puts high requirements on the taste, the experienced effect of nicotine (i.e. the release of nicotine) and the texture and “chewability” of the nicotine chewing gum.

Especially using natural ingredients such targets may be difficult to achieve, as the modern pallet has become used to artificial ingredients. The invention presented herein achieves these targets by very specific selections of ingredients, the amounts of such ingredients, and the preparation of the nicotine chewing gum.

It should thus be noted that the invention herein provides specific selections, as opposed to the prior art which may mention some of the ingredients in general, but never in such specific selections.

The novelty of the invention lies in its focus on:

Specific use of a natural gum base (chicle in combination with gum arabica or acacia) for nicotine delivery, addressing texture and processing challenges.

Precise control over nicotine release profiles, ensuring a consistent and efficient release during buccal use. A detailed and innovative manufacturing method that handles the unique properties of natural gum.

Integration of natural sweeteners and flavors to enhance consumer experience. Environmental sustainability, offering a biodegradable alternative to synthetic nicotine gums.

These aspects differentiate the inventive product from the broader and more general descriptions found in the field, the invention showcasing a more targeted, innovative approach to nicotine gum design and production.

The invention presented, is a designed natural chewing gum for nicotine administration where the chewing gum, let alone from the nicotine substance, is based on natural ingredients. Even the nicotine substance may be based on natural ingredients but due to drug administration control and demands for purity, a synthetic nicotine substance is preferred.

The new natural chewing gum uses a gum base composition with the active substance nicotine added, and matured over a longer time, and chopped into chunks, which represents a portion for usage, with a precision-controlled amount of nicotine substance remaining in each portion, according to strict nicotine substance content and administration requirements. As the natural gum base is softer than synthetic gum base, drying and cooling is required to process and manufacture a pleasant chewing gum with acceptable stiffness and chewing response as appreciated by chewing gum consumers.

As a result, each portion contains exactly the specified amount of nicotine substance within given margins. Each portion, or chunk, is then covered by a glazing with flavors to disguise the unpleasant taste of nicotine.

As will be discussed herein, the invention emphasizes the use of a natural gum base, specifically chicle that may be mixed with gum arabica (or gum acacia) for stabilizing and binding, to replace traditional synthetic gum bases. These natural bases are highlighted for their environmental benefits, biodegradability, and sustainability. Additionally, the invention outlines methods to address challenges related to the softer texture of natural bases, such as specific cooling, drying, and glazing processes to ensure the final product retains the desired chewability and stiffness.

In some embodiments the nicotine substance used is nicotine polacrilex 36. This is not a natural nicotine substance, and thus goes against the general aim of the invention; to provide a natural chewing gum. However, the inventors are actively and consciously stepping away from the general aim in order to ensure that the chewing gum does not add to the addiction of the user, as natural nicotine is more addictive than nicotine polacrilex 36. This would thus go against an obvious implementation of a natural chewing gum.

The invented natural chewing gum with nicotine is designed to administer its active nicotine substance during buccal usage up to a duration of 30 minutes. During the 30 minutes, at least 85% of the total nicotine substance of the natural chewing gum with nicotine, is released to its user's body.

The natural chewing gum with nicotine is designed to: a) release 42% to 46%, preferably 45% of its nicotine substance the first 5 minutes during buccal usage. b) release 70% to 75%, preferably 73% of its nicotine substance the first 15 minutes during buccal usage. c) provide a near constant release from 73% to 88% of its nicotine substance from 15 minutes to 30 minutes during buccal usage.

The constant release corresponds to a linear release curve 56 of 1% nicotine per minute from the time 15 minutes to 30 minutes after first buccal usage.

For the natural chewing gum with nicotine, the constant nicotine release curve approximation intersects the nicotine release curve from the time 15 minutes to 30 minutes, measured from the time of the first buccal usage.

A key innovation is the controlled release profile of nicotine during buccal use. As disclosed herein the nicotine gum is engineered to release 42-46% of the nicotine in the first five minutes and continue releasing at a steady rate up to 30 minutes, achieving about 90% total release. Herein will be outlined a precise method for mixing, maturing, and glazing to optimize this release curve, making it more efficient than existing synthetic products.

As desired among nicotine users, the new natural chewing gum with nicotine is designed to, during buccal use, release its amount of nicotine substance, according to curve, with more efficient substance release during up to the first twenty minutes, compared to a traditional well-known synthetic nicotine chewing gum, as seen in in the nicotine release diagram in FIG. 3. The new natural chewing gum with nicotine, provides a more efficient early nicotine release, according to curve, during the first five, or even up to six minutes compared, compared to chewing gum substance based compressed tablets.

As will be disclosed, the invention introduces a specific manufacturing method involving steps like heat mixing, drying, cooling, chunk cutting, and glazing. This method addresses challenges unique to natural gum bases, such as stickiness and texture differences compared to synthetic gums. The detailed process is intended to achieve a consistent nicotine release while maintaining a desirable chewing texture.

In accordance with embodiments, a natural chewing gum is provided, comprising a natural chewing gum base made of natural components with a quantity of an active substance nicotine and a glazing layer with one or more taste enhancers.

For example, the invention provides a specific integration of natural sweeteners (like xylitol and stevia) and natural flavor enhancers (such as strawberry and peppermint) to mask the unpleasant taste of nicotine. This choice supports the nicotine chewing gum's positioning as a healthier, natural alternative to synthetic gums, which often use artificial sweeteners and flavors. Even if such natural sweeteners are known in general, they are not known specifically for nicotine chewing gums to mask the taste of nicotine, nor are they known in the amounts and the mixing discussed herein.

The new natural chewing gum is also designed to deliver the active substance during oral buccal use over an extended duration up to 30 minutes, at least practical for 20 minutes. This is achieved through the composition(s) presented herein. The nicotine substance enters the human body thru the buccal mucosa during buccal usage, and during chewing, saliva interaction, and buccal absorption into the bloodstream for systemic circulation to body organs, tissue, and the brain creating the sensation from nicotine usage as appreciated by its user.

Chewing gum provides a slower and more controlled release of nicotine compared to smoking; which can help reduce withdrawal symptoms and cravings for individuals trying to quit smoking.

The natural chewing gum base comprises gum base (such as chicle), gum arabica (or acacia), xylitol, and nicotine in specific quantities. The natural chewing gum base is covered with a glazing layer comprising xylitol, stevia, and glycerin in specific quantities. The new natural chewing gum 20 comprises glycerin, beet powder, and spirulina in specific quantities. Spirulina is a protein source and appreciated ingredients for health effects. The nicotine in the natural chewing gum base is designed to release a nicotine substance during oral buccal use over a time of 0 to 30 minutes, during which about 90% of the nicotine substance is released. The taste enhancer comprises Strawberry Flavoring, or , Natural Peppermint Flavoring, Stabilized Menthol Plus Flavoring, and Stabilized menthol in specific quantities.

In accordance with other embodiments, a method for creating an improved natural chewing gum with nicotine is provided.

The method comprises the steps where the sequence of the steps may be slightly different:

- manufacturing a natural chewing gum base;

- manufacturing the chewing gum base with nicotine;

- cooling the chewing gum base;

- manufacturing chewing gum base chunk portions of proper size, wight and with desired amount of nicotine substance;

- maturing and drying of the chewing gum base;

- manufacturing of glazing mix with flavoring ingredients for taste,

- glazing the chewing gum base chunk portions into the natural chewing gum with nicotine,

- drying and optional maturing process, before air-tight sealing and/or packaging.

The new natural chewing gum with nicotine 20 is also designed for therapeutic treatment of nicotine withdrawal effects. The primary usage of the natural chewing gum with nicotine 20 is seen as a controlled way to administer nicotine to its users through oral buccal usage.

