CHEWING GUM SUITABLE FOR DIABETICS FIELD OF THE INVENTION

The present invention is directed to chewing gum suitable for diabetes patients or ameliorating the symptoms of diabetes. In particular, the present invention relates to chewing gum comprising water-soluble indigestible polysaccharides and inorganic mineral filler.

In particular, such chewing gum may be useful together with active ingredients such as nicotine.

BACKGROUND

Diabetes mellitus afflicts nearly 15 million people in the United States. About 15 percent have insulin-dependent diabetes (IDDM; type I diabetes), which is believed to be caused by autoimmune destruction of pancreatic islet beta cells.

In such patients, insulin therapy is essential for life.

About 80% of patients have non-insulin-dependent diabetes (NIDDM; type II diabetes), a heterogeneous disorder characterized by both impaired insulin secretion and insulin resistance.

A few patients who appear to have type II diabetes may actually have a slowly progressive form of type I diabetes and eventually become dependent on insulin. Most patients with type II diabetes, however, can be treated without insulin. They are usually overweight and have the insulin resistance of obesity superimposed on the insulin resistance intrinsic to the disease. Weight loss, especially early in the disease, can restore normal glucose levels in the blood of these patients. Their diabetes may develop when the impact of the combined insulin resistances exceeds the ability of their pancreatic beta cells to compensate. Plasma insulin levels in such patients, which are often higher than those in people of normal weight who do not have diabetes, are not appropriate to their obesity and hyperglycemia. People with type II diabetes who are not obese may have a primary defect in insulin secretion in which elevations of plasma glucose levels cause not only insulin resistance but also the further deterioration of pancreatic beta cell functioning. Patients with type II diabetes are generally treated with diet modifications and sulfonylureas and/or diguanides. Unfortunately, about 11-36% of patients with type II diabetes fail to respond well to diet and sulfonylurea therapy after one year of treatment. Within 5-7 years, about half of patients with type II diabetes receiving sulfonylurea treatment need to start insulin therapy. These patients tend to be resistant to insulin, thus high doses of insulin are administered, which in turn leads to hyperinsulinemia which can play a role in the development of atherosclerosis.

Traditionally, chewing gum may be problematic for some users for a number of reasons. Firstly, sugar gives rise to problems for people in need to control blood sugar levels such as diabetics. In sugar- free gum, sugar is partly or fully replaced by sugar alcohols. These still have a sweet taste but do not have the same cariogenic effect as sugar. Secondly, such polyols will still affect blood sugar. Furthermore, the laxative effect of polyols may also be of considerable nuisance to people with gastrointestinal problems.

There is a need for chewing gum which has health benefits and can be used by most people.

SUMMARY OF THE INVENTION

One aspect of the invention pertains to a chewing gum suitable for diabetes patients or ameliorating the symptoms of diabetes, the chewing gum comprising a plurality of individual chewing gum granules which are being compressed in a tableting machine together with chewing gum ingredients to form a coherent compressed chewing gum, the chewing gum granules comprising water-insoluble gum base in an amount of SO- 60% by weight of the chewing gum, and the chewing gum ingredients comprising inorganic mineral filler particles in an amount of 20-60% by weight of the chewing gum and a water-soluble indigestible polysaccharide, the chewing gum being without digestible sugar or sugar alcohol. It has surprisingly been found by the present inventors that water-soluble indigestible polysaccharides can be incorporated into chewing gum, together with added filler to a certain extent substituting water-soluble bulking agents such as sugar and sugar alcohols. According to the invention, new chewing gum formulations have been established wherein water-soluble indigestible polysaccharides together with inorganic mineral filler and gum base provide for a texture similar to conventional formulations. Sugar and/or sugar alcohols can thus be omitted from the formulation, whereby a chewing gum suitable for diabetics can be obtained. Water-insoluble indigestible polysaccharides resist to be digested by the endogenous secretions of the human digestive tract.

According to an embodiment of the invention, the inorganic mineral filler particles are mixed as individual particles with the plurality of individual chewing gum granules before compression.

In this way, the inorganic mineral filler particles may fulfill a similar function to digestible sugar or sugar alcohol traditionally used as bulking agents in chewing gum made by compression.

Although the water-soluble indigestible polysaccharides are water-soluble they may be retained in the tablet matrix for a longer period of time than conventionally used sugar alcohols or sugar. This means that the immediate dissolving of large amounts of tablet material may be avoided and the volume of the chewable material may reduce more slowly than in chewing gum tablets comprising sugar and/or sugar alcohols.

Surprisingly, the formulations with water-soluble indigestible polysaccharide and mineral filler as substitutes for polyols have an excellent mouth feel, crunch, juiciness and a more spongy and soft texture than the standard compressed formulation with polyols.

According to embodiments of the invention water-soluble indigestible polysaccharides are not mixed into the gum base before granulation but are mixed with gum base granules prior to compression.

According to further embodiments of the invention the water-soluble indigestible polysaccharide is present in an amount of 2-50% by weight of the chewing gum, such as 3-40% by weight of the chewing gum, such as 4 -30% by weight of the chewing gum or 5-20% by weight of the chewing gum.

According to an embodiment of the invention, the chewing gum ingredients comprise two different water-soluble indigestible polysaccharides.

It has been found that different water-soluble indigestible polysaccharides contribute differently to texture-related parameters such as mouth feel, elasticity and cohesion and also may influence the delivery of flavor, sweetness and active ingredients differently.

It has been shown to be advantageous according to embodiments of the invention to work with two different water-soluble indigestible polysaccharides in order to obtain a chewing gum resembling conventional chewing gum without applying sugar and/or sugar alcohols as bulking agents.

According to embodiments of the invention, two different water-soluble indigestible polysaccharides may be used to provide a chewing gum with a texture and taste resembling or being superior to prior art products. For example, a water-soluble indigestible polysaccharides may provide juiciness and elasticity to the gum, while a different water-soluble indigestible polysaccharide may counteract the dry and powdery chew-feel from the inorganic mineral filler, whereby sugar and/or sugar alcohols may be substituted by inorganic mineral filler without negatively affecting texture and taste.

According to embodiments of the invention, more than two different water-soluble indigestible polysaccharides may be incorporated in the chewing gum to obtain chewing gum with particularly advantageous properties for diabetes patients and others wanting to minimize their glycemic load.

According to the invention a relatively high amount of gum base may be used to achieve a desirable texture. According to an embodiment of the invention the chewing gum ingredients comprise a water-soluble indigestible polysaccharide in an amount of 2-20% by weight of the chewing gum and a different water-soluble indigestible polysaccharide in an amount of 5-30% by weight of the chewing gum. It has surprisingly been found that formulations according to embodiments of the invention with two different water-soluble indigestible polysaccharides synergistically may provide a very attractive release of for example flavor. Flavor may be released for prolonged periods, making the chewing gum last for longer time, before it is discarded by the user.

Avoiding digestible sugar alcohols in a chewing gum formulation may have several benefits. One advantage of the above embodiment may be that a user may be able to use more chewing gums per day compared to conventional chewing gums. This may be due to the fact that this formulation will have a minimum effect on blood glucose level, and, at the same time, reduce the laxative effect that is commonly seen for polyols like sorbitol, xylitol, isomalt etc.

In an embodiment of the invention the water-soluble indigestible polysaccharide comprises monomers selected from the group consisting of galactose, mannose, glucose, fructose, rhamnose, arabinose, galacturonic acid and combinations thereof.

In an embodiment of the invention the water-soluble indigestible polysaccharide comprises monomers selected from glucose and/or fructose.

According to embodiments of the invention, water-soluble indigestible polysaccharides comprising glucose monomers in the polysaccharide chain are particularly useful. The polysaccharide chain of the water-soluble indigestible polysaccharide may in certain embodiments, consist of glucose monomers.

According to embodiments of the invention, water-soluble indigestible polysaccharides comprising fructose monomers in the polysaccharide chain are particularly useful. The polysaccharide chain of the water-soluble indigestible polysaccharide may in certain embodiments, consist of fructose monomers.

According to embodiments of the invention, water-soluble indigestible hetero- polysaccharides comprising both glucose and fructose in the polysaccharide chain are particularly useful. In an embodiment of the invention the water-soluble indigestible polysaccharide comprises a homo-polysaccharide.