The nicotine substance 34 may be a natural ingredient 38 or a synthetic manufactured ingredient 36. Both alternatives provide advantages such as sustainability aspects for the natural nicotine ingredient 38 vs precision in substance quality for the synthetic ingredient 36. However, it should be noted that it is the synthetic nicotine that is useful and most preferred for the type of natural chewing gum product 20 invented. As the nicotine substance is such a minor amount of the weight percent of the natural chewing gum 20, the natural chewing gum will still be considered as being natural even when being used with synthetic nicotine. About 90% of the nicotine substance may leave the chewing gum 20 within 30 minutes of buccal usage, thus leaving only a fraction of the nicotine with the waste product, which is the remaining natural chewing gum with nicotine 20. Technical problem

A natural chewing gum base 30 has different properties than traditional synthetic chewing gum base, which makes the natural chewing gum base more challenging to use for manufacturing of an attractive nicotine administration product 20, not least concerning the taste and flavorings. Nicotine substance 34 is known to have an unpleasant taste and may be provided in the form of synthetic nicotine 36 or natural nicotine 38.

Synthetic nicotine 36 is chemically produced in a laboratory and is not derived from the tobacco plant. The taste of synthetic nicotine can be influenced by the specific synthesis process and the purification steps involved. Manufacturers may work to create synthetic nicotine that closely mimics the taste and effects of natural nicotine.

Natural nicotine 38 is derived from the tobacco plant. The taste of natural nicotine can be influenced by factors such as the specific tobacco variety, cultivation conditions, and extraction methods. Natural nicotine 38 may have a slightly different taste profile compared to synthetic nicotine, but individual preferences can vary.

Hence, there is a need for an efficient and user attractive nicotine chewing gum with less environmental and health concerns than synthetic chewing gum, with a preferable nicotine administration effect, while concerning a sustainability lifecycle perspective and ethical usage of natural vs synthetic products; and while providing a preferable nicotine release curve 53 during buccal usage 70. A recognized preferably nicotine release profile 53 would release nicotine more quickly during buccal usage withing the first five, or even six minutes of usage, than traditional synthetic nicotine chewing gums 54. A quick release, gives a quick response and nicotine substance withdrawal relief than a slower nicotine release curve 54.

The challenge is to create and manufacture a more sustainable chewing gum for the environment and human body 70, using ingredients, and a chewing gum that can rapidly be broken down. Synthetical chewing gum usually remains in the environment for far too many years.

A better alternative to traditional synthetic nicotine chewing gum would be to reduce harmful effects on nature and animals if the chewing gum is not properly recycled.

It is a challenge to communicate and influence chewing gum consumers to follow proper recycling instructions for chewing gums. As a result, chewing gum is often found to have been wasted without caring for the environment, thus leaving chewing gum remaining on ground, nature, soil, and in water. Synthetic chewing gums may remain unaffected in nature for many years compared to natural chewing gum bases that naturally break down. It is also believed that natural chewing gum possesses a lower threat to humans, animals and living organisms, than synthetically manufactured chewing gum base.

It is a challenge to make a tasty nicotine chewing gum that administers the nicotine substance to its users for a considerable time. Nicotine has an unpleasant taste. Prior art synthetic chewing gums are known to only release nicotine substances according to a certain response profile 54 while releasing nicotine, giving the user specific type of experience, as the nicotine effect reduces according to the response profile.

The pouches and chewing gum of natural gum arabica have been presented for drug administration of cannabis according to patent application WO 2023/002199 Composition comprising a constituent, derivative, or extract of cannabis.

Earlier attempts have been made to add nicotine to pouches cannabis according to earlier mentioned patent, with natural gum base, but such product with cannabis is considered harmful for animals such as dogs, birds, cats, and children, while not being legal nor desired in most places of the earth.

Also, such pouches have been seen to release the nicotine substance quickly, thus making the administration of nicotine last only for too short a time. It is recognized that a longer and more even distribution of nicotine is favorable. The patent application WO 2023/002199 is directed towards administration of a cannabis drug, and not just with nicotine alone as the potent active substance for administration. WO 2023/002199 does not address how to control the administration of a nicotine product with a product based on natural ingredients only.

As the natural gum base is much softer than a synthetic gum base, it makes it a challenge to manufacture chewing gum that in the western countries is recognized to provide acceptable chewing consistence and resilience. Traditionally, natural chewing gum base have been chewed upon for centuries, in eastern countries.

Hence, the inventor has invented an improved production method for the new natural chewing gums with nicotine 20, with composition presented in FIG. 1 , a nicotine release profile depicted in diagram in FIG. 3, and a corresponding manufacturing process as presented in FIG. 4. Solution to problem

The technical effect of the new chewing gum for administration of nicotine is that the new ingredients/substance list eliminates the need for synthetic chewing gum base, by providing chicle with acacia or gum arabica as replacement for synthetic gum. Even the nicotine substance can be made from natural nicotine 38, but due to food industry regulations, and precision of the substance control and administration, the manufacturing process preferably would use synthetical nicotine 36. As nicotine only constitutes a minor fraction of the natural chewing gum, the usage of synthetic nicotine 36 will still result in what is recognized as a natural chewing gum with nicotine 20, and to be considered as a natural nicotine chewing gum.

As a result, the whole product 20 (possibly apart from the Nicotine substance 36) becomes a natural product, a preferable product from a sustainability perspective, even when the synthetical nicotine substance 36 ingredient is used.

The invention is a natural chewing gum with nicotine 20, preferably and due to legislation reasons with a synthetic nicotine 36; with a complete gum base 30 and flavoring 42 or taste enhancer alternatives 42, and natural ingredients such as sweeteners 44 in a glazing layer 40. According to another aspect, the invention is a manufacturing method for production of a natural chewing gum with nicotine 20 and flavoring alternatives 42 with sweeteners 44.

The manufacturing method describes how to manufacture a natural chewing gum with nicotine substance 20, that is heat mixed and cut into chunks of portion size, matured, dried, and glazed with taste enhancers, flavorings 42 of for example mint or strawberry taste. The manufacturing process leads to a natural chewing gum with nicotine 20 that is stiffer and more responsive than its natural gum base, while delivering a preferable nicotine release profile 53 curve during buccal usage 70.

A natural nicotine gum made from chicle, using gum arabic or acacia, with nicotine polacrilex stands out due to its:

• Eco-friendly, plant-based origins: Completely natural, biodegradable, and aligned with health-conscious consumer preferences.

• Unique texture and dissolution: Offers a distinct gum experience with quicker dissolution, similar to a lozenge, making it ideal for people who prefer shorter chew times. • Enhanced flavor compatibility: With its neutral base, gum Arabic (and acacia) allows flavors to shine, making for a pleasant taste experience that can mask nicotine’s slight bitterness.

• Controlled, steady nicotine release: A milder release profile compared to traditional synthetic gums, helping to reduce cravings without intense bursts of nicotine. This product is especially suitable for eco-conscious users and those looking for a clean-label alternative in smoking cessation. By highlighting its natural ingredients, environmental benefits, and unique texture, gum arabic nicotine gum can appeal to a niche but growing segment of the nicotine gum market.

Advantageous effects of invention

The advantage of the natural chewing gum with nicotine 20 and flavorings 42 is that its users during buccal usage 70 of the chewing gum 20 can enjoy the administration of nicotine over a prolonged length of time up to 30 minutes with a quicker initial release of nicotine substance 34, 36, 38 , compared to other synthetic nicotine chewing gums. It is also recognized that natural substances are preferred among consumers, compared to synthetic ingredients. Motives that a natural chewing gum is preferred ranges from sustainability aspects and usage of natural resources, as well as risks associated to synthetic substances with unforeseen negative effects, and accumulation of negative substances in the human body. Natural chewing gum with nicotine, is preferred from being recognized as “natural” and benefits for the environment, compared to synthetic alternatives.

Other merits of the natural chewing gum with nicotine 20 are as follows:

Ingredients: Natural chewing gums typically use plant-based ingredients, such as chicle a natural latex from the sapodilla tree, natural gum base, natural sweeteners, and natural flavors. In contrast, synthetic gums may contain artificial sweeteners, flavors, and preservatives, which some individuals prefer to avoid due to concerns about potential health effects.