In an embodiment of the invention the water-soluble indigestible polysaccharide comprises polydextrose. In an embodiment of the invention the polydextrose has an average number of monomers in the polydextrose chain of between 8 and 1000.

Polydextrose is a preferred water-soluble indigestible polysaccharide according to embodiments of the present invention. This type of polysaccharide counteracts the dry and powdery effect when the chewing gum contains larger amounts of inorganic mineral filler. In particular, when the chewing gum contains little or no sugar alcohol, the amount of inorganic mineral filler is typically raised to provide bulkiness. It has surprisingly been found that polydextrose improves the texture and mouth-feel of such a chewing gum, providing a commercially interesting chewing gum alternative for diabetics or other people wanting a chewing gum with no added sugar and/or sugar alcohols.

In an embodiment of the invention, the water-soluble indigestible polysaccharide comprises monomers selected from galactose and/or mannose.

According to embodiments of the invention water-soluble indigestible polysaccharides comprising galactose monomers in the polysaccharide chain are particularly useful. Surprisingly, these water-soluble indigestible polysaccharides, together with inorganic mineral filler, provide bulk and texture similar to, or better than, what is normally obtained by sugar alcohols.

According to embodiments of the invention water-soluble indigestible polysaccharides comprising mannose in the polysaccharide chain are particularly useful. Surprisingly, these water-soluble indigestible polysaccharides together with inorganic mineral filler provide bulk and texture similar to, or better than, what is normally obtained by sugar alcohols.

According to embodiments of the invention water-soluble indigestible polysaccharides being galactomannans are particularly useful. Surprisingly, these water-soluble indigestible polysaccharides provide bulk and texture similar to, or better than, what is normally obtained by sugar alcohols.

Also, such galactomannans may provide bulk and juiciness to the chewing gum. These water-soluble indigestible polysaccharides may provide desirable crunch to the chewing gum and counteract the powdery chew-feel that may arise from using mineral filler in the chewing gum.

In an embodiment of the invention the water-soluble indigestible polysaccharide comprises a hetero-polysaccharide.

In an embodiment of the invention the water-soluble indigestible polysaccharide comprises partly hydrolyzed guar gum. Partially hydrolyzed guar gum (PHGG) may be produced for example from the enzymatic hydrolysis of galactomannans by endo-P-D.mannanase.

In an embodiment of the invention the partly hydrolyzed guar gum has a molecular weight of 2000 - 200000 Da. According to embodiments of the invention, the partly hydrolyzed guar gum has a molecular weight of 2000 - 100000 Da, such as 2000 - 50000 Da.

Partly hydrolyzed guar gum is a preferred water-soluble indigestible polysaccharide according to embodiments of the present invention. This type of polysaccharide provides juiciness and elasticity to the final gum.

In an embodiment of the invention the two different water-soluble indigestible polysaccharides consist of a water-soluble indigestible polysaccharide being polydextrose and a water-soluble indigestible polysaccharide being partly hydrolyzed guar gum. According to preferred embodiment of the invention the water-soluble indigestible polysaccharides comprise polydextrose and/or hydrolyzed guar gum. Polydextrose is a synthetic polysaccharide based on glucose monomers while guar gum is a naturally occurring galactomannan obtained from guar beans having a polymeric chain comprising galactose and mannose monomers.

Polydextrose together with guar gum provides a good balance between texture and release of flavor and/or active ingredients from the chewing gum.

In an embodiment of the invention, the water-soluble indigestible polysaccharide comprises an arabinogalactan.

Water-soluble indigestible polysaccharides from a variety of sources may be used according to embodiments of the invention.

In an embodiment of the invention the chewing gum comprises a water-soluble indigestible polysaccharide in an amount of 2 -15% by weight of the chewing gum and a different water-soluble indigestible polysaccharide in an amount of 2 -20% by weight of the chewing gum, preferably a water-soluble indigestible polysaccharide in an amount of 5 -10% by weight of the chewing gum and a different water-soluble indigestible polysaccharide in an amount of 5 -15% by weight of the chewing gum.

In an embodiment of the invention the inorganic mineral filler is present in an amount of 25-45%) by weight of the chewing gum, such as in an amount of 30-40 %> by weight of the chewing gum.

In an embodiment of the invention the inorganic mineral filler is selected from the group consisting of magnesium- and calcium carbonate, sodium sulphate, ground limestone, silicate compounds such as magnesium- and aluminum silicate, kaolin and clay, aluminum oxide, silicium oxide, talc, titanium oxide, mono-, di- and tri-calcium phosphates, and combinations thereof.

Comparatively large amounts of filler may be used in the chewing gum according to embodiments of the invention because the water-soluble indigestible polysaccharide counteracts the dry and powdery mouth-feel normally associated with inorganic mineral fillers. In this way an appealing and commercially acceptable mouth-feel may be obtained.

In an embodiment of the invention the inorganic mineral filler is calcium carbonate.

A particularly useful inorganic mineral filler to be used together with water-soluble indigestible polysaccharide according to embodiments of the present invention is calcium carbonate. Comparatively large amounts of filler may be used because water-soluble indigestible polysaccharides have surprisingly been found by the present inventors to counteract the dry and powdery mouth- feel normally associated with inorganic mineral fillers. In this way an appealing and commercially acceptable mouth-feel may be obtained.

In an embodiment of the invention the chewing gum comprises flavor in an amount of 0.1 - 5% by weight of the chewing gum.

Flavor may advantageously be incorporated in the chewing gum, for example in an amount of 0.2 -3.0% by weight of the chewing gum.

In an embodiment of the invention the chewing gum comprises one or more active ingredients. In an embodiment of the invention active ingredients are added to the chewing gum together with the mixture of water-soluble indigestible polysaccharide and inorganic mineral filler.

Chewing gum according to embodiments of the invention has shown to be excellent carriers for active ingredients. The water-soluble indigestible polysaccharide is moderating the release of active ingredients to some extent, slowing down the immediate release. This may be very advantageous, in particular if the active is not neutral with respect to taste, and taste masking of the active may be an issue. The chewing gum formulations according to embodiments of the present invention are particularly useful to deliver flavor and active ingredients. It has surprisingly been found that formulations with water-soluble indigestible polysaccharide may provide a very attractive release of for example flavor. Furthermore, if two different water-soluble indigestible polysaccharides are used in the chewing gum formulation, a surprising synergy provides for a flavor release for prolonged periods, making the chewing gum last for longer time before it is discarded by the user.

Surprisingly, the same may be found for other ingredients, such as active ingredients, for example, nicotine. It is believed that the water-soluble indigestible polysaccharide is able to moderate the release of active ingredients in an attractive way, for example to sustain the release by temporarily trapping the active ingredient within the water-soluble indigestible polysaccharide matrix.

In preferred embodiments of the invention, all substances increasing the level of blood sugar in the user are avoided. These embodiments are particularly useful for people with diabetics or similar disorders. Further, it is known that sugar alcohols have a laxative effect, being a nuisance to some users. For chewing gum comprising active ingredients it may be particularly interesting to avoid sugar and sugar alcohols in order to make possible multiple doses of active over a day without the, to some people, adverse effects of sugar and sugar alcohols. In an embodiment of the invention the chewing gum comprises nicotine.

In an embodiment of the invention the nicotine is selected from the group consisting of nicotine salts, nicotine free base, nicotine bound in a complex, tobacco fibers or any combination thereof.

In this way, a nicotine chewing gum that can help smokers, who are also diabetic patients, to quit smoking, has been obtained.

In an embodiment of the invention the chewing gum comprises artificial sweetener. In preferred embodiments of the present invention the low amount or absence of sugar and sugar alcohols is counteracted by the use of artificial sweetener to provide sweetness to the gum, and at the same time not interfering with the suitability of certain embodiments for diabetics. In an embodiment of the invention the artificial sweetener is selected from the group consisting of sucralose, aspartame, salts of acesulfame, alitame, saccharin and its salts, cyclamic acid and its salts, glycyrrhizin, dihydrochalcones, thaumatin, monellin, stevioside or combinations thereof. Artificial sweeteners are ideal for use in chewing gum according to embodiments of the invention, because most, if not all, sweetness may be provided by this type of compound, when a chewing gum suitable for diabetics is desired.