Biodegradability: Natural gums, especially those made from chicle, are biodegradable. Chewing gum made from synthetic materials, such as those derived from petroleum, is not biodegradable and can contribute to environmental pollution when improperly disposed of. Environmental Impact: The production of natural gums can have a lower environmental impact compared to the production of synthetic gums. Harvesting chicle, for example, involves tapping the sapodilla tree without harming it, making it a more sustainable option.

Allergen Concerns: Some individuals may have sensitivities or allergies to certain synthetic ingredients commonly found in gum, such as artificial colors or preservatives. Natural gums may be a preferable option for those with sensitivities.

Consumer Preferences: As awareness of health and environmental issues grows, consumers are increasingly seeking products with natural and sustainable ingredients. Natural chewing gums align with these preferences and may be perceived as a healthier and more environmentally friendly choice.

Taste and Texture: Natural gums often have a different texture and flavoring profile compared to synthetic gums. Some people find the taste and chewiness of natural gum to be more appealing.

It has also been found that by making use of a natural gum base, a new method makes it possible to saturate the gum base with nicotine substance, resulting in a preferred and actual nicotine release profile 53 during buccal usage 70 of the natural chewing gum with nicotine 20. See FIG. 3. As a result, the nicotine release is more efficient during the first six, or at least five minutes during buccal usage, compared to the nicotine release profile 54 for synthetic nicotine chewing gums, and chewable disintegrating chewable tables, of a discontinued product as seen in nicotine release profile 55.

Furthermore, the inventor has designed a heat mixing method, see FIG. 4, for blending the gum base and nicotine, to make the chewing gum dissipate and release its nicotine substance over a long time, a method that was found not practical when using a synthetic gum base.

Delivery of nicotine during oral buccal use ranged over a specific duration from 5 second to 15 minutes, preferably from 10 seconds to 12 minutes, see diagram over substance release on FIG. 3.

Brief Description of Drawings

The invention is described, by way of example, with reference to the accompanying drawings, which follows. FIG. 1 illustrates, composition diagram of a cross section with the chewing gum extending in a three-dimensional perspective. The cross section visualizes a cut through view of the natural chewing gum with nicotine 20 comprising a chewing gum base with nicotine 30 covered by a glazing layer 40.

FIG. 2 illustrates placement of natural chewing gum with nicotine 20 for buccal usage 70 for administration and release of the nicotine substance over a controlled time according to nicotine substance release diagram presented in FIG. 3.

FIG. 3 illustrates nicotine substance for buccal usage of the natural chewing gum Nicorette with nicotine, as a substance release over time as plot 53. The diagram also shows a synthetic competitor nicotine chewing gum product 54 based on a gum base, and a discontinued chewable nicotine tablet Pharmagum S which contains a chewing gum base with nicotine substance release curve 55.

FIG. 4 illustrates a manufacturing method as a flowchart, with all steps required for manufacturing of the natural chewing gum with nicotine 20, using natural substances, or ingredients. The active substance nicotine 34 may be provided as natural nicotine 38, or preferably as synthetic nicotine 36 for improved process control and to adhere to regulations.

Detailed Description of the Invention

The new natural chewing gum with nicotine 20 is made of a natural gum base 30 wherein the nicotine 34, 36, 38 has been heat mixed, dried, cooled, cut into chunks or portions of intended sizes, and matured to achieve a preferable nicotine release profile 53, for buccal usage 70.

A feasible chewing gum glazing 40 is designed to mask the unpleasant taste of nicotine in the natural chewing gum base with nicotine 30, for oral buccal usage 70, according to method steps explained in relation to manufacturing method in FIG. 4.

The chewing natural gum base with nicotine 30 is then glazed with glazing 40 preferably in a tumbler, where the glazing 40 deposits as a cover around the natural gum base with nicotine 30. After drying a maturing, the natural chewing gum with nicotine 20 may be packaged in preferably air tight air packaging material to protect the product and to conserve the product from further drying, aging, and foreign substances in the environment; while offering an attractive presentation of the product for its consumers and buccal usage 70. As nicotine is a central ingredient, it is therefore described and introduced as follows.

Nicotine polacrilex 36 is a synthetic form of nicotine, the same active naturally occurring nicotine 38 as in tobacco, but in a form that is less addictive than smoking cigarettes.

Nicotine polacrilex (CAS No.: 96055-45-7) is commonly used in nicotine replacement products, such as chewing gum and patches, for people who are trying to quit smoking, or enjoying nicotine use. It helps relieve withdrawal symptoms and smoking cravings in people trying to quit smoking, and comfort people using and/or being addicted to the nicotine substance. Nicotine polacrilex is released slowly in the body when chewed or used in the form of gum or patches.

The unique identification number CAS No. 96055-45-7 is used to catalog chemical substances and substances, and the EC number usually refers to the European Union (EU) identification number for chemicals. These numbers are used to ensure that chemicals are properly identified and traceable in the context of regulations and safety.

These identification numbers help ensure proper traceability and handling of the substance.

Nicotine polacrilex 36 is typically created by coupling nicotine molecules to an acrylic acid polymer, such as polacrilex. As a result, the nicotine substance provides for a slower release of the nicotine substance. The purpose of using this synthetic form of nicotine is to reduce addictive properties compared to tobacco smoking, while also helping to relieve withdrawal symptoms in people who are trying to quit smoking.

Nicotine itself is a chemical compound found naturally in tobacco plants, and it is one of the main substances that cause addiction to tobacco. In nicotine replacement products, including those containing nicotine polacrilex, the goal is to provide, or administer the nicotine to its, users with a controlled dose of nicotine to help them gradually reduce their smoking addiction and quit smoking, or at least to ensure precision in administration of nicotine for example for buccal usage 70.

With the new natural chewing gum with nicotine 20, a buccal usage 70 releases its substance nicotine substance 34 according to a nicotine release profile over time, in relation to the total nicotine releasable, whether it is an unclassified type of nicotine 34, synthetic 36, or natural 38. The nicotine release is further controlled by the way the nicotine has been integrated with the natural gum base 30, as a result from a heat mixing and maturing process.

The natural chewing gum with nicotine 20, as proposed in the invention is composed out of the substances as follows:

• NATURAL FLAVOURING, Strawberry flavoring, is a natural flavoring agent used in foods or beverages to impart flavor.

• Spirulina Powder is a dietary supplement made from spirulina algae and is considered nutritious due to its high protein content and other nutrients.

• BEET ROOT POWDER is a powder that is made from beetroot and can be used for coloring, flavoring, or as a dietary supplement.

• FruitMax® Red Beet Red WS-P is a dark red powder produced by pressing and drying beetroot. It can be used as a natural dye and flavoring.

• Gum Acacia (Acacia Senegal) a water-soluble gum obtained from acacia trees, is often used as a thickener and stabilizer in foods and beverages. The gum base component gum acacia may be mentioned under the general term gum arabic.

Flavorings may be added to the natural chewing gum with nicotine 20, to make the product tasty and to disguise the taste of nicotine, using the flavors follows: strawberry, mint, raspberry, vanilla, mango, cola, cinnamon, licorice, melon, and lemon. Strawberry and mint flavoring has been found to be well suited as taste enhancers for the natural chewing gum 20.

Some specific examples of flavors in addition to beet root powder are given below.

Herbal Mint Medley: A blend of peppermint, spearmint, and natural chlorophyll. Contains chlorophyll, a natural detoxifier and deodorizer, which helps keep breath fresh. Uses only plant-based mint extracts and colors for an all-natural approach.

Lemon Ginger Energizer: Natural lemon oil and ginger extract. Ginger adds a subtle spice while being a natural digestive aid, paired with lemon’s refreshing tang. This combination provides a gentle energy boost and soothes the stomach, making it a popular choice for morning use.

Matcha Mint Revitalize: Organic matcha and spearmint. The antioxidant power of matcha offers a unique twist for a nicotine gum, adding an energizing, earthy flavor. Spearmint enhances freshness and complements the natural taste of green tea. Lavender Vanilla Calm: Lavender and vanilla extracts. Known for its relaxing properties, lavender is paired with sweet vanilla for a calming, floral experience. This combination aims to help reduce stress and anxiety while addressing nicotine cravings.

Berry Basil Blend: Natural blackberry, raspberry, and basil extracts. Basil offers a mildly sweet, herbal balance to the rich berry flavors. Packed with antioxidants from berry extracts, this flavor profile feels fresh and unique for those looking for a twist on traditional fruit gum.

Coconut Lime Zest: Natural coconut and lime oils. Inspired by tropical flavors, coconut and lime create a creamy, zesty taste. This gum is refreshing and exotic, appealing to those looking for a summery escape without added sugars or artificial flavors.

Chai Spice Serenity: Cinnamon, cardamom, and clove. These spices, often used in traditional chai, provide a warm, comforting sensation. This combination helps soothe cravings with a naturally sweet, spicy profile, appealing to those who enjoy more sophisticated flavors.

Turmeric Lemon Detox: Turmeric and lemon oil. Turmeric’s anti-inflammatory properties and lemon’s cleansing qualities make this a unique choice for those focused on health. The slightly earthy, citrusy flavor is ideal for mindful users looking for wellness-inspired products.

Green Apple & Cinnamon Delight: Crisp green apple with a hint of cinnamon. The tartness of green apple pairs beautifully with warm cinnamon, creating a taste reminiscent of an apple pie. This gum is designed to feel indulgent and satisfying, great for curbing both nicotine and snack cravings naturally.

Honey Mint Boost: Natural honey and peppermint. Honey adds a natural sweetness and smooth texture, enhancing the crisp coolness of peppermint. This option is perfect for those who want a gentle, lightly sweetened flavor without any synthetic additives.

Detailed description of figures

FIG. 1 illustrates, composition diagram of a cross section with the natural chewing gum with nicotine 20 extending in a three-dimensional perspective. The cross section visualizes a cut through view of the natural chewing gum with nicotine 20 comprising a chewing gum base with nicotine 30 covered by a glazing layer 40. When manufactured the natural chewing gum can be shaped with a surface and shape 22 as a random result from tumbling of the gum base 30 with glazing layer 40 or shaped by a tool to a preferred shape, or for brand recognition. The natural gum base 30 is made of chicle combined with gum acacia or gum arabica 32 (for stabilizing and/or binding purposes) giving its texture and a resilient chewable chewing gum base with added nicotine 34 substance. A nicotine substance 34 that may be of synthetic nicotine 36, or natural nicotine 38. The natural gum base is then heat-mixed to incorporate the nicotine substance within the natural gum base.

A synthetic nicotine 36 of a type called nicotine polacrilex, is preferred over a natural nicotine 38, by reasons mentioned earlier, resulting in a higher quality product with a controlled nicotine release percentage 53 during buccal usage 70 of the natural chewing gum with nicotine 34, preferably said synthetic nicotine 36. Hence, the nicotine 34 in use may either be a preferred synthetic nicotine 36 or a less preferred natural nicotine 38 normally based on tobacco.

Then a glazing layer 40 made of: Flavoring or taste enhancers 42, for example: mint, strawberry, and more flavors to disguise the taste of an otherwise rather unpleasant taste of nicotine 34, 36, 38; and Natural ingredients 44 in the glazing layer, comprising a natural sweetener such as stevia, or natural color, or a combination.

During manufacturing, the glazing 40 is added to portion cut gum base 30 chunks, by tumbling or mixing the natural gum base 30 and glazing 40, as seen in FIG. 1.

The picture shows a cut through view showing both the natural gum base 30 and the glazing layer 40.

FIG. 2 illustrates placement of natural chewing gum with nicotine 20 for buccal usage 70 for administration and release of the nicotine substance 34, 36, 38 over a controlled time according to nicotine substance release diagram presented in FIG. 3. During buccal usage 70, the nicotine substance 34, 36, 38, is released from the natural gum base 30, and may release the nicotine substance gradually from a synthetic nicotine 36 of type nicotine polacrilex, into the buccal mucosa in the mouth where the lining of the cheek and the area under the tongue is thin and highly vascularized. Nicotine can then pass through the mucous membrane and enter the bloodstream directly, transporting the nicotine substance to various organs and tissues throughout the body, including the brain, for its intended sensation. Chewing of the natural chewing gum with nicotine 20, will result in an increased release of flavorings and taste enhancers, as well as more nicotine substance 34, 36, 38 from the gum base 30, while further mixing the flavoring and the gum base in the buccal cavity 70. FIG. 3 shows a diagram 50 illustrating nicotine substance release percentage 51 of total amount of nicotine, during buccal usage 70 of the natural chewing gum with nicotine 20, as a substance release in the buccal cavity 70 over time 52 as plot 53. The diagram also shows a prior art synthetic nicotine chewing gum product 54 called Nicorette, which is based on a synthetic gum base. The diagram also shows a discontinued chewable nicotine tablet Pharmagum S which contains a chewing gum base with release curve 55.

The competitor release curves 54 and 55 have extracted from a scientific article:

“In vitro release of nicotine from chewing gum formulations”, published in May 2004, by Yamini Morjaria et Al. The scientific article can be found at, https://www.researchgate.net/figure/In-vitro-release-of-nicotine-from-compressible-gum- formulations-and-a-commercial-gum_figl_242217341 and shows the vitro release of nicotine from compressible gum formulations and a commercial gum (Nicorette® 4mg) using the European Pharmacopoeia chewing gum apparatus. Nicotine substance release data for the new natural chewing gum with nicotine 20 has been scientifically determined with a comparable method.

FIG. 4 illustrates a manufacturing method as a flowchart, with steps required for manufacturing of the natural chewing gum with nicotine 20, using natural substances, and natural ingredients. The active substance nicotine 34 may be provided as natural nicotine 38, or preferably as synthetic nicotine 36 for improved substance administration precision, nicotine purity, and to adhere to medical and food regulations.

The natural chewing gum 20 is the primary product that delivers the active substance, nicotine 34, 36, 38, to the user's body. This is achieved through the careful selection and combination of natural ingredients. Instead of using synthetic ingredients, natural components such as xylitol, stevia, or glycerin could be used. These ingredients not only make up the natural oral product but also contribute to its taste and texture, making it more palatable for the user.

The gum base comprising chicle and gum arabic (or acacia) 30 plays a crucial role in the creation of the natural chewing gum. It substitutes the non-natural gum base typically found in synthetic chewing gums. This could be replaced with other natural gum bases like xanthan gum, guar gum, or locust bean gum. The choice of gum base impacts the texture and chewability of the gum, thereby influencing the release duration of the active substance. The glazing layer 40 adds color and taste to the natural chewing gum. This layer is made up of natural ingredients and could include alternatives like carrot powder, spinach powder, or kale powder. These ingredients not only impart color but also enhance the taste of the gum, masking the taste of the active substance.

Taste enhancers 42 are another critical component of the new natural chewing gum 20. They improve the product's palatability by adding flavoring 42. Different flavoring variants like orange, pineapple, or blueberry can be added to cater to different user preferences. It has been recognized that strawberry and mint flavoring 42 is well suited to disguise the unpleasant taste of nicotine 34, 36, 38.

Nicotine 34, 36, 38, the active substance, is released to the user's body from the new natural chewing gum with nicotine 20. It could be in the form of synthetic nicotine 36 or natural nicotine 38. Synthetic nicotine 36, such as Nicotine salts or Nicotine lozenges, is often used in nicotine replacement products due to its controlled release properties. On the other hand, natural nicotine 38, sourced from the tobacco plant, can provide a more natural alternative.

FIG. 4 furthermore illustrates, in a flowchart a method 60 for manufacturing of natural chewing gum with nicotine 20; with operations and steps in accordance with certain embodiments. Further detailed description of the method is found the heading:

Method for manufacturing the natural chewing gum with nicotine 20. Here, follows a general description of the method in FIG. 4.