In an embodiment of the invention the chewing gum further comprises less than 1 % by weight of water-insoluble indigestible polysaccharides. In an embodiment of the invention the chewing gum further comprises 1 - 10% by weight of water-insoluble indigestible polysaccharides. According to embodiments of the present invention, water-insoluble indigestible polysaccharides may also be used in the chewing gum. Such water-insoluble polysaccharides may be used to provide bulkiness and mass to the chewing gum together with the gum base, when the water-soluble indigestible polysaccharides have been dissolved and swallowed.

In an embodiment of the invention the chewing gum comprises tobacco.

In an embodiment of the invention the chewing gum has no content of water- insoluble indigestible polysaccharides.

According to an embodiment, said chewing gum comprises between 0 and 1 % by weight of water-insoluble polysaccharides. E.g. said chewing gum may also be substantially free of water-insoluble polysaccharides. In an embodiment of the invention the chewing gum comprises water-insoluble gum base in an amount of 35-55% by weight of the chewing gum, such as in an amount of 40-50%) by weight of the chewing gum, such as in an amount of 42-48%) by weight of the chewing gum. In an embodiment of the invention the chewing gum comprises at least two compressed layers.

According to embodiments of the invention it may be preferred to separate some ingredients by placing them in distinct and different layers, for example ingredients that may else react with each other. It may also be advantageous to have different colors for the layers for both aesthetical reasons and indicative reasons, for example when different colors indicate different flavor or different active ingredients.

According to embodiments of the invention, gum base may be isolated in distinct layers of the tablet. In this way a standard granulated gum base may be used together with different gum-base-free layers avoiding the mixing of particles containing gum base with other particles.

The invention also pertains to a method of producing a chewing gum according to any of the embodiments described above and in any of the claims 1-31, the method comprising the steps of

a) providing a plurality of individual chewing gum granules with a content of water- insoluble gum base of 30-60% by weight of the chewing gum,

b) providing chewing gum ingredients comprising inorganic mineral filler particles in an amount of 20-60%) by weight of the chewing gum and a water-soluble indigestible polysaccharide,

c) mixing the plurality of individual chewing gum granules a) with the chewing gum ingredients b), and

d) compressing the mixture c) in a tableting machine to form a coherent compressed chewing gum.

The invention further pertains to a chewing gum suitable for diabetes patients or suitable for ameliorating the symptoms of diabetes, the chewing gum comprising water-insoluble gum base in an amount of 30-60%> by weight of the chewing gum and chewing gum ingredients, the chewing gum ingredients comprising an inorganic mineral filler in an amount of 20-60%) by weight of the chewing gum, a water- soluble indigestible polysaccharide in an amount of 2-20% by weight of the chewing gum and a different water-soluble indigestible polysaccharide in an amount of 5-30% by weight of the chewing gum, the chewing gum being without digestible sugar or sugar alcohol. It has been found by the present inventors that water-soluble indigestible polysaccharides can be processed as an ingredient in both extruded chewing gum and compressed chewing gum.

According to embodiments of the invention, the chewing gum suitable for diabetes patients or suitable for ameliorating the symptoms of diabetes, the chewing gum comprising water-insoluble gum base in an amount of 30-60% by weight of the chewing gum and chewing gum ingredients, the chewing gum ingredients comprising an inorganic mineral filler in an amount of 20-60% by weight of the chewing gum, a water-soluble indigestible polysaccharide in an amount of 2-20% by weight of the chewing gum and a different water-soluble indigestible polysaccharide in an amount of 5-30% by weight of the chewing gum, the chewing gum being without digestible sugar or sugar alcohol comprise the features of any of the claims 4-31 and any of the embodiments described above.

DETAILED DESCRIPTION

As used herein, by the phrase "chewing gum" is meant any chewing gum such as extruded chewing gum, centre-filled chewing gum, toffee-imitating chewing gum, or compressed chewing gum, slabs or sticks.

By the terms "gum base" and "gum base matrix" is meant the mainly water-insoluble and hydrophobic gum base ingredients that are mixed together before the bulk portion of the chewing gum is added.

The term "bulk portion" intends to mean the mainly water-soluble and hydrophilic chewing gum ingredients that may be mixed into the gum base matrix after it has been made. The term "weight of the chewing gum" or similar wording meaning the same is defined in the present context as weight of the chewing gum, not including the weight of an outer coating, such as a hard coating, soft coating, and the like. By the phrase "texture" is meant a qualitative measure of the visco-elastic properties of the chewing gum and of the overall mouth-feel experienced by the user during the chewing process. Thus the term "texture" encompasses measurable quantities such as hardness and elasticity as well as more subjective parameters related to the chew-feel experienced by a user.

When referring to the word "layer", this is meant to describe a section in a chewing gum having a certain composition. For example, in a round, ball-shaped chewing gum, there may be a center of one composition and a shell having a different composition and in a traditional circular tablet there is a certain circular section of one thickness and composition and another circular section of the same or a different thickness having a different composition.

The phrase "hydrophobic" is used to describe the ability of a substance to dissolve in or blend with non-polar substances such as e.g. oils, waxes and hydrocarbon-based polymers.

The phrase "hydrophilic" is used to describe the ability of a substance to dissolve in or blend with polar substances, such as e.g. water. The phrase "enhancer" is used to describe substances that in one way or another support the release of flavor, active ingredients and the like form the chewing gum, support the uptake of pharmaceutical ingredients by a user, support the perception of flavors, coolness and the like or in other ways moderating the functions of the chewing gum in a desired way. By the phrase "digestible sugar" is meant carbohydrates like glucose, sucrose, lactose, fructose, galactose and the like, all raising blood glucose levels, when ingested. By the phrase "sugar alcohols" is meant substances also known as polyols, for example xylitol, sorbitol, manitol and isomalt, all raising blood glucose levels, when ingested.

As opposed to this, water-soluble indigestible polysaccharides do not contribute significantly to blood glucose levels when ingested. Water-insoluble indigestible polysaccharides resist to be digested by the endogenous secretions of the human digestive tract.

According to the presently preferred embodiments of the invention, no digestible sugar and no sugar alcohols are added to the chewing gum. Thereby, a chewing gum not significantly increasing blood glucose level in a person when chewed by that person may be obtained.

According to embodiments of the invention, the chewing gum is a compressed chewing gum tablet.

According to further embodiments of the invention, the chewing gum is an extruded chewing gum. The compressed chewing gum tablet may have one, two or more layers, such as 3 or 4 layers.

In such multi-layer formulations it is possible to add active ingredients or pharmaceutically active ingredients or enhancers in the same layer, in different layers or in all layers. By placing such ingredients in different layers it is possible to control the release of for example the active ingredient from the chewing gum depending on the desired effect.

It is also possible to separate ingredients that normally will react with each other by using for example three different layers. For example, the middle layer may function as a barrier between layer 1 and layer 3.

According to an embodiment of the invention, said chewing gum comprises a first compressed layer comprising granules with a content of gum base and a second compressed gum base free layer comprising a mixture of water-soluble indigestible polysaccharides and inorganic mineral filler.

According to an embodiment of the invention, said second gum-base-free layer furthermore comprises one or more active ingredients. In some embodiments of the invention, a buffer is added, the buffer being selected from the group consisting of tris buffers, amino acid buffers, carbonate, including monocarbonate, bicarbonate or sesqui carbonate, glycerinate, phosphate, glycerophosphate, acetate, glyconate or citrate of an alkali metal, such as potassium and sodium, e.g. trisodium and tripotassium citrate, or ammonium, and mixtures thereof.

When buffer is used, a preferred buffer is sodium bicarbonate. In some embodiments buffer is not part of the chewing gum. In some other embodiments, buffer is part of the chewing gum. In some embodiments of the invention, the amount of buffer is 0.5 to 10% by weight of the chewing gum.

In some embodiments of the invention the buffer is selected from the group consisting of Acetic acid, Adipic acid, Citric acid, Fumaric acid, Glucono-5-lactone, Gluconic acid, Lactic acid, Malic acid, Maleic acid, Tartaric acid, Succinic acid, Propionic acid, Ascorbic acid, Phosphoric acid, Sodium orthophosphate, Potassium orthophosphate, Calcium orthophosphate, Sodium diphosphate, Potassium diphosphate, Calcium diphosphate, Pentasodium triphosphate, Pentapotassium triphosphate, Sodium polyphosphate, Potassium polyphosphate, Carbonic acid, Sodium carbonate, Sodium bicarbonate, Potassium carbonate, Calcium carbonate, Magnesium carbonate, Magnesium oxide, or any combination thereof.

The buffer may to some extent be microencapsulated or otherwise coated as granules with polymers and/or lipids being less soluble in saliva than is the one or more buffering agents. Such microencapsulation controls the dissolution rate whereby is extended the time frame of the buffering effect.

However, in presently preferred embodiments an alkaline buffer is preferred, such as sodium carbonate or calcium carbonate. According to embodiments of the invention a preferred amount of gum base matrix in the final chewing gum is above 30 percent by weight of the chewing gum before any optionally applied coating, such as above 35 percent by weight of the chewing gum core, such as above 40 percent by weight of the chewing gum, such as above 45 percent by weight of the chewing gum, such as about 40 percent by weight of the chewing gum, such as about 47 percent by weight of the chewing gum.

According to the invention a preferred amount of gum base matrix in the final chewing gum before any optional coating is between 30 and 60 percent by weight of the chewing gum, such as between 35 and 55 percent by weight of the chewing gum, such as between 40 and 50 percent by weight of the chewing gum, such as between 42 and 48 percent by weight of the chewing gum.

The formulation of gum bases can vary substantially depending on the particular product to be prepared and on the desired masticatory and other sensory characteristics of the final product. However, typical ranges (% by weight) of the gum base components are: 5 to 80% by weight elastomeric compounds, 5 to 80% by weight natural and/or synthetic resins (elastomer plasticizers), 0 to 40% by weight waxes, 5 to 35% by weight softener other than waxes, 0 to 50% by weight filler, and 0 to 5% by weight of miscellaneous ingredients such as antioxidants, colorants, etc. According to presently preferred embodiments of the invention, substantial amounts of inorganic mineral filler are added to the chewing gum as an ingredient separate from the gum base. The gum base itself may also comprise filler material.

Elastomers provide the rubbery, cohesive nature to the gum, which varies depending on this ingredient's chemical structure and how it may be compounded with other ingredients. Elastomers suitable for use in the gum base and gum of the present invention may include natural or synthetic types.

Elastomer plasticizers vary the firmness of the gum base. Their specificity on elastomer inter-molecular chain interaction (plasticizing) along with their varying softening points cause varying degrees of finished gum firmness and compatibility when used in gum base. This may be important if it is desired to provide more elastomeric chain exposure to the alkane chains of the waxes. The elastomers (rubbers) employed in the gum base may vary depending upon various factors such as the type of gum base desired, the texture of gum formulation desired and the other components used in the formulation to make the final chewing gum product.

The elastomer may be any water-insoluble polymer known in the art, and includes those gum polymers utilized for chewing gums and bubble gums. Illustrative examples of suitable polymers in gum bases include both natural and synthetic elastomers. For example, those polymers which are suitable in gum bases include, without limitation, natural substances (of vegetable origin) such as chicle gum, natural rubber, crown gum, nispero, rosidinha, jelutong, perillo, niger gutta, tunu, balata, guttapercha, lechi capsi, sorva, gutta kay, and the like, and mixtures thereof. Examples of synthetic elastomers include, without limitation, styrene-butadiene copolymers (SBR), polyisobutylene, isobutylene-isoprene copolymers, polyethylene, polyvinyl acetate and the like, and mixtures thereof. Natural resins may be used according to the invention and may be natural rosin esters, often referred to as ester gums including as examples glycerol esters of partially hydrogenated rosins, glycerol esters of polymerised rosins, glycerol esters of partially dimerized rosins, glycerol esters of tally oil rosins, pentaerythritol esters of partially hydrogenated rosins, methyl esters of rosins, partially hydrogenated methyl esters of rosins, pentaerythritol esters of rosins, synthetic resins such as terpene resins derived from alpha-pinene, beta-pinene, and/or d-limonene, and natural terpene resins.

In an embodiment of the invention, the resin comprises terpene resins, e.g. derived from alpha-pinene, beta-pinene, and/or d-limonene, natural terpene resins, glycerol esters of gum rosins, tall oil rosins, wood rosins or other derivatives thereof such as glycerol esters of partially hydrogenated rosins, glycerol esters of polymerized rosins, glycerol esters of partially dimerised rosins, pentaerythritol esters of partially hydrogenated rosins, methyl esters of rosins, partially hydrogenated methyl esters of rosins or pentaerythritol esters of rosins and combinations thereof.

In an embodiment of the invention, said chewing gum ingredients are selected from the group consisting of flavors, dry-binders, tableting aids, anti-caking agents, emulsifiers, antioxidants, enhancers, absorption enhancers, buffers, high intensity sweeteners, softeners, colors, active ingredients, water-soluble indigestible polysaccharides, water-insoluble polysaccharides or any combination thereof.

In an embodiment of the invention, said emulsifiers are selected from the group of cyclodextrins, polyoxyethylene castor oil derivatives, polyoxyethylene alkyl ethers, macrogol alkyl ethers, block copolymers of ethylene and propylene oxides, polyoxyethylene alkyl ethers, polyoxyethylene glycols, polyoxyethylene sorbitan fatty acid esters, polyoxyethylene (20) sorbitan monostearates, polyoxyethylene (20) sorbitan monooleates, polyoxyethylene stearates, sobitan esters, diacetyl tartaric ester of monoglycerides, lactylated monoglycerides, or any combination thereof. In an embodiment of the invention, said chewing gum comprises emulsifiers in an amount in the range of 0.1% to 25% by weight of said chewing gum.

In an embodiment of the invention the chewing gum comprises flavor. Flavor may typically be present in amounts between 0.01 and 5% by weight of the chewing gum.

Non-exhaustive examples of flavors suitable in embodiments of the present invention are coconut, coffee, chocolate, vanilla, grape fruit, orange, lime, menthol, liquorice, caramel aroma, honey aroma, peanut, walnut, cashew, hazelnut, almonds, pineapple, strawberry, raspberry, tropical fruits, cherries, cinnamon, peppermint, wintergreen, spearmint, eucalyptus, and mint, fruit essence such as from apple, pear, peach, strawberry, apricot, raspberry, cherry, pineapple, and plum essence. The essential oils include peppermint, spearmint, menthol, eucalyptus, clove oil, bay oil, anise, thyme, cedar leaf oil, nutmeg, and oils of the fruits mentioned above. Petroleum waxes aid in the curing of the finished gum made from the gum base as well as improve shelf life and texture. Wax crystal size influences the release of flavor. Those waxes high in iso-alkanes have a smaller crystal size than those waxes high in normal-alkanes, especially those with normal-alkanes of carbon numbers less than 30. The smaller crystal size allows slower release of flavor since there is more hindrance of the flavor's escape from this wax versus a wax having larger crystal sizes. The compatibility of gum bases made using normal-alkanic waxes is less when compared to gum bases made with iso-alkanic waxes. Petroleum wax (refined paraffin and microcrystalline wax) and paraffin wax are composed of mainly straight-chained normal-alkanes and branched iso-alkanes. The ratio of normal-alkanes to iso-alkanes varies. The normal-alkanic waxes typically have carbon chain lengths >C-18 but the lengths are not predominantly longer than C-30. The branched and ring structures are located near the end of the chain for those waxes that are predominantly normal-alkanic. The viscosity of normal-alkanic waxes is <10 mm2/s (at 100 °C) and the combined number average molecular weight is <600 g/mole.

The iso-alkanic waxes typically have carbon lengths that are predominantly greater than C-30. The branched chains and ring structures are located randomly along the carbon chain in those waxes that are predominantly iso-alkanic. The viscosity of iso- alkanic waxes is greater than 10 mm2/s (at 100 °C) and the combined number average molecular weight is >600 g/mole.

Synthetic waxes are produced by means that are atypical for petroleum wax production and are thus not considered petroleum wax. The synthetic waxes may include waxes containing branched alkanes and copolymerized with monomers such as, but not limited to propylene, polyethylene, and Fischer Tropsch type waxes.

Polyethylene wax is a synthetic wax containing alkane units of varying lengths having attached thereto ethylene monomers.