The manufacturing method is composed of the four main steps 100, 200, 300, and 400, optionally followed by step 500 that is, Packaging of the natural chewing gum portions.

Starting with step 100, Manufacturing natural chewing gum base. The process begins by replacing synthetic ingredients of chewing gum with natural components. For instance, instead of using a synthetic gum base like butadiene-styrene rubber, a natural gum base 32 such as chicle combined with acacia or gum Arabic for stabilizing and/or binding puirposes, or alternatives like xanthan gum or guar gum can be used. This step involves the replacement of non-natural components from the formulation and the introduction of natural components. The output of this step is a mixture of a natural chewing gum 110, heat-mixed with ingredients as a gum base 30, 32, with the addition of the active substance, nicotine 34, that is either a synthetic nicotine 36, or a natural nicotine 38. In step 200 making chewing gum base portions with nicotine, the active substance, nicotine, is added 210, as either the preferred synthetic nicotine 212, or as added as natural nicotine 214, before heat-based mixing 220. The nicotine can be derived as natural nicotine 214 from the tobacco plant or preferably provided in a synthetic form like nicotine polacrilex 212.

Alternatively, nicotine salts could be used. The input for this step is the natural gum base 30, 32 from step 100. After maturing and drying 230, as well as cooling 240, output is a mixture of natural components and nicotine 30, that are extruded and cut into chunks of portion size according to a desired and specified natural chewing gum with nicotine 20 weight and active nicotine 34, 36, 38 substance weight provided. The measure of success for this step is the uniform distribution of nicotine in the mixture, and its ability to release nicotine during buccal usage 70 in FIG. 2. according to a desired nicotine release profile 53 as described in FIG. 3.

Step 220 involves heat-based mixing of the components to ensure a uniform distribution of the active substance and other ingredients. This could be done manually or using a mixer. The input is the mixture from step 210, 212, 214 and the output is a homogenous mixture of natural components and nicotine.

In step 230, the mixture is allowed to mature for a specified period. This could range from one hour to a week depending on the specific formulation and the desired properties of the final product. The input is the homogenous mixture from step 230 and the output is a matured mixture ready for shaping.

According to step 240, colling the gum base, which is the mixture from step 230, is then cooled down to make it more stable, extrudable and cut able. As natura gum base is of a soft and sticky consistency, cooling is necessary before the next step.

Step 250 involves extruding and cutting the matured mixture into chunks of the desired size and cutting or chopping the chunks to portion size. The input is the matured dried and chilled mixture from step 240 and the output is chunks of natural chewing gum with nicotine.

If the gum base with nicotine were consumed via buccal usage 70, the taste of nicotine would be recognized as unpleasant by most users. Hence, glazing is needed as can be manufactured by natural glazing mix with flavor, as described in step 300 with sub-steps 310, 320, 322, 324, 329. The glazing mix can be prepared in advance. First the glazing ingredients are added from at least two of the following lists of ingredients: xylitol, stevia, glycerin, beet powder, spirulina, and gum arabica. Flavorings can be added with options as described in step 322 using mint flavor, step 324 using strawberry flavor, or any other flavors as in step 329.

In step 400, applying the glazing layer, the step is using the portion sized chunks from step 200, and 250 as input. This could be done by adding the gum base chunks as in step 410, and adding glazing mix as in step 420, before tumbling blend of chewing gum base chunks 30 and glazing mix 40 in step 430; with a glazing mix made of natural ingredients like beet root powder or alternatives like carrot powder or spinach powder. The input to mentioned step is the chewing gum base chunks 30 from step 250 and the glazing mix from step 300, and 320 adding taste enhancer and/or flavor, and the output is glazed chunks of natural chewing gum with nicotine.

Before packaging in preferably air-tight sealed packaging as described in step 500, the now glazed natural chewing gums with nicotine 20 are dried as described in step 440.

Finally, in the optional step 500, the glazed chunks are packaged preferably in an air-tight sealed packaging, and ready for distribution. This could be done manually or using a packaging machine. The input is the glazed chunks from step 400, more specifically after the drying of natural chewing gum portions with nicotine that is step 440; the output is a packaged natural chewing gum with nicotine 20. The measure of success for step 500 is the proper sealing of the packages to ensure the freshness and quality of the product.

The natural chewing gum (20)

The natural chewing gum with nicotine 20 is comprised of, but not limited to, a composition of a natural chewing gum base 30 of natural ingredients or substances, and an active substance nicotine 34, a synthetic nicotine 36, or a natural nicotine 38. The natural chewing gum with nicotine 20 is further coated by a glazing layer 40 containing one or more taste enhancers and optional natural ingredients such as sweaters to disguise the rather unpleasant taste of nicotine contained in the gum base core 30.

The natural chewing gum 20 is further configured to deliver its active nicotine 34, synthetic nicotine 36, or natural nicotine 38 substance during oral buccal 70 use over a specific duration from 5 seconds to 15 minutes, preferably from 10 seconds to 12 minutes.

The natural chewing gum with nicotine 20 as described may also comprise a gum base 32 of a quantity from 28% to 40% preferably 32% weight percent of the natural chewing gum 20. The natural chewing gum with nicotine 20 as described may also comprise a gum base (chicle) 32 of a quantity from 38% to 60% preferably 50% weight percent of the natural chewing gum 20.

The remaining weight is composed of a glazing layer 40 as coating around the core gum base 30.

Said natural chewing gum with nicotine 20 have a natural gum base 30 that comprises an amount of gum arabica of a quantity from 1% to 4% preferably 2% weight percent or 5% to 15% preferably 10% weight percent of the natural chewing gum 20.

The natural chewing gum with nicotine 20 as further specified in claim 1 to 3, may have a natural chewing gum base 30 comprising xylitol of a quantity from 45 or 50% to 65% preferably 57% weight percent of the natural chewing gum 20.

Said natural chewing gum with nicotine 20 may have a natural gum base 30 that comprises a nicotine substance amount of a quantity from 0.02% to 0.2%, preferably 0.09% to 0.1% weight percent of the natural chewing gum 20.

The natural chewing gum with nicotine 20 as further specified in claim 1 to 5, may have a natural chewing gum base 30 covered with a glazing layer 40 that may comprises xylitol of a quantity from 50% to 65% preferably 57% weight percent of the natural chewing gum with nicotine 20; stevia a sweetener of a quantity from 1% to 5% preferably 2% weight percent of the natural chewing gum 20; and an amount of glycerin also a kind of sweetener but that also improves shelf life and texture, of a quantity from 1% to 5% preferably 2% weight percent of the natural chewing gum 20.

Also, the natural chewing gum with nicotine 20 as further specified in claim 1 to 6, may comprise glycerin of a quantity from 1.3% to 2.5% preferably 2% weight percent of the natural chewing gum 20.

The natural chewing gum with nicotine 20 may comprise a beet powder, for coloring, of a quantity from 0.1% to 0.3% preferably 0.2% weight percent of the natural chewing gum 20.

The natural chewing gum with nicotine 20 may comprise a spirulina as a flavor enhancer, coloring and with positive health effects, of a quantity from 0.05% to 0.2% preferably 0.1% weight percent of the natural chewing gum 20. The natural chewing gum with nicotine 20 may be comprising of natural chewing gum base 30 with an active substance nicotine 34 in the form of a synthetic nicotine 36. The active substance nicotine 34, 35, 36 preferably constitutes 1% of the natural chewing gum 20.

The natural chewing gum with nicotine 20 as further specified in claim 1 to 11 may be designed to release at 70% to 75%, preferably 73% of its nicotine substance 34, synthetic 35, or natural nicotine 36 during oral buccal 70 use, during and between a time 0 minute to 15 minutes from start of buccal usage 70.

Furthermore, said natural chewing gum with nicotine 20 may be designed to release between 42% to 46% preferably 45% of its nicotine substance 34, 36, 38 during oral buccal 70 use within the time between 0 minute to 5 minutes from start of buccal usage 70.