Waxes and fats are conventionally used for the adjustment of the texture and for softening of the chewing gum base when preparing chewing gum bases. In connection with the present invention, any conventionally used and suitable type of natural and synthetic wax and fat may be used, such as for instance rice bran wax, polyethylene wax, petroleum wax (refined paraffin and microcrystalline wax), sorbitan monostearate, tallow, propylene glycol, paraffin, beeswax, carnauba wax, candelilla wax, cocoa butter, degreased cocoa powder and any suitable oil or fat, as e.g. completely or partially hydrogenated vegetable oils or completely or partially hydrogenated animal fats.

Antioxidants prolong shelf life and storage of gum base, finished gum or their respective components including fats and flavor oils.

Antioxidants suitable for use in gum base include butylated hydroxyanisole (BHA), butylated hydroxytoluene (BHT), betacarotenes, tocopherols, acidulants such as Vitamin C, propyl gallate, other synthetic and natural types or mixtures thereof. In some embodiments, one or more colors can be included in the chewing gum.

In some embodiments of the invention the chewing gum comprises pharmaceutically active ingredients. In an embodiment of the invention, the pharmaceutically active ingredients are selected from the group consisting of antihistamines, anti-smoking agents, agents used for diabetes, decongestrants, peptides, pain-relieving agents, antacids, nausea- relieving agents, statines, or any combination thereof. In an embodiment of the invention, the pharmaceutically active ingredients are selected from the group consisting of cetirizine, levo cetirizine, nicotine, nicotine polacrilex, nicotine in combination with alkaline agents, metformin, metformin HCL, phenylephrine, GLP-1, exenatide, MC-4 receptor antagonist, PPY(3-36), deca- peptide, KSL-W (acetate), fluor, chlorhexidine, or any combination thereof.

In an embodiment of the invention, the pharmaceutically active ingredients are selected from the group consisting of

loratadine, des-loratadine, nicotine bitartrate, nicotine in combination with caffeine, nicotine antagonists, combinations thereof or compounds comprising one or more of these, pseudoephedrine, flurbiprofen, paracetamol, acetylsalicylic acid, Ibuprofen, antacida, cimetidine, ranitidine, ondansetron, granisetron, metoclopramid, simvastatin, lovastatin, fluvastatin, acyclovir, benzydamin, rimonabant , varenicline, sildenafil, naltrexone, fluor in combination with fruit acids, derivatives, salts or isomers of chlorhexidine, or any combination thereof.

In an embodiment of the invention, the pharmaceutically active ingredient is selected from the therapeutical groups consisting of:

Antipyretic, Anti allergic, Anti-arrytmic, Appetite suppressant, Anti-inflammatory, Broncho dilator, Cardiovascular drugs, Coronary dilator, Cerebral dilator, Peripheral vasodilator, Anti-infective, Psychotropic, Anti-manic, Stimulant, Decongestant, Gastro-intestinal sedative, Sexual dysfunction agent, Desinfectants, Anti-anginal substance, Vasodilator, Anti-hypertensive agent, Vasoconstrictor, Migraine treating agent, Anti-biotic, Tranquilizer, Anti-psychotic, Anti-tumor drug, Anticoagulant, Hypnotic, Sedative, Anti-emetic, Anti-nauseant, Anti-convulsant, Neuromuscular agent, Hyper and hypoglycaemic, Thyroid and anti-thyroid, Diuretic, Antispasmodic, Uterine relaxant, Anorectics, Spasmolytics, Anabolic agent, Erythropoietic agent, Anti-asthmatic, Expectorant, Cough suppressant, Mucolytic, Anti-uricemic agent, Dental vehicle, Breath freshener, Antacid, Anti-diuretic, Anti- flatulent, Betablocker, Teeth Whitener, Enzyme, Co-enzyme, Protein, Energy Booster, Fiber, Probiotics, Prebiotics, Antimicrobial agent, NSAID, Anti-tussives, Decongestrants, Anti-histamines, Anti-diarrheals, Hydrogen antagonists, Proton pump inhibitors, General nonselective CNS depressants, General nonselective CNS stimulants, Selectively CNS function modifying drugs, Antiparkinsonism, Narcotic- analgetics, Analgetic-antipyretics, Psychopharmacological drugs, diagnostica sex hormones allergens, antifungal agents, Chronic Obstructive Pulmonary Disease (COPD) or any combination thereof.

In an embodiment of the invention, said active ingredient is selected from the group consisting of: ace-inhibitors, antianginal drugs, antiarrhythrmas, anti-asthmatics, anti-cholesterolemics, analgesics, anesthetics, anticonvulsants, anti-depressants, anti- diabetic agents, anti-diarrhea preparations, antidotes, anti-histamines, antihypertensive drugs, anti-inflammatory agents, anti-lipid agents, antimanics, anti- nauseants, anti-stroke agents, anti-thyroid preparations, anti-tumor drugs, anti-viral agents, acne drugs, alkaloids, amino acid preparations, anti-tussives, antiuricemic drugs, anti-viral drugs, anabolic preparations, systemic and non-systemic antiinfective agents, anti-neoplastics, anti-parkinsonian agents, anti-rheumatic agents, appetite stimulants, biological response modifiers, blood modifiers, bone metabolism regulators, cardiovascular agents, central nervous system stimulates, cholinesterase inhibitors, contraceptives, decongestants, dietary supplements, dopamine receptor agonists, .endometriosis management agents, enzymes, erectile dysfunction therapies such as sildenafil citrate, which is currently marketed as Viagra™, fertility agents, gastrointestinal agents, homeopathic remedies, hormones, hypercalcemia and hypocalcemia management agents, immunomodulators, inmosuppressives, migraine preparations, motion sickness treatments, muscle relaxants, obesity management agents, osteoporosis preparations, oxytocics, parasympatholytics, parasympathomimetics, prostaglandins, psychotherapeutic agents, respiratory agents, sedatives, smoking cessation aids such as bromocryptine or nicotine, sympatholytics, tremor preparations, urinary tract agents, vasodilators, laxatives, antacids, ion exchange resins, anti-pyretics, appetite suppressants, expectorants, anti-anxiety agents, anti-ulcer agents, anti-inflammatory substances, coronary dilators, cerebral dilators, peripheral vasodilators, psycho-tropics, stimulants, anti-hypertensive drugs, vasoconstrictors, migraine treatments, antibiotics, tranquilizers, anti-psychotics, anti-tumor drugs, anti-coagulants, antithrombotic drugs, hypnotics, anti-emetics, anti-nauseants, anti-con vulsants, neuromuscular drugs, hyper- and hypo-glycemic agents, thyroid and anti-thyroid preparations, diuretics, anti-spasmodics, terine relaxants, anti-obesity drugs, erythropoietic drugs, anti-asthmatics, cough suppressants, mucolytics, DNA and genetic modifying drugs, and combinations thereof. In an embodiment of the invention, said active ingredient is selected from the group consisting of anti-histamines, decongestants, smoking cessation aids, diabetes II agents, or any combination thereof. In an embodiment of the invention, said pharmaceutically active ingredient is selected from the group consisting of ephedrine, pseudo ephedrine, caffeine, loratadine, sildenafil, simvastatin, sumatriptan, acetaminophen, calcium carbonate, vitamin D, ibuprofen, aspirin, alginic acid in combination with aluminum hydroxide and sodium bicarbonate, ondansetron, Tibolon, Rimonabant, Varenicline, allergenes, sitagliptin or any derivatives thereof, salts thereof, isomers thereof, combinations thereof or compounds comprising one or more of these.

According to embodiments of the invention, the chewing gum comprises active ingredients.

In an embodiment of the invention, active ingredient is selected from the group consisting of phytochemicals, such as resveratrol and anthocyanin; herbals, such as green tea or thyme; antioxidants, such as polyphenols; micronutrients; mouth moisteners, such as acids; throat soothing ingredients; appetite suppressors; breath fresheners, such as zinc compounds or copper compounds; diet supplements; cold suppressors; cough suppressors; vitamins, such as vitamin A, vitamin C or vitamin E; minerals, such as chromium; metal ions; alkaline materials, such as carbonates; salts; herbals, dental care agents, such as re-mineralization agents, antibacterial agents, anti-caries agents, plaque acid buffering agents, tooth whiteners, stain removers or desensitizing agents; and combinations thereof.