The natural chewing gum with nicotine 20 is further described in claim 14 specifying that the natural chewing gum is designed to provide a constant release from 70% to 75%, preferably 73% of its nicotine substance 34 during oral buccal usage 70 from 15 minutes from start of buccal usage 70 to 30 minutes from start of buccal usage 70. The constant release of nicotine 34, 36, 38, provides for a smooth withdrawal of the nicotine substance during buccal usage 70.

The natural chewing gum with nicotine 20 as also specified in 15 is designed to provide a constant release that is a linear release curve 56, corresponding to a 1% nicotine substance release of the total nicotine provided in the natural chewing gum with nicotine 20 at the start of the buccal usage 70. The 1% release of nicotine 34, 36, 38 substance per minute from 15 minutes from start of buccal usage 70 to 30 minutes from start of buccal usage 70.

Regarding taste enhancers and flavorings to disguise any unpleasant nicotine taste, the natural chewing gum with nicotine 20 may be provided with a strawberry taste enhancer 42 comprising at least a flavoring of Strawberry Type Natural Flavoring of a quantity 2% weight percent of the natural chewing gum; and a Strawberry Flavoring of a quantity 3% weight percent of the natural chewing gum 20.

An alternative taste enhancement for mint taste for the natural chewing gum with nicotine 20 can be provided using a taste enhancer 42 that is a mint flavoring comprising Natural Peppermint Flavoring of a quantity 1% weight percent of the natural chewing gum 20;

Natural Peppermint Flavoring of a quantity 2% weight percent of the natural chewing gum 20; and Natural Flavoring Stabilized Menthol Plus of a quantity 2% weight percent of the natural chewing gum 20.

The natural chewing gum with nicotine 20 as further specified in claim 1 to 15 is separated into chunks or portions of a weight of each chewing gum portion 20 within the range 0.8 gram to 2.4 gram, preferably between 1.2 gram and 1.6 gram. The size of the portions and concentration of the active substance nicotine 34, 36, 38 determines the amount of nicotine releasable 53 from each natural chewing gum with nicotine 20, that is the final product for consumption and buccal usage 70.

Method for manufacturing the natural chewing gum with nicotine 20

The invention is enabled by and includes a method for manufacturing the natural chewing gum with nicotine 20 as also detailed in patent claim 1 to 16. The method as further specified in claim 17 comprises the following steps for manufacturing, where the sequency of the manufacturing steps may vary as steps can execute in parallel, or be prepared in advance, as illustrated in FIG. 4.

During manufacturing, artificial components typically used in chewing gum production are substituted with natural ingredients such as xanthan gum, a natural thickening agent, erythritol, a natural sweetener, monk fruit sweetener, another natural sweetener, and essential oils, which are used for flavoring.

The manufacturing steps are as follows:

The first step number 100 is the manufacturing of a natural chewing gum base 30 comprising the sub-steps: adding chewing gum base ingredients 110 (mainly chicle and gum Arabic or acacia), and heat-based mixing 120 of natural gum base. Ingredients that may be added, are beyond the gum base comprising gum arabica, also xylitol.

The next step 200 is the manufacturing of chewing gum base portions 30 with nicotine 34, 36, 38 comprising the sub-steps: adding 210 nicotine substance 34 of preferably synthetic nicotine 36, or natural nicotine 38; mixing 220 gum base 32 and nicotine 34, 36, 38 using a heat-based mixing method; and then maturing 230 and drying the gum base 30 now with a nicotine substance well integrated in the natural gum base 30; followed by the step cooling 240 the gum base 30; and extruding and cutting 250 the gum base 30 into chunks of portion size. Nicotine can be provided as nicotine salts when added 210 to the mixture. Nicotine salts are a type of nicotine that is more easily absorbed by the body, providing a more immediate and satisfying nicotine hit. This is carefully measured and mixed 220 into the natural ingredient mixture to ensure even distribution throughout the gum.

The combined mixture is then mixed thoroughly at step 220. This involves using a large industrial mixer to blend and mix the ingredients together until they form a homogeneous mass. This ensures that the nicotine and flavors are evenly distributed throughout the gum, providing a consistent taste and nicotine delivery with each chew.

The mixture is let to mature in step 230, which involves leaving the mixture to rest for a certain time ranging from minutes to days, allowing the flavors to meld together and the texture to become more chewable. The exact duration of this maturing process can vary, but it is carefully monitored to ensure optimal results.

Once the mixture has matured 230, it is cooled 240, extruded and cut 250 into individual pieces. This involves feeding the mixture into an extruder, which shapes it into long, thin ropes. These ropes are then cut into small, gum-sized pieces. The size and shape of the pieces can be adjusted as needed to suit the desired product specifications.

Later, the cut pieces are glazed 400, which involves coating the pieces in a shiny, protective layer, which not only enhances the appearance of the gum but also helps to preserve its freshness and flavor. The glaze is typically made from a mixture of natural ingredients, and it is applied using a special glazing machine.

But first the glazing needs to be prepared. Step 300 is the manufacturing of a glazing mix 40 with flavoring 42 comprises the sub-steps: adding 310 glazing ingredients 44; and adding 320 natural flavoring 42. The flavoring may comprise: adding mint flavoring 322, adding strawberry flavoring 324, or adding other flavorings 329 configured to disguise the taste of nicotine 34, 36, 38.

Mentioned step 300 and step 200 are followed by step 400, that is: glazing the natural chewing gum base portions 30, comprising the sub-steps: adding 410 gum base chunks 30 of 45 to 80 weight percentage of the blend 30, 40; adding 420 glazing mix 40 with flavoring 42 of 20 to 55 weight percentage of blend 30, 40; tumbling 430 blend of gum base chunks 30 and glazing mix 40 until glazing forms around portion chunks 22, resulting in glazed natural chewing gums with nicotine 20; and finally drying 440 the natural chewing gum portions with nicotine 20.

The mentioned steps including the drying step 440 executes before the natural chewing gum with nicotine 20, is moving to the final and optional manufacturing step 500, that is packaging of said natural chewing gum with nicotine 20 portions in a preferably air-tight sealed packaging. Step 500 is therefore an optional step, but the drying process in step 440 is required before the natural chewing gum with nicotine 20 can be seen as completely manufactured. The drying step dries and matures the chewing gum 20 before packaging, shipping, sale, and consumption.

Mentioned method may be further enhanced with new flavorings at step: adding natural flavoring 320; by adding natural but not necessary plant-based flavorings of at least one of strawberry, mint, raspberry, vanilla, mango, cola, cinnamon, licorice, melon, and lemon. Of course, more flavoring compositions are possible to disguise the bitterness taste of nicotine and perhaps scents from nicotine.

A specific example of a recipe for a natural chewing gum with nicotine is discussed below, which applies to the embodiments discussed above.

1. Nicotine polacrilex: Sufficient to provide 1 mg or 3 mg per piece (typical dosage for nicotine gum; consult a professional for accurate measurements)

2. Gum base: 28 grams gum base

3. Corn syrup: 20 grams (for chewiness)

4. Powdered sugar: 7,5 grams (for sweetness)

5. Flavoring: Few drops.

6. Food-grade coloring a few drops for visual appeal

7. Rice flour: for dusting and preventing stickiness.

A specific example of a method that follows the method steps discussed above with regards to figure 4 is also discussed below. The used equipment may include a double boiler (or a bowl that fits snugly over a pot of boiling water), a saucepan, a mixing spoon or spatula and wax paper.

First we start 100 with preparing the Double Boiler. Fill the bottom of the double boiler or saucepan with water. Heat it to around 180°F (82°C). This temperature is hot enough to melt the chicle but not so hot that it will burn or it. Place the top part of the double boiler (or a heat-safe bowl) over the simmering water.

Next we melt 200 the gum base and add the natural gum base (chicle along with gum Arabic and/or acacia)) into the top of the double boiler. Allow it to heat slowly, stirring occasionally 220. The chicle will gradually melt, becoming soft and pliable. This process can take up to 10-15 minutes. If a different natural gum base is used, adjust the temperature according to its melting point (usually around 170-190°f or 76-88°c).