In an embodiment of the invention, said active ingredient is selected from the group consisting of di-peptides, tri-peptides, oligo-peptides, deca-peptides, deca-peptide KSL, deca-peptide KSL-W, amino acids, proteins, or any combination thereof. In an embodiment of the invention, said active ingredient comprise probiotic bacteria, such as lactobacilli, bifidobacteria, lactococcus, streptococcus, leuconostoccus, pediococcus or enterococcus. In an embodiment of the invention, said active ingredient is selected from the group consisting of pharmaceuticals, nutraceuticals, medicaments, nutrients, nutritional supplements, drugs, dental care agents, herbals, and the like and combinations thereof. In an embodiment of the invention, said active ingredient is selected from the ATC anatomical groups consisting of agents acting on:

A alimentary tract and metabolism, B blood and blood forming organs, C cardiovascular system, D dermatologicals, G genito urinary system and sex hormones, H systemic hormonal preparations, J antiinfectives for systemic use, L antineoplastic and immunomodulating agents, M musculoskeletal system, N nervous system, P antiparasitic products, insecticides and repellents, R respiratory system and S sensory organs, V various, or any combination thereof.

In an embodiment of the invention, said active ingredient is selected from the ATC therapeutical groups consisting of:

A01 Stomatological preparations, A02 Drugs for acid related disorders, A04 Antiemetics and antinauseants, A06 Laxatives, A07 Antidiarrheals, intestinal anti- inflammatory/anti-infective agents, A08 Antiobesity preparations, excluding diet products, A10 Drugs used in diabetes, All Vitamins, A12 Mineral supplements, B01 Antithrombotic agents, B03 Antianemic preparations, C01 Cardiac therapy, CIO Serum lipid reducing agents, D01 Antifungals for dermatological use, G03 Sex hormones, G04 Urologicals, M01 Anti-inflammatory and antirheumatic products, M09 Other drugs for disorders of the musculo-skeletal system, N01 Anesthetics, N02 analgesics, N07 Other nervous system drugs, R01 Nasal preparations, R02 Throat preparations, R03 Drugs for obstructive airway diseases, R05 Cough and cold preparations, and R06 Antihistamines for systemic use, V01 allergens, V04 diagnostic agents, or any combination thereof.

In an embodiment of the invention, said active ingredient is selected from the group consisting of metformin, cetirizine, levo cetirizine, phenylephrine, flurbiprofen, nicotine, nicotine bitartrate, nicotine polacnlex, nicotine in combination with alkaline agents, nicotine in combination with caffeine, sodium picosulfate, fluor, fluor in combination with fruit acids, chlorhexidine, or any derivatives thereof, salts thereof, isomers thereof, nicotine antagonists, combinations thereof or compounds comprising one or more of these.

In an embodiment of the invention, the chewing gum comprises tobacco alkaloid.

In an embodiment of the invention, the tobacco alkaloid is nicotine.

In an embodiment of the invention, said nicotine is in a form selected from nicotine salts, nicotine free base, nicotine bound in a complex, or any combination thereof.

In an embodiment of the invention, said complex comprises an ion exchange resin.

In an embodiment of the invention, said ion exchange resin is a weakly acidic cation exchange resin.

According to an embodiment of the invention, a preferred example of a weakly acidic cation exchange resin is polacrilex.

In an embodiment of the invention, said complex comprises an adsorbent.

In an embodiment of the invention, said adsorbent is selected from the group consisting of finely divided silicic acid, amorphous silica, magnesium silicate, calcium silicate, kaolin, clays, crystalline aluminosilicates, macaloid bentonite, activated carbon, alumina, hydroxylapatite, microcrystalline cellulose, or any combination thereof. In an embodiment of the invention, said nicotine salts are selected from the group comprising nicotine hydrochloride, nicotine dihydrochloride, nicotine monotartrate, nicotine bitartrate, nicotine sulfate, nicotine zinc chloride, nicotine salicylate, or any combination thereof. According to embodiments of the present invention the chewing gum comprises enhancers.

In an embodiment of the invention, said enhancers are selected from the group consisting of bile salts, cetomacrogols, chelating agents, citrates, cyclodextrins, detergents, enamine derivatives, fatty acids, labrasol, lecithins, phospholipids, syntetic and natural surfactants, nonionic surfactants, cell envelope disordering compounds, solvents, steroidal detergents, chelators, solubilization agents, charge modifying agents, pH control agents, degradative enzyme inhibitors, mucolytic or mucus clearing agents, membrane penetration-enhancing agents, modulatory agents of epithelial junction physiology, vasodilator agents, selective transport-enhancing agents, or any combination thereof.

pH control agents include buffers.

In an embodiment of the invention, said enhancers are selected from the group consisting of cetylpyridinium chloride (CPC), benzalkonium chloride, sodium lauryl sulfate, polysorbate 80, Polysorbate 20, cetyltrimethylammonium bromide, laureth 9, sodium salicylate, sodium EDTA, EDTA, aprotinin, sodium taurocholate, saponins, bile salt derivatives, fatty acids, sucrose esters, azone emulsion, dextran sulphate, linoleic acid, labrafil, transcutol, urea, azone, nonionic surfactants, sulfoxides, sauric acid/PG, POE 23 lauryl ether, methoxy salicylate, dextran sulfate, methanol, ethanol, sodium cholate, Sodium taurocholate, Lysophosphatidyl choline, Alkylglycosides, polysorbates, Sorbitan esters, Pol oxamer block copolymers, PEG-35 castor oil, PEG- 40 hydrogenated castor oil, Caprocaproyl macrogol-8 glycerides, PEG-8 caprylic/capric, glycerides, Dioctyl sulfosuccinate, Polyethylene lauryl ether, Ethoxydiglycol, Propylene glycol, mono-di-caprylate, Glycerol monocaprylate, Glyceryl fatty acids (C.sub.8-C.sub. l8) ethoxylated.

Oleic acid, Linoleic acid, Glyceryl caprylate/caprate, Glyceryl monooleate, Glyceryl monolaurate, Capryliccapric triglycerides, Ethoxylated nonylphenols, PEG-(8-50) stearates, Olive oil PEG-6, esters, Triolein PEG-6 esters, Lecithin, d-alpha tocopherol polyethylene glycol 1,000 succinate, Citric acid, Sodium citrate, BRIJ, Sodium laurate, 5-methoxysalicylic acid, Bile salts, Acetyl salicylate, ZOT, Docosahexaenoic acid, Alkylglycosides, Sodium glycocholate (GC-Na), Sodium taurocholate (TC-Na), EDTA, Choline salicylate, Sodium caprate (Cap-Na), N- lauryl-beta-D-maltopyranoside (LM), Diethyl maleate, Labrasol, Sodium salicylate, Mentol, Alkali metal alkyl sulphate, Sodium lauryl sulphate, Glycerin, Bile acid, Lecithin, phosphatidylcholine, phosphatidylserine, sphingomyelin, phophatidylethanolamine, cephalin, lysolecithin, Hyaluronic acid: alkalimetal salts, sodium, alkaline earth and aluminum, Octylphenoxypolyethoxyethanol, Glycolic acid, Lactic acid, Chamomile extract, Cucumber extract, Borage oil, Evening primrose oil, Polyglycerin, Lysine, Polylysine, Triolein, Monoolein, Monooleates, Monolaurates, Polydocanol alkyl ethers, Chenodeoxycholate, Deoxycholate, Glycocholic acid, Taurocholic acid, Glycodeoxycholic acid, Taurodeoxycholic acid, Sodium glycocholate, Phosphatidylcholine, Phosphatidylserine, Sphingomyelin, Phosphatidylethanolamine, Cephalin, Lysolecithin, Alkali metal hyaluronates, Chitosan, Poly-L-arginine, Alkyl glucoside, Saccharide alkyl ester, Fusidic acid derivatives, Sodium taurdihydrofusidate (STDHF), L-a-phosphatidylcholine Didecanoyl (DDPC), Nitroglycerine, nitropruside, NOC5 [3-(2-hydroxy-l-(methyl- ethyl)-2-nitrosohydrazino)-l- propanamine], NOC12 [iV-ethyl-2-(l-ethyl-hydroxy-2- nitrosohydrazino)-ethanamine, SNAP [S-nitroso-N-acetyl-DL-penicillamine, NORI, NOR4, deacylmethyl sulfoxide, azone, salicylamide, glyceryl-l,3-diacetoacetate, 1,2- isopropylideneglycerine-3-acetoacetate), Amino acids, Amino acid salts, monoaminocarboxlic acids, Glycine, alanine, phenylalanine, proline, hydroxyproline, hydroxyamino acids, serine, acidic amino acids, aspartic acid, Glutamic acid, Basic amino acids, Lysine, N-acetylamino acids, N-acetylalanine, N-acetylphenylalanine, TM-acetyl serine, N-acetylglycine, N-acetyllysine, N-acetylglutamic acid, N- acetylproline, N-acetylhydroxyproline , lactic acid, malic acid and citric acid and alkali metal salts thereof, pyrrolidonecarboxylic acids, alkylpyrrolidonecarboxylic acid esters, N-alkylpyrrolidones, proline acyl esters, sodium lauryl phosphate, sodium lauryl sulphate, sodium oleyl phosphate, sodium myristyl sulphate, polyoxy ethylene alkyl ethers, polyoxy ethylene alkyl esters, and caproic acid, alkylsaccharide, fusidic acid, polyethylene glycol, cetyl alcohol, polyvinylpyrolidone, Polyvinyl alcohol, Lanolin alcohol, Sorbitan monooleate, Ethylene glycol tetraacetic acid, Bile acid conjugate with taurine, Cholanic acid and salts, Cyclodextran, Cyclodextrin, Cyclodextrin (beta), Hydroxypropyl-β- cyclodetran, Sulfobutylether-P-cyclodextran, Methyl-P-cyclodextrin, Chitosan glutamate, Chitosan acetate, Chitosan hydrochloride, Chitosan hydrolactate, 1-0- alkyl-2-hydroxy-sn-glycero-3-phosphocholine, 3-0-alkyl-2-acetoyl-sn-glycero-l- phosphocholine, 1 -O-alkyl-2-O-acetyl- sn-gly cero-3 -phospho(N,N,N- trimethyl)hexanolamine, Propylene glycol, Tetradecylmaltoside (TDM), Sucrose dedecanoate.