Thereafter we add the com syrup and flavoring 300. Once the gum base is melted and smooth, add the corn syrup. Stir well to combine. The corn syrup adds chewiness and helps hold the gum together. Add a few drops of your chosen flavoring oil 320. Be cautious with flavorings, as some oils are potent and can be overpowering if you add too much.

Next we add powdered sugar and powdered nicotine 210. Gradually stir in the powdered sugar and nicotine until the mixture thickens and is harder to stir. When the mixture becomes too difficult to mix in the pot, remove it from the heat.

Then we knead the gum. Dust a clean surface with powdered sugar to prevent sticking. Place the warm gum mixture on the surface, and let it cool 240 slightly until it is comfortable to handle. Knead the gum, adding more powdered sugar as needed to get the desired consistency. This kneading process is essential for texture.

Lastly we shape and wrap the gum 250. Once the gum reaches a smooth consistency, roll it out and cut it into pieces, or shape it into small balls. Dust the pieces with rice flour or cornstarch to prevent them from sticking. Wrap each piece in wax paper for storage 500.

Temperature control: Avoid overheating the gum base, as this can make it brittle. Keeping the temperature around 180°F (82°C) is ideal.

Storage: Store your gum in an airtight container at room temperature for 4 days before packing in bag.

The invention thus discloses a natural nicotine gum using chicle with gum arabic (or acacia) as a base with nicotine polacrilex which offers a distinctive and unique alternative to traditional chewing gums. Key benefits of using chicle as a base for a Nicotine gum includes that it is Natural and Biodegradable. Chicle is a natural sap derived from the acacia tree, making it a renewable and biodegradable material. This is an attractive feature for eco- conscious consumers who prefer natural, plant-based products. Unlike synthetic gum bases, chicle is completely plant-based and decomposes naturally, aligning with the increasing demand for environmentally friendly products.

Other benefits include a gentle dissolution and unique texture. Chicle (with gum Arabic or acacia) provides a distinct texture that is different from conventional chewing gum. It dissolves more easily in the mouth and becomes slightly softer over time. This makes it ideal for users who may not want a gum that must be chewed for a long time. Instead, it provides a shorter, dissolvable gum experience similar to a lozenge.

Other benefits include a gradual Nicotine Release. The gum base allows for a steady, controlled release of nicotine polacrilex as it gradually dissolves in the mouth. This release method is beneficial because it enables users to control their nicotine intake over time without the sharp, immediate “hit” associated with smoking, reducing cravings in a milder way.

Other benefits include a natural flavor compatibility. (Chicle with) Gum arabic has a neutral taste, allowing added flavors to shine through. This makes it well-suited to natural flavors, like mint, citrus, or herbal extracts, which can mask nicotine’s slight bitterness. The versatility in flavoring enables customization, offering a more pleasant and varied user experience than traditional nicotine gum.

The proposed chewing gum is also sensitive to consumer health trends. Natural nicotine gum with chicle and gum arabic as a base appeals to consumers seeking wellness-focused, cleanlabel products. Many people prefer avoiding synthetic additives, and chicle as well as gum arabic is a familiar, trusted ingredient found in foods and health products. It aligns with dietary preferences, as it’s vegan, gluten-free, and free from artificial preservatives, making it suitable for a wider audience.

The natural chewing gum as discussed herein also has digestive benefits. Chicle with gum arabic has prebiotic properties that can support digestive health by feeding beneficial gut bacteria. While the main purpose of nicotine gum is smoking cessation, the addition of a gum base with prebiotic benefits can add a secondary health benefit, enhancing the product’s appeal. Some unique attributes of Chicle with Gum Arabic Nicotine Chewing Gum includes a distinct experience compared to traditional chewing gum. Unlike synthetic gum bases, chicle with gum arabic doesn’t maintain a chewy, elastic texture. Instead, it offers a unique dissolvable experience, more like a lozenge or pastille. This makes it ideal for individuals who prefer a shorter chewing time or find traditional gum bases too firm.

The natural chewing gum is also of an eco-friendly and health-conscious product design. As a plant-derived and sustainably harvested material, the natural gum base supports eco- friendly production values. Combined with natural flavorings and a biodegradable format, it appeals to consumers concerned about product sustainability and health. Packaging for natural gum-based nicotine gum can also emphasize these eco-friendly qualities, setting it apart from conventional gums on store shelves.

The chewing gum herein has no synthetic ingredients. This nicotine gum uses a simple, natural gum base, free from artificial softeners, fillers, or synthetic polymers. Many synthetic gums use bases derived from petroleum, which some consumers prefer to avoid. A chicle with gum arabic base presents a cleaner label, allowing for transparent ingredient lists that consumers appreciate.

The chewing gum herein also allows for a quick dissolution for faster nicotine satisfaction. While traditional gum is designed to be chewed for extended periods, chicle with gum arabic gradually dissolves as it’s chewed, allowing for faster nicotine delivery and a shorter gum experience. This makes it convenient for individuals seeking quick relief from nicotine cravings without needing to chew gum for long periods.

There is also a reduced risk of over-chewing. Conventional nicotine gums often need to be chewed intermittently to avoid nicotine overconsumption in one sitting. With chicle with gum arabic, the natural dissolution process allows for a more controlled and timed release, which minimizes the risk of excessive nicotine intake. Reference Signs List

Description of reference numbers used in drawings are defined as follows. Each figure reference number is followed by a short name of the item, arrow, flow of information or method step presentation, and a brief description.

To avoid risks of mixing figure numbers with reference sign numbers, numbers 1-19 are omitted.

Method steps are numbered as 100, 110, ... to 500.

20 = The natural chewing gum with nicotine.

22 = Shape and surface of natural chewing gum with nicotine after glazing 40 has matured. In Fig. 1 presented as a cut through intersection view.

30 = Natural gum base, the core of the natural chewing gum with nicotine 20. It is made of a natural gum base, preferably chicle (with gum Arabic or acacia) with an added heat-mixed nicotine 34 substance that may be of synthetic nicotine 36, or natural nicotine 38.

32 = acacia, or gum arabica.

34 = Nicotine, synthetic or natural.

36 = Synthetic nicotine.

38 = Natural nicotine.

40 = Glazing layer, presented as a cut thru section

42= Natural flavoring with or without taste enhancers, for example: mint, strawberry, and more flavors to disguise the taste of an otherwise unpleasant taste of nicotine 34, 36, 38.

44= Natural ingredients in the glazing layer, such as sweetener stevia, or natural color.

50 = Diagram visualizing how the percentage of nicotine is released 51 from the natural chewing gum with nicotine, thru a buccal usage in the human body over time as a function of the Release time [minutes] 52, according to nicotine release function 53 depicted as a line diagram graph.

51 = Percentage of nicotine release [%] in the human body.

52 = Accumulated release time [minutes] for nicotine substance in the human body, counted from the time when the substance is placed in the buccal cavity for administration of nicotine.

53 = Accumulated nicotine release from buccal usage of the natural chewing gum with nicotine, presented as a function of time. As seen the nicotine substance is released more rapidly with a natural gum base compared to the gum using synthetic gum base 54.

54 = Accumulated nicotine release from buccal usage of synthetic nicotine chewing gum with brand Nicorette, presented as a function of time.

55 = Accumulated nicotine release from buccal usage of an earlier chewable nicotine tablet, a discontinued product called Pharmagum M having a gum base, presented as a function of time. The discontinued product Pharmagum M was a chewable compressed tablet or pill that disintegrated when chewed upon, thus not a real chewing gum, though it also contained a gum base. Even in comparison with the natural chewing gum with nicotine 53, the release curve of Pharmagum M 55 was comparable slower at releasing nicotine the first 6 minutes.

56 = Linear release curve showing a nicotine release of 1% per minute from 15 to 30 minutes.

60 = Method for manufacturing of natural chewing gum with nicotine, as further described by method steps from 100, 110, ... to 500.

70 = Buccal cavity in human mouth, where the chewing gum is placed for administration of nicotine substance while the user is chewing on the natural chewing with nicotine (20).

Methods steps:

100 = Manufacturing natural chewing gum base.

The first step for manufacturing of the natural chewing gum with nicotine.

110 = Adding chewing gum base ingredients.

120 = Heat-based mixing of natural gum base.

200 = Making chewing gum base portions with nicotine.

210 = Adding nicotine.

212 = Adding synthetic nicotine.

214 = Adding natural nicotine.

220 = Heat-based mixing.

230 = Maturing and drying gum base.

240 = Cooling gum base.

250 = Extruding and cutting gum base into chunks of portion size based on specified chewing gum weight amount.

300 = Manufacturing glazing mixture with flavor. 310 = Adding glazing ingredients.

320 = Adding taste enhancer and/or flavor(s).

322 = Adding mint flavor.

324 = Adding strawberry flavor. 329 = Adding other flavors.

400 = Glazing of natural chewing gum base portions.

410 = Adding gum base chunks of 45-80% of total weight.

420 = Adding glazing mix with flavoring of 20-55% of weight.

430 = Tumbling blend 30, 40 of chewing gum base with nicotine 30, with glazing mix 40 until glazing forms around portion chunks 22.

440 = Drying natural chewing gum portions with nicotine.

500 = Packaging the natural chewing gum portions, preferably in an air-tight packaging.

Claims

1. A natural chewing gum with nicotine (20) comprising: a natural chewing gum base (30), an active substance nicotine (34, 36, 38), a natural glazing layer (40) and one or more natural flavorings (42), wherein the natural chewing gum with nicotine (20) is configured to deliver its active nicotine (34, 36, 38) substance during oral buccal (70) use over a duration up to 30 minutes, preferably up to at least 15 minutes from start of buccal usage (70).

2. The natural chewing gum with nicotine (20) according to claim 1 or 2, wherein the natural chewing gum base (30) comprises: a natural gum base (32), such as chicle, of a quantity from 28% to 40% preferably 32% weight percent of the natural chewing gum with nicotine (20).

3. The natural chewing gum with nicotine (20) according to claim 2, wherein the natural gum base (30) also comprises: gum arabica of a quantity from 1% to 4% preferably 2% weight percent of the natural chewing gum.

4. The natural chewing gum with nicotine (20) according to any preceding claim, wherein the natural flavorings comprises: xylitol of a quantity from 45% to 65% weight percent of the natural chewing gum with nicotine (20).

5. The natural chewing gum with nicotine (20) according to any preceding claim, wherein the chewing gum comprises: a nicotine of a quantity from 0.02% to 0.2%, preferably 0.09% to 0.1% weight percent of the natural chewing gum with nicotine (20).

6. The natural chewing gum with nicotine (20) according to any preceding claim, wherein the natural chewing gum base (30) is covered with a glazing layer (40) which comprises: xylitol of a quantity from 45% to 65% weight percent of the natural chewing gum with nicotine (20); stevia of a quantity from 1% to 5% preferably 2% weight percent of the natural chewing gum with nicotine (20); and a glycerin of a quantity from 1% to 5% preferably 2% weight percent of the natural chewing gum with nicotine (20).

7. The natural chewing gum with nicotine (20) according to any preceding claim, wherein the -natural chewing gum with nicotine (20) comprises: glycerin of a quantity from 1.3% to 2.5% preferably 2% weight percent of the natural chewing gum with nicotine (20).

8. The natural chewing gum with nicotine (20) according to any preceding claim, wherein the natural chewing gum with nicotine (20) comprises: a beet root powder of a quantity from 0.1% to 0.3% preferably 0.2% weight percent of the natural chewing gum with nicotine (20).

9. The natural chewing gum with nicotine (20) according to any preceding claim, wherein the natural chewing gum with nicotine (20) comprises: a spirulina of a quantity from 0.05% to 0.2% preferably 0.1% weight percent of the natural chewing gum with nicotine (20).

10. The natural chewing gum with nicotine (20) according to any preceding claim wherein the natural chewing gum base (30) comprises an active substance nicotine (34) in the form of a synthetic nicotine (36); nicotine polacrilex 36.

11. The natural chewing gum with nicotine (20) according to any preceding claim, wherein the active substance nicotine (34, 35, 36) constitutes 0.17% to 0.19%, preferably 0.18% of the natural chewing gum with nicotine (20).

12. The natural chewing gum with nicotine (20) according to any preceding claim, wherein the chewing gum is designed to release 70% to 75%, preferably 73% of its nicotine substance (34, 35, 36) during oral buccal usage (70) between 0 minute to 15 minutes from start of buccal usage (70).

13. The natural chewing gum with nicotine (20) according to any preceding claim, wherein the chewing gum is designed release between 42% to 46%, preferably 45% of its nicotine substance (34, 36, 38) during oral buccal usage (70) between 0 minute to 5 minutes from start of buccal usage.

14. The natural chewing gum with nicotine (20) according to any preceding claim, wherein the natural chewing gum is designed to provide a constant release from 70% to 75%, preferably 73% of its nicotine substance (34, 36, 38) during oral buccal usage (70) from 15 minutes from start of buccal usage (70) to 30 minutes from start of buccal usage (70).

15. The natural chewing gum with nicotine (20) according to any preceding claim wherein the natural chewing gum is designed to provide a constant release that is a linear release (56) of 1% nicotine substance (34, 36, 38) per minute from 15 minutes from start of buccal usage (70) to 30 minutes from start of buccal usage (70).

16. The natural chewing gum with nicotine (20) of any preceding claim, wherein the natural flavoring (42) is comprising:

Strawberry Type Natural Flavoring of a quantity 2% weight percent of the natural chewing gum with nicotine (20); and

Strawberry Flavoring of a quantity 3% weight percent of the natural chewing gum with nicotine (20).

17. The natural chewing gum with nicotine (20) of any preceding claim, wherein the natural flavoring (42) is comprising:

Natural Peppermint Flavoring of a quantity 3% weight percent of the natural chewing gum with nicotine (20); and

Flavoring Stabilized Menthol Plus of a quantity 2% weight percent of the natural chewing gum with nicotine (20).

18. The natural chewing gum with nicotine (20) according to any preceding claim, wherein the weight of each chewing gum portion (20) is within the range 0.8 gram to 2.4 gram, preferably between 1.2 gram and 1.6 gram.

19. A method for manufacturing the natural chewing gum with nicotine (20) according to any preceding claim, comprising the steps:

(100) manufacturing natural chewing gum base (30) comprising:

(110) adding chewing gum base ingredients, and

(120) heat-based mixing of natural gum base;

(200) manufacturing chewing gum base portions (30) with nicotine (34, 36, 38) comprising the steps:

(210) adding nicotine substance (34) of preferably synthetic nicotine (36), or natural nicotine (38);

(220) mixing gum base (32) and nicotine (34, 36, 38) using heat-based mixing;

(230) maturing and drying gum base (30);

(240) cooling gum base (30);

(250) extruding and cutting gum base (30) into chunks of portion size;

(300) manufacturing glazing mix (40) with flavoring (42) comprising the steps:

(310) adding glazing ingredients (44);

(320) adding natural flavoring (42); and

(400) glazing the natural chewing gum base portions (30), comprising the steps:

(410) adding gum base chunks (30) of 45 to 80 weight percentage of the blend (30, 40);

(420) adding glazing mix (40) with flavoring (42) of

20 to 55 weight percentage of blend (30, 40);

(430) tumbling blend of gum base chunks (30) and glazing mix 40 until glazing forms around portion chunks (22), resulting in glazed natural chewing gums with nicotine (20); and

(440) drying natural chewing gum portions with nicotine; before and optionally (500) packaging said natural chewing gum portions in preferably air-tight sealed packaging.

20. The method according to claim 20 wherein the step adding natural flavoring (320) comprises: adding natural but not necessary plant-based flavorings of at least one of: strawberry, mint, raspberry, vanilla, mango, cola, cinnamon, licorice, melon, and lemon.