In an embodiment of the invention, said pH control agents are selected from the group consisting of Acetic acid, Adipic acid, Citric acid, Fumaric acid, Glucono-δ- lactone, Gluconic acid, Lactic acid, Malic acid, Maleic acid, Tartaric acid, Succinic acid, Propionic acid, Ascorbic acid, Phosphoric acid, Sodium orthophosphate, Potassium orthophosphate, Calcium orthophosphate, Sodium diphosphate, Potassium diphosphate, Calcium diphosphate, Pentasodium triphosphate, Pentapotassium triphosphate, Sodium polyphosphate, Potassium polyphosphate, Carbonic acid, Sodium carbonate, Sodium bicarbonate, Potasium carbonate, Calcium carbonate, Magnesium carbonate, Magnesium oxide, or any combination thereof. High intensity artificial sweetening agents can also be used according to preferred embodiments of the invention. Preferred high intensity sweeteners include, but are not limited to sucralose, aspartame, salts of acesulfame, alitame, saccharin and its salts, cyclamic acid and its salts, glycyrrhizin, dihydrochalcones, thaumatin, monellin, stevioside and the like, alone or in combination.

In order to provide longer lasting sweetness and flavor perception, it may be desirable to encapsulate or otherwise control the release of at least a portion of the artificial sweeteners.

Techniques such as wet granulation, wax granulation, spray drying, spray chilling, fluid bed coating, conservation, encapsulation in yeast cells and fiber extrusion may be used to achieve desired release characteristics. Encapsulation of sweetening agents can also be provided using another chewing gum component such as a resinous compound.

Usage level of the artificial sweetener will vary considerably and will depend on factors such as potency of the sweetener, rate of release, desired sweetness of the product, level and type of flavor used and cost considerations. Thus, the active level of artificial sweetener may vary from about 0.001 to about 8% by weight (preferably from about 0.02 to about 8% by weight). When carriers used for encapsulation are included, the usage level of the encapsulated sweetener will be proportionately higher. Combinations of sugar and/or non-sugar sweeteners may be used in the chewing gum.

A chewing gum and/or gum base may, if desired, include one or more fillers/texturizers including as examples, magnesium- and calcium carbonate, sodium sulphate, ground limestone, silicate compounds such as magnesium- and aluminum silicate, kaolin and clay, aluminum oxide, silicium oxide, talc, titanium oxide, mono-, di- and tri-calcium phosphates, cellulose polymers, such as wood, and combinations thereof.

According to an embodiment of the invention, one preferred filler/texturizer may be calcium carbonate.

A number of chewing gum components well known within the art may be applied within the scope of the present invention. Such components comprise but are not limited to waxes, fats, softeners, fillers, flavors, anti-oxidants, emulsifiers, colouring agents, binding agents and acidulants

In an embodiment of the invention, the chewing gum is provided with an outer coating selected from the group consisting of hard coating, soft coating and edible film-coating or any combination thereof.

The following non-limiting examples illustrate different variations of the present invention. The examples are meant for indicating the inventive concept; hence the mentioned examples should not be understood as exhaustive for the present invention.

EXAMPLES Example 1

Composition of standard 2 layer compressed chewing gum

Three different examples of compressed chewing gum were prepared according to standard procedures. The materials for layer 1 are mixed and dosed into a cavity and compressed slightly. The materials for layer 2 are mixed and dosed on top of layer 1, the two layers being compressed to for a two-layer tablet. The below numbers refer to % by weight of each layer in a compressed two layer tablet. In this case, layer 1 comprises about 80% of the tablet while layer 2 comprises about 20% of the tablet. Composition of a standard compressed two layer tablets:

a e - ompos t ons o stan ar compresse two- ayer c ew ng gum are given in percent by weight of each layer.

Example la:

A compressed formulation without any active ingredient included and which purpose is to achieve a good taste experience and a long lasting taste and freshness.

Example lb:

A compressed formulation with an active ingredient included in layer 1. This active ingredient is fluoride. The fluoride for oral care purposes is added in layer 1 with gum base to insure a slower release of fluoride. The fluoride has the purpose of working in the oral cavity. Together with the effect of the active ingredient the product provides a good taste and a long lasting taste and freshness.

Example lc:

A compressed formulation with an active ingredient included in layer 1 (see example lb) and furthermore an active ingredient added in layer 2. Vitamin D is a fat-soluble hydrophobic ingredient. To insure a desired release of this active ingredient form the chewing gum, Vitamin D is added in layer 2.

If Vitamin D is added in layer 1, the release is slower due to an incorporation of Vitamin D in the gum base matrix doing chewing. Again the flavor and texture will insure a good taste and a long lasting freshness.

Table 1 shows three standard formulations of compressed two-layer chewing gum. In these formulations it is possible to add active ingredients in layer 1 or layer 2 or in both layers. By placing the active ingredient in different layers it is possible to control the release of the active ingredient from the chewing gum depending on the desired effect. It is also possible to separating actives that normally will react with each other by using three different layers.

In these examples two layer compressed chewing gum tablets have been prepared, but one-layer tablets or tablets with more than 2 layers can also be made, depending on, for example, desired taste, release and/or texture.

Example 2:

Composition of compressed chewing gum formulation without polyols

Two different examples of compressed chewing gum formulations have been listed in table 2 below. In these two formulations the polyols of the comparative compositions in Example 1 have been substituted by calcium carbonate, polydextrose and partly hydrolyzed guar gum (PHGG). The below numbers refer to % by weight of the one-layer compressed tablet. Composition of new formulations without polyols, one-layer tablet:

Ingredients Exi imple 2a Example 2b

Gum base 45% 45%

Calcium carbonate 36.7% 36.7%

Polydextrose 10% 10%

PHGG 5% 5%

Flavor 2% 2%

Encapsulated flavours 1% 1%

HIS 3.22% 0.22%

Color 3.08% 0.06%

Sodium fluoride 0.02%

Table 2 - Compositions of compressed chewing gum. Amounts are given in percent by weight of each composition.

A very chalky taste and dusty chew-feel is normally associated with chewing gum including substantial amounts of calcium carbonate. By including water-soluble indigestible polysaccharide it is possible to reduce this chalky taste and dusty chew- feel and obtain a better mouth-feel, comparable to standard products comprising polyols.

Table 2 shows two examples of compressed chewing gum compositions where polyols have been fully substituted by calcium carbonate and water-soluble indigestible polysaccharides.

By including both polydextrose and PHGG, it is possible to obtain a chewing gum with an excellent texture and taste. The water-soluble indigestible polysaccharides counteract the aforementioned chalky taste and dusty chew-feel effectively. Polydextrose, for example, provides volume and crunch to the chewing gum tablet and may be used to regulate release of, for example, flavor, the release being influenced in the direction of more control and less burst. PHGG, besides counteracting the dusty mouth-feel from the mineral filler, provides volume and a spongy texture to the chewing gum tablet.

It has therefore been established that the combination of inorganic mineral filler with indigestible water-soluble polysaccharide is capable to fully substitute the polyols used in the standard tablets of Example 1.

Example 2a:

The formulations in Table 2 provide a desirable flavor release together with a good taste and an excellent overall texture, in that the formulation achieves a soft and spongy chew and a good juiciness.

Example 2b:

Incorporation of active ingredients in the formulation in Table 2 provides a new and convenient way of administering actives to diabetics and other people in need for regulating blood sugar or just wanting to avoid sugar and sugar alcohols. Fluoride can be incorporated and an oral care effect similar to that achieved in comparative Example lb can be obtained.

Thus it is also possible to incorporate active ingredients in this new compressed formulation. By adding actives for oral care like fluoride extra benefits are achieved. Example 3:

Composition of 2-layer compressed chewing gum formulation without polyols

Using the same new formulations as in example 2 it is possible to manufacture a compressed chewing gum having two- or more layers. Using two layers provides the possibility to add active ingredient in each layer to control the release also for fat soluble active ingredient as for instance Vitamin D. The fat soluble actives may be added in layer two, to prevent excessive incorporating into the gum base during chewing, and insure a desired release.

The below numbers refer to % by weight of each layer in a compressed two layer tablet. In this case, layer 1 comprises about 80% of the tablet while layer 2 comprises about 20% of the tablet.

New formulation without polyols; two layers:

Table 3 - Compositions of 2-layer compressed chewing gum. Amounts are given in percent by weight of each layer. Example 3a:

Layer 1 is the same formulation as used for the one-layer tablet of example 2a. Furthermore a second layer without gum base is added- the second layer still without polyols.

This second layer comprises calcium carbonate in combination with polydextrose and PHGG. By adding a second layer several advantages may be achieved, for example an adjusted initial chew, a two-color tablet etc.

Example 3b:

The same formulation as example 3 a is used, except with active ingredients included in both layers.

The benefits are the same as in example 3a, and

furthermore, it is also possible to add active ingredients that are fat soluble and therefore preferably are added in layer 2 without gum base to insure a desired release.

Furthermore, it is possible to add actives that normally react with each other and therefore need to be separated in two different layers.

Example 4:

Different combinations of gum base, calcium carbonate, PHGG, water-insoluble polysaccharide and polydextrose have been tried. All samples have been sensory evaluated with focus on taste and texture.

The following evaluation scale was used:

"+" meaning not suitable in commercial products

"++" meaning acceptable for some purposes,

"+++" meaning clearly acceptable and comparable to standard products and

"++++" meaning very good and exceeding standard products.

Sensory evaluation Parameters Trial 1 Trial 2 Trial 3

Gum base 35% 40% 45%

Calcium

63% 53% 40% carbonate

PHGG 2%

Polydextrose 5% 10%

++ Dusty initially. +++ Slightly dusty

+ Very dusty

Taste Too high flavor and nice crunchiness.

initially

release Good flavor release

+ Plastic and too ++ Plastic but +++ More elastic and

Texture

small volume more volume good volume

Table 4 - Sensory evaluation on trials were different parameters as gum base, water-soluble indigestible polysaccharide and polydextrose is varied. Amounts are given in percent by weight of each composition, leaving 2% for flavor and high intensive sweeteners.

In the above table the best sensory evaluation is achieved in trial 3, with a gum base amount of 45% to ensure a proper volume of the tablet, 2% PHGG and 10% polydextrose in combination to improve the taste and texture.

Formulations with varying amounts of polydextrose, PHGG and Calcium Carbonate:

Sensory evaluation

Parameters Trial 4 Trial 5 Trial 6

Gum base 45% 45% 45%

Calcium

38% 33%

carbonate

PHGG 5% 15% 53%

Polydextrose 10% 5% ++++ Nice

crunchiness good +++ Fast flavor

Taste + Not recommendable flavor release and release

juiciness

++ Somewhat soft + Too soft and

++++ Elastic, soft,

and sticky, unpleasant mouth feel,

Texture sponginess.

acceptable mouth the gum base matrix Suitable volume

feel. tends to disintegrate

Table 5 - Sensory evaluation on trials were different parameters as water-soluble indigestible polysaccharide and polydextrose is varied. Amounts are given in percent by weight of each composition, leaving 2% for flavor and high intensive sweeteners. In the above table the best sensory evaluation is achieved in trial 4, with a gum base amount of 45%, 5% PHGG and 10% polydextrose. It is evident that high amounts of PHGG alone have a negative effect on both taste and texture.

Sensory evaluation

Parameters Trial 7 Trial 8 Trial 9 Trial 10 (4)

Gum base 45% 45% 45% 45%

Calcium carbonate 53% 48% 43% 38%

PHGG 5% 5%

Polydextrose 1 < >% 10%

+++ Dusty

++++ Good

++ Fast flavor initially. Good

++ Very crunchiness release, crunchiness.

Taste dusty good flavor slightly dusty Good flavor

initially release and taste release, more

juiciness controlled

+ Plastic, +++ Elastic, ++ Elastic and ++++ Elastic,

Texture

non- soft, good good volume soft, good elastic. sponginess. sponginess.

Suitable Suitable volume volume

Table 6 - Sensory evaluation on trials were different parameters as water-soluble indigestible polysaccharide and polydextrose is varied. Amounts are given in percent by weight of each composition, leaving 2% for flavor and high intensive sweeteners. In the above table the best sensory evaluation is achieved in trial 10 (=trial 4), with a gum base amount of 45%, 5% PHGG and 10% polydextrose. PHGG alone lower the initial dust from calcium carbonate and gives a nice spongy texture. Polydextrose alone gives the product more volume and has a good effect on the flavor release, the flavor release is more in control. A synergistic effect is achieved by adding polydextrose and PHGG in combination.

Use of water-insoluble polysaccharide in chewing gum:

Sensory evaluation

Parameters Trial 11 Trial 12 Trial 13

Gum base 45% 45% 45%

Calcium

43% 48% 38%

carbonate

Microcrystalline

10% 5% 5%

cellulose

Polydextrose 10%

+Dusty. No + Dusty. No ++ Slightly dusty but

Taste control of flavor control of flavor good crunchiness.

release release Better flavor release

+ Plastic and

+ Plastic and sticky

Texture sticky and very ++ Acceptable elasticity and soft surface

soft surface Table 7 - Sensory evaluation on trials were different parameters as insoluble polysaccharide and polydextrose are varied. Amounts are given in percent by weight of each composition leaving 2% for flavor and high intensive sweeteners. In the above table water-insoluble polysaccharide was tested in chewing gum. The tests indicate that water-soluble indigestible polysaccharide is needed together with water-insoluble polysaccharide to achieve acceptable results. Polydextrose is seen to have a positive effect on the taste and the texture. The use of water-insoluble polysaccharide may be acceptable in some formulations.

Example 5:

Sensory evaluation and comparison of the standard compressed product with polyols and an example of a formulation according to an embodiment of the invention without polyols:

Table 8 - Sensory evaluation of standard compressed chewing gum (example la) and trial 4 (example

4). Both formulations are good products with an appealing taste and texture. The new formulation without polyols has improved crunchiness, juiciness and more spongy and soft texture. Surprisingly, the formulations with water-soluble indigestible polysaccharide and mineral filler as substitutes for polyols have an excellent mouth feel, crunch, juiciness and a more spongy and soft texture than the standard compressed formulation with polyols.

Example 6

Embodiments of the invention are described in the above examples as one layer tablets and two layer tablets, the two-layer compressed chewing gum tablets having layer 1 containing gum base and layer 2 without gum base.

Experiments have shown that it is also possible to make a two layer tablet with gum base in both layers, and a three layer tablet with gum base in the top- and bottom layers and a layer with no gum base in the middle.

Example 7:

The formulations of Examples 2a and 2b of Example 2 above were used to manufacture chewing gum by extrusion of the blend of all pre-mixed materials. This extruded chewing gum is comparable to standard extruded gum and has a soft texture and good flavor release